BetterBirth: A Trial of the WHO Safe Childbirth Checklist Program (BetterBirth)

• ClinicalTrials.gov Identifier: NCT02148952
• Recruitment Status: Completed
• First Posted: May 29, 2014
• Results First Posted: February 20, 2019
• Last Update Posted: February 20, 2019
• Sponsor: Harvard School of Public Health
• Collaborators: World Health Organization; Population Services International; Jawaharlal Nehru Medical College; Community Empowerment Lab; Brigham and Women's Hospital; Bill and Melinda Gates Foundation; MacArthur Foundation
• Information provided by (Responsible Party): Atul Gawande, Harvard School of Public Health

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Health Services Research
• Conditions: Maternal Death; Maternal Morbidity; Stillbirth; Neonatal Death
• Intervention: Behavioral: WHO Safe Childbirth Checklist Program
• Enrollment: 157689

Participant Flow

Recruitment Details
Pre-assignment Details	320 facilities were assessed for eligibility. 200 were excluded (37 did not meet inclusion criteria, 163 did not have a matching facility identified). A total of 163,939 women were screened for eligibility; of those, 161,107 women were eligible for participation, and 157,689 women consented and were enrolled into the trial.

Arm/Group Title	Intervention Health Facility Participants		Control Health Facility Participants
Arm/Group Description	Women at intervention facilities who registered for labor and delivery, eligible for inclusion, and who provided consent. Intervention Health Facilities received the WHO Safe Childbirth Checklist Program. WHO Safe Childbirth Checklist Program: The IHF group will receive the WHO Safe Childbirth Checklist Program designed to maximize likelihood of effective and sustained uptake of the program by birth attendants in the designated facilities. The program includes three key implementation steps that involve: engagement of leadership and clinicians at the state, district, and local levels, a formal launch to introduce the Checklist, and support through peer coaching and data feedback. The intervention facilities will also receive a standardized maternity register to ensure appropriate data collection.		Women at control health facilities who registered for labor and delivery, eligible for inclusion, and who provided consent. Matched control facilities provided comparison for intervention facilities.
Period Title: Assessing Eligibility and Consent
	Number of participants	Number of units (facilities)	Number of participants	Number of units (facilities)
Started [1]	83166	60	80773	60
Completed [2]	80063	60	77626	60
Not Completed	3103	0	3147	0
Reason Not Completed
Were not eligible for inclusion	1241		1591
Did not consent or declined follow-up	1862		1556
[1] This includes all women who registered for delivery.; [2] This includes all women who were eligible for inclusion and consented to follow-up.
Period Title: Follow-Up
	Number of participants	Number of units (facilities)	Number of participants	Number of units (facilities)
Started	80063	60	77626	60
Completed	79798	60	77347	60
Not Completed	265	0	279	0
Reason Not Completed
Lost to Follow-up	219		231
Withdrawal by Subject	46		48

Baseline Characteristics

Arm/Group Title		Intervention Health Facility Participants	Control Health Facility Participants	Total
Arm/Group Description		Women at intervention facilities who registered for labor and delivery, eligible for inclusion, and who provided consent. Intervention Health Facilities received the WHO Safe Childbirth Checklist Program. WHO Safe Childbirth Checklist Program: The IHF group will receive the WHO Safe Childbirth Checklist Program designed to maximize likelihood of effective and sustained uptake of the program by birth attendants in the designated facilities. The program includes three key implementation steps that involve: engagement of leadership and clinicians at the state, district, and local levels, a formal launch to introduce the Checklist, and support through peer coaching and data feedback. The intervention facilities will also receive a standardized maternity register to ensure appropriate data collection.	Women at control health facilities who registered for labor and delivery, eligible for inclusion, and who provided consent. Matched control facilities provided comparison for intervention facilities.	Total of all reporting groups
Overall Number of Baseline Participants		81,925	79,182	161107
Overall Number of Units Analyzed; Type of Units Analyzed: Facilities		60	60	120
Baseline Analysis Population Description		The baseline analysis population may refer to number of women, number of newborns, or number of facilities, depending on the measure. We obtained facility consent to collect baseline information for a total of 161,107 women who were eligible for inclusion. A total of 157,687 women consented to participate in follow-up.
Age, Continuous [1]; Mean (Full Range); Unit of measure: Years
	Number Analyzed	81,925 participants	79,182 participants	161107 participants
		25.6; (25.5 to 25.8)	25.7; (25.5 to 25.9)	25.66; (25.54 to 25.79)
		[1] Measure Description: Please note the measure of dispersion is a 95% confidence interval (not full range).
Sex/Gender, Customized [1] [2]; Measure Type: Count of Participants; Unit of measure: Participants
Sex of newborn	Number Analyzed	81447 participants	78663 participants	160110 participants
	Male	40558 49.8%	39063 49.7%	79621 49.7%
	Female	36976 45.4%	36266 46.1%	73242 45.7%
	Unknown	3913 4.8%	3334 4.2%	7247 4.5%
		[1] Measure Description: Sex of the newborn.; [2] Measure Analysis Population Description: This refers to the number of newborns whose mothers were enrolled in the trial. In "unknown" cases, the mother was referred to another facility before the data were captured.
Sex: Female, Male [1]; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	81,925 participants	79,182 participants	161107 participants
	Female	81925 100.0%	79182 100.0%	161107 100.0%
	Male	0 0.0%	0 0.0%	0 0.0%
		[1] Measure Description: Pregnant women were enrolled in the trial; thus, all are female.
Race and Ethnicity Not Collected [1]; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	0 participants	0 participants	0 participants
				0
		[1] Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
India	Number Analyzed	81,925 participants	79,182 participants	161107 participants
		81925	79182	161107
Mean Annual Delivery Load [1]; Mean (Full Range); Unit of measure: Deliveries
	Number Analyzed	60 Facilities	60 Facilities	120 Facilities
		1599; (1486 to 1712)	1683; (1552 to 1814)	1641; (1531 to 1751)
		[1] Measure Description: This characteristic was used for facility matching before randomization. Please note the measure of dispersion is a 95% confidence interval (not full range).
Functional Classification [1]; Count of Units; Unit of measure: Facilities
	Number Analyzed	60 Facilities	60 Facilities	120 Facilities
	Primary health center	23 38.3%	23 38.3%	46 38.3%
	Community Health Center	27 45.0%	29 48.3%	56 46.7%
	First referral unit	10 16.7%	8 13.3%	18 15.0%
		[1] Measure Description: This characteristic was used for facility matching before randomization.
Mean distance to district hospital [1]; Mean (Full Range); Unit of measure: Km
	Number Analyzed	60 Facilities	60 Facilities	120 Facilities
		29.5; (25.9 to 33.1)	30.3; (27.2 to 33.4)	29.9; (27.0 to 32.8)
		[1] Measure Description: This characteristic was used for facility matching before randomization. Please note the measure of dispersion is a 95% confidence interval (not full range).
Mean skilled birth attendants per facility [1]; Mean (Full Range); Unit of measure: Number of skilled birth attendants
	Number Analyzed	60 Facilities	60 Facilities	120 Facilities
		4.4; (4.1 to 4.7)	4.4; (4.1 to 4.7)	4.4; (4.1 to 4.7)
		[1] Measure Description: This characteristic was used for facility matching before randomization. Please note the measure of dispersion is a 95% confidence interval (not full range).
Cluster Size [1]; Mean (Full Range); Unit of measure: Participants per site
	Number Analyzed	81,925 participants	79,182 participants	161107 participants
		1365; (515 to 2697)	1320; (646 to 2198)	1343; (1261 to 1423)
		[1] Measure Description: Cluster size is the total number of pregnant women enrolled per site (cluster). Please note the measure of dispersion is a 95% confidence interval (not full range).
Mean previous pregnancies [1]; Mean (Full Range); Unit of measure: Previous pregnancies
	Number Analyzed	81,925 participants	79,182 participants	161107 participants
		2.4; (2.3 to 2.4)	2.3; (2.3 to 2.4)	2.36; (2.32 to 2.39)
		[1] Measure Description: Please note the measure of dispersion is a 95% confidence interval (not full range).
Minutes between admission and delivery [1]; Mean (Full Range); Unit of measure: Minutes
	Number Analyzed	81,925 participants	79,182 participants	161107 participants
		200; (184 to 216)	206; (191 to 220)	203; (192 to 213)
		[1] Measure Description: Please note the measure of dispersion is a 95% confidence interval (not full range).
Providers attending delivery; Measure Type: Count of Participants; Unit of measure: Participants
Doctor	Number Analyzed	81925 participants	79,182 participants	161107 participants
		11115 13.6%	11599 14.6%	22714 14.1%
Nurse	Number Analyzed	81,925 participants	79,182 participants	161107 participants
		66687 81.4%	64117 81.0%	130804 81.2%
Auxiliary nurse midwife	Number Analyzed	81,925 participants	79,182 participants	161107 participants
		15311 18.7%	14549 18.4%	29860 18.5%
Others	Number Analyzed	81,925 participants	79,182 participants	161107 participants
		2633 3.2%	6560 8.3%	9193 5.7%
No. of offspring; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	81,925 participants	79,182 participants	161107 participants
	Singleton	80402 98.1%	77582 98.0%	157984 98.1%
	Sets of twins	515 0.6%	533 0.7%	1048 0.7%
	Sets of triplets	5 0.0%	5 0.0%	10 0.0%
	Unknown	1,003 1.2%	1,062 1.3%	2065 1.3%
Low birth weight [1] [2]; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	81447 participants	78663 participants	160110 participants
		22316 27.4%	22728 28.9%	45044 28.1%
		[1] Measure Description: Occurrence of low birth weight. Low birth weight was defined as 2500 g or less.; [2] Measure Analysis Population Description: This refers to the number of newborns whose mothers were enrolled in the trial.
Preterm birth [1] [2]; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	81447 participants	78663 participants	160110 participants
		15941 19.6%	17703 22.5%	33644 21.0%
		[1] Measure Description: Occurrence of preterm birth. Preterm birth was defined as fewer than 37 weeks of gestation.; [2] Measure Analysis Population Description: This refers to the number of newborns whose mothers were enrolled in the trial.

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants With Composite Measure of Perinatal Death, Maternal Death, or Maternal Severe Complications Within 7 Days
Description	The primary outcome was a composite outcome of events occurring within the first 7 days after delivery, incorporating stillbirth; early neonatal death; maternal death; or self-reported maternal severe complications, including seizures, loss of consciousness for more than 1 hour, fever with foul-smelling vaginal discharge, hemorrhage, or stroke.
Time Frame	0-7 days after delivery

Outcome Measure Data

Analysis Population Description

The denominator for this analysis is all women who had non-missing information about their death, their baby(s) and their morbidity.

Arm/Group Title	Intervention Health Facility Participants	Control Health Facility Participants
Arm/Group Description:	Women/newborn dyads at intervention facilities who registered for labor and delivery, eligible for inclusion, and who provided consent. Intervention Health Facilities received the WHO Safe Childbirth Checklist Program. WHO Safe Childbirth Checklist Program: The IHF group will receive the WHO Safe Childbirth Checklist Program designed to maximize likelihood of effective and sustained uptake of the program by birth attendants in the designated facilities. The program includes three key implementation steps that involve: engagement of leadership and clinicians at the state, district, and local levels, a formal launch to introduce the Checklist, and support through peer coaching and data feedback. The intervention facilities will also receive a standardized maternity register to ensure appropriate data collection.	Women/newborn dyads at control health facilities who registered for labor and delivery, eligible for inclusion, and who provided consent. Matched control facilities provided comparison for intervention facilities.
Overall Number of Participants Analyzed	79334	76897
Measure Type: Number; Unit of Measure: percentage of women/newborn dyads
	15.1	15.3

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Intervention Health Facility Participants, Control Health Facility Participants
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	We hypothesized a 15% reduction in the composite outcome between the intervention and control arm.
Statistical Test of Hypothesis	P-Value	0.90
	Comments	[Not Specified]
	Method	Chi-squared, Corrected
	Comments	In secondary analyses, a Rao-Scott test with 3 degrees of freedom resulted in a p value of 0.88.
Method of Estimation	Estimation Parameter	Risk Ratio (RR)
	Estimated Value	0.99
	Confidence Interval	(2-Sided) 95%; 0.83 to 1.18
	Estimation Comments	Relative risks are for the intervention group as compared with the control group and are adjusted for clustering and matching. The denominators shift owing to missing data on outcomes.

2. Secondary Outcome

Title	Percentage of Participants With Perinatal Death or Maternal Death Within 7 Days
Description	Percentage of participants with composite rate of perinatal death and maternal death within 7 days
Time Frame	0-7 days after delivery

Outcome Measure Data

Analysis Population Description

The denominator for this analysis is all women who had non-missing information about their death, and their baby(s)

Arm/Group Title	Intervention Health Facility Participants	Control Health Facility Participants
Arm/Group Description:	Women/newborn dyads at intervention facilities who registered for labor and delivery, eligible for inclusion, and who provided consent. Intervention Health Facilities received the WHO Safe Childbirth Checklist Program. WHO Safe Childbirth Checklist Program: The IHF group will receive the WHO Safe Childbirth Checklist Program designed to maximize likelihood of effective and sustained uptake of the program by birth attendants in the designated facilities. The program includes three key implementation steps that involve: engagement of leadership and clinicians at the state, district, and local levels, a formal launch to introduce the Checklist, and support through peer coaching and data feedback. The intervention facilities will also receive a standardized maternity register to ensure appropriate data collection.	Women/newborn dyads at control health facilities who registered for labor and delivery, eligible for inclusion, and who provided consent. Matched control facilities provided comparison for intervention facilities.
Overall Number of Participants Analyzed	79789	77337
Measure Type: Number; Unit of Measure: percentage of women and newborns
	4.9	4.7

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Intervention Health Facility Participants, Control Health Facility Participants
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.67
	Comments	[Not Specified]
	Method	Chi-squared, Corrected
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Risk Ratio (RR)
	Estimated Value	1.03
	Confidence Interval	(2-Sided) 95%; 0.89 to 1.20
	Estimation Comments	Relative risks are for the intervention group as compared with the control group and are adjusted for clustering and matching. The denominators shift owing to missing data on outcomes.

3. Secondary Outcome

Title	Count of Participants With Perinatal Death Within 7 Days
Description	Count of participants with perinatal death within 7 days (combined stillbirth or neonatal death)
Time Frame	0-7 days

Outcome Measure Data

Analysis Population Description

There is a discrepancy between the denominator of each primary and secondary outcome because there were a different number of newborns than mothers in the trial. Additionally, we do not have data on every participant for every question. As such, the denominator is specific for each outcome.

Arm/Group Title	Intervention Health Facility Participants	Control Health Facility Participants
Arm/Group Description:	Women/newborn dyads at intervention facilities who registered for labor and delivery, eligible for inclusion, and who provided consent. Intervention Health Facilities received the WHO Safe Childbirth Checklist Program. WHO Safe Childbirth Checklist Program: The IHF group will receive the WHO Safe Childbirth Checklist Program designed to maximize likelihood of effective and sustained uptake of the program by birth attendants in the designated facilities. The program includes three key implementation steps that involve: engagement of leadership and clinicians at the state, district, and local levels, a formal launch to introduce the Checklist, and support through peer coaching and data feedback. The intervention facilities will also receive a standardized maternity register to ensure appropriate data collection.	Women/newborn dyads at control health facilities who registered for labor and delivery, eligible for inclusion, and who provided consent. Matched control facilities provided comparison for intervention facilities.
Overall Number of Participants Analyzed	79790	77338
Measure Type: Count of Participants; Unit of Measure: Participants
	3839 4.8%	3606 4.7%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Intervention Health Facility Participants, Control Health Facility Participants
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.68
	Comments	[Not Specified]
	Method	Chi-squared, Corrected
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Risk Ratio (RR)
	Estimated Value	1.03
	Confidence Interval	(2-Sided) 95%; 0.89 to 1.20
	Estimation Comments	[Not Specified]

4. Secondary Outcome

Title	Count of Participants With Stillbirth
Description	Newborn outcome; rate of stillbirth
Time Frame	0-7 days after delivery

Outcome Measure Data

Analysis Population Description

The denominator for this analysis is all women who had non-missing information about whether their baby(s) experienced stillbirth.

Arm/Group Title	Intervention Health Facility Participants	Control Health Facility Participants
Arm/Group Description:	Women/newborn dyads at intervention facilities who registered for labor and delivery, eligible for inclusion, and who provided consent. Intervention Health Facilities received the WHO Safe Childbirth Checklist Program. WHO Safe Childbirth Checklist Program: The IHF group will receive the WHO Safe Childbirth Checklist Program designed to maximize likelihood of effective and sustained uptake of the program by birth attendants in the designated facilities. The program includes three key implementation steps that involve: engagement of leadership and clinicians at the state, district, and local levels, a formal launch to introduce the Checklist, and support through peer coaching and data feedback. The intervention facilities will also receive a standardized maternity register to ensure appropriate data collection.	Women/newborn dyads at control health facilities who registered for labor and delivery, eligible for inclusion, and who provided consent. Matched control facilities provided comparison for intervention facilities.
Overall Number of Participants Analyzed	80061	77454
Measure Type: Count of Participants; Unit of Measure: Participants
	1513 1.9%	1559 2.0%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Intervention Health Facility Participants, Control Health Facility Participants
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.56
	Comments	[Not Specified]
	Method	Chi-squared, Corrected
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Risk Ratio (RR)
	Estimated Value	0.94
	Confidence Interval	(2-Sided) 95%; 0.76 to 1.16
	Estimation Comments	Relative risks are for the intervention group as compared with the control group and are adjusted for clustering and matching. The denominators shift owing to missing data on outcomes.

5. Secondary Outcome

Title	Count of Participants With Early Neonatal Death
Description	Newborn outcome; rate of early neonatal death
Time Frame	0-7 days after delivery

Outcome Measure Data

Analysis Population Description

The denominator for this analysis is all women who had non-missing information about whether their baby(s) experienced neonatal death.

Arm/Group Title	Intervention Health Facility Participants	Control Health Facility Participants
Arm/Group Description:	Women/newborn dyads at intervention facilities who registered for labor and delivery, eligible for inclusion, and who provided consent. Intervention Health Facilities received the WHO Safe Childbirth Checklist Program. WHO Safe Childbirth Checklist Program: The IHF group will receive the WHO Safe Childbirth Checklist Program designed to maximize likelihood of effective and sustained uptake of the program by birth attendants in the designated facilities. The program includes three key implementation steps that involve: engagement of leadership and clinicians at the state, district, and local levels, a formal launch to introduce the Checklist, and support through peer coaching and data feedback. The intervention facilities will also receive a standardized maternity register to ensure appropriate data collection.	Women/newborn dyads at control health facilities who registered for labor and delivery, eligible for inclusion, and who provided consent. Matched control facilities provided comparison for intervention facilities.
Overall Number of Participants Analyzed	78360	75851
Measure Type: Count of Participants; Unit of Measure: Participants
	2409 3.1%	2119 2.8%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Intervention Health Facility Participants, Control Health Facility Participants
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.19
	Comments	[Not Specified]
	Method	Chi-squared, Corrected
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Risk Ratio (RR)
	Estimated Value	1.10
	Confidence Interval	(2-Sided) 95%; 0.95 to 1.27
	Estimation Comments	[Not Specified]

6. Secondary Outcome

Title	Count of Participants With Maternal Death
Description	Maternal outcome; rate of maternal death
Time Frame	0-7 days after delivery

Outcome Measure Data

Analysis Population Description

The denominator for this analysis is all women who had non-missing information about maternal death status.

Arm/Group Title	Intervention Health Facility Participants	Control Health Facility Participants
Arm/Group Description:	Women at intervention facilities who registered for labor and delivery, eligible for inclusion, and who provided consent. Intervention Health Facilities received the WHO Safe Childbirth Checklist Program. WHO Safe Childbirth Checklist Program: The IHF group will receive the WHO Safe Childbirth Checklist Program designed to maximize likelihood of effective and sustained uptake of the program by birth attendants in the designated facilities. The program includes three key implementation steps that involve: engagement of leadership and clinicians at the state, district, and local levels, a formal launch to introduce the Checklist, and support through peer coaching and data feedback. The intervention facilities will also receive a standardized maternity register to ensure appropriate data collection.	Women at control health facilities who registered for labor and delivery, eligible for inclusion, and who provided consent. Matched control facilities provided comparison for intervention facilities.
Overall Number of Participants Analyzed	79,797	77,346
Measure Type: Count of Participants; Unit of Measure: Participants
	78 0.1%	71 0.1%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Intervention Health Facility Participants, Control Health Facility Participants
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.73
	Comments	[Not Specified]
	Method	Chi-squared, Corrected
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Risk Ratio (RR)
	Estimated Value	1.11
	Confidence Interval	(2-Sided) 95%; 0.74 to 1.53
	Estimation Comments	Relative risks are for the intervention group as compared with the control group and are adjusted for clustering and matching. The denominators shift owing to missing data on outcomes.

7. Secondary Outcome

Title	Count of Participants With Severe Maternal Complications
Description	Maternal outcome; any severe maternal complication within 7 days
Time Frame	0-7 days after delivery

Outcome Measure Data

Analysis Population Description

The denominator for this analysis is all women who had non-missing information about each morbidity. Not every respondent answered each question, so each row has a different denominator. Only women who answered all specific morbidity questions were incorporated into the participant count for "any maternal severe complication within 7 days".

Arm/Group Title		Intervention Health Facility Participants	Control Health Facility Participants
Arm/Group Description:		Women at intervention facilities who registered for labor and delivery, eligible for inclusion, and who provided consent. Intervention Health Facilities received the WHO Safe Childbirth Checklist Program. WHO Safe Childbirth Checklist Program: The IHF group will receive the WHO Safe Childbirth Checklist Program designed to maximize likelihood of effective and sustained uptake of the program by birth attendants in the designated facilities. The program includes three key implementation steps that involve: engagement of leadership and clinicians at the state, district, and local levels, a formal launch to introduce the Checklist, and support through peer coaching and data feedback. The intervention facilities will also receive a standardized maternity register to ensure appropriate data collection.	Women at control health facilities who registered for labor and delivery, eligible for inclusion, and who provided consent. Matched control facilities provided comparison for intervention facilities.
Overall Number of Participants Analyzed		79706	77257
Measure Type: Count of Participants; Unit of Measure: Participants
Any maternal severe complication within 7 days	Number Analyzed	79342 participants	76907 participants
		9086 11.5%	9037 11.8%
Seizures	Number Analyzed	79706 participants	77257 participants
		67 0.1%	70 0.1%
Loss of consciousness for >1 hour	Number Analyzed	79649 participants	77196 participants
		505 0.6%	493 0.6%
High fever with foul-smelling vaginal discharge	Number Analyzed	79459 participants	77018 participants
		4073 5.1%	3871 5.0%
Hemorrhage	Number Analyzed	79648 participants	77198 participants
		5745 7.2%	5875 7.6%
Stroke	Number Analyzed	79703 participants	77257 participants
		9 0.0%	12 0.0%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Intervention Health Facility Participants, Control Health Facility Participants
	Comments	Rate any severe maternal complication within 7 days
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.81
	Comments	[Not Specified]
	Method	Chi-squared, Corrected
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Risk Ratio (RR)
	Estimated Value	0.97
	Confidence Interval	(2-Sided) 95%; 0.79 to 1.20
	Estimation Comments	Relative risks are for the intervention group as compared with the control group and are adjusted for clustering and matching. The denominators shift owing to missing data on outcomes.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Intervention Health Facility Participants, Control Health Facility Participants
	Comments	Rate of seizures
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.76
	Comments	[Not Specified]
	Method	Chi-squared, Corrected
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Risk Ratio (RR)
	Estimated Value	0.89
	Confidence Interval	(2-Sided) 95%; 0.57 to 1.52
	Estimation Comments	Relative risks are for the intervention group as compared with the control group and are adjusted for clustering and matching. The denominators shift owing to missing data on outcomes.

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Intervention Health Facility Participants, Control Health Facility Participants
	Comments	Rate of loss of consciousness for > 1 hr
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.97
	Comments	[Not Specified]
	Method	Chi-squared, Corrected
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Risk Ratio (RR)
	Estimated Value	0.98
	Confidence Interval	(2-Sided) 95%; 0.70 to 1.41
	Estimation Comments	Relative risks are for the intervention group as compared with the control group and are adjusted for clustering and matching. The denominators shift owing to missing data on outcomes.

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Intervention Health Facility Participants, Control Health Facility Participants
	Comments	Rate of high fever with foul-smelling vaginal discharge
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.90
	Comments	[Not Specified]
	Method	Chi-squared, Corrected
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Risk Ratio (RR)
	Estimated Value	1.02
	Confidence Interval	(2-Sided) 95%; 0.76 to 1.38
	Estimation Comments	Relative risks are for the intervention group as compared with the control group and are adjusted for clustering and matching. The denominators shift owing to missing data on outcomes.

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Intervention Health Facility Participants, Control Health Facility Participants
	Comments	Rate of hemorrhage
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.61
	Comments	[Not Specified]
	Method	Chi-squared, Corrected
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Risk Ratio (RR)
	Estimated Value	0.95
	Confidence Interval	(2-Sided) 95%; 0.77 to 1.17
	Estimation Comments	Relative risks are for the intervention group as compared with the control group and are adjusted for clustering and matching. The denominators shift owing to missing data on outcomes.

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Intervention Health Facility Participants, Control Health Facility Participants
	Comments	Rate of stroke
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.41
	Comments	[Not Specified]
	Method	Chi-squared, Corrected
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Risk Ratio (RR)
	Estimated Value	0.50
	Confidence Interval	(2-Sided) 95%; 0.34 to 1.58
	Estimation Comments	Relative risks are for the intervention group as compared with the control group and are adjusted for clustering and matching. The denominators shift owing to missing data on outcomes.

8. Secondary Outcome

Title	Count of Participants With Cesarean Section
Description	Rate of cesarean section
Time Frame	Around the time of delivery during facility stay, an expected average of 2 days (although individual patients may vary)

Outcome Measure Data

Analysis Population Description

The denominator for this analysis is all women who had non-missing information about whether they had a cesarean section.

Arm/Group Title	Intervention Health Facility Participants	Control Health Facility Participants
Arm/Group Description:	Women at intervention facilities who registered for labor and delivery, eligible for inclusion, and who provided consent. Intervention Health Facilities received the WHO Safe Childbirth Checklist Program. WHO Safe Childbirth Checklist Program: The IHF group will receive the WHO Safe Childbirth Checklist Program designed to maximize likelihood of effective and sustained uptake of the program by birth attendants in the designated facilities. The program includes three key implementation steps that involve: engagement of leadership and clinicians at the state, district, and local levels, a formal launch to introduce the Checklist, and support through peer coaching and data feedback. The intervention facilities will also receive a standardized maternity register to ensure appropriate data collection.	Women at control health facilities who registered for labor and delivery, eligible for inclusion, and who provided consent. Matched control facilities provided comparison for intervention facilities.
Overall Number of Participants Analyzed	80922	78120
Measure Type: Count of Participants; Unit of Measure: Participants
	1469 1.8%	1330 1.7%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Intervention Health Facility Participants, Control Health Facility Participants
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.74
	Comments	[Not Specified]
	Method	Chi-squared, Corrected
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Risk Ratio (RR)
	Estimated Value	1.07
	Confidence Interval	(2-Sided) 95%; 0.72 to 1.58
	Estimation Comments	[Not Specified]

9. Secondary Outcome

Title	Count of Participants With Maternal Referral, Before or After Delivery
Description	Maternal outcome; Rate of maternal inter-facility transfer
Time Frame	0-7 days after delivery

Outcome Measure Data

Analysis Population Description

The denominator for this analysis is all women who had non-missing information about their status regarding referral before and after delivery.

Arm/Group Title	Intervention Health Facility Participants	Control Health Facility Participants
Arm/Group Description:	Women at intervention facilities who registered for labor and delivery, eligible for inclusion, and who provided consent. Intervention Health Facilities received the WHO Safe Childbirth Checklist Program. WHO Safe Childbirth Checklist Program: The IHF group will receive the WHO Safe Childbirth Checklist Program designed to maximize likelihood of effective and sustained uptake of the program by birth attendants in the designated facilities. The program includes three key implementation steps that involve: engagement of leadership and clinicians at the state, district, and local levels, a formal launch to introduce the Checklist, and support through peer coaching and data feedback. The intervention facilities will also receive a standardized maternity register to ensure appropriate data collection.	Women at control health facilities who registered for labor and delivery, eligible for inclusion, and who provided consent. Matched control facilities provided comparison for intervention facilities.
Overall Number of Participants Analyzed	81925	79182
Measure Type: Count of Participants; Unit of Measure: Participants
	5381 6.6%	4779 6.0%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Intervention Health Facility Participants, Control Health Facility Participants
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.57
	Comments	[Not Specified]
	Method	Chi-squared, Corrected
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Risk Ratio (RR)
	Estimated Value	1.09
	Confidence Interval	(2-Sided) 95%; 0.81 to 1.47
	Estimation Comments	Relative risks are for the intervention group as compared with the control group and are adjusted for clustering and matching. The denominators shift owing to missing data on outcomes.

10. Secondary Outcome

Title	Count of Participants With Newborn Referral
Description	Newborn outcome; Newborn referral
Time Frame	0-7 days after delivery

Outcome Measure Data

Analysis Population Description

The denominator for this analysis is all women who had non-missing information about their newborn(s) referral status.

Arm/Group Title	Intervention Health Facility Participants	Control Health Facility Participants
Arm/Group Description:	Women/newborn dyads at intervention facilities who registered for labor and delivery, eligible for inclusion, and who provided consent. Intervention Health Facilities received the WHO Safe Childbirth Checklist Program. WHO Safe Childbirth Checklist Program: The IHF group will receive the WHO Safe Childbirth Checklist Program designed to maximize likelihood of effective and sustained uptake of the program by birth attendants in the designated facilities. The program includes three key implementation steps that involve: engagement of leadership and clinicians at the state, district, and local levels, a formal launch to introduce the Checklist, and support through peer coaching and data feedback. The intervention facilities will also receive a standardized maternity register to ensure appropriate data collection.	Women/newborn dyads at control health facilities who registered for labor and delivery, eligible for inclusion, and who provided consent. Matched control facilities provided comparison for intervention facilities.
Overall Number of Participants Analyzed	81925	79182
Measure Type: Count of Participants; Unit of Measure: Participants
	1455 1.8%	1186 1.5%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Intervention Health Facility Participants, Control Health Facility Participants
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.41
	Comments	[Not Specified]
	Method	Chi-squared, Corrected
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Risk Ratio (RR)
	Estimated Value	1.19
	Confidence Interval	(2-Sided) 95%; 0.78 to 1.80
	Estimation Comments	Relative risks are for the intervention group as compared with the control group and are adjusted for clustering and matching. The denominators shift owing to missing data on outcomes.

11. Secondary Outcome

Title	Count of Participants With Hysterectomy Within 7 Days
Description	Rate of hysterectomy within 7 days
Time Frame	0-7 days after delivery

Outcome Measure Data

Analysis Population Description

The denominator for this analysis is all women who had non-missing information about their hysterectomy status within 7 days.

Arm/Group Title	Intervention Health Facility Participants	Control Health Facility Participants
Arm/Group Description:	Women at intervention facilities who registered for labor and delivery, eligible for inclusion, and who provided consent. Intervention Health Facilities received the WHO Safe Childbirth Checklist Program. WHO Safe Childbirth Checklist Program: The IHF group will receive the WHO Safe Childbirth Checklist Program designed to maximize likelihood of effective and sustained uptake of the program by birth attendants in the designated facilities. The program includes three key implementation steps that involve: engagement of leadership and clinicians at the state, district, and local levels, a formal launch to introduce the Checklist, and support through peer coaching and data feedback. The intervention facilities will also receive a standardized maternity register to ensure appropriate data collection.	Women at control health facilities who registered for labor and delivery, eligible for inclusion, and who provided consent. Matched control facilities provided comparison for intervention facilities.
Overall Number of Participants Analyzed	79705	77252
Measure Type: Count of Participants; Unit of Measure: Participants
	19 0.0%	18 0.0%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Intervention Health Facility Participants, Control Health Facility Participants
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.95
	Comments	[Not Specified]
	Method	Chi-squared, Corrected
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Risk Ratio (RR)
	Estimated Value	1.00
	Confidence Interval	(2-Sided) 95%; 0.45 to 2.13
	Estimation Comments	Relative risks are for the intervention group as compared with the control group and are adjusted for clustering and matching. The denominators shift owing to missing data on outcomes.

12. Secondary Outcome

Title	Count of Participants With Blood Transfusion Within 7 Days
Description	Rate of blood transfusion within 7 days
Time Frame	0-7 days after delivery

Outcome Measure Data

Analysis Population Description

The denominator for this analysis is all women who had non-missing information about their status regarding blood transfusion within 7 days.

Arm/Group Title	Intervention Health Facility Participants	Control Health Facility Participants
Arm/Group Description:	Women at intervention facilities who registered for labor and delivery, eligible for inclusion, and who provided consent. Intervention Health Facilities received the WHO Safe Childbirth Checklist Program. WHO Safe Childbirth Checklist Program: The IHF group will receive the WHO Safe Childbirth Checklist Program designed to maximize likelihood of effective and sustained uptake of the program by birth attendants in the designated facilities. The program includes three key implementation steps that involve: engagement of leadership and clinicians at the state, district, and local levels, a formal launch to introduce the Checklist, and support through peer coaching and data feedback. The intervention facilities will also receive a standardized maternity register to ensure appropriate data collection.	Women at control health facilities who registered for labor and delivery, eligible for inclusion, and who provided consent. Matched control facilities provided comparison for intervention facilities.
Overall Number of Participants Analyzed	79697	77254
Measure Type: Count of Participants; Unit of Measure: Participants
	640 0.8%	625 0.8%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Intervention Health Facility Participants, Control Health Facility Participants
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.97
	Comments	[Not Specified]
	Method	Chi-squared, Corrected
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Risk Ratio (RR)
	Estimated Value	0.99
	Confidence Interval	(2-Sided) 95%; 0.69 to 1.43
	Estimation Comments	[Not Specified]

13. Secondary Outcome

Title	Count of Mothers Returning to Facility for a Health Problem Within 7 Days
Description	Maternal Outcome; Rate of need for follow-up care for Mother
Time Frame	0-7 days after delivery

Outcome Measure Data

Analysis Population Description

The denominator for this analysis is all women who had non-missing information about returning to a health facility for a health problem within 7 days.

Arm/Group Title	Intervention Health Facility Participants	Control Health Facility Participants
Arm/Group Description:	Women at intervention facilities who registered for labor and delivery, eligible for inclusion, and who provided consent. Intervention Health Facilities received the WHO Safe Childbirth Checklist Program. WHO Safe Childbirth Checklist Program: The IHF group will receive the WHO Safe Childbirth Checklist Program designed to maximize likelihood of effective and sustained uptake of the program by birth attendants in the designated facilities. The program includes three key implementation steps that involve: engagement of leadership and clinicians at the state, district, and local levels, a formal launch to introduce the Checklist, and support through peer coaching and data feedback. The intervention facilities will also receive a standardized maternity register to ensure appropriate data collection.	Women at control health facilities who registered for labor and delivery, eligible for inclusion, and who provided consent. Matched control facilities provided comparison for intervention facilities.
Overall Number of Participants Analyzed	79655	77220
Measure Type: Count of Participants; Unit of Measure: Participants
	2014 2.5%	2141 2.8%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Intervention Health Facility Participants, Control Health Facility Participants
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.32
	Comments	[Not Specified]
	Method	Chi-squared, Corrected
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Risk Ratio (RR)
	Estimated Value	0.91
	Confidence Interval	(2-Sided) 95%; 0.76 to 1.10
	Estimation Comments	Relative risks are for the intervention group as compared with the control group and are adjusted for clustering and matching. The denominators shift owing to missing data on outcomes.

14. Secondary Outcome

Title	Count of Newborns Returning to Facility for a Health Problem Within 7 Days
Description	Newborn outcome; Rate of need for follow-up care for newborn (or at least one newborn in case of twins)
Time Frame	0-7 days after delivery

Outcome Measure Data

Analysis Population Description

The denominator for this analysis is all women who had non-missing information about status of at least one baby returning to the facility for a health problem within 7 days.

Arm/Group Title	Intervention Health Facility Participants	Control Health Facility Participants
Arm/Group Description:	Women/newborn dyads at intervention facilities who registered for labor and delivery, eligible for inclusion, and who provided consent. Intervention Health Facilities received the WHO Safe Childbirth Checklist Program. WHO Safe Childbirth Checklist Program: The IHF group will receive the WHO Safe Childbirth Checklist Program designed to maximize likelihood of effective and sustained uptake of the program by birth attendants in the designated facilities. The program includes three key implementation steps that involve: engagement of leadership and clinicians at the state, district, and local levels, a formal launch to introduce the Checklist, and support through peer coaching and data feedback. The intervention facilities will also receive a standardized maternity register to ensure appropriate data collection.	Women/newborn dyads at control health facilities who registered for labor and delivery, eligible for inclusion, and who provided consent. Matched control facilities provided comparison for intervention facilities.
Overall Number of Participants Analyzed	77419	75117
Measure Type: Count of Participants; Unit of Measure: Participants
	4474 5.8%	4722 6.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Intervention Health Facility Participants, Control Health Facility Participants
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.30
	Comments	[Not Specified]
	Method	Chi-squared, Corrected
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Risk Ratio (RR)
	Estimated Value	0.92
	Confidence Interval	(2-Sided) 95%; 0.78 to 1.08
	Estimation Comments	Relative risks are for the intervention group as compared with the control group and are adjusted for clustering and matching. The denominators shift owing to missing data on outcomes.

15. Other Pre-specified Outcome

Title	Mean Number of 18 Essential Birth Practices Performed at 2 Months Post-intervention Start
Description	Birth attendant's rate of completion of "Process measures" resulting from Safe Childbirth Checklist program will be assessed in a sample of total birth events at 2 months after the intervention is introduced to intervention facilities. The below measures reflect the mean number of 18 essential birth practices performed across the intervention versus control facilities at 2 months post-intervention start.
Time Frame	2 months post-intervention start

Outcome Measure Data

Analysis Population Description

The denominator for this analysis is all women who were observed for at least one pause point 2 months post-intervention start in the site.

Arm/Group Title	Intervention Health Facility Participants	Control Health Facility Participants
Arm/Group Description:	Women/newborn dyads at intervention facilities who registered for labor and delivery, eligible for inclusion, and who provided consent for observation. Intervention Health Facilities received the WHO Safe Childbirth Checklist Program. WHO Safe Childbirth Checklist Program: The IHF group will receive the WHO Safe Childbirth Checklist Program designed to maximize likelihood of effective and sustained uptake of the program by birth attendants in the designated facilities. The program includes three key implementation steps that involve: engagement of leadership and clinicians at the state, district, and local levels, a formal launch to introduce the Checklist, and support through peer coaching and data feedback. The intervention facilities will also receive a standardized maternity register to ensure appropriate data collection.	Women/newborn dyads at control health facilities who registered for labor and delivery, eligible for inclusion, and who provided consent for observation. Matched control facilities provided comparison for intervention facilities.
Overall Number of Participants Analyzed	1259	1304
Mean (95% Confidence Interval); Unit of Measure: essential birth practices performed
	13.1; (12.1 to 14.0)	7.5; (6.9 to 8.1)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Intervention Health Facility Participants, Control Health Facility Participants
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	Chi-squared, Corrected
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Other
	Estimated Value	0
	Estimation Comments	[Not Specified]

16. Other Pre-specified Outcome

Title	Count of Participants Where Essential Birth Practices Were Observed at Admission, 2 Months Post-intervention Start
Description	Birth attendant's rate of completion of "Process measures" resulting from Safe Childbirth Checklist program will be assessed in a sample of total birth events at 2 months after the intervention is introduced to intervention facilities. The below measures reflect the essential birth practices performed at the time of the woman's admission to the facility, 2 months post-intervention start.
Time Frame	2 months post-intervention start

Outcome Measure Data

Analysis Population Description

The denominator for this analysis is all women who were observed at admission, 2 months post-intervention start in the site.

Arm/Group Title	Intervention Health Facility Participants	Control Health Facility Participants
Arm/Group Description:	Women at intervention facilities who registered for labor and delivery, were eligible for inclusion, and who provided consent for observation. Intervention Health Facilities received the WHO Safe Childbirth Checklist Program. WHO Safe Childbirth Checklist Program: The IHF group will receive the WHO Safe Childbirth Checklist Program designed to maximize likelihood of effective and sustained uptake of the program by birth attendants in the designated facilities. The program includes three key implementation steps that involve: engagement of leadership and clinicians at the state, district, and local levels, a formal launch to introduce the Checklist, and support through peer coaching and data feedback. The intervention facilities will also receive a standardized maternity register to ensure appropriate data collection.	Women at control facilities who registered for labor and delivery, were eligible for inclusion, and who provided consent for observation. Matched control facilities provided comparison for intervention facilities.
Overall Number of Participants Analyzed	1048	1090
Measure Type: Count of Participants; Unit of Measure: Participants
Birth companion present	1048 100.0%	1087 99.7%
Maternal blood pressure taken	606 57.8%	64 5.9%
Maternal temperature taken	569 54.3%	4 0.4%
Partography started	10 1.0%	1 0.1%
Checklist use	595 56.8%	1 0.1%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Intervention Health Facility Participants, Control Health Facility Participants
	Comments	Birth Companion Present
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.18
	Comments	[Not Specified]
	Method	Chi-squared, Corrected
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Other
	Estimated Value	0
	Estimation Comments	The relative risk could not be calculated owing to 100% or 0% values in one group.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Intervention Health Facility Participants, Control Health Facility Participants
	Comments	Maternal blood pressure taken
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	Chi-squared, Corrected
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Risk Ratio (RR)
	Estimated Value	9.8
	Confidence Interval	(2-Sided) 95%; 3.4 to 28.3
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Intervention Health Facility Participants, Control Health Facility Participants
	Comments	Maternal temperature taken
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	Chi-squared, Corrected
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Risk Ratio (RR)
	Estimated Value	132
	Confidence Interval	(2-Sided) 95%; 26.9 to 645
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Intervention Health Facility Participants, Control Health Facility Participants
	Comments	Partography started
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.01
	Comments	[Not Specified]
	Method	Chi-squared, Corrected
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Risk Ratio (RR)
	Estimated Value	7.3
	Confidence Interval	(2-Sided) 95%; 1.5 to 35.6
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Intervention Health Facility Participants, Control Health Facility Participants
	Comments	Checklist use
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	Chi-squared, Corrected
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Risk Ratio (RR)
	Estimated Value	413
	Confidence Interval	(2-Sided) 95%; 65.8 to 2589
	Estimation Comments	[Not Specified]

17. Other Pre-specified Outcome

Title	Count of Participants Where Essential Birth Practices Were Observed Just Before Pushing, 2 Months Post-intervention Start
Description	Birth attendant's rate of completion of "Process measures" resulting from Safe Childbirth Checklist program will be assessed in a sample of total birth events at 2 months after the intervention is introduced to intervention facilities. The below measures reflect the essential birth practices performed at the time of labor just before pushing, 2 months post-intervention start.
Time Frame	2 months post-intervention start

Outcome Measure Data

Analysis Population Description

The denominator for this analysis is all women who were observed at the time of labor just before pushing, 2 months post-intervention start in the site.

Arm/Group Title	Intervention Health Facility Participants	Control Health Facility Participants
Arm/Group Description:	Women at intervention facilities who registered for labor and delivery, were eligible for inclusion, and who provided consent for observation. Intervention Health Facilities received the WHO Safe Childbirth Checklist Program. WHO Safe Childbirth Checklist Program: The IHF group will receive the WHO Safe Childbirth Checklist Program designed to maximize likelihood of effective and sustained uptake of the program by birth attendants in the designated facilities. The program includes three key implementation steps that involve: engagement of leadership and clinicians at the state, district, and local levels, a formal launch to introduce the Checklist, and support through peer coaching and data feedback. The intervention facilities will also receive a standardized maternity register to ensure appropriate data collection.	Women at control facilities who registered for labor and delivery, were eligible for inclusion, and who provided consent for observation. Matched control facilities provided comparison for intervention facilities.
Overall Number of Participants Analyzed	1039	1130
Measure Type: Count of Participants; Unit of Measure: Participants
Hand hygiene	367 35.3%	7 0.6%
No oxytocin given before delivery	704 67.8%	333 29.5%
Clean towel available	874 84.1%	166 14.7%
Clean scissors or blade available	843 81.1%	847 75.0%
Cord tie available	1035 99.6%	1122 99.3%
Mucus extractor available	990 95.3%	1057 93.5%
Neonatal bag and mask available	991 95.4%	1109 98.1%
Pads available	965 92.9%	502 44.4%
Checklist Use	255 24.5%	1 0.1%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Intervention Health Facility Participants, Control Health Facility Participants
	Comments	Hand hygiene
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	Chi-squared, Corrected
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Risk Ratio (RR)
	Estimated Value	53.3
	Confidence Interval	(2-Sided) 95%; 13.1 to 217
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Intervention Health Facility Participants, Control Health Facility Participants
	Comments	No oxytocin given before delivery
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.007
	Comments	[Not Specified]
	Method	Chi-squared, Corrected
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Risk Ratio (RR)
	Estimated Value	2.3
	Confidence Interval	(2-Sided) 95%; 1.3 to 4.2
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Intervention Health Facility Participants, Control Health Facility Participants
	Comments	Clean towel available
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	Chi-squared, Corrected
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Risk Ratio (RR)
	Estimated Value	5.7
	Confidence Interval	(2-Sided) 95%; 2.7 to 12.1
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Intervention Health Facility Participants, Control Health Facility Participants
	Comments	Clean scissors or blade available
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.72
	Comments	[Not Specified]
	Method	Chi-squared, Corrected
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Risk Ratio (RR)
	Estimated Value	1.1
	Confidence Interval	(2-Sided) 95%; 0.7 to 1.7
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Intervention Health Facility Participants, Control Health Facility Participants
	Comments	Cord tie available
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.48
	Comments	[Not Specified]
	Method	Chi-squared, Corrected
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Risk Ratio (RR)
	Estimated Value	1.0
	Confidence Interval	(2-Sided) 95%; 1.0 to 1.0
	Estimation Comments	[Not Specified]

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Intervention Health Facility Participants, Control Health Facility Participants
	Comments	Mucus extractor available
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.73
	Comments	[Not Specified]
	Method	Chi-squared, Corrected
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Risk Ratio (RR)
	Estimated Value	1.0
	Confidence Interval	(2-Sided) 95%; 0.9 to 1.1
	Estimation Comments	[Not Specified]

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Intervention Health Facility Participants, Control Health Facility Participants
	Comments	Neonatal bag and mask available
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.56
	Comments	[Not Specified]
	Method	Chi-squared, Corrected
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Risk Ratio (RR)
	Estimated Value	1.0
	Confidence Interval	(2-Sided) 95%; 0.9 to 1.1
	Estimation Comments	[Not Specified]

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Intervention Health Facility Participants, Control Health Facility Participants
	Comments	Pads available
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.005
	Comments	[Not Specified]
	Method	Chi-squared, Corrected
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Risk Ratio (RR)
	Estimated Value	2.1
	Confidence Interval	(2-Sided) 95%; 1.3 to 3.5
	Estimation Comments	[Not Specified]

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Intervention Health Facility Participants, Control Health Facility Participants
	Comments	Checklist use
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	Chi-squared, Corrected
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Risk Ratio (RR)
	Estimated Value	185
	Confidence Interval	(2-Sided) 95%; 19.7 to 1738
	Estimation Comments	[Not Specified]

18. Other Pre-specified Outcome

Title	Count of Participants Where Essential Birth Practices Were Observed Within One Minute After Delivery, 2 Months Post-intervention Start
Description	Birth attendant's rate of completion of "Process measures" resulting from Safe Childbirth Checklist program will be assessed in a sample of total birth events at 2 months after the intervention is introduced to intervention facilities. The below measures reflect the essential birth practices performed at the time within one minute after the woman's delivery, 2 months post-intervention start.
Time Frame	2 months post-intervention start

Outcome Measure Data

Analysis Population Description

The denominator for this analysis is all women who were observed within one minute after delivery, 2 months post-intervention start in the site.

Arm/Group Title	Intervention Health Facility Participants	Control Health Facility Participants
Arm/Group Description:	Women/newborn dyads at intervention facilities who registered for labor and delivery, eligible for inclusion, and who provided consent for observation. Intervention Health Facilities received the WHO Safe Childbirth Checklist Program. WHO Safe Childbirth Checklist Program: The IHF group will receive the WHO Safe Childbirth Checklist Program designed to maximize likelihood of effective and sustained uptake of the program by birth attendants in the designated facilities. The program includes three key implementation steps that involve: engagement of leadership and clinicians at the state, district, and local levels, a formal launch to introduce the Checklist, and support through peer coaching and data feedback. The intervention facilities will also receive a standardized maternity register to ensure appropriate data collection.	Women/newborn dyads at control health facilities who registered for labor and delivery, eligible for inclusion, and who provided consent for observation. Matched control facilities provided comparison for intervention facilities.
Overall Number of Participants Analyzed	1038	1129
Measure Type: Count of Participants; Unit of Measure: Participants
Oxytocin Administered	825 79.5%	231 20.5%
Neonatal bag used	47 4.5%	82 7.3%
Birth companion present	1037 99.9%	1125 99.6%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Intervention Health Facility Participants, Control Health Facility Participants
	Comments	Oxytocin administered
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	Chi-squared, Corrected
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Risk Ratio (RR)
	Estimated Value	3.9
	Confidence Interval	(2-Sided) 95%; 2.1 to 7.2
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Intervention Health Facility Participants, Control Health Facility Participants
	Comments	Neonatal bag used
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.25
	Comments	[Not Specified]
	Method	Chi-squared, Corrected
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Risk Ratio (RR)
	Estimated Value	0.6
	Confidence Interval	(2-Sided) 95%; 0.3 to 1.4
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Intervention Health Facility Participants, Control Health Facility Participants
	Comments	Birth attendant present
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.25
	Comments	[Not Specified]
	Method	Chi-squared, Corrected
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Risk Ratio (RR)
	Estimated Value	1.0
	Confidence Interval	(2-Sided) 95%; 1.0 to 1.0
	Estimation Comments	[Not Specified]

19. Other Pre-specified Outcome

Title	Count of Participants Where Essential Birth Practices Were Observed Within One Hour After Delivery, 2 Months Post-intervention Start
Description	Birth attendant's rate of completion of "Process measures" resulting from Safe Childbirth Checklist program will be assessed in a sample of total birth events at 2 months after the intervention is introduced to intervention facilities. The below measures reflect the essential birth practices performed within one hour after delivery, 2 months post-intervention start.
Time Frame	2 months post-intervention start

Outcome Measure Data

Analysis Population Description

The denominator for this analysis is all women who were observed at one hour after delivery, 2 months post-intervention start in the site.

Arm/Group Title	Intervention Health Facility Participants	Control Health Facility Participants
Arm/Group Description:	Women/newborn dyads at intervention facilities who registered for labor and delivery, eligible for inclusion, and who provided consent for observation. Intervention Health Facilities received the WHO Safe Childbirth Checklist Program. WHO Safe Childbirth Checklist Program: The IHF group will receive the WHO Safe Childbirth Checklist Program designed to maximize likelihood of effective and sustained uptake of the program by birth attendants in the designated facilities. The program includes three key implementation steps that involve: engagement of leadership and clinicians at the state, district, and local levels, a formal launch to introduce the Checklist, and support through peer coaching and data feedback. The intervention facilities will also receive a standardized maternity register to ensure appropriate data collection.	Women/newborn dyads at control health facilities who registered for labor and delivery, eligible for inclusion, and who provided consent for observation. Matched control facilities provided comparison for intervention facilities.
Overall Number of Participants Analyzed	1006	1102
Measure Type: Count of Participants; Unit of Measure: Participants
Newborn weight taken	906 90.1%	884 80.2%
Newborn temperature taken	433 43.0%	1 0.1%
Skin-to-skin care initiated at birth	794 78.9%	119 10.8%
Skin-to-skin care maintained for 1 hr	194 19.3%	5 0.5%
Initiation of breast-feeding	700 69.6%	39 3.5%
Checklist use	747 74.3%	0 0.0%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Intervention Health Facility Participants, Control Health Facility Participants
	Comments	Newborn weight taken
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.25
	Comments	[Not Specified]
	Method	Chi-squared, Corrected
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Risk Ratio (RR)
	Estimated Value	1.1
	Confidence Interval	(2-Sided) 95%; 0.9 to 1.4
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Intervention Health Facility Participants, Control Health Facility Participants
	Comments	Newborn temperature taken
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	Chi-squared, Corrected
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Risk Ratio (RR)
	Estimated Value	317
	Confidence Interval	(2-Sided) 95%; 50.4 to 1989
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Intervention Health Facility Participants, Control Health Facility Participants
	Comments	Skin-to-skin care initiated at birth
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	Chi-squared, Corrected
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Risk Ratio (RR)
	Estimated Value	7.3
	Confidence Interval	(2-Sided) 95%; 2.4 to 22.0
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Intervention Health Facility Participants, Control Health Facility Participants
	Comments	Skin-to-skin care maintained for 1 hr
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	Chi-squared, Corrected
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Risk Ratio (RR)
	Estimated Value	38.7
	Confidence Interval	(2-Sided) 95%; 7.7 to 194
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Intervention Health Facility Participants, Control Health Facility Participants
	Comments	Initiation of breast-feeding
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	Chi-squared, Corrected
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Risk Ratio (RR)
	Estimated Value	19.4
	Confidence Interval	(2-Sided) 95%; 11.4 to 33.2
	Estimation Comments	[Not Specified]

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Intervention Health Facility Participants, Control Health Facility Participants
	Comments	Checklist use
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	Chi-squared, Corrected
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Other
	Estimated Value	0
	Estimation Comments	The relative risk could not be calculated owing to 100% or 0% values in one group.

20. Other Pre-specified Outcome

Title	Count of Participants Where Essential Birth Practices Were Observed at Anytime During Delivery, 2 Months Post-intervention Start
Description	Birth attendant's rate of completion of "Process measures" resulting from Safe Childbirth Checklist program will be assessed in a sample of total birth events at 2 months after the intervention is introduced to intervention facilities. The below measures reflect the essential birth practices performed at anytime during the observation period of the woman's delivery, 2 months post-intervention start.
Time Frame	2 months post-intervention start

Outcome Measure Data

Analysis Population Description

The denominator for this analysis is all women who were observed at any time during delivery, 2 months post-intervention start in the site.

Arm/Group Title	Intervention Health Facility Participants	Control Health Facility Participants
Arm/Group Description:	Women at intervention facilities who registered for labor and delivery, were eligible for inclusion, and who provided consent for observation. Intervention Health Facilities received the WHO Safe Childbirth Checklist Program. WHO Safe Childbirth Checklist Program: The IHF group will receive the WHO Safe Childbirth Checklist Program designed to maximize likelihood of effective and sustained uptake of the program by birth attendants in the designated facilities. The program includes three key implementation steps that involve: engagement of leadership and clinicians at the state, district, and local levels, a formal launch to introduce the Checklist, and support through peer coaching and data feedback. The intervention facilities will also receive a standardized maternity register to ensure appropriate data collection.	Women at control facilities who registered for labor and delivery, were eligible for inclusion, and who provided consent for observation. Matched control facilities provided comparison for intervention facilities.
Overall Number of Participants Analyzed	1259	1304
Measure Type: Count of Participants; Unit of Measure: Participants
Maternal temperature taken	792 62.9%	4 0.3%
Maternal blood pressure taken	854 67.8%	89 6.8%
Mother given magnesium sulfate	1 0.1%	3 0.2%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Intervention Health Facility Participants, Control Health Facility Participants
	Comments	Maternal temperature taken
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	Chi-squared, Corrected
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Risk Ratio (RR)
	Estimated Value	182
	Confidence Interval	(2-Sided) 95%; 33.5 to 993
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Intervention Health Facility Participants, Control Health Facility Participants
	Comments	Maternal blood pressure taken
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	Chi-squared, Corrected
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Risk Ratio (RR)
	Estimated Value	9.9
	Confidence Interval	(2-Sided) 95%; 3.8 to 25.8
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Intervention Health Facility Participants, Control Health Facility Participants
	Comments	Mother given magnesium sulfate
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.30
	Comments	[Not Specified]
	Method	Chi-squared, Corrected
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Risk Ratio (RR)
	Estimated Value	0.4
	Confidence Interval	(2-Sided) 95%; 0.1 to 2.1
	Estimation Comments	[Not Specified]

21. Other Pre-specified Outcome

Title	Mean Number of 18 Essential Birth Practices Performed at 12 Months Post-intervention Start
Description	Birth attendant's rate of completion of "Process measures" resulting from Safe Childbirth Checklist program will be assessed in a sample of total birth events at 12 months after the intervention is introduced to intervention facilities. The below measures reflect the mean number of 18 essential birth practices performed across the intervention versus control facilities at 12 months post-intervention start.
Time Frame	12 months post-intervention start

Outcome Measure Data

Analysis Population Description

The denominator for this analysis is all women who were observed for at least one pause point 12 months post-intervention start in the site.

Arm/Group Title	Intervention Health Facility Participants	Control Health Facility Participants
Arm/Group Description:	Women/newborn dyads at intervention facilities who registered for labor and delivery, eligible for inclusion, and who provided consent for observation. Intervention Health Facilities received the WHO Safe Childbirth Checklist Program. WHO Safe Childbirth Checklist Program: The IHF group will receive the WHO Safe Childbirth Checklist Program designed to maximize likelihood of effective and sustained uptake of the program by birth attendants in the designated facilities. The program includes three key implementation steps that involve: engagement of leadership and clinicians at the state, district, and local levels, a formal launch to introduce the Checklist, and support through peer coaching and data feedback. The intervention facilities will also receive a standardized maternity register to ensure appropriate data collection.	Women/newborn dyads at control health facilities who registered for labor and delivery, eligible for inclusion, and who provided consent for observation. Matched control facilities provided comparison for intervention facilities.
Overall Number of Participants Analyzed	1127	1198
Mean (95% Confidence Interval); Unit of Measure: essential birth practices performed
	11.1; (10.4 to 11.8)	7.9; (7.4 to 8.4)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Intervention Health Facility Participants, Control Health Facility Participants
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	Chi-squared, Corrected
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Other
	Estimated Value	0
	Estimation Comments	[Not Specified]

22. Other Pre-specified Outcome

Title	Count of Participants Where Essential Birth Practices Were Observed at Admission, 12 Months Post-intervention Start
Description	Birth attendant's rate of completion of "Process measures" resulting from Safe Childbirth Checklist program will be assessed in a sample of total birth events at 12 months after the intervention is introduced to intervention facilities. The below measures reflect the essential birth practices performed at the time of the woman's admission to the facility, 12 months post-intervention start.
Time Frame	12 months post-intervention start

Outcome Measure Data

Analysis Population Description

The denominator for this analysis is all women who were observed at admission, 12 months post-intervention start in the site.

Arm/Group Title	Intervention Health Facility Participants	Control Health Facility Participants
Arm/Group Description:	Women at intervention facilities who registered for labor and delivery, were eligible for inclusion, and who provided consent for observation. Intervention Health Facilities received the WHO Safe Childbirth Checklist Program. WHO Safe Childbirth Checklist Program: The IHF group will receive the WHO Safe Childbirth Checklist Program designed to maximize likelihood of effective and sustained uptake of the program by birth attendants in the designated facilities. The program includes three key implementation steps that involve: engagement of leadership and clinicians at the state, district, and local levels, a formal launch to introduce the Checklist, and support through peer coaching and data feedback. The intervention facilities will also receive a standardized maternity register to ensure appropriate data collection.	Women at control facilities who registered for labor and delivery, were eligible for inclusion, and who provided consent for observation. Matched control facilities provided comparison for intervention facilities.
Overall Number of Participants Analyzed	1007	1009
Measure Type: Count of Participants; Unit of Measure: Participants
Birth companion present	1004 99.7%	1006 99.7%
Maternal blood pressure taken	219 21.7%	11 1.1%
Maternal temperature taken	153 15.2%	0 0.0%
Partography started	7 0.7%	0 0.0%
Checklist use	175 17.4%	0 0.0%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Intervention Health Facility Participants, Control Health Facility Participants
	Comments	Birth companion present
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	1.00
	Comments	[Not Specified]
	Method	Chi-squared, Corrected
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Risk Ratio (RR)
	Estimated Value	1.0
	Confidence Interval	(2-Sided) 95%; 1.0 to 1.0
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Intervention Health Facility Participants, Control Health Facility Participants
	Comments	Maternal blood pressure taken
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	Chi-squared, Corrected
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Risk Ratio (RR)
	Estimated Value	19.1
	Confidence Interval	(2-Sided) 95%; 7.9 to 46.5
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Intervention Health Facility Participants, Control Health Facility Participants
	Comments	Maternal temperature taken
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	Chi-squared, Corrected
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Other
	Estimated Value	0
	Estimation Comments	The relative risk could not be calculated due to 100% or 0% values in one group.

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Intervention Health Facility Participants, Control Health Facility Participants
	Comments	Partography started
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	Chi-squared, Corrected
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Other
	Estimated Value	0
	Estimation Comments	The relative risk could not be calculated owing to 100% or 0% values in one group.

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Intervention Health Facility Participants, Control Health Facility Participants
	Comments	Checklist use
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	Chi-squared, Corrected
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Other
	Estimated Value	0
	Estimation Comments	The relative risk could not be calculated owing to 100% or 0% values in one group.

23. Other Pre-specified Outcome

Title	Count of Participants Where Essential Birth Practices Were Observed Just Before Pushing, 12 Months Post-intervention Start
Description	Birth attendant's rate of completion of "Process measures" resulting from Safe Childbirth Checklist program will be assessed in a sample of total birth events at 12 months after the intervention is introduced to intervention facilities. The below measures reflect the essential birth practices performed at the time just before pushing, 12 months post-intervention start
Time Frame	12 months post-intervention start

Outcome Measure Data

Analysis Population Description

The denominator for this analysis is all women who were observed at the time just before pushing, 12 months post-intervention start in the site.

Arm/Group Title	Intervention Health Facility Participants	Control Health Facility Participants
Arm/Group Description:	Women at intervention facilities who registered for labor and delivery, were eligible for inclusion, and who provided consent for observation. Intervention Health Facilities received the WHO Safe Childbirth Checklist Program. WHO Safe Childbirth Checklist Program: The IHF group will receive the WHO Safe Childbirth Checklist Program designed to maximize likelihood of effective and sustained uptake of the program by birth attendants in the designated facilities. The program includes three key implementation steps that involve: engagement of leadership and clinicians at the state, district, and local levels, a formal launch to introduce the Checklist, and support through peer coaching and data feedback. The intervention facilities will also receive a standardized maternity register to ensure appropriate data collection.	Women at control facilities who registered for labor and delivery, were eligible for inclusion, and who provided consent for observation. Matched control facilities provided comparison for intervention facilities.
Overall Number of Participants Analyzed	1018	1042
Measure Type: Count of Participants; Unit of Measure: Participants
Hand hygiene	126 12.4%	6 0.6%
No oxytocin given before delivery	527 51.8%	263 25.2%
Clean towel available	721 70.8%	314 30.1%
Clean scissors or blade available	1004 98.6%	1008 96.7%
Cord tie available	1009 99.1%	1039 99.7%
Mucus extractor available	999 98.1%	1000 96.0%
Neonatal bag and mask available	1017 99.9%	1036 99.4%
Pads available	768 75.4%	559 53.6%
Checklist Use	55 5.4%	1 0.1%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Intervention Health Facility Participants, Control Health Facility Participants
	Comments	Hand hygiene
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	Chi-squared, Corrected
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Risk Ratio (RR)
	Estimated Value	19.9
	Confidence Interval	(2-Sided) 95%; 6.6 to 60.4
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Intervention Health Facility Participants, Control Health Facility Participants
	Comments	No oxytocin given before delivery
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.04
	Comments	[Not Specified]
	Method	Chi-squared, Corrected
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Risk Ratio (RR)
	Estimated Value	2.1
	Confidence Interval	(2-Sided) 95%; 1.0 to 4.1
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Intervention Health Facility Participants, Control Health Facility Participants
	Comments	Clean towel available
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.006
	Comments	[Not Specified]
	Method	Chi-squared, Corrected
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Risk Ratio (RR)
	Estimated Value	2.4
	Confidence Interval	(2-Sided) 95%; 1.3 to 4.3
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Intervention Health Facility Participants, Control Health Facility Participants
	Comments	Clean scissors or blade available
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.34
	Comments	[Not Specified]
	Method	Chi-squared, Corrected
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Risk Ratio (RR)
	Estimated Value	1.0
	Confidence Interval	(2-Sided) 95%; 1.0 to 1.1
	Estimation Comments	[Not Specified]

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Intervention Health Facility Participants, Control Health Facility Participants
	Comments	Cord tie available
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.25
	Comments	[Not Specified]
	Method	Chi-squared, Corrected
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Risk Ratio (RR)
	Estimated Value	1.0
	Confidence Interval	(2-Sided) 95%; 1.0 to 1.0
	Estimation Comments	[Not Specified]

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Intervention Health Facility Participants, Control Health Facility Participants
	Comments	Mucus extractor available
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.50
	Comments	[Not Specified]
	Method	Chi-squared, Corrected
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Risk Ratio (RR)
	Estimated Value	1.0
	Confidence Interval	(2-Sided) 95%; 1.0 to 1.1
	Estimation Comments	[Not Specified]

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Intervention Health Facility Participants, Control Health Facility Participants
	Comments	Neonatal bag and mask available
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.32
	Comments	[Not Specified]
	Method	Chi-squared, Corrected
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Risk Ratio (RR)
	Estimated Value	1.0
	Confidence Interval	(2-Sided) 95%; 1.0 to 1.0
	Estimation Comments	[Not Specified]

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Intervention Health Facility Participants, Control Health Facility Participants
	Comments	Pads available
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.11
	Comments	[Not Specified]
	Method	Chi-squared, Corrected
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Risk Ratio (RR)
	Estimated Value	1.4
	Confidence Interval	(2-Sided) 95%; 0.9 to 2.1
	Estimation Comments	[Not Specified]

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Intervention Health Facility Participants, Control Health Facility Participants
	Comments	Checklist available
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	Chi-squared, Corrected
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Risk Ratio (RR)
	Estimated Value	37.9
	Confidence Interval	(2-Sided) 95%; 7.3 to 196
	Estimation Comments	[Not Specified]

24. Other Pre-specified Outcome

Title	Count of Participants Where Essential Birth Practices Were Observed Within One Minute After Delivery, 12 Months Post-intervention Start
Description	Birth attendant's rate of completion of "Process measures" resulting from Safe Childbirth Checklist program will be assessed in a sample of total birth events at 12 months after the intervention is introduced to intervention facilities. The below measures reflect the essential birth practices performed within one minute after delivery, 12 months post-intervention start
Time Frame	12 months post-intervention start

Outcome Measure Data

Analysis Population Description

The denominator for this analysis is all women who were observed within one minute after delivery, 12 months post-intervention start in the site.

Arm/Group Title	Intervention Health Facility Participants	Control Health Facility Participants
Arm/Group Description:	Women/newborn dyads at intervention facilities who registered for labor and delivery, eligible for inclusion, and who provided consent for observation. Intervention Health Facilities received the WHO Safe Childbirth Checklist Program. WHO Safe Childbirth Checklist Program: The IHF group will receive the WHO Safe Childbirth Checklist Program designed to maximize likelihood of effective and sustained uptake of the program by birth attendants in the designated facilities. The program includes three key implementation steps that involve: engagement of leadership and clinicians at the state, district, and local levels, a formal launch to introduce the Checklist, and support through peer coaching and data feedback. The intervention facilities will also receive a standardized maternity register to ensure appropriate data collection.	Women/newborn dyads at control health facilities who registered for labor and delivery, eligible for inclusion, and who provided consent for observation. Matched control facilities provided comparison for intervention facilities.
Overall Number of Participants Analyzed	1019	1041
Measure Type: Count of Participants; Unit of Measure: Participants
Oxytocin Administered	549 53.9%	154 14.8%
Neonatal bag used	30 2.9%	49 4.7%
Birth companion present	1016 99.7%	1035 99.4%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Intervention Health Facility Participants, Control Health Facility Participants
	Comments	Oxytocin administered
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	Chi-squared, Corrected
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Risk Ratio (RR)
	Estimated Value	3.6
	Confidence Interval	(2-Sided) 95%; 1.8 to 7.5
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Intervention Health Facility Participants, Control Health Facility Participants
	Comments	Neonatal bag used
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.19
	Comments	[Not Specified]
	Method	Chi-squared, Corrected
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Risk Ratio (RR)
	Estimated Value	0.6
	Confidence Interval	(2-Sided) 95%; 0.3 to 1.3
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Intervention Health Facility Participants, Control Health Facility Participants
	Comments	Birth companion present
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.50
	Comments	[Not Specified]
	Method	Chi-squared, Corrected
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Risk Ratio (RR)
	Estimated Value	1.0
	Confidence Interval	(2-Sided) 95%; 1.0 to 1.0
	Estimation Comments	[Not Specified]

25. Other Pre-specified Outcome

Title	Count of Participants Where Essential Birth Practices Were Observed Within One Hour After Delivery, 12 Months Post-intervention Start
Description	Birth attendant's rate of completion of "Process measures" resulting from Safe Childbirth Checklist program will be assessed in a sample of total birth events at 12 months after the intervention is introduced to intervention facilities. The below measures reflect the essential birth practices performed within one hour after delivery, 12 months post-intervention start
Time Frame	12 months post-intervention start

Outcome Measure Data

Analysis Population Description

The denominator for this analysis is all women who were observed within one hour after delivery, 12 months post-intervention start in the site.

Arm/Group Title	Intervention Health Facility Participants	Control Health Facility Participants
Arm/Group Description:	Women/newborn dyads at intervention facilities who registered for labor and delivery, eligible for inclusion, and who provided consent for observation. Intervention Health Facilities received the WHO Safe Childbirth Checklist Program. WHO Safe Childbirth Checklist Program: The IHF group will receive the WHO Safe Childbirth Checklist Program designed to maximize likelihood of effective and sustained uptake of the program by birth attendants in the designated facilities. The program includes three key implementation steps that involve: engagement of leadership and clinicians at the state, district, and local levels, a formal launch to introduce the Checklist, and support through peer coaching and data feedback. The intervention facilities will also receive a standardized maternity register to ensure appropriate data collection.	Women/newborn dyads at control health facilities who registered for labor and delivery, eligible for inclusion, and who provided consent for observation. Matched control facilities provided comparison for intervention facilities.
Overall Number of Participants Analyzed	1000	1014
Measure Type: Count of Participants; Unit of Measure: Participants
Newborn weight taken	947 94.7%	843 83.1%
Newborn temperature taken	225 22.5%	2 0.2%
Skin-to-skin care initiated at birth	685 68.5%	84 8.3%
Skin-to-skin care maintained for 1 hr	51 5.1%	0 0.0%
Initiation of breast-feeding	369 36.9%	47 4.6%
Checklist use	351 35.1%	0 0.0%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Intervention Health Facility Participants, Control Health Facility Participants
	Comments	Newborn weight taken
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.08
	Comments	[Not Specified]
	Method	Chi-squared, Corrected
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Risk Ratio (RR)
	Estimated Value	1.1
	Confidence Interval	(2-Sided) 95%; 1.0 to 1.3
	Estimation Comments	[Not Specified]

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Intervention Health Facility Participants, Control Health Facility Participants
	Comments	Newborn temperature taken
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	Chi-squared, Corrected
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Risk Ratio (RR)
	Estimated Value	91.5
	Confidence Interval	(2-Sided) 95%; 11.0 to 758
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Intervention Health Facility Participants, Control Health Facility Participants
	Comments	Skin-to-skin care initiated at birth
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	Chi-squared, Corrected
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Risk Ratio (RR)
	Estimated Value	8.2
	Confidence Interval	(2-Sided) 95%; 2.5 to 27.5
	Estimation Comments	[Not Specified]

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Intervention Health Facility Participants, Control Health Facility Participants
	Comments	Skin-to-skin care maintained for 1 hr
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.01
	Comments	[Not Specified]
	Method	Chi-squared, Corrected
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Other
	Estimated Value	0
	Estimation Comments	The relative risk could not be calculated owing to 100% or 0% values in one group.

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Intervention Health Facility Participants, Control Health Facility Participants
	Comments	Initiation of breast-feeding
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	Chi-squared, Corrected
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Risk Ratio (RR)
	Estimated Value	7.9
	Confidence Interval	(2-Sided) 95%; 3.7 to 16.7
	Estimation Comments	[Not Specified]

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Intervention Health Facility Participants, Control Health Facility Participants
	Comments	Checklist use
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	Chi-squared, Corrected
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Other
	Estimated Value	0
	Estimation Comments	The relative risk could not be calculated owing to 100% or 0% values in one group.

26. Other Pre-specified Outcome

Title	Count of Participants Where Essential Birth Practices Were Observed at Anytime, 12 Months Post-intervention Start
Description	Birth attendant's rate of completion of "Process measures" resulting from Safe Childbirth Checklist program will be assessed in a sample of total birth events at 12 months after the intervention is introduced to intervention facilities. The below measures reflect the essential birth practices performed at any time during the observation period, 12 months post-intervention start.
Time Frame	12 months post-intervention start

Outcome Measure Data

Analysis Population Description

The denominator for this analysis is all women who were observed at anytime, 12 months post-intervention start in the site.

Arm/Group Title	Intervention Health Facility Participants	Control Health Facility Participants
Arm/Group Description:	Women at intervention facilities who registered for labor and delivery, eligible for inclusion, and who provided consent for observation. Intervention Health Facilities received the WHO Safe Childbirth Checklist Program. WHO Safe Childbirth Checklist Program: The IHF group will receive the WHO Safe Childbirth Checklist Program designed to maximize likelihood of effective and sustained uptake of the program by birth attendants in the designated facilities. The program includes three key implementation steps that involve: engagement of leadership and clinicians at the state, district, and local levels, a formal launch to introduce the Checklist, and support through peer coaching and data feedback. The intervention facilities will also receive a standardized maternity register to ensure appropriate data collection.	Women at control health facilities who registered for labor and delivery, eligible for inclusion, and who provided consent for observation. Matched control facilities provided comparison for intervention facilities.
Overall Number of Participants Analyzed	1127	1198
Measure Type: Count of Participants; Unit of Measure: Participants
Maternal temperature taken	343 30.4%	0 0.0%
Maternal blood pressure taken	425 37.7%	35 2.9%
Mother given magnesium sulfate	1 0.1%	1 0.1%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Intervention Health Facility Participants, Control Health Facility Participants
	Comments	Maternal temperature taken
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	Chi-squared, Corrected
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Other
	Estimated Value	0
	Estimation Comments	The relative risk could not be calculated owing to 100% or 0% values in one group.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Intervention Health Facility Participants, Control Health Facility Participants
	Comments	Maternal blood pressure taken
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<0.001
	Comments	[Not Specified]
	Method	Chi-squared, Corrected
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Risk Ratio (RR)
	Estimated Value	12.7
	Confidence Interval	(2-Sided) 95%; 4.7 to 34.3
	Estimation Comments	[Not Specified]

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Intervention Health Facility Participants, Control Health Facility Participants
	Comments	Mother given magnesium sulfate
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.95
	Comments	[Not Specified]
	Method	Chi-squared, Corrected
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Risk Ratio (RR)
	Estimated Value	1.1
	Confidence Interval	(2-Sided) 95%; 0.2 to 6.6
	Estimation Comments	[Not Specified]

Adverse Events

Time Frame	Adverse events were monitored for occurrence and reporting throughout the duration of the study period (2 years).
Adverse Event Reporting Description	Maternal & neonatal mortality were measured as outcomes, not as adverse events. No adverse events such as death or morbidity were linked to direct effect of the trial. Our adverse events included loss of a consent form or a breach of PHI. While our outcomes denominators reflect either the woman/newborn dyad or women only, this denominator includes all individual mothers plus all individual newborns enrolled in the trial, in order to obtain an all cause mortality count.
Arm/Group Title	Intervention Health Facility Participants	Control Health Facility Participants
Arm/Group Description	Women/newborn dyads at intervention facilities who registered for labor and delivery, eligible for inclusion, and who provided consent. Intervention Health Facilities received the WHO Safe Childbirth Checklist Program. WHO Safe Childbirth Checklist Program: The IHF group will receive the WHO Safe Childbirth Checklist Program designed to maximize likelihood of effective and sustained uptake of the program by birth attendants in the designated facilities. The program includes three key implementation steps that involve: engagement of leadership and clinicians at the state, district, and local levels, a formal launch to introduce the Checklist, and support through peer coaching and data feedback. The intervention facilities will also receive a standardized maternity register to ensure appropriate data collection.	Women/newborn dyads at control health facilities who registered for labor and delivery, eligible for inclusion, and who provided consent. Matched control facilities provided comparison for intervention facilities.
All-Cause Mortality
	Intervention Health Facility Participants	Control Health Facility Participants
	Affected / at Risk (%)	Affected / at Risk (%)
Total	3917/159587 (2.45%)	3677/154684 (2.38%)
Serious Adverse Events
	Intervention Health Facility Participants	Control Health Facility Participants
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/159587 (0.00%)	0/154684 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Intervention Health Facility Participants	Control Health Facility Participants
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/159587 (0.00%)	0/154684 (0.00%)

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Name/Title: Dr. Katherine Semrau
• Organization: Ariadne Labs
• Phone: 617-384-6555
• EMail: betterbirth@ariadnelabs.org

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Molina RL, Neal BJ, Bobanski L, Singh VP, Neville BA, Delaney MM, Lipsitz S, Karlage A, Shetye M, Semrau KEA. Nurses' and auxiliary nurse midwives' adherence to essential birth practices with peer coaching in Uttar Pradesh, India: a secondary analysis of the BetterBirth trial. Implement Sci. 2020 Jan 3;15(1):1. doi: 10.1186/s13012-019-0962-7.

Hirschhorn LR, Krasne M, Maisonneuve J, Kara N, Kalita T, Henrich N, Rana D, Maji P, Delaney MM, Firestone R, Sharma N, Kumar V, Gawande AA, Semrau KEA. Integration of the Opportunity-Ability-Motivation behavior change framework into a coaching-based WHO Safe Childbirth Checklist program in India. Int J Gynaecol Obstet. 2018 Sep;142(3):321-328. doi: 10.1002/ijgo.12542. Epub 2018 Jun 20.

Maisonneuve JJ, Semrau KEA, Maji P, Pratap Singh V, Miller KA, Solsky I, Dixit N, Sharma J, Lagoo J, Panariello N, Neal BJ, Kalita T, Kara N, Kumar V, Hirschhorn LR. Effectiveness of a WHO Safe Childbirth Checklist Coaching-based intervention on the availability of Essential Birth Supplies in Uttar Pradesh, India. Int J Qual Health Care. 2018 Dec 1;30(10):769-777. doi: 10.1093/intqhc/mzy086.

Semrau KEA, Hirschhorn LR, Marx Delaney M, Singh VP, Saurastri R, Sharma N, Tuller DE, Firestone R, Lipsitz S, Dhingra-Kumar N, Kodkany BS, Kumar V, Gawande AA; BetterBirth Trial Group. Outcomes of a Coaching-Based WHO Safe Childbirth Checklist Program in India. N Engl J Med. 2017 Dec 14;377(24):2313-2324. doi: 10.1056/NEJMoa1701075.

Gass JD Jr, Misra A, Yadav MNS, Sana F, Singh C, Mankar A, Neal BJ, Fisher-Bowman J, Maisonneuve J, Delaney MM, Kumar K, Singh VP, Sharma N, Gawande A, Semrau K, Hirschhorn LR. Implementation and results of an integrated data quality assurance protocol in a randomized controlled trial in Uttar Pradesh, India. Trials. 2017 Sep 7;18(1):418. doi: 10.1186/s13063-017-2159-1.

Semrau KE, Hirschhorn LR, Kodkany B, Spector JM, Tuller DE, King G, Lipsitz S, Sharma N, Singh VP, Kumar B, Dhingra-Kumar N, Firestone R, Kumar V, Gawande AA. Effectiveness of the WHO Safe Childbirth Checklist program in reducing severe maternal, fetal, and newborn harm in Uttar Pradesh, India: study protocol for a matched-pair, cluster-randomized controlled trial. Trials. 2016 Dec 7;17(1):576.

• Responsible Party: Atul Gawande, Harvard School of Public Health
• ClinicalTrials.gov Identifier: NCT02148952
• Other Study ID Numbers: HSPH OPP1017378
• First Submitted: February 13, 2014
• First Posted: May 29, 2014
• Results First Submitted: January 17, 2018
• Results First Posted: February 20, 2019
• Last Update Posted: February 20, 2019