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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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:
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
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
Hide 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            
Arm/Group Title Intervention Health Facility Participants Control Health Facility Participants Total
Hide 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
Hide 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.
1.Primary Outcome
Title Percentage of Participants With Composite Measure of Perinatal Death, Maternal Death, or Maternal Severe Complications Within 7 Days
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Description Percentage of participants with composite rate of perinatal death and maternal death within 7 days
Time Frame 0-7 days after delivery
Hide Outcome Measure Data
Hide 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
Hide 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
Hide 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
Hide Description Count of participants with perinatal death within 7 days (combined stillbirth or neonatal death)
Time Frame 0-7 days
Hide Outcome Measure Data
Hide 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
Hide 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%
Hide 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
Hide Description Newborn outcome; rate of stillbirth
Time Frame 0-7 days after delivery
Hide Outcome Measure Data
Hide 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
Hide 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%
Hide 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
Hide Description Newborn outcome; rate of early neonatal death
Time Frame 0-7 days after delivery
Hide Outcome Measure Data
Hide 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
Hide 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%
Hide 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
Hide Description Maternal outcome; rate of maternal death
Time Frame 0-7 days after delivery
Hide Outcome Measure Data
Hide 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
Hide 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%
Hide 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
Hide Description Maternal outcome; any severe maternal complication within 7 days
Time Frame 0-7 days after delivery
Hide Outcome Measure Data
Hide 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
Hide 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%
Hide 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.
Hide 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.
Hide 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.
Hide 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.
Hide 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.
Hide 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
Hide 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)
Hide Outcome Measure Data
Hide 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
Hide 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%
Hide 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
Hide Description Maternal outcome; Rate of maternal inter-facility transfer
Time Frame 0-7 days after delivery
Hide Outcome Measure Data
Hide 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
Hide 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%
Hide 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
Hide Description Newborn outcome; Newborn referral
Time Frame 0-7 days after delivery
Hide Outcome Measure Data
Hide 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
Hide 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%
Hide 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
Hide Description Rate of hysterectomy within 7 days
Time Frame 0-7 days after delivery
Hide Outcome Measure Data
Hide 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
Hide 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%
Hide 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
Hide Description Rate of blood transfusion within 7 days
Time Frame 0-7 days after delivery
Hide Outcome Measure Data
Hide 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
Hide 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%
Hide 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
Hide Description Maternal Outcome; Rate of need for follow-up care for Mother
Time Frame 0-7 days after delivery
Hide Outcome Measure Data
Hide 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
Hide 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%
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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%
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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)
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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%
Hide 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.
Hide 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]
Hide 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]
Hide 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]
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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%
Hide 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]
Hide 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]
Hide 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]
Hide 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]
Hide 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]
Hide 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]
Hide 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]
Hide 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]
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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%
Hide 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]
Hide 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]
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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%
Hide 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]
Hide 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]
Hide 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]
Hide 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]
Hide 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]
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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%
Hide 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]
Hide 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]
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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)
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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%
Hide 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]
Hide 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]
Hide 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.
Hide 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.
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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%
Hide 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]
Hide 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]
Hide 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]
Hide 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]
Hide 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]
Hide 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]
Hide 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]
Hide 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]
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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%
Hide 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]
Hide 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]
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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%
Hide 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]
Hide 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]
Hide 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]
Hide 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.
Hide 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]
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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%
Hide 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.
Hide 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]
Hide 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]
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
Hide 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%) 
Hide 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%) 
Hide 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%) 
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
Layout table for Results Point of Contact information
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):
Layout table for additonal information
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