BetterBirth: A Trial of the WHO Safe Childbirth Checklist Program (BetterBirth)
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ClinicalTrials.gov Identifier: NCT02148952 |
Recruitment Status :
Completed
First Posted : May 29, 2014
Results First Posted : February 20, 2019
Last Update Posted : February 20, 2019
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Study Type | Interventional |
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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 | |||
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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. |
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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.
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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 | |
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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 | |
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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.
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Age, Continuous
[1] Mean (Full Range) Unit of measure: Years |
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Number Analyzed | 81,925 participants | 79,182 participants | 161107 participants | |
25.6
(25.5 to 25.8)
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25.7
(25.5 to 25.9)
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25.66
(25.54 to 25.79)
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[1]
Measure Description: Please note the measure of dispersion is a 95% confidence interval (not full range).
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Sex/Gender, Customized
[1] [2] Measure Type: Count of Participants Unit of measure: Participants |
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Sex of newborn | Number Analyzed | 81447 participants | 78663 participants | 160110 participants |
Male |
40558 49.8%
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39063 49.7%
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79621 49.7%
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Female |
36976 45.4%
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36266 46.1%
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73242 45.7%
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Unknown |
3913 4.8%
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3334 4.2%
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7247 4.5%
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[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.
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Sex: Female, Male
[1] Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 81,925 participants | 79,182 participants | 161107 participants | |
Female |
81925 100.0%
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79182 100.0%
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161107 100.0%
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Male |
0 0.0%
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0 0.0%
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0 0.0%
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[1]
Measure Description: Pregnant women were enrolled in the trial; thus, all are female.
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Race and Ethnicity Not Collected
[1] Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 0 participants | 0 participants | 0 participants | |
0 | ||||
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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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 |
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Number Analyzed | 60 Facilities | 60 Facilities | 120 Facilities | |
1599
(1486 to 1712)
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1683
(1552 to 1814)
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1641
(1531 to 1751)
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[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).
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Functional Classification
[1] Count of Units Unit of measure: Facilities |
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Number Analyzed | 60 Facilities | 60 Facilities | 120 Facilities | |
Primary health center |
23 38.3%
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23 38.3%
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46 38.3%
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Community Health Center |
27 45.0%
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29 48.3%
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56 46.7%
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First referral unit |
10 16.7%
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8 13.3%
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18 15.0%
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[1]
Measure Description: This characteristic was used for facility matching before randomization.
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Mean distance to district hospital
[1] Mean (Full Range) Unit of measure: Km |
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Number Analyzed | 60 Facilities | 60 Facilities | 120 Facilities | |
29.5
(25.9 to 33.1)
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30.3
(27.2 to 33.4)
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29.9
(27.0 to 32.8)
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[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).
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Mean skilled birth attendants per facility
[1] Mean (Full Range) Unit of measure: Number of skilled birth attendants |
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Number Analyzed | 60 Facilities | 60 Facilities | 120 Facilities | |
4.4
(4.1 to 4.7)
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4.4
(4.1 to 4.7)
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4.4
(4.1 to 4.7)
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[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).
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Cluster Size
[1] Mean (Full Range) Unit of measure: Participants per site |
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Number Analyzed | 81,925 participants | 79,182 participants | 161107 participants | |
1365
(515 to 2697)
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1320
(646 to 2198)
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1343
(1261 to 1423)
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[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).
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Mean previous pregnancies
[1] Mean (Full Range) Unit of measure: Previous pregnancies |
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Number Analyzed | 81,925 participants | 79,182 participants | 161107 participants | |
2.4
(2.3 to 2.4)
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2.3
(2.3 to 2.4)
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2.36
(2.32 to 2.39)
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[1]
Measure Description: Please note the measure of dispersion is a 95% confidence interval (not full range).
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Minutes between admission and delivery
[1] Mean (Full Range) Unit of measure: Minutes |
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Number Analyzed | 81,925 participants | 79,182 participants | 161107 participants | |
200
(184 to 216)
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206
(191 to 220)
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203
(192 to 213)
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[1]
Measure Description: Please note the measure of dispersion is a 95% confidence interval (not full range).
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Providers attending delivery
Measure Type: Count of Participants Unit of measure: Participants |
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Doctor | Number Analyzed | 81925 participants | 79,182 participants | 161107 participants |
11115 13.6%
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11599 14.6%
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22714 14.1%
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Nurse | Number Analyzed | 81,925 participants | 79,182 participants | 161107 participants |
66687 81.4%
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64117 81.0%
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130804 81.2%
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Auxiliary nurse midwife | Number Analyzed | 81,925 participants | 79,182 participants | 161107 participants |
15311 18.7%
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14549 18.4%
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29860 18.5%
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Others | Number Analyzed | 81,925 participants | 79,182 participants | 161107 participants |
2633 3.2%
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6560 8.3%
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9193 5.7%
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No. of offspring
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 81,925 participants | 79,182 participants | 161107 participants | |
Singleton |
80402 98.1%
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77582 98.0%
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157984 98.1%
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Sets of twins |
515 0.6%
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533 0.7%
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1048 0.7%
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Sets of triplets |
5 0.0%
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5 0.0%
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10 0.0%
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Unknown |
1,003 1.2%
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1,062 1.3%
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2065 1.3%
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Low birth weight
[1] [2] Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 81447 participants | 78663 participants | 160110 participants | |
22316 27.4%
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22728 28.9%
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45044 28.1%
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[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.
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Preterm birth
[1] [2] Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 81447 participants | 78663 participants | 160110 participants | |
15941 19.6%
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17703 22.5%
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33644 21.0%
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[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.
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Name/Title: | Dr. Katherine Semrau |
Organization: | Ariadne Labs |
Phone: | 617-384-6555 |
EMail: | betterbirth@ariadnelabs.org |
Responsible Party: | Atul Gawande, Harvard School of Public Health (HSPH) |
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 |