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CompletedNCT02148952BetterBirthUpdated Jun 26, 2024Results posted

BetterBirth: A Trial of the WHO Safe Childbirth Checklist Program

An interventional study of WHO Safe Childbirth Checklist Program in Maternal Death, Maternal Morbidity and Stillbirth, sponsored by Harvard School of Public Health (HSPH). Completed at 1 site in India. Per ClinicalTrials.gov, last updated 2024-06-26.

Sponsored by Harvard School of Public Health (HSPH) · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
157,689
Allocation
Randomized
Sex
All
01

Study summary

The purpose of this study is to measure the impact of a checklist-based childbirth safety program (the WHO Safe Childbirth Checklist Program) on reduction of severe maternal, fetal, and newborn harm in institutional deliveries in north India.

Read the detailed description

The WHO Safe Childbirth Checklist Program is a quality improvement program designed to support health workers to deliver evidence-based practices to women and newborns around the time of institutional childbirths. At the program's core is the Safe Childbirth Checklist, a 31-item list of essential practices that target the major causes of maternal and newborn mortality in low-resource settings globally. The program was developed over 3 years by a partnership of WHO and HSPH, working with a large international network of experts and stakeholders in maternal, fetal, and newborn health. Pilot testing of the program at a public-sector birth center in south India demonstrated dramatic improvements in health worker adherence to essential childbirth-related clinical care standards. The current study is a matched-pair, cluster randomized trial to measure the efficacy of the program in reducing severe maternal and newborn harm. This trial will be conducted at approximately 120 health facilities in Uttar Pradesh, India.

02

Conditions studied

  • Maternal Death
  • Maternal Morbidity
  • Stillbirth
  • Neonatal Death

Keywords

  • Maternal Health
  • Maternal Death
  • Maternal Morbidity
  • Stillbirth
  • Neonatal Mortality
  • Quality Improvement
  • Resource Limited Settings
  • Checklist
  • Safe Childbirth
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • For measuring outcomes, inclusion criteria are all mothers admitted to a study site for childbirth and newborn babies who are to be followed-up. In case a mother or baby from an enrolled site is referred out to another facility (before or after delivery) the mother-baby dyad will be included in the study and the outcome will be allocated to the referring facility
  • For a smaller subset of birth events (approximately 4,650 deliveries total), health worker practices will be observed to measure the impact of the SCC program on delivery of essential practices, as a secondary outcome. A convenience sample of women who agree to observation and their babies cared for by the health workers around the time of childbirth at the facility during data collectors' duty hours will be included in this component of the study.

Exclusion criteria

Exclusion Criteria:

  • Mothers who have been referred into the facility by an inter-facility transfer.
  • Mothers being managed for abortion.
  • Mothers who refuse consent for follow-up
04

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
157,689 participants (actual)

Study arms

  • Experimental
    Intervention Health Facility

    WHO Safe Childbirth Checklist Program

    Behavioral: WHO Safe Childbirth Checklist Program

  • No intervention
    Control Health Facility

    Matched control facilities providing comparison for intervention facilities

Interventions

  • BehavioralWHO 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.

05

What researchers measure

Primary outcomes

  1. Percentage of Participants With Composite Measure of Perinatal Death, Maternal Death, or Maternal Severe Complications Within 7 Days

    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

Secondary outcomes

  1. Percentage of Participants With Perinatal Death or Maternal Death Within 7 Days

    Percentage of participants with composite rate of perinatal death and maternal death within 7 days

    Time frame: 0-7 days after delivery

  2. Count of Participants With Perinatal Death Within 7 Days

    Count of participants with perinatal death within 7 days (combined stillbirth or neonatal death)

    Time frame: 0-7 days

  3. Count of Participants With Stillbirth

    Newborn outcome; rate of stillbirth

    Time frame: 0-7 days after delivery

  4. Count of Participants With Early Neonatal Death

    Newborn outcome; rate of early neonatal death

    Time frame: 0-7 days after delivery

  5. Count of Participants With Maternal Death

    Maternal outcome; rate of maternal death

    Time frame: 0-7 days after delivery

  6. Count of Participants With Severe Maternal Complications

    Maternal outcome; any severe maternal complication within 7 days

    Time frame: 0-7 days after delivery

  7. Count of Participants With Cesarean Section

    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)

  8. Count of Participants With Maternal Referral, Before or After Delivery

    Maternal outcome; Rate of maternal inter-facility transfer

    Time frame: 0-7 days after delivery

  9. Count of Participants With Newborn Referral

    Newborn outcome; Newborn referral

    Time frame: 0-7 days after delivery

  10. Count of Participants With Hysterectomy Within 7 Days

    Rate of hysterectomy within 7 days

    Time frame: 0-7 days after delivery

  11. Count of Participants With Blood Transfusion Within 7 Days

    Rate of blood transfusion within 7 days

    Time frame: 0-7 days after delivery

  12. Count of Mothers Returning to Facility for a Health Problem Within 7 Days

    Maternal Outcome; Rate of need for follow-up care for Mother

    Time frame: 0-7 days after delivery

  13. Count of Newborns Returning to Facility for a Health Problem Within 7 Days

    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

Other outcomes

  1. Mean Number of 18 Essential Birth Practices Performed at 2 Months Post-intervention Start

    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

  2. Count of Participants Where Essential Birth Practices Were Observed at Admission, 2 Months Post-intervention Start

    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

  3. Count of Participants Where Essential Birth Practices Were Observed Just Before Pushing, 2 Months Post-intervention Start

    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

  4. Count of Participants Where Essential Birth Practices Were Observed Within One Minute After Delivery, 2 Months Post-intervention Start

    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

  5. Count of Participants Where Essential Birth Practices Were Observed Within One Hour After Delivery, 2 Months Post-intervention Start

    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

  6. Count of Participants Where Essential Birth Practices Were Observed at Anytime During Delivery, 2 Months Post-intervention Start

    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

  7. Mean Number of 18 Essential Birth Practices Performed at 12 Months Post-intervention Start

    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

  8. Count of Participants Where Essential Birth Practices Were Observed at Admission, 12 Months Post-intervention Start

    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

  9. Count of Participants Where Essential Birth Practices Were Observed Just Before Pushing, 12 Months Post-intervention Start

    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

  10. Count of Participants Where Essential Birth Practices Were Observed Within One Minute After Delivery, 12 Months Post-intervention Start

    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

  11. Count of Participants Where Essential Birth Practices Were Observed Within One Hour After Delivery, 12 Months Post-intervention Start

    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

  12. Count of Participants Where Essential Birth Practices Were Observed at Anytime, 12 Months Post-intervention Start

    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

06

Results

Posted Feb 20, 2019

Participant flow

Assessing Eligibility and Consent
Participant flow — Assessing Eligibility and Consent
MilestoneIntervention Health Facility ParticipantsControl Health Facility Participants
Started8316680773
Completed8006377626
Not completed31033147
Withdrew: Were not eligible for inclusion12411591
Withdrew: Did not consent or declined follow-up18621556
Follow-Up
Participant flow — Follow-Up
MilestoneIntervention Health Facility ParticipantsControl Health Facility Participants
Started8006377626
Completed7979877347
Not completed265279
Withdrew: Lost to follow-up219231
Withdrew: Withdrawal by subject4648

Outcome measures

PrimaryPercentage of Participants With Composite Measure of Perinatal Death, Maternal Death, or Maternal Severe Complications Within 7 Days

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
Reported as:
Number · percentage of women/newborn dyads
Percentage of Participants With Composite Measure of Perinatal Death, Maternal Death, or Maternal Severe Complications Within 7 Days
percentage of women/newborn dyadsIntervention Health Facility ParticipantsControl Health Facility Participants
Percentage of Participants With Composite Measure of Perinatal Death, Maternal Death, or Maternal Severe Complications Within 7 Days15.115.3
Statistical analysis
  • Intervention Health Facility Participants vs Control Health Facility Participants · Chi-squared, Corrected · p = 0.90 · Risk ratio (rr): 0.99 · 95% CI 0.83 to 1.18Relative 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.
SecondaryPercentage of Participants With Perinatal Death or Maternal Death Within 7 Days

Percentage of participants with composite rate of perinatal death and maternal death within 7 days

Time frame:
0-7 days after delivery
Reported as:
Number · percentage of women and newborns
Percentage of Participants With Perinatal Death or Maternal Death Within 7 Days
percentage of women and newbornsIntervention Health Facility ParticipantsControl Health Facility Participants
Percentage of Participants With Perinatal Death or Maternal Death Within 7 Days4.94.7
Statistical analysis
  • Intervention Health Facility Participants vs Control Health Facility Participants · Chi-squared, Corrected · p = 0.67 · Risk ratio (rr): 1.03 · 95% CI 0.89 to 1.20Relative 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.
SecondaryCount of Participants With Perinatal Death Within 7 Days

Count of participants with perinatal death within 7 days (combined stillbirth or neonatal death)

Time frame:
0-7 days
Reported as:
Count of participants · Participants
Count of Participants With Perinatal Death Within 7 Days
ParticipantsIntervention Health Facility ParticipantsControl Health Facility Participants
Count of Participants With Perinatal Death Within 7 Days38393606
Statistical analysis
  • Intervention Health Facility Participants vs Control Health Facility Participants · Chi-squared, Corrected · p = 0.68 · Risk ratio (rr): 1.03 · 95% CI 0.89 to 1.20
SecondaryCount of Participants With Stillbirth

Newborn outcome; rate of stillbirth

Time frame:
0-7 days after delivery
Reported as:
Count of participants · Participants
Count of Participants With Stillbirth
ParticipantsIntervention Health Facility ParticipantsControl Health Facility Participants
Count of Participants With Stillbirth15131559
Statistical analysis
  • Intervention Health Facility Participants vs Control Health Facility Participants · Chi-squared, Corrected · p = 0.56 · Risk ratio (rr): 0.94 · 95% CI 0.76 to 1.16Relative 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.
SecondaryCount of Participants With Early Neonatal Death

Newborn outcome; rate of early neonatal death

Time frame:
0-7 days after delivery
Reported as:
Count of participants · Participants
Count of Participants With Early Neonatal Death
ParticipantsIntervention Health Facility ParticipantsControl Health Facility Participants
Count of Participants With Early Neonatal Death24092119
Statistical analysis
  • Intervention Health Facility Participants vs Control Health Facility Participants · Chi-squared, Corrected · p = 0.19 · Risk ratio (rr): 1.10 · 95% CI 0.95 to 1.27
SecondaryCount of Participants With Maternal Death

Maternal outcome; rate of maternal death

Time frame:
0-7 days after delivery
Reported as:
Count of participants · Participants
Count of Participants With Maternal Death
ParticipantsIntervention Health Facility ParticipantsControl Health Facility Participants
Count of Participants With Maternal Death7871
Statistical analysis
  • Intervention Health Facility Participants vs Control Health Facility Participants · Chi-squared, Corrected · p = 0.73 · Risk ratio (rr): 1.11 · 95% CI 0.74 to 1.53Relative 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.
SecondaryCount of Participants With Severe Maternal Complications

Maternal outcome; any severe maternal complication within 7 days

Time frame:
0-7 days after delivery
Reported as:
Count of participants · Participants
Count of Participants With Severe Maternal Complications
ParticipantsIntervention Health Facility ParticipantsControl Health Facility Participants
Any maternal severe complication within 7 days90869037
Seizures6770
Loss of consciousness for >1 hour505493
High fever with foul-smelling vaginal discharge40733871
Hemorrhage57455875
Stroke912
Statistical analysis
  • Intervention Health Facility Participants vs Control Health Facility Participants · Chi-squared, Corrected · p = 0.81 · Risk ratio (rr): 0.97 · 95% CI 0.79 to 1.20Relative 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.
  • Intervention Health Facility Participants vs Control Health Facility Participants · Chi-squared, Corrected · p = 0.76 · Risk ratio (rr): 0.89 · 95% CI 0.57 to 1.52Relative 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.
  • Intervention Health Facility Participants vs Control Health Facility Participants · Chi-squared, Corrected · p = 0.97 · Risk ratio (rr): 0.98 · 95% CI 0.70 to 1.41Relative 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.
  • Intervention Health Facility Participants vs Control Health Facility Participants · Chi-squared, Corrected · p = 0.90 · Risk ratio (rr): 1.02 · 95% CI 0.76 to 1.38Relative 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.
  • Intervention Health Facility Participants vs Control Health Facility Participants · Chi-squared, Corrected · p = 0.61 · Risk ratio (rr): 0.95 · 95% CI 0.77 to 1.17Relative 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.
  • Intervention Health Facility Participants vs Control Health Facility Participants · Chi-squared, Corrected · p = 0.41 · Risk ratio (rr): 0.50 · 95% CI 0.34 to 1.58Relative 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.
SecondaryCount of Participants With Cesarean Section

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)
Reported as:
Count of participants · Participants
Count of Participants With Cesarean Section
ParticipantsIntervention Health Facility ParticipantsControl Health Facility Participants
Count of Participants With Cesarean Section14691330
Statistical analysis
  • Intervention Health Facility Participants vs Control Health Facility Participants · Chi-squared, Corrected · p = 0.74 · Risk ratio (rr): 1.07 · 95% CI 0.72 to 1.58
SecondaryCount of Participants With Maternal Referral, Before or After Delivery

Maternal outcome; Rate of maternal inter-facility transfer

Time frame:
0-7 days after delivery
Reported as:
Count of participants · Participants
Count of Participants With Maternal Referral, Before or After Delivery
ParticipantsIntervention Health Facility ParticipantsControl Health Facility Participants
Count of Participants With Maternal Referral, Before or After Delivery53814779
Statistical analysis
  • Intervention Health Facility Participants vs Control Health Facility Participants · Chi-squared, Corrected · p = 0.57 · Risk ratio (rr): 1.09 · 95% CI 0.81 to 1.47Relative 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.
SecondaryCount of Participants With Newborn Referral

Newborn outcome; Newborn referral

Time frame:
0-7 days after delivery
Reported as:
Count of participants · Participants
Count of Participants With Newborn Referral
ParticipantsIntervention Health Facility ParticipantsControl Health Facility Participants
Count of Participants With Newborn Referral14551186
Statistical analysis
  • Intervention Health Facility Participants vs Control Health Facility Participants · Chi-squared, Corrected · p = 0.41 · Risk ratio (rr): 1.19 · 95% CI 0.78 to 1.80Relative 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.
SecondaryCount of Participants With Hysterectomy Within 7 Days

Rate of hysterectomy within 7 days

Time frame:
0-7 days after delivery
Reported as:
Count of participants · Participants
Count of Participants With Hysterectomy Within 7 Days
ParticipantsIntervention Health Facility ParticipantsControl Health Facility Participants
Count of Participants With Hysterectomy Within 7 Days1918
Statistical analysis
  • Intervention Health Facility Participants vs Control Health Facility Participants · Chi-squared, Corrected · p = 0.95 · Risk ratio (rr): 1.00 · 95% CI 0.45 to 2.13Relative 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.
SecondaryCount of Participants With Blood Transfusion Within 7 Days

Rate of blood transfusion within 7 days

Time frame:
0-7 days after delivery
Reported as:
Count of participants · Participants
Count of Participants With Blood Transfusion Within 7 Days
ParticipantsIntervention Health Facility ParticipantsControl Health Facility Participants
Count of Participants With Blood Transfusion Within 7 Days640625
Statistical analysis
  • Intervention Health Facility Participants vs Control Health Facility Participants · Chi-squared, Corrected · p = 0.97 · Risk ratio (rr): 0.99 · 95% CI 0.69 to 1.43
SecondaryCount of Mothers Returning to Facility for a Health Problem Within 7 Days

Maternal Outcome; Rate of need for follow-up care for Mother

Time frame:
0-7 days after delivery
Reported as:
Count of participants · Participants
Count of Mothers Returning to Facility for a Health Problem Within 7 Days
ParticipantsIntervention Health Facility ParticipantsControl Health Facility Participants
Count of Mothers Returning to Facility for a Health Problem Within 7 Days20142141
Statistical analysis
  • Intervention Health Facility Participants vs Control Health Facility Participants · Chi-squared, Corrected · p = 0.32 · Risk ratio (rr): 0.91 · 95% CI 0.76 to 1.10Relative 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.
SecondaryCount of Newborns Returning to Facility for a Health Problem Within 7 Days

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
Reported as:
Count of participants · Participants
Count of Newborns Returning to Facility for a Health Problem Within 7 Days
ParticipantsIntervention Health Facility ParticipantsControl Health Facility Participants
Count of Newborns Returning to Facility for a Health Problem Within 7 Days44744722
Statistical analysis
  • Intervention Health Facility Participants vs Control Health Facility Participants · Chi-squared, Corrected · p = 0.30 · Risk ratio (rr): 0.92 · 95% CI 0.78 to 1.08Relative 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.
Other pre-specifiedMean Number of 18 Essential Birth Practices Performed at 2 Months Post-intervention Start

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
Reported as:
Mean · essential birth practices performed
Mean Number of 18 Essential Birth Practices Performed at 2 Months Post-intervention Start
essential birth practices performedIntervention Health Facility ParticipantsControl Health Facility Participants
Mean Number of 18 Essential Birth Practices Performed at 2 Months Post-intervention Start13.1 (12.1 to 14.0)7.5 (6.9 to 8.1)
Statistical analysis
  • Intervention Health Facility Participants vs Control Health Facility Participants · Chi-squared, Corrected · p = <0.001 · Other: 0
Other pre-specifiedCount of Participants Where Essential Birth Practices Were Observed at Admission, 2 Months Post-intervention Start

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
Reported as:
Count of participants · Participants
Count of Participants Where Essential Birth Practices Were Observed at Admission, 2 Months Post-intervention Start
ParticipantsIntervention Health Facility ParticipantsControl Health Facility Participants
Birth companion present10481087
Maternal blood pressure taken60664
Maternal temperature taken5694
Partography started101
Checklist use5951
Statistical analysis
  • Intervention Health Facility Participants vs Control Health Facility Participants · Chi-squared, Corrected · p = 0.18 · Other: 0The relative risk could not be calculated owing to 100% or 0% values in one group.
  • Intervention Health Facility Participants vs Control Health Facility Participants · Chi-squared, Corrected · p = <0.001 · Risk ratio (rr): 9.8 · 95% CI 3.4 to 28.3
  • Intervention Health Facility Participants vs Control Health Facility Participants · Chi-squared, Corrected · p = <0.001 · Risk ratio (rr): 132 · 95% CI 26.9 to 645
  • Intervention Health Facility Participants vs Control Health Facility Participants · Chi-squared, Corrected · p = 0.01 · Risk ratio (rr): 7.3 · 95% CI 1.5 to 35.6
  • Intervention Health Facility Participants vs Control Health Facility Participants · Chi-squared, Corrected · p = <0.001 · Risk ratio (rr): 413 · 95% CI 65.8 to 2589
Other pre-specifiedCount of Participants Where Essential Birth Practices Were Observed Just Before Pushing, 2 Months Post-intervention Start

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
Reported as:
Count of participants · Participants
Count of Participants Where Essential Birth Practices Were Observed Just Before Pushing, 2 Months Post-intervention Start
ParticipantsIntervention Health Facility ParticipantsControl Health Facility Participants
Hand hygiene3677
No oxytocin given before delivery704333
Clean towel available874166
Clean scissors or blade available843847
Cord tie available10351122
Mucus extractor available9901057
Neonatal bag and mask available9911109
Pads available965502
Checklist Use2551
Statistical analysis
  • Intervention Health Facility Participants vs Control Health Facility Participants · Chi-squared, Corrected · p = <0.001 · Risk ratio (rr): 53.3 · 95% CI 13.1 to 217
  • Intervention Health Facility Participants vs Control Health Facility Participants · Chi-squared, Corrected · p = 0.007 · Risk ratio (rr): 2.3 · 95% CI 1.3 to 4.2
  • Intervention Health Facility Participants vs Control Health Facility Participants · Chi-squared, Corrected · p = <0.001 · Risk ratio (rr): 5.7 · 95% CI 2.7 to 12.1
  • Intervention Health Facility Participants vs Control Health Facility Participants · Chi-squared, Corrected · p = 0.72 · Risk ratio (rr): 1.1 · 95% CI 0.7 to 1.7
  • Intervention Health Facility Participants vs Control Health Facility Participants · Chi-squared, Corrected · p = 0.48 · Risk ratio (rr): 1.0 · 95% CI 1.0 to 1.0
  • Intervention Health Facility Participants vs Control Health Facility Participants · Chi-squared, Corrected · p = 0.73 · Risk ratio (rr): 1.0 · 95% CI 0.9 to 1.1
  • Intervention Health Facility Participants vs Control Health Facility Participants · Chi-squared, Corrected · p = 0.56 · Risk ratio (rr): 1.0 · 95% CI 0.9 to 1.1
  • Intervention Health Facility Participants vs Control Health Facility Participants · Chi-squared, Corrected · p = 0.005 · Risk ratio (rr): 2.1 · 95% CI 1.3 to 3.5
  • Intervention Health Facility Participants vs Control Health Facility Participants · Chi-squared, Corrected · p = <0.001 · Risk ratio (rr): 185 · 95% CI 19.7 to 1738
Other pre-specifiedCount of Participants Where Essential Birth Practices Were Observed Within One Minute After Delivery, 2 Months Post-intervention Start

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
Reported as:
Count of participants · Participants
Count of Participants Where Essential Birth Practices Were Observed Within One Minute After Delivery, 2 Months Post-intervention Start
ParticipantsIntervention Health Facility ParticipantsControl Health Facility Participants
Oxytocin Administered825231
Neonatal bag used4782
Birth companion present10371125
Statistical analysis
  • Intervention Health Facility Participants vs Control Health Facility Participants · Chi-squared, Corrected · p = <0.001 · Risk ratio (rr): 3.9 · 95% CI 2.1 to 7.2
  • Intervention Health Facility Participants vs Control Health Facility Participants · Chi-squared, Corrected · p = 0.25 · Risk ratio (rr): 0.6 · 95% CI 0.3 to 1.4
  • Intervention Health Facility Participants vs Control Health Facility Participants · Chi-squared, Corrected · p = 0.25 · Risk ratio (rr): 1.0 · 95% CI 1.0 to 1.0
Other pre-specifiedCount of Participants Where Essential Birth Practices Were Observed Within One Hour After Delivery, 2 Months Post-intervention Start

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
Reported as:
Count of participants · Participants
Count of Participants Where Essential Birth Practices Were Observed Within One Hour After Delivery, 2 Months Post-intervention Start
ParticipantsIntervention Health Facility ParticipantsControl Health Facility Participants
Newborn weight taken906884
Newborn temperature taken4331
Skin-to-skin care initiated at birth794119
Skin-to-skin care maintained for 1 hr1945
Initiation of breast-feeding70039
Checklist use7470
Statistical analysis
  • Intervention Health Facility Participants vs Control Health Facility Participants · Chi-squared, Corrected · p = 0.25 · Risk ratio (rr): 1.1 · 95% CI 0.9 to 1.4
  • Intervention Health Facility Participants vs Control Health Facility Participants · Chi-squared, Corrected · p = <0.001 · Risk ratio (rr): 317 · 95% CI 50.4 to 1989
  • Intervention Health Facility Participants vs Control Health Facility Participants · Chi-squared, Corrected · p = <0.001 · Risk ratio (rr): 7.3 · 95% CI 2.4 to 22.0
  • Intervention Health Facility Participants vs Control Health Facility Participants · Chi-squared, Corrected · p = <0.001 · Risk ratio (rr): 38.7 · 95% CI 7.7 to 194
  • Intervention Health Facility Participants vs Control Health Facility Participants · Chi-squared, Corrected · p = <0.001 · Risk ratio (rr): 19.4 · 95% CI 11.4 to 33.2
  • Intervention Health Facility Participants vs Control Health Facility Participants · Chi-squared, Corrected · p = <0.001 · Other: 0The relative risk could not be calculated owing to 100% or 0% values in one group.
Other pre-specifiedCount of Participants Where Essential Birth Practices Were Observed at Anytime During Delivery, 2 Months Post-intervention Start

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
Reported as:
Count of participants · Participants
Count of Participants Where Essential Birth Practices Were Observed at Anytime During Delivery, 2 Months Post-intervention Start
ParticipantsIntervention Health Facility ParticipantsControl Health Facility Participants
Maternal temperature taken7924
Maternal blood pressure taken85489
Mother given magnesium sulfate13
Statistical analysis
  • Intervention Health Facility Participants vs Control Health Facility Participants · Chi-squared, Corrected · p = <0.001 · Risk ratio (rr): 182 · 95% CI 33.5 to 993
  • Intervention Health Facility Participants vs Control Health Facility Participants · Chi-squared, Corrected · p = <0.001 · Risk ratio (rr): 9.9 · 95% CI 3.8 to 25.8
  • Intervention Health Facility Participants vs Control Health Facility Participants · Chi-squared, Corrected · p = 0.30 · Risk ratio (rr): 0.4 · 95% CI 0.1 to 2.1
Other pre-specifiedMean Number of 18 Essential Birth Practices Performed at 12 Months Post-intervention Start

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
Reported as:
Mean · essential birth practices performed
Mean Number of 18 Essential Birth Practices Performed at 12 Months Post-intervention Start
essential birth practices performedIntervention Health Facility ParticipantsControl Health Facility Participants
Mean Number of 18 Essential Birth Practices Performed at 12 Months Post-intervention Start11.1 (10.4 to 11.8)7.9 (7.4 to 8.4)
Statistical analysis
  • Intervention Health Facility Participants vs Control Health Facility Participants · Chi-squared, Corrected · p = <0.001 · Other: 0
Other pre-specifiedCount of Participants Where Essential Birth Practices Were Observed at Admission, 12 Months Post-intervention Start

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
Reported as:
Count of participants · Participants
Count of Participants Where Essential Birth Practices Were Observed at Admission, 12 Months Post-intervention Start
ParticipantsIntervention Health Facility ParticipantsControl Health Facility Participants
Birth companion present10041006
Maternal blood pressure taken21911
Maternal temperature taken1530
Partography started70
Checklist use1750
Statistical analysis
  • Intervention Health Facility Participants vs Control Health Facility Participants · Chi-squared, Corrected · p = 1.00 · Risk ratio (rr): 1.0 · 95% CI 1.0 to 1.0
  • Intervention Health Facility Participants vs Control Health Facility Participants · Chi-squared, Corrected · p = <0.001 · Risk ratio (rr): 19.1 · 95% CI 7.9 to 46.5
  • Intervention Health Facility Participants vs Control Health Facility Participants · Chi-squared, Corrected · p = <0.001 · Other: 0The relative risk could not be calculated due to 100% or 0% values in one group.
  • Intervention Health Facility Participants vs Control Health Facility Participants · Chi-squared, Corrected · p = <0.001 · Other: 0The relative risk could not be calculated owing to 100% or 0% values in one group.
  • Intervention Health Facility Participants vs Control Health Facility Participants · Chi-squared, Corrected · p = <0.001 · Other: 0The relative risk could not be calculated owing to 100% or 0% values in one group.
Other pre-specifiedCount of Participants Where Essential Birth Practices Were Observed Just Before Pushing, 12 Months Post-intervention Start

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
Reported as:
Count of participants · Participants
Count of Participants Where Essential Birth Practices Were Observed Just Before Pushing, 12 Months Post-intervention Start
ParticipantsIntervention Health Facility ParticipantsControl Health Facility Participants
Hand hygiene1266
No oxytocin given before delivery527263
Clean towel available721314
Clean scissors or blade available10041008
Cord tie available10091039
Mucus extractor available9991000
Neonatal bag and mask available10171036
Pads available768559
Checklist Use551
Statistical analysis
  • Intervention Health Facility Participants vs Control Health Facility Participants · Chi-squared, Corrected · p = <0.001 · Risk ratio (rr): 19.9 · 95% CI 6.6 to 60.4
  • Intervention Health Facility Participants vs Control Health Facility Participants · Chi-squared, Corrected · p = 0.04 · Risk ratio (rr): 2.1 · 95% CI 1.0 to 4.1
  • Intervention Health Facility Participants vs Control Health Facility Participants · Chi-squared, Corrected · p = 0.006 · Risk ratio (rr): 2.4 · 95% CI 1.3 to 4.3
  • Intervention Health Facility Participants vs Control Health Facility Participants · Chi-squared, Corrected · p = 0.34 · Risk ratio (rr): 1.0 · 95% CI 1.0 to 1.1
  • Intervention Health Facility Participants vs Control Health Facility Participants · Chi-squared, Corrected · p = 0.25 · Risk ratio (rr): 1.0 · 95% CI 1.0 to 1.0
  • Intervention Health Facility Participants vs Control Health Facility Participants · Chi-squared, Corrected · p = 0.50 · Risk ratio (rr): 1.0 · 95% CI 1.0 to 1.1
  • Intervention Health Facility Participants vs Control Health Facility Participants · Chi-squared, Corrected · p = 0.32 · Risk ratio (rr): 1.0 · 95% CI 1.0 to 1.0
  • Intervention Health Facility Participants vs Control Health Facility Participants · Chi-squared, Corrected · p = 0.11 · Risk ratio (rr): 1.4 · 95% CI 0.9 to 2.1
  • Intervention Health Facility Participants vs Control Health Facility Participants · Chi-squared, Corrected · p = <0.001 · Risk ratio (rr): 37.9 · 95% CI 7.3 to 196
Other pre-specifiedCount of Participants Where Essential Birth Practices Were Observed Within One Minute After Delivery, 12 Months Post-intervention Start

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
Reported as:
Count of participants · Participants
Count of Participants Where Essential Birth Practices Were Observed Within One Minute After Delivery, 12 Months Post-intervention Start
ParticipantsIntervention Health Facility ParticipantsControl Health Facility Participants
Oxytocin Administered549154
Neonatal bag used3049
Birth companion present10161035
Statistical analysis
  • Intervention Health Facility Participants vs Control Health Facility Participants · Chi-squared, Corrected · p = <0.001 · Risk ratio (rr): 3.6 · 95% CI 1.8 to 7.5
  • Intervention Health Facility Participants vs Control Health Facility Participants · Chi-squared, Corrected · p = 0.19 · Risk ratio (rr): 0.6 · 95% CI 0.3 to 1.3
  • Intervention Health Facility Participants vs Control Health Facility Participants · Chi-squared, Corrected · p = 0.50 · Risk ratio (rr): 1.0 · 95% CI 1.0 to 1.0
Other pre-specifiedCount of Participants Where Essential Birth Practices Were Observed Within One Hour After Delivery, 12 Months Post-intervention Start

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
Reported as:
Count of participants · Participants
Count of Participants Where Essential Birth Practices Were Observed Within One Hour After Delivery, 12 Months Post-intervention Start
ParticipantsIntervention Health Facility ParticipantsControl Health Facility Participants
Newborn weight taken947843
Newborn temperature taken2252
Skin-to-skin care initiated at birth68584
Skin-to-skin care maintained for 1 hr510
Initiation of breast-feeding36947
Checklist use3510
Statistical analysis
  • Intervention Health Facility Participants vs Control Health Facility Participants · Chi-squared, Corrected · p = 0.08 · Risk ratio (rr): 1.1 · 95% CI 1.0 to 1.3
  • Intervention Health Facility Participants vs Control Health Facility Participants · Chi-squared, Corrected · p = <0.001 · Risk ratio (rr): 91.5 · 95% CI 11.0 to 758
  • Intervention Health Facility Participants vs Control Health Facility Participants · Chi-squared, Corrected · p = <0.001 · Risk ratio (rr): 8.2 · 95% CI 2.5 to 27.5
  • Intervention Health Facility Participants vs Control Health Facility Participants · Chi-squared, Corrected · p = 0.01 · Other: 0The relative risk could not be calculated owing to 100% or 0% values in one group.
  • Intervention Health Facility Participants vs Control Health Facility Participants · Chi-squared, Corrected · p = <0.001 · Risk ratio (rr): 7.9 · 95% CI 3.7 to 16.7
  • Intervention Health Facility Participants vs Control Health Facility Participants · Chi-squared, Corrected · p = <0.001 · Other: 0The relative risk could not be calculated owing to 100% or 0% values in one group.
Other pre-specifiedCount of Participants Where Essential Birth Practices Were Observed at Anytime, 12 Months Post-intervention Start

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
Reported as:
Count of participants · Participants
Count of Participants Where Essential Birth Practices Were Observed at Anytime, 12 Months Post-intervention Start
ParticipantsIntervention Health Facility ParticipantsControl Health Facility Participants
Maternal temperature taken3430
Maternal blood pressure taken42535
Mother given magnesium sulfate11
Statistical analysis
  • Intervention Health Facility Participants vs Control Health Facility Participants · Chi-squared, Corrected · p = <0.001 · Other: 0The relative risk could not be calculated owing to 100% or 0% values in one group.
  • Intervention Health Facility Participants vs Control Health Facility Participants · Chi-squared, Corrected · p = <0.001 · Risk ratio (rr): 12.7 · 95% CI 4.7 to 34.3
  • Intervention Health Facility Participants vs Control Health Facility Participants · Chi-squared, Corrected · p = 0.95 · Risk ratio (rr): 1.1 · 95% CI 0.2 to 6.6

Adverse events

Collected over Adverse events were monitored for occurrence and reporting throughout the duration of the study period (2 years).. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Intervention Health Facility Participants3,917/159,587 (2.5%)0/159,587 (0%)0/159,587 (0%)
Control Health Facility Participants3,677/154,684 (2.4%)0/154,684 (0%)0/154,684 (0%)

Baseline characteristics

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
Age, Continuous(years)Intervention Health Facility ParticipantsControl Health Facility ParticipantsTotal
Mean25.6 (25.5 to 25.8)25.7 (25.5 to 25.9)25.66 (25.54 to 25.79)
Sex/Gender, Customized
Sex/Gender, Customized(Participants)Intervention Health Facility ParticipantsControl Health Facility ParticipantsTotal
Sex of newborn — Male405583906379621
Sex of newborn — Female369763626673242
Sex of newborn — Unknown391333347247
Sex: Female, Male
Sex: Female, Male(Participants)Intervention Health Facility ParticipantsControl Health Facility ParticipantsTotal
Female8192579182161107
Male000
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)Intervention Health Facility ParticipantsControl Health Facility ParticipantsTotal
Count of participants——0
Region of Enrollment
Region of Enrollment(participants)Intervention Health Facility ParticipantsControl Health Facility ParticipantsTotal
India8192579182161107
Mean Annual Delivery Load
Mean Annual Delivery Load(deliveries)Intervention Health Facility ParticipantsControl Health Facility ParticipantsTotal
Mean1599 (1486 to 1712)1683 (1552 to 1814)1641 (1531 to 1751)
Functional Classification
Functional Classification(Facilities)Intervention Health Facility ParticipantsControl Health Facility ParticipantsTotal
Primary health center232346
Community Health Center272956
First referral unit10818
Mean distance to district hospital
Mean distance to district hospital(km)Intervention Health Facility ParticipantsControl Health Facility ParticipantsTotal
Mean29.5 (25.9 to 33.1)30.3 (27.2 to 33.4)29.9 (27.0 to 32.8)

8 further baseline measures are reported on the registry.

07

Study locations

1 site
  • PSI
    Lucknow, Uttar Pradesh 226 010, India
08

References and documents

Publications

  • Lofgren KT, Bobanski L, Tuller DE, Singh VP, Marx Delaney M, Jurczak A, Ragavan M, Kalita T, Karlage A, Resch SC, Semrau KEA. Estimating maternity ward birth attendant time use in India: a microcosting study. BMJ Open. 2022 Feb 7;12(2):e054164. doi: 10.1136/bmjopen-2021-054164. PubMed 35131826 ↗
  • Semrau KE, Miller KA, Lipsitz S, Fisher-Bowman J, Karlage A, Neville BA, Krasne M, Gass J, Jurczak A, Pratap Singh V, Singh S, Marx Delaney M, Hirschhorn LR, Kodkany B, Kumar V, Gawande AA. Does adherence to evidence-based practices during childbirth prevent perinatal mortality? A post-hoc analysis of 3,274 births in Uttar Pradesh, India. BMJ Glob Health. 2020 Sep;5(9):e002268. doi: 10.1136/bmjgh-2019-002268. PubMed 32928798 ↗
  • Barnhart DA, Semrau KEA, Zigler CM, Molina RL, Delaney MM, Hirschhorn LR, Spiegelman D. Optimizing the development and evaluation of complex interventions: lessons learned from the BetterBirth Program and associated trial. Implement Sci Commun. 2020 Feb 25;1:29. doi: 10.1186/s43058-020-00014-8. eCollection 2020. PubMed 32885188 ↗
  • Molina RL, Neal BJ, Bobanski L, Singh VP, Neville BA, Delaney MM, Lipsitz S, Karlage A, Shetye M, Semrau KEA. Nurses' and auxiliary nurse midwives' adherence to essential birth practices with peer coaching in Uttar Pradesh, India: a secondary analysis of the BetterBirth trial. Implement Sci. 2020 Jan 3;15(1):1. doi: 10.1186/s13012-019-0962-7. PubMed 31900167 ↗
  • Hirschhorn LR, Krasne M, Maisonneuve J, Kara N, Kalita T, Henrich N, Rana D, Maji P, Delaney MM, Firestone R, Sharma N, Kumar V, Gawande AA, Semrau KEA. Integration of the Opportunity-Ability-Motivation behavior change framework into a coaching-based WHO Safe Childbirth Checklist program in India. Int J Gynaecol Obstet. 2018 Sep;142(3):321-328. doi: 10.1002/ijgo.12542. Epub 2018 Jun 20. PubMed 29862506 ↗
  • Maisonneuve JJ, Semrau KEA, Maji P, Pratap Singh V, Miller KA, Solsky I, Dixit N, Sharma J, Lagoo J, Panariello N, Neal BJ, Kalita T, Kara N, Kumar V, Hirschhorn LR. Effectiveness of a WHO Safe Childbirth Checklist Coaching-based intervention on the availability of Essential Birth Supplies in Uttar Pradesh, India. Int J Qual Health Care. 2018 Dec 1;30(10):769-777. doi: 10.1093/intqhc/mzy086. PubMed 29718354 ↗
  • Semrau KEA, Hirschhorn LR, Marx Delaney M, Singh VP, Saurastri R, Sharma N, Tuller DE, Firestone R, Lipsitz S, Dhingra-Kumar N, Kodkany BS, Kumar V, Gawande AA; BetterBirth Trial Group. Outcomes of a Coaching-Based WHO Safe Childbirth Checklist Program in India. N Engl J Med. 2017 Dec 14;377(24):2313-2324. doi: 10.1056/NEJMoa1701075. PubMed 29236628 ↗
  • Gass JD Jr, Misra A, Yadav MNS, Sana F, Singh C, Mankar A, Neal BJ, Fisher-Bowman J, Maisonneuve J, Delaney MM, Kumar K, Singh VP, Sharma N, Gawande A, Semrau K, Hirschhorn LR. Implementation and results of an integrated data quality assurance protocol in a randomized controlled trial in Uttar Pradesh, India. Trials. 2017 Sep 7;18(1):418. doi: 10.1186/s13063-017-2159-1. PubMed 28882167 ↗
  • Semrau KE, Hirschhorn LR, Kodkany B, Spector JM, Tuller DE, King G, Lipsitz S, Sharma N, Singh VP, Kumar B, Dhingra-Kumar N, Firestone R, Kumar V, Gawande AA. Effectiveness of the WHO Safe Childbirth Checklist program in reducing severe maternal, fetal, and newborn harm in Uttar Pradesh, India: study protocol for a matched-pair, cluster-randomized controlled trial. Trials. 2016 Dec 7;17(1):576. doi: 10.1186/s13063-016-1673-x. PubMed 27923401 ↗

Study documents

  • Protocol and statistical analysis plan · Oct 11, 2017

Documents are hosted by the registry — open the source record to download them.

09

Registry details

Key details

Study ID
NCT02148952
Lead sponsor
Harvard School of Public Health (HSPH)
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
Responsible party
Katherine Semrau (Principal Investigator, Harvard School of Public Health (HSPH)) — Principal investigator
First posted
May 29, 2014
Start date
Nov 2014
Primary completion
Jan 20, 2017
Completion
Jul 18, 2017
Results posted
Feb 20, 2019
Last update
Jun 26, 2024

Study contacts

Atul Gawande, MD, MPH
principal investigator · Harvard School of Public Health (HSPH)
Vishwajeet Kumar, MBBS, MPH
principal investigator · Community Empowerment Lab
Bhala Kodkany, MBBS
principal investigator · Jawarhlal Nehru Medical College
Katherine Semrau, PhD
principal investigator · Harvard Medical School/ Ariadne Labs

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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