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

October 12, 2018 updated by: Atul Gawande, Harvard School of Public Health (HSPH)

A Matched-pair, Cluster Randomized Trial to Measure the Efficacy of the WHO Safe Childbirth Checklist Program on Severe Maternal, Fetal and Newborn Harm

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

157689

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Uttar Pradesh
      • Lucknow, Uttar Pradesh, India, 226 010
        • PSI

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Health Facility
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.
No Intervention: Control Health Facility
Matched control facilities providing comparison for intervention facilities

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Composite Measure of Perinatal Death, Maternal Death, or Maternal Severe Complications Within 7 Days
Time Frame: 0-7 days after delivery
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.
0-7 days after delivery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Perinatal Death or Maternal Death Within 7 Days
Time Frame: 0-7 days after delivery
Percentage of participants with composite rate of perinatal death and maternal death within 7 days
0-7 days after delivery
Count of Participants With Perinatal Death Within 7 Days
Time Frame: 0-7 days
Count of participants with perinatal death within 7 days (combined stillbirth or neonatal death)
0-7 days
Count of Participants With Stillbirth
Time Frame: 0-7 days after delivery
Newborn outcome; rate of stillbirth
0-7 days after delivery
Count of Participants With Early Neonatal Death
Time Frame: 0-7 days after delivery
Newborn outcome; rate of early neonatal death
0-7 days after delivery
Count of Participants With Maternal Death
Time Frame: 0-7 days after delivery
Maternal outcome; rate of maternal death
0-7 days after delivery
Count of Participants With Severe Maternal Complications
Time Frame: 0-7 days after delivery
Maternal outcome; any severe maternal complication within 7 days
0-7 days after delivery
Count of Participants With Cesarean Section
Time Frame: Around the time of delivery during facility stay, an expected average of 2 days (although individual patients may vary)
Rate of cesarean section
Around the time of delivery during facility stay, an expected average of 2 days (although individual patients may vary)
Count of Participants With Maternal Referral, Before or After Delivery
Time Frame: 0-7 days after delivery
Maternal outcome; Rate of maternal inter-facility transfer
0-7 days after delivery
Count of Participants With Newborn Referral
Time Frame: 0-7 days after delivery
Newborn outcome; Newborn referral
0-7 days after delivery
Count of Participants With Hysterectomy Within 7 Days
Time Frame: 0-7 days after delivery
Rate of hysterectomy within 7 days
0-7 days after delivery
Count of Participants With Blood Transfusion Within 7 Days
Time Frame: 0-7 days after delivery
Rate of blood transfusion within 7 days
0-7 days after delivery
Count of Mothers Returning to Facility for a Health Problem Within 7 Days
Time Frame: 0-7 days after delivery
Maternal Outcome; Rate of need for follow-up care for Mother
0-7 days after delivery
Count of Newborns Returning to Facility for a Health Problem Within 7 Days
Time Frame: 0-7 days after delivery
Newborn outcome; Rate of need for follow-up care for newborn (or at least one newborn in case of twins)
0-7 days after delivery

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Number of 18 Essential Birth Practices Performed at 2 Months Post-intervention Start
Time Frame: 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.
2 months post-intervention start
Count of Participants Where Essential Birth Practices Were Observed at Admission, 2 Months Post-intervention Start
Time Frame: 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.
2 months post-intervention start
Count of Participants Where Essential Birth Practices Were Observed Just Before Pushing, 2 Months Post-intervention Start
Time Frame: 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.
2 months post-intervention start
Count of Participants Where Essential Birth Practices Were Observed Within One Minute After Delivery, 2 Months Post-intervention Start
Time Frame: 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.
2 months post-intervention start
Count of Participants Where Essential Birth Practices Were Observed Within One Hour After Delivery, 2 Months Post-intervention Start
Time Frame: 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.
2 months post-intervention start
Count of Participants Where Essential Birth Practices Were Observed at Anytime During Delivery, 2 Months Post-intervention Start
Time Frame: 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.
2 months post-intervention start
Mean Number of 18 Essential Birth Practices Performed at 12 Months Post-intervention Start
Time Frame: 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.
12 months post-intervention start
Count of Participants Where Essential Birth Practices Were Observed at Admission, 12 Months Post-intervention Start
Time Frame: 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.
12 months post-intervention start
Count of Participants Where Essential Birth Practices Were Observed Just Before Pushing, 12 Months Post-intervention Start
Time Frame: 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
12 months post-intervention start
Count of Participants Where Essential Birth Practices Were Observed Within One Minute After Delivery, 12 Months Post-intervention Start
Time Frame: 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
12 months post-intervention start
Count of Participants Where Essential Birth Practices Were Observed Within One Hour After Delivery, 12 Months Post-intervention Start
Time Frame: 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
12 months post-intervention start
Count of Participants Where Essential Birth Practices Were Observed at Anytime, 12 Months Post-intervention Start
Time Frame: 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.
12 months post-intervention start

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Vishwajeet Kumar, MBBS, MPH, Community Empowerment Lab
  • Principal Investigator: Bhala Kodkany, MBBS, Jawarhlal Nehru Medical College
  • Principal Investigator: Katherine Semrau, PhD, Harvard Medical School/ Ariadne Labs

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Actual)

January 20, 2017

Study Completion (Actual)

July 18, 2017

Study Registration Dates

First Submitted

February 13, 2014

First Submitted That Met QC Criteria

May 23, 2014

First Posted (Estimate)

May 29, 2014

Study Record Updates

Last Update Posted (Actual)

February 20, 2019

Last Update Submitted That Met QC Criteria

October 12, 2018

Last Verified

October 1, 2018

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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