- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02148952
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
Status
Completed
Conditions
Intervention / Treatment
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.
Collaborators
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
- 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.
- 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.
- 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.
- Molina RL, Neal BJ, Bobanski L, Singh VP, Neville BA, Delaney MM, Lipsitz S, Karlage A, Shetye M, Semrau KEA. Nurses' and auxiliary nurse midwives' adherence to essential birth practices with peer coaching in Uttar Pradesh, India: a secondary analysis of the BetterBirth trial. Implement Sci. 2020 Jan 3;15(1):1. doi: 10.1186/s13012-019-0962-7.
- Hirschhorn LR, Krasne M, Maisonneuve J, Kara N, Kalita T, Henrich N, Rana D, Maji P, Delaney MM, Firestone R, Sharma N, Kumar V, Gawande AA, Semrau KEA. Integration of the Opportunity-Ability-Motivation behavior change framework into a coaching-based WHO Safe Childbirth Checklist program in India. Int J Gynaecol Obstet. 2018 Sep;142(3):321-328. doi: 10.1002/ijgo.12542. Epub 2018 Jun 20.
- Maisonneuve JJ, Semrau KEA, Maji P, Pratap Singh V, Miller KA, Solsky I, Dixit N, Sharma J, Lagoo J, Panariello N, Neal BJ, Kalita T, Kara N, Kumar V, Hirschhorn LR. Effectiveness of a WHO Safe Childbirth Checklist Coaching-based intervention on the availability of Essential Birth Supplies in Uttar Pradesh, India. Int J Qual Health Care. 2018 Dec 1;30(10):769-777. doi: 10.1093/intqhc/mzy086.
- Semrau KEA, Hirschhorn LR, Marx Delaney M, Singh VP, Saurastri R, Sharma N, Tuller DE, Firestone R, Lipsitz S, Dhingra-Kumar N, Kodkany BS, Kumar V, Gawande AA; BetterBirth Trial Group. Outcomes of a Coaching-Based WHO Safe Childbirth Checklist Program in India. N Engl J Med. 2017 Dec 14;377(24):2313-2324. doi: 10.1056/NEJMoa1701075.
- Gass JD Jr, Misra A, Yadav MNS, Sana F, Singh C, Mankar A, Neal BJ, Fisher-Bowman J, Maisonneuve J, Delaney MM, Kumar K, Singh VP, Sharma N, Gawande A, Semrau K, Hirschhorn LR. Implementation and results of an integrated data quality assurance protocol in a randomized controlled trial in Uttar Pradesh, India. Trials. 2017 Sep 7;18(1):418. doi: 10.1186/s13063-017-2159-1.
- Semrau KE, Hirschhorn LR, Kodkany B, Spector JM, Tuller DE, King G, Lipsitz S, Sharma N, Singh VP, Kumar B, Dhingra-Kumar N, Firestone R, Kumar V, Gawande AA. Effectiveness of the WHO Safe Childbirth Checklist program in reducing severe maternal, fetal, and newborn harm in Uttar Pradesh, India: study protocol for a matched-pair, cluster-randomized controlled trial. Trials. 2016 Dec 7;17(1):576. doi: 10.1186/s13063-016-1673-x.
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
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HSPH OPP1017378
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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