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

Primary Purpose

Maternal Death, Maternal Morbidity, Stillbirth

Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
WHO Safe Childbirth Checklist Program
Sponsored by
Harvard School of Public Health (HSPH)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Maternal Death focused on measuring Maternal Health, Maternal Death, Maternal Morbidity, Stillbirth, Neonatal Mortality, Quality Improvement, Resource Limited Settings, Checklist, Safe Childbirth

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • PSI

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention Health Facility

Control Health Facility

Arm Description

WHO Safe Childbirth Checklist Program

Matched control facilities providing comparison for intervention facilities

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
Count of Participants With Perinatal Death Within 7 Days
Count of participants with perinatal death within 7 days (combined stillbirth or neonatal death)
Count of Participants With Stillbirth
Newborn outcome; rate of stillbirth
Count of Participants With Early Neonatal Death
Newborn outcome; rate of early neonatal death
Count of Participants With Maternal Death
Maternal outcome; rate of maternal death
Count of Participants With Severe Maternal Complications
Maternal outcome; any severe maternal complication within 7 days
Count of Participants With Cesarean Section
Rate of cesarean section
Count of Participants With Maternal Referral, Before or After Delivery
Maternal outcome; Rate of maternal inter-facility transfer
Count of Participants With Newborn Referral
Newborn outcome; Newborn referral
Count of Participants With Hysterectomy Within 7 Days
Rate of hysterectomy within 7 days
Count of Participants With Blood Transfusion Within 7 Days
Rate of blood transfusion within 7 days
Count of Mothers Returning to Facility for a Health Problem Within 7 Days
Maternal Outcome; Rate of need for follow-up care for Mother
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)

Full Information

First Posted
February 13, 2014
Last Updated
October 12, 2018
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
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1. Study Identification

Unique Protocol Identification Number
NCT02148952
Brief Title
BetterBirth: A Trial of the WHO Safe Childbirth Checklist Program
Acronym
BetterBirth
Official Title
A Matched-pair, Cluster Randomized Trial to Measure the Efficacy of the WHO Safe Childbirth Checklist Program on Severe Maternal, Fetal and Newborn Harm
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
November 2014 (undefined)
Primary Completion Date
January 20, 2017 (Actual)
Study Completion Date
July 18, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the 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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
157689 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Health Facility
Arm Type
Experimental
Arm Description
WHO Safe Childbirth Checklist Program
Arm Title
Control Health Facility
Arm Type
No Intervention
Arm Description
Matched control facilities providing comparison for intervention facilities
Intervention Type
Behavioral
Intervention Name(s)
WHO Safe Childbirth Checklist Program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage of Participants With Composite Measure of Perinatal Death, Maternal Death, or Maternal Severe Complications Within 7 Days
Description
The primary outcome was a composite outcome of events occurring within the first 7 days after delivery, incorporating stillbirth; early neonatal death; maternal death; or self-reported maternal severe complications, including seizures, loss of consciousness for more than 1 hour, fever with foul-smelling vaginal discharge, hemorrhage, or stroke.
Time Frame
0-7 days after delivery
Secondary Outcome Measure Information:
Title
Percentage of Participants With Perinatal Death or Maternal Death Within 7 Days
Description
Percentage of participants with composite rate of perinatal death and maternal death within 7 days
Time Frame
0-7 days after delivery
Title
Count of Participants With Perinatal Death Within 7 Days
Description
Count of participants with perinatal death within 7 days (combined stillbirth or neonatal death)
Time Frame
0-7 days
Title
Count of Participants With Stillbirth
Description
Newborn outcome; rate of stillbirth
Time Frame
0-7 days after delivery
Title
Count of Participants With Early Neonatal Death
Description
Newborn outcome; rate of early neonatal death
Time Frame
0-7 days after delivery
Title
Count of Participants With Maternal Death
Description
Maternal outcome; rate of maternal death
Time Frame
0-7 days after delivery
Title
Count of Participants With Severe Maternal Complications
Description
Maternal outcome; any severe maternal complication within 7 days
Time Frame
0-7 days after delivery
Title
Count of Participants With Cesarean Section
Description
Rate of cesarean section
Time Frame
Around the time of delivery during facility stay, an expected average of 2 days (although individual patients may vary)
Title
Count of Participants With Maternal Referral, Before or After Delivery
Description
Maternal outcome; Rate of maternal inter-facility transfer
Time Frame
0-7 days after delivery
Title
Count of Participants With Newborn Referral
Description
Newborn outcome; Newborn referral
Time Frame
0-7 days after delivery
Title
Count of Participants With Hysterectomy Within 7 Days
Description
Rate of hysterectomy within 7 days
Time Frame
0-7 days after delivery
Title
Count of Participants With Blood Transfusion Within 7 Days
Description
Rate of blood transfusion within 7 days
Time Frame
0-7 days after delivery
Title
Count of Mothers Returning to Facility for a Health Problem Within 7 Days
Description
Maternal Outcome; Rate of need for follow-up care for Mother
Time Frame
0-7 days after delivery
Title
Count of Newborns Returning to Facility for a Health Problem Within 7 Days
Description
Newborn outcome; Rate of need for follow-up care for newborn (or at least one newborn in case of twins)
Time Frame
0-7 days after delivery
Other Pre-specified Outcome Measures:
Title
Mean Number of 18 Essential Birth Practices Performed at 2 Months Post-intervention Start
Description
Birth attendant's rate of completion of "Process measures" resulting from Safe Childbirth Checklist program will be assessed in a sample of total birth events at 2 months after the intervention is introduced to intervention facilities. The below measures reflect the mean number of 18 essential birth practices performed across the intervention versus control facilities at 2 months post-intervention start.
Time Frame
2 months post-intervention start
Title
Count of Participants Where Essential Birth Practices Were Observed at Admission, 2 Months Post-intervention Start
Description
Birth attendant's rate of completion of "Process measures" resulting from Safe Childbirth Checklist program will be assessed in a sample of total birth events at 2 months after the intervention is introduced to intervention facilities. The below measures reflect the essential birth practices performed at the time of the woman's admission to the facility, 2 months post-intervention start.
Time Frame
2 months post-intervention start
Title
Count of Participants Where Essential Birth Practices Were Observed Just Before Pushing, 2 Months Post-intervention Start
Description
Birth attendant's rate of completion of "Process measures" resulting from Safe Childbirth Checklist program will be assessed in a sample of total birth events at 2 months after the intervention is introduced to intervention facilities. The below measures reflect the essential birth practices performed at the time of labor just before pushing, 2 months post-intervention start.
Time Frame
2 months post-intervention start
Title
Count of Participants Where Essential Birth Practices Were Observed Within One Minute After Delivery, 2 Months Post-intervention Start
Description
Birth attendant's rate of completion of "Process measures" resulting from Safe Childbirth Checklist program will be assessed in a sample of total birth events at 2 months after the intervention is introduced to intervention facilities. The below measures reflect the essential birth practices performed at the time within one minute after the woman's delivery, 2 months post-intervention start.
Time Frame
2 months post-intervention start
Title
Count of Participants Where Essential Birth Practices Were Observed Within One Hour After Delivery, 2 Months Post-intervention Start
Description
Birth attendant's rate of completion of "Process measures" resulting from Safe Childbirth Checklist program will be assessed in a sample of total birth events at 2 months after the intervention is introduced to intervention facilities. The below measures reflect the essential birth practices performed within one hour after delivery, 2 months post-intervention start.
Time Frame
2 months post-intervention start
Title
Count of Participants Where Essential Birth Practices Were Observed at Anytime During Delivery, 2 Months Post-intervention Start
Description
Birth attendant's rate of completion of "Process measures" resulting from Safe Childbirth Checklist program will be assessed in a sample of total birth events at 2 months after the intervention is introduced to intervention facilities. The below measures reflect the essential birth practices performed at anytime during the observation period of the woman's delivery, 2 months post-intervention start.
Time Frame
2 months post-intervention start
Title
Mean Number of 18 Essential Birth Practices Performed at 12 Months Post-intervention Start
Description
Birth attendant's rate of completion of "Process measures" resulting from Safe Childbirth Checklist program will be assessed in a sample of total birth events at 12 months after the intervention is introduced to intervention facilities. The below measures reflect the mean number of 18 essential birth practices performed across the intervention versus control facilities at 12 months post-intervention start.
Time Frame
12 months post-intervention start
Title
Count of Participants Where Essential Birth Practices Were Observed at Admission, 12 Months Post-intervention Start
Description
Birth attendant's rate of completion of "Process measures" resulting from Safe Childbirth Checklist program will be assessed in a sample of total birth events at 12 months after the intervention is introduced to intervention facilities. The below measures reflect the essential birth practices performed at the time of the woman's admission to the facility, 12 months post-intervention start.
Time Frame
12 months post-intervention start
Title
Count of Participants Where Essential Birth Practices Were Observed Just Before Pushing, 12 Months Post-intervention Start
Description
Birth attendant's rate of completion of "Process measures" resulting from Safe Childbirth Checklist program will be assessed in a sample of total birth events at 12 months after the intervention is introduced to intervention facilities. The below measures reflect the essential birth practices performed at the time just before pushing, 12 months post-intervention start
Time Frame
12 months post-intervention start
Title
Count of Participants Where Essential Birth Practices Were Observed Within One Minute After Delivery, 12 Months Post-intervention Start
Description
Birth attendant's rate of completion of "Process measures" resulting from Safe Childbirth Checklist program will be assessed in a sample of total birth events at 12 months after the intervention is introduced to intervention facilities. The below measures reflect the essential birth practices performed within one minute after delivery, 12 months post-intervention start
Time Frame
12 months post-intervention start
Title
Count of Participants Where Essential Birth Practices Were Observed Within One Hour After Delivery, 12 Months Post-intervention Start
Description
Birth attendant's rate of completion of "Process measures" resulting from Safe Childbirth Checklist program will be assessed in a sample of total birth events at 12 months after the intervention is introduced to intervention facilities. The below measures reflect the essential birth practices performed within one hour after delivery, 12 months post-intervention start
Time Frame
12 months post-intervention start
Title
Count of Participants Where Essential Birth Practices Were Observed at Anytime, 12 Months Post-intervention Start
Description
Birth attendant's rate of completion of "Process measures" resulting from Safe Childbirth Checklist program will be assessed in a sample of total birth events at 12 months after the intervention is introduced to intervention facilities. The below measures reflect the essential birth practices performed at any time during the observation period, 12 months post-intervention start.
Time Frame
12 months post-intervention start

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Atul Gawande, MD, MPH
Organizational Affiliation
Harvard School of Public Health (HSPH)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Vishwajeet Kumar, MBBS, MPH
Organizational Affiliation
Community Empowerment Lab
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bhala Kodkany, MBBS
Organizational Affiliation
Jawarhlal Nehru Medical College
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Katherine Semrau, PhD
Organizational Affiliation
Harvard Medical School/ Ariadne Labs
Official's Role
Principal Investigator
Facility Information:
Facility Name
PSI
City
Lucknow
State/Province
Uttar Pradesh
ZIP/Postal Code
226 010
Country
India

12. IPD Sharing Statement

Citations:
PubMed Identifier
35131826
Citation
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.
Results Reference
derived
PubMed Identifier
32928798
Citation
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.
Results Reference
derived
PubMed Identifier
32885188
Citation
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.
Results Reference
derived
PubMed Identifier
31900167
Citation
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.
Results Reference
derived
PubMed Identifier
29862506
Citation
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.
Results Reference
derived
PubMed Identifier
29718354
Citation
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.
Results Reference
derived
PubMed Identifier
29236628
Citation
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.
Results Reference
derived
PubMed Identifier
28882167
Citation
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.
Results Reference
derived
PubMed Identifier
27923401
Citation
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.
Results Reference
derived
Links:
URL
http://www.ariadnelabs.org/
Description
Ariadne Labs

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BetterBirth: A Trial of the WHO Safe Childbirth Checklist Program

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