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

• ClinicalTrials.gov Identifier: NCT02148952
• Recruitment Status: Completed
• First Posted: May 29, 2014
• Results First Posted: February 20, 2019
• Last Update Posted: February 20, 2019
• Sponsor: Harvard School of Public Health
• 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
• Information provided by (Responsible Party): Atul Gawande, Harvard School of Public Health

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.

Condition or disease	Intervention/treatment	Phase
Maternal Death; Maternal Morbidity; Stillbirth; Neonatal Death	Behavioral: WHO Safe Childbirth Checklist Program	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 157689 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• 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 Start Date: November 2014
• Actual Primary Completion Date: January 20, 2017
• Actual Study Completion Date: July 18, 2017

Arms and Interventions

Arm	Intervention/treatment
Experimental: Intervention Health Facility; WHO Safe Childbirth Checklist Program	Behavioral: 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

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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
2. 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)
3. Count of Participants With Stillbirth [ Time Frame: 0-7 days after delivery ]
   Newborn outcome; rate of stillbirth
4. Count of Participants With Early Neonatal Death [ Time Frame: 0-7 days after delivery ]
   Newborn outcome; rate of early neonatal death
5. Count of Participants With Maternal Death [ Time Frame: 0-7 days after delivery ]
   Maternal outcome; rate of maternal death
6. Count of Participants With Severe Maternal Complications [ Time Frame: 0-7 days after delivery ]
   Maternal outcome; any severe maternal complication within 7 days
7. 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
8. 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
9. Count of Participants With Newborn Referral [ Time Frame: 0-7 days after delivery ]
   Newborn outcome; Newborn referral
10. Count of Participants With Hysterectomy Within 7 Days [ Time Frame: 0-7 days after delivery ]
    Rate of hysterectomy within 7 days
11. Count of Participants With Blood Transfusion Within 7 Days [ Time Frame: 0-7 days after delivery ]
    Rate of blood transfusion within 7 days
12. 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
13. 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)

Other Outcome Measures:

1. 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. 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.
3. 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.
4. 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.
5. 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.
6. 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.
7. 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.
8. 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.
9. 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
10. 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
11. 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. 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.

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

India

PSI

Lucknow, Uttar Pradesh, India, 226 010

Sponsors and Collaborators

Harvard School of Public Health

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

Investigators

• Principal Investigator: Atul Gawande, MD, MPH; Harvard School of Public Health
• 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

  Study Documents (Full-Text)

Documents provided by Atul Gawande, Harvard School of Public Health:

Study Protocol and Statistical Analysis Plan  [PDF] October 11, 2017

More Information

Additional Information:

WHO Safe Childbirth Checklist 

Ariadne Labs 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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). pii: 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.

• Responsible Party: Atul Gawande, Principal Investigator, Harvard School of Public Health
• ClinicalTrials.gov Identifier: NCT02148952
• Other Study ID Numbers: HSPH OPP1017378
• First Posted: May 29, 2014
• Results First Posted: February 20, 2019
• Last Update Posted: February 20, 2019
• Last Verified: October 2018

Keywords provided by Atul Gawande, Harvard School of Public Health:

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

Additional relevant MeSH terms:

Stillbirth; Perinatal Death; Maternal Death; Death; Pathologic Processes; Fetal Death; Pregnancy Complications; Parental Death