Clinical trial NCT02148952: BetterBirth: A Trial of the WHO Safe Childbirth Checklist Program
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
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: Harvard School of Public Health (HSPH)
Sponsor class: OTHER
Collaborators: name: World Health Organization
name: Population Services International
name: Jawaharlal Nehru Medical College
name: Community Empowerment Lab
name: Brigham and Women's Hospital
name: Bill and Melinda Gates Foundation
name: MacArthur Foundation
First posted: 2014-05-29
Enrollment: 157689
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Percentage of Participants With Composite Measure of Perinatal Death, Maternal Death, or Maternal Severe Complications Within 7 Days
timeFrame: 0-7 days after delivery
Secondary outcomes:
measure: Percentage of Participants With Perinatal Death or Maternal Death Within 7 Days
timeFrame: 0-7 days after delivery
measure: Count of Participants With Perinatal Death Within 7 Days
timeFrame: 0-7 days
measure: Count of Participants With Stillbirth
timeFrame: 0-7 days after delivery
measure: Count of Participants With Early Neonatal Death
timeFrame: 0-7 days after delivery
measure: Count of Participants With Maternal Death
timeFrame: 0-7 days after delivery
measure: Count of Participants With Severe Maternal Complications
timeFrame: 0-7 days after delivery
measure: Count of Participants With Cesarean Section
timeFrame: Around the time of delivery during facility stay, an expected average of 2 days (although individual patients may vary)
measure: Count of Participants With Maternal Referral, Before or After Delivery
timeFrame: 0-7 days after delivery
measure: Count of Participants With Newborn Referral
timeFrame: 0-7 days after delivery
measure: Count of Participants With Hysterectomy Within 7 Days
timeFrame: 0-7 days after delivery
measure: Count of Participants With Blood Transfusion Within 7 Days
timeFrame: 0-7 days after delivery
measure: Count of Mothers Returning to Facility for a Health Problem Within 7 Days
timeFrame: 0-7 days after delivery
measure: Count of Newborns Returning to Facility for a Health Problem Within 7 Days
timeFrame: 0-7 days after delivery
Other outcomes:
measure: Mean Number of 18 Essential Birth Practices Performed at 2 Months Post-intervention Start
timeFrame: 2 months post-intervention start
measure: Count of Participants Where Essential Birth Practices Were Observed at Admission, 2 Months Post-intervention Start
timeFrame: 2 months post-intervention start
measure: Count of Participants Where Essential Birth Practices Were Observed Just Before Pushing, 2 Months Post-intervention Start
timeFrame: 2 months post-intervention start
measure: Count of Participants Where Essential Birth Practices Were Observed Within One Minute After Delivery, 2 Months Post-intervention Start
timeFrame: 2 months post-intervention start
measure: Count of Participants Where Essential Birth Practices Were Observed Within One Hour After Delivery, 2 Months Post-intervention Start
timeFrame: 2 months post-intervention start
measure: Count of Participants Where Essential Birth Practices Were Observed at Anytime During Delivery, 2 Months Post-intervention Start
timeFrame: 2 months post-intervention start
measure: Mean Number of 18 Essential Birth Practices Performed at 12 Months Post-intervention Start
timeFrame: 12 months post-intervention start
measure: Count of Participants Where Essential Birth Practices Were Observed at Admission, 12 Months Post-intervention Start
timeFrame: 12 months post-intervention start
measure: Count of Participants Where Essential Birth Practices Were Observed Just Before Pushing, 12 Months Post-intervention Start
timeFrame: 12 months post-intervention start
measure: Count of Participants Where Essential Birth Practices Were Observed Within One Minute After Delivery, 12 Months Post-intervention Start
timeFrame: 12 months post-intervention start
measure: Count of Participants Where Essential Birth Practices Were Observed Within One Hour After Delivery, 12 Months Post-intervention Start
timeFrame: 12 months post-intervention start
measure: Count of Participants Where Essential Birth Practices Were Observed at Anytime, 12 Months Post-intervention Start
timeFrame: 12 months post-intervention start
Locations:
city: Lucknow
country: India
facility: PSI
state: Uttar Pradesh
Study officials:
affiliation: Harvard School of Public Health (HSPH)
name: Atul Gawande, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Community Empowerment Lab
name: Vishwajeet Kumar, MBBS, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Jawarhlal Nehru Medical College
name: Bhala Kodkany, MBBS
role: PRINCIPAL_INVESTIGATOR
affiliation: Harvard Medical School/ Ariadne Labs
name: Katherine Semrau, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.
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.
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.
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.