NCT02148952

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
157,689

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 13, 2014

Completed
4 months until next milestone

First Posted

Study publicly available on registry

May 29, 2014

Completed
5 months until next milestone

Study Start

First participant enrolled

November 1, 2014

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 18, 2017

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

February 20, 2019

Completed
Last Updated

June 26, 2024

Status Verified

June 1, 2024

Enrollment Period

2.2 years

First QC Date

February 13, 2014

Results QC Date

January 17, 2018

Last Update Submit

June 24, 2024

Conditions

Maternal DeathMaternal MorbidityStillbirthNeonatal Death

Keywords

Maternal HealthMaternal DeathMaternal MorbidityStillbirthNeonatal MortalityQuality ImprovementResource Limited SettingsChecklistSafe Childbirth

Outcome Measures

Primary Outcomes (1)

  • 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.

    0-7 days after delivery

Secondary Outcomes (13)

  • Percentage of Participants With Perinatal Death or Maternal Death Within 7 Days

    0-7 days after delivery

  • Count of Participants With Perinatal Death Within 7 Days

    0-7 days

  • Count of Participants With Stillbirth

    0-7 days after delivery

  • Count of Participants With Early Neonatal Death

    0-7 days after delivery

  • Count of Participants With Maternal Death

    0-7 days after delivery

  • +8 more secondary outcomes

Other Outcomes (12)

  • Mean Number of 18 Essential Birth Practices Performed 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

    2 months post-intervention start

  • Count of Participants Where Essential Birth Practices Were Observed Just Before Pushing, 2 Months Post-intervention Start

    2 months post-intervention start

  • +9 more other outcomes

Study Arms (2)

Intervention Health Facility

EXPERIMENTAL

WHO Safe Childbirth Checklist Program

Behavioral: WHO Safe Childbirth Checklist Program

Control Health Facility

NO INTERVENTION

Matched control facilities providing comparison for intervention facilities

Interventions

WHO Safe Childbirth Checklist ProgramBEHAVIORAL

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.

Intervention Health Facility

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PSI

Lucknow, Uttar Pradesh, 226 010, India

Location

Related Publications (9)

  • 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.

    PMID: 35131826DERIVED

  • 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.

    PMID: 32928798DERIVED

  • 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.

    PMID: 32885188DERIVED

  • 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.

    PMID: 31900167DERIVED

  • 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.

    PMID: 29862506DERIVED

  • 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.

    PMID: 29718354DERIVED

  • 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.

    PMID: 29236628DERIVED

  • 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.

    PMID: 28882167DERIVED

  • 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.

    PMID: 27923401DERIVED

Related Links

MeSH Terms

Conditions

Maternal DeathStillbirthPerinatal Death

Condition Hierarchy (Ancestors)

Parental DeathDeathPathologic ProcessesPathological Conditions, Signs and SymptomsFetal DeathPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Results Point of Contact

Title
Dr. Katherine Semrau
Organization
Ariadne Labs
betterbirth@ariadnelabs.org
617-384-6555

Study Officials

  • Atul Gawande, MD, MPH

    Harvard School of Public Health (HSPH)

    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

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 13, 2014

First Posted

May 29, 2014

Study Start

November 1, 2014

Primary Completion

January 20, 2017

Study Completion

July 18, 2017

Last Updated

June 26, 2024

Results First Posted

February 20, 2019

Record last verified: 2024-06

Locations

IN(1)