Maternal DeathBetterBirthNCT02148952
BetterBirth: A Trial of the WHO Safe Childbirth Checklist Program
A study testing WHO Safe Childbirth Checklist Program in people with Maternal Death and Maternal Morbidity, run by Harvard School of Public Health (HSPH) at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Maternal Death, Maternal Morbidity, Stillbirth
- What is being tested?
- WHO Safe Childbirth Checklist Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 157,689 participants
- Where
- 1 siteIndia
- Study dates
- Nov 2014to 18 Jul 2017
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Maternal Death, Maternal Morbidity, Stillbirth, Neonatal Death
- Being tested
- WHO Safe Childbirth Checklist Program
- Keywords
- Maternal Health, Maternal Death, Maternal Morbidity, Stillbirth, Neonatal Mortality, Quality Improvement, Resource Limited Settings, Checklist, Safe Childbirth
- Medical subject headings
- Maternal Death, Stillbirth, Perinatal Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WHO Safe Childbirth Checklist ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Health Facility | Experimental | WHO Safe Childbirth Checklist Program Receives: Behavioral: WHO Safe Childbirth Checklist Program |
| Control Health Facility | No intervention | Matched control facilities providing comparison for intervention facilities |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 0-7 days after delivery
Secondary outcomes (13)
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
Measured: 0-7 days after delivery
Count of Participants With Perinatal Death Within 7 Days
Count of participants with perinatal death within 7 days (combined stillbirth or neonatal death)
Measured: 0-7 days
Count of Participants With Stillbirth
Newborn outcome; rate of stillbirth
Measured: 0-7 days after delivery
Count of Participants With Early Neonatal Death
Newborn outcome; rate of early neonatal death
Measured: 0-7 days after delivery
Count of Participants With Maternal Death
Maternal outcome; rate of maternal death
Measured: 0-7 days after delivery
Count of Participants With Severe Maternal Complications
Maternal outcome; any severe maternal complication within 7 days
Measured: 0-7 days after delivery
Count of Participants With Cesarean Section
Rate of cesarean section
Measured: 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
Maternal outcome; Rate of maternal inter-facility transfer
Measured: 0-7 days after delivery
Count of Participants With Newborn Referral
Newborn outcome; Newborn referral
Measured: 0-7 days after delivery
Count of Participants With Hysterectomy Within 7 Days
Rate of hysterectomy within 7 days
Measured: 0-7 days after delivery
Count of Participants With Blood Transfusion Within 7 Days
Rate of blood transfusion within 7 days
Measured: 0-7 days after delivery
Count of Mothers Returning to Facility for a Health Problem Within 7 Days
Maternal Outcome; Rate of need for follow-up care for Mother
Measured: 0-7 days after delivery
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)
Measured: 0-7 days after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2014 (estimated)
- Study startNov 2014
- Primary completion20 Jan 2017
- Study completion18 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Maternal DeathStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 157,689 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harvard School of Public Health (HSPH)
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Principal investigator, Katherine Semrau, Harvard School of Public Health (HSPH)
- Investigators
- Atul Gawande, MD, MPH, Principal investigator, Harvard School of Public Health (HSPH)Vishwajeet Kumar, MBBS, MPH, Principal investigator, Community Empowerment LabBhala Kodkany, MBBS, Principal investigator, Jawarhlal Nehru Medical CollegeKatherine Semrau, PhD, Principal investigator, Harvard Medical School/ Ariadne Labs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02148952
- Sponsor's protocol ID
- HSPH OPP1017378
- Acronym
- BetterBirth
- Status last verified
- Jun 2024
- First submitted
- 13 Feb 2014
- Last updated
- 26 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
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.
PubMed 35131826Semrau 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.
PubMed 32928798Barnhart 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.
PubMed 32885188Molina 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.
PubMed 31900167Hirschhorn 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.
PubMed 29862506Maisonneuve 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.
PubMed 29718354Semrau 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.
PubMed 29236628Gass 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.
PubMed 28882167Semrau 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.
PubMed 27923401Hirschhorn LR, Semrau K, Kodkany B, Churchill R, Kapoor A, Spector J, Ringer S, Firestone R, Kumar V, Gawande A. Learning before leaping: integration of an adaptive study design process prior to initiation of BetterBirth, a large-scale randomized controlled trial in Uttar Pradesh, India. Implement Sci. 2015 Aug 14;10:117. doi: 10.1186/s13012-015-0309-y.
PubMed 26271331