BetterBirth: A Trial of the WHO Safe Childbirth Checklist Program (BetterBirth)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02148952 |
Recruitment Status :
Completed
First Posted : May 29, 2014
Results First Posted : February 20, 2019
Last Update Posted : February 20, 2019
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Maternal Death Maternal Morbidity Stillbirth Neonatal Death | Behavioral: WHO Safe Childbirth Checklist Program | Not Applicable |
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 |
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
|
- 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.
- 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
- 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)
- Count of Participants With Stillbirth [ Time Frame: 0-7 days after delivery ]Newborn outcome; rate of stillbirth
- Count of Participants With Early Neonatal Death [ Time Frame: 0-7 days after delivery ]Newborn outcome; rate of early neonatal death
- Count of Participants With Maternal Death [ Time Frame: 0-7 days after delivery ]Maternal outcome; rate of maternal death
- Count of Participants With Severe Maternal Complications [ Time Frame: 0-7 days after delivery ]Maternal outcome; any severe maternal complication within 7 days
- 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
- 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
- Count of Participants With Newborn Referral [ Time Frame: 0-7 days after delivery ]Newborn outcome; Newborn referral
- Count of Participants With Hysterectomy Within 7 Days [ Time Frame: 0-7 days after delivery ]Rate of hysterectomy within 7 days
- Count of Participants With Blood Transfusion Within 7 Days [ Time Frame: 0-7 days after delivery ]Rate of blood transfusion within 7 days
- 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
- 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)
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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
- 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
- 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
- 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.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02148952
India | |
PSI | |
Lucknow, Uttar Pradesh, India, 226 010 |
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 |
Documents provided by Atul Gawande, Harvard School of Public Health:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 Key Record Dates |
Results First Posted: | February 20, 2019 |
Last Update Posted: | February 20, 2019 |
Last Verified: | October 2018 |
Maternal Health Maternal Death Maternal Morbidity Stillbirth Neonatal Mortality |
Quality Improvement Resource Limited Settings Checklist Safe Childbirth |
Stillbirth Perinatal Death Maternal Death Death |
Pathologic Processes Fetal Death Pregnancy Complications Parental Death |