BetterBirth: A Trial of the WHO Safe Childbirth Checklist Program

Stillbirth Clinical Trial

— BetterBirth  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02148952
• Other study ID #: HSPH OPP1017378
• Status: Completed
• Phase: N/A
• Start date: November 2014
• Est. completion date: July 18, 2017

Study information

• Verified date: October 2018
• Source: Harvard School of Public Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 157689
• Est. completion date: July 18, 2017
• Est. primary completion date: January 20, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Death
• Maternal Death
• Maternal Morbidity
• Neonatal Death
• Perinatal Death
• Stillbirth

Intervention

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.

Locations

Country	Name	City	State
India	PSI	Lucknow	Uttar Pradesh

Sponsors (8)

Lead Sponsor	Collaborator
Harvard School of Public Health	Bill and Melinda Gates Foundation, Brigham and Women's Hospital, Community Empowerment Lab, Jawaharlal Nehru Medical College, MacArthur Foundation, Population Services International, World Health Organization

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Mean Number of 18 Essential Birth Practices Performed at 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 months post-intervention start
Other	Count of Participants Where Essential Birth Practices Were Observed at Admission, 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.	2 months post-intervention start
Other	Count of Participants Where Essential Birth Practices Were Observed Just Before Pushing, 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.	2 months post-intervention start
Other	Count of Participants Where Essential Birth Practices Were Observed Within One Minute After Delivery, 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.	2 months post-intervention start
Other	Count of Participants Where Essential Birth Practices Were Observed Within One Hour After Delivery, 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.	2 months post-intervention start
Other	Count of Participants Where Essential Birth Practices Were Observed at Anytime During Delivery, 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.	2 months post-intervention start
Other	Mean Number of 18 Essential Birth Practices Performed at 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.	12 months post-intervention start
Other	Count of Participants Where Essential Birth Practices Were Observed at Admission, 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.	12 months post-intervention start
Other	Count of Participants Where Essential Birth Practices Were Observed Just Before Pushing, 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	12 months post-intervention start
Other	Count of Participants Where Essential Birth Practices Were Observed Within One Minute After Delivery, 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	12 months post-intervention start
Other	Count of Participants Where Essential Birth Practices Were Observed Within One Hour After Delivery, 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 months post-intervention start
Other	Count of Participants Where Essential Birth Practices Were Observed at Anytime, 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.	12 months post-intervention start
Primary	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	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	0-7 days after delivery
Secondary	Count of Participants With Perinatal Death Within 7 Days	Count of participants with perinatal death within 7 days (combined stillbirth or neonatal death)	0-7 days
Secondary	Count of Participants With Stillbirth	Newborn outcome; rate of stillbirth	0-7 days after delivery
Secondary	Count of Participants With Early Neonatal Death	Newborn outcome; rate of early neonatal death	0-7 days after delivery
Secondary	Count of Participants With Maternal Death	Maternal outcome; rate of maternal death	0-7 days after delivery
Secondary	Count of Participants With Severe Maternal Complications	Maternal outcome; any severe maternal complication within 7 days	0-7 days after delivery
Secondary	Count of Participants With Cesarean Section	Rate of cesarean section	Around the time of delivery during facility stay, an expected average of 2 days (although individual patients may vary)
Secondary	Count of Participants With Maternal Referral, Before or After Delivery	Maternal outcome; Rate of maternal inter-facility transfer	0-7 days after delivery
Secondary	Count of Participants With Newborn Referral	Newborn outcome; Newborn referral	0-7 days after delivery
Secondary	Count of Participants With Hysterectomy Within 7 Days	Rate of hysterectomy within 7 days	0-7 days after delivery
Secondary	Count of Participants With Blood Transfusion Within 7 Days	Rate of blood transfusion within 7 days	0-7 days after delivery
Secondary	Count of Mothers Returning to Facility for a Health Problem Within 7 Days	Maternal Outcome; Rate of need for follow-up care for Mother	0-7 days after delivery
Secondary	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)	0-7 days after delivery

External Links

•   Ariadne Labs
•   WHO Safe Childbirth Checklist