BetterBirth: A Trial of the WHO Safe Childbirth Checklist Program

Not Applicable

Completed

Conditions: Neonatal Death
Maternal Morbidity
Stillbirth
Maternal Death

Interventions: Behavioral: WHO Safe Childbirth Checklist Program

Registration Number: NCT02148952

Lead Sponsor: Harvard School of Public Health (HSPH)

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 157689

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Health Facility	WHO Safe Childbirth Checklist Program	WHO Safe Childbirth Checklist Program

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Composite Measure of Perinatal Death, Maternal Death, or Maternal Severe Complications Within 7 Days	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.

Secondary Outcome Measures

Name	Time	Method
Count of Participants With Perinatal Death Within 7 Days	0-7 days	Count of participants with perinatal death within 7 days (combined stillbirth or neonatal death)
Count of Participants With Stillbirth	0-7 days after delivery	Newborn outcome; rate of stillbirth
Count of Participants With Newborn Referral	0-7 days after delivery	Newborn outcome; Newborn referral
Count of Participants With Hysterectomy Within 7 Days	0-7 days after delivery	Rate of hysterectomy within 7 days
Count of Mothers Returning to Facility for a Health Problem Within 7 Days	0-7 days after delivery	Maternal Outcome; Rate of need for follow-up care for Mother
Percentage of Participants With Perinatal Death or Maternal Death Within 7 Days	0-7 days after delivery	Percentage of participants with composite rate of perinatal death and maternal death within 7 days
Count of Participants With Maternal Referral, Before or After Delivery	0-7 days after delivery	Maternal outcome; Rate of maternal inter-facility transfer
Count of Participants With Early Neonatal Death	0-7 days after delivery	Newborn outcome; rate of early neonatal death
Count of Participants With Maternal Death	0-7 days after delivery	Maternal outcome; rate of maternal death
Count of Participants With Cesarean Section	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 Newborns Returning to Facility for a Health Problem Within 7 Days	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)
Count of Participants With Severe Maternal Complications	0-7 days after delivery	Maternal outcome; any severe maternal complication within 7 days
Count of Participants With Blood Transfusion Within 7 Days	0-7 days after delivery	Rate of blood transfusion within 7 days