N/A N=163,939 Randomized Health Services Research

BetterBirth: A Trial of the WHO Safe Childbirth Checklist Program

Maternal Death · Maternal Morbidity · Stillbirth · Neonatal Death

Bottom Line

View on ClinicalTrials.gov: NCT02148952 ↗

Enrolled (actual)

163,939

Serious AEs

0.0%

Results posted

Feb 2019

Primary outcome: Primary: Percentage of Participants With Composite Measure of Perinatal Death, Maternal Death, or Maternal Severe Complications Within 7 Days — 15.1; 15.3 percentage of women/newborn dyads — p=0.90

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: WHO Safe Childbirth Checklist Program (Behavioral)
Age: Pediatric, Adult, Older Adult
Sex: All
Sponsor: Harvard School of Public Health (HSPH)
Primary completion: Jan 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Participants With Composite Measure of Perinatal Death, Maternal Death, or Maternal Severe Complications Within 7 Days	15.1; 15.3	0.90
SECONDARY Percentage of Participants With Perinatal Death or Maternal Death Within 7 Days	4.9; 4.7	0.67
SECONDARY Count of Participants With Perinatal Death Within 7 Days	3839; 3606	0.68
SECONDARY Count of Participants With Stillbirth	1513; 1559	0.56
SECONDARY Count of Participants With Early Neonatal Death	2409; 2119	0.19
SECONDARY Count of Participants With Maternal Death	78; 71	0.73
SECONDARY Count of Participants With Severe Maternal Complications	9086; 9037; 67; 70; 505; 493	0.81
SECONDARY Count of Participants With Cesarean Section	1469; 1330	0.74
SECONDARY Count of Participants With Maternal Referral, Before or After Delivery	5381; 4779	0.57
SECONDARY Count of Participants With Newborn Referral	1455; 1186	0.41
SECONDARY Count of Participants With Hysterectomy Within 7 Days	19; 18	0.95
SECONDARY Count of Participants With Blood Transfusion Within 7 Days	640; 625	0.97
SECONDARY Count of Mothers Returning to Facility for a Health Problem Within 7 Days	2014; 2141	0.32
SECONDARY Count of Newborns Returning to Facility for a Health Problem Within 7 Days	4474; 4722	0.30

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02148952). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.