Clinical Trial: BetterBirth: A Trial of the WHO Safe Childbirth Checklist Program

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

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

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 Summary: 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.
Sponsor: Harvard School of Public Health

Current Primary Outcome: Composite measure of maternal mortality, severe maternal complications, stillbirths, and neonatal mortality [ Time Frame: 0-7 days after childbirth ]

The severe maternal complications component is defined by any of: seizures, loss of consciousness for >1 hour, fever with chills and foul smelling vaginal discharge, postpartum hemorrhage, and stroke.


Original Primary Outcome: Composite measure of maternal mortality, severe maternal complications, stillbirths, and neonatal mortality [ Time Frame: 0-7 days after childbirth ]

The severe maternal complications component is defined by any of: seizures, loss of consciousness for >1 hour, fever with chills and foul smelling vaginal discharge, and stroke.


Current Secondary Outcome:

  • Combined maternal, fetal and newborn mortality [ Time Frame: 7 days from childbirth ]
    Composite rate of maternal death at 7 days, stillbirth, and neonatal death at 7 days
  • Rate of maternal death [ Time Frame: 7 days from childbirth ]
    Maternal outcome
  • Rate of stillbirth [ Time Frame: 7 days from childbirth ]
    Newborn outcome
  • Rate of severe maternal complications [ Time Frame: 7 days from childbirth ]
    Maternal outcome
  • Rate of need for follow-up care for Mother [ Time Frame: 7 days from childbirth ]
    Maternal Outcome
  • Rate of early neonatal death [ Time Frame: 7 days from childbirth ]
    Newborn outcome
  • Rate of need for follow-up care for newborn [ Time Frame: 7 days from childbirth ]
    Newborn outcome


Original Secondary Outcome: Same as current

Information By: Harvard School of Public Health

Dates:
Date Received: February 13, 2014
Date Started: November 2014
Date Completion: September 2017
Last Updated: February 14, 2017
Last Verified: February 2017