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Completed

NCT Number: NCT02148952

BetterBirth: A Trial of the WHO Safe Childbirth Checklist Program

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.

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Key information

Conditions

Maternal Death Death Female Urogenital Diseases and Pregnancy Complications Fetal Death Maternal Morbidity Neonatal Death Parental Death Pathologic Processes Pathological Conditions, Signs and Symptoms Perinatal Death Pregnancy Complications Stillbirth Urogenital Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

PSI

Lucknow, Uttar Pradesh, 226 010, India

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

WHO Safe Childbirth Checklist Program

Behavioral

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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)

  3. Count of Participants With Stillbirth

    Time frame: 0-7 days after delivery

    Newborn outcome; rate of stillbirth

  4. Count of Participants With Early Neonatal Death

    Time frame: 0-7 days after delivery

    Newborn outcome; rate of early neonatal death

  5. Count of Participants With Maternal Death

    Time frame: 0-7 days after delivery

    Maternal outcome; rate of maternal death

  6. Count of Participants With Severe Maternal Complications

    Time frame: 0-7 days after delivery

    Maternal outcome; any severe maternal complication within 7 days

  7. 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

  8. 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

  9. Count of Participants With Newborn Referral

    Time frame: 0-7 days after delivery

    Newborn outcome; Newborn referral

  10. Count of Participants With Hysterectomy Within 7 Days

    Time frame: 0-7 days after delivery

    Rate of hysterectomy within 7 days

  11. Count of Participants With Blood Transfusion Within 7 Days

    Time frame: 0-7 days after delivery

    Rate of blood transfusion within 7 days

  12. 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

  13. 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)

Other outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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

  10. 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

  11. 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

  12. 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.

Sponsors and collaborators

Lead sponsor

Harvard School of Public Health (HSPH)

Other

Collaborators

  • 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

Registry information

Official study 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

Acronym: BetterBirth

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
May 29, 2014
Registry last updated
Jun 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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