Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

BetterBirth: A Trial of the WHO Safe Childbirth Checklist Program (BetterBirth)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02148952
Recruitment Status : Completed
First Posted : May 29, 2014
Results First Posted : February 20, 2019
Last Update Posted : February 20, 2019
Sponsor:
Collaborators:
World Health Organization
Population Services International
Jawaharlal Nehru Medical College
Community Empowerment Lab
Brigham and Women's Hospital
Bill and Melinda Gates Foundation
MacArthur Foundation
Information provided by (Responsible Party):
Atul Gawande, Harvard School of Public Health

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.

Condition or disease Intervention/treatment Phase
Maternal Death Maternal Morbidity Stillbirth Neonatal Death Behavioral: WHO Safe Childbirth Checklist Program Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 157689 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
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
Study Start Date : November 2014
Actual Primary Completion Date : January 20, 2017
Actual Study Completion Date : July 18, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Childbirth

Arm Intervention/treatment
Experimental: Intervention Health Facility
WHO Safe Childbirth Checklist Program
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.

No Intervention: Control Health Facility
Matched control facilities providing comparison for intervention facilities



Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02148952


Locations
Layout table for location information
India
PSI
Lucknow, Uttar Pradesh, India, 226 010
Sponsors and Collaborators
Harvard School of Public Health
World Health Organization
Population Services International
Jawaharlal Nehru Medical College
Community Empowerment Lab
Brigham and Women's Hospital
Bill and Melinda Gates Foundation
MacArthur Foundation
Investigators
Layout table for investigator information
Principal Investigator: Atul Gawande, MD, MPH Harvard School of Public Health
Principal Investigator: Vishwajeet Kumar, MBBS, MPH Community Empowerment Lab
Principal Investigator: Bhala Kodkany, MBBS Jawarhlal Nehru Medical College
Principal Investigator: Katherine Semrau, PhD Harvard Medical School/ Ariadne Labs
  Study Documents (Full-Text)

Documents provided by Atul Gawande, Harvard School of Public Health:

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Atul Gawande, Principal Investigator, Harvard School of Public Health
ClinicalTrials.gov Identifier: NCT02148952     History of Changes
Other Study ID Numbers: HSPH OPP1017378
First Posted: May 29, 2014    Key Record Dates
Results First Posted: February 20, 2019
Last Update Posted: February 20, 2019
Last Verified: October 2018
Keywords provided by Atul Gawande, Harvard School of Public Health:
Maternal Health
Maternal Death
Maternal Morbidity
Stillbirth
Neonatal Mortality
Quality Improvement
Resource Limited Settings
Checklist
Safe Childbirth
Additional relevant MeSH terms:
Layout table for MeSH terms
Stillbirth
Perinatal Death
Maternal Death
Death
Pathologic Processes
Fetal Death
Pregnancy Complications
Parental Death