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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

Tracking Information
First Submitted Date  ICMJE February 13, 2014
First Posted Date  ICMJE May 29, 2014
Results First Submitted Date  ICMJE January 17, 2018
Results First Posted Date  ICMJE February 20, 2019
Last Update Posted Date February 20, 2019
Study Start Date  ICMJE November 2014
Actual Primary Completion Date January 20, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 12, 2018)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 23, 2014)
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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 12, 2018)
  • 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
  • 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)
  • Count of Participants With Stillbirth [ Time Frame: 0-7 days after delivery ]
    Newborn outcome; rate of stillbirth
  • Count of Participants With Early Neonatal Death [ Time Frame: 0-7 days after delivery ]
    Newborn outcome; rate of early neonatal death
  • Count of Participants With Maternal Death [ Time Frame: 0-7 days after delivery ]
    Maternal outcome; rate of maternal death
  • Count of Participants With Severe Maternal Complications [ Time Frame: 0-7 days after delivery ]
    Maternal outcome; any severe maternal complication within 7 days
  • 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
  • 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
  • Count of Participants With Newborn Referral [ Time Frame: 0-7 days after delivery ]
    Newborn outcome; Newborn referral
  • Count of Participants With Hysterectomy Within 7 Days [ Time Frame: 0-7 days after delivery ]
    Rate of hysterectomy within 7 days
  • Count of Participants With Blood Transfusion Within 7 Days [ Time Frame: 0-7 days after delivery ]
    Rate of blood transfusion within 7 days
  • 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
  • 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)
Original Secondary Outcome Measures  ICMJE
 (submitted: May 23, 2014)
  • 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
Current Other Pre-specified Outcome Measures
 (submitted: October 12, 2018)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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
  • 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
  • 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
  • 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.
Original Other Pre-specified Outcome Measures
 (submitted: May 23, 2014)
  • Rate of maternal temperature obtained on admission [ Time Frame: During facility stay, an expected average of 2 days (although individual patients may vary) ]
    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.
  • Rate of Safe Childbirth Checklist use [ Time Frame: During facility stay, an expected average of 2 days (although individual patients may vary) ]
    Percentage of deliveries for which the care facility uses the Safe Childbirth Checklist during observation periods
  • Rate of blood transfusion [ Time Frame: 0-7 days after childbirth ]
    Ancillary measure related to childbirth outcomes.
  • Rate of hysterectomy [ Time Frame: 0-7 days after childbirth ]
    Ancillary measure related to childbirth outcomes
  • Rate of c-section [ Time Frame: Around the time of delivery during facility stay, an expected average of 2 days (although individual patients may vary) ]
    Ancillary measure related to childbirth outcomes
  • Rate of maternal blood pressure [ Time Frame: During facility stay, an expected average of 2 days (although individual patients may vary) ]
    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.
  • Rate of partograph use [ Time Frame: During facility stay, an expected average of 2 days (although individual patients may vary) ]
    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
  • Rate of appropriate hand hygiene (use of soap and water, and wearing clean gloves) by health workers at the time of delivery [ Time Frame: During facility stay, an expected average of 2 days (although individual patients may vary) ]
    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.
  • Rate of birth companion present at the time of birth [ Time Frame: During facility stay, an expected average of 2 days (although individual patients may vary) ]
    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.
  • Rate of oxytocin administration within 1 minute after birth [ Time Frame: Around the time of delivery during facility stay, an expected average of 2 days (although individual patients may vary) ]
    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.
  • Rate of newborn weight obtained within 1 hour after birth [ Time Frame: After delivery during facility stay, an expected average of 2 days (although individual patients may vary) ]
    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.
  • Rate of initiation of breastfeeding within 1 hour after birth [ Time Frame: After delivery during facility stay, an expected average of 2 days (although individual patients may vary) ]
    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.
  • Rate of inappropriate initiation of oxytocin before delivery of the baby [ Time Frame: During facility stay, an expected average of 2 days (although individual patients may vary) ]
    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.
  • Rate of skin-to-skin care [ Time Frame: After birth during facility stay, an expected average of 2 days (although individual patients may vary) ]
    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.
  • Rates of availability of Safe Birth Supplies [ Time Frame: At baseline and every 3 months following until the end of study, an expected time period of 40 weeks ]
  • Patient Satisfaction [ Time Frame: 0-7 days from childbirth ]
  • Change in safety attitudes [ Time Frame: Once before study period and once between 4-6 months after data collection starts ]
  • Checklist utilization [ Time Frame: Between 4-6 months after study start ]
  • Rate of administration of antibiotics to Mothers [ Time Frame: During facility stay, an expected average of 2 days (although individual patients may vary) ]
  • Rate of administration of Antibiotics to Babies [ Time Frame: After birth during facility stay, an expected average of 2 days (although individual patients may vary) ]
  • Rate of administration of antiretrovirals for mothers [ Time Frame: During facility stay, an expected average of 2 days (although individual patients may vary) ]
  • Rate of administration of antiretrovirals for babies [ Time Frame: During facility stay, an expected average of 2 days (although individual patients may vary) ]
  • Rate of newborn temperature obtained within 1 hour after birth [ Time Frame: After birth during facility stay, an expected average of 2 days (although individual patients may vary) ]
    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.
 
Descriptive Information
Brief Title  ICMJE BetterBirth: A Trial of the WHO Safe Childbirth Checklist Program
Official Title  ICMJE 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 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE
  • Maternal Death
  • Maternal Morbidity
  • Stillbirth
  • Neonatal Death
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Experimental: Intervention Health Facility
    WHO Safe Childbirth Checklist Program
    Intervention: Behavioral: WHO Safe Childbirth Checklist Program
  • No Intervention: Control Health Facility
    Matched control facilities providing comparison for intervention facilities
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 12, 2018)
157689
Original Estimated Enrollment  ICMJE
 (submitted: May 23, 2014)
171964
Actual Study Completion Date  ICMJE July 18, 2017
Actual Primary Completion Date January 20, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE India
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02148952
Other Study ID Numbers  ICMJE HSPH OPP1017378
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Atul Gawande, Harvard School of Public Health
Study Sponsor  ICMJE Harvard School of Public Health
Collaborators  ICMJE
  • 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  ICMJE
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
PRS Account Harvard School of Public Health
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP