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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02148952
First Posted: May 29, 2014
Last Update Posted: August 3, 2017
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.
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
  Purpose
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 Intervention
Maternal Death Maternal Morbidity Stillbirth Neonatal Death Behavioral: WHO Safe Childbirth Checklist Program

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Atul Gawande, Harvard School of Public Health:

Primary Outcome Measures:
  • 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 and foul smelling vaginal discharge, postpartum hemorrhage, and stroke.


Secondary Outcome Measures:
  • 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

  • Rate of inter-facility transfer [ Time Frame: 7 days from childbirth ]
    Maternal outcome

  • Rate of inter-facility transfer [ Time Frame: 7 days from childbirth ]
    Newborn outcome


Other Outcome Measures:
  • 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.

  • Rate of magnesium sulfate administration [ 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 neonatal bag use [ 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.

  • Mother referred out of facility [ 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.


Enrollment: 161107
Study Start Date: November 2014
Estimated Study Completion Date: September 2017
Primary Completion Date: January 20, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

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.


Ages Eligible for Study:   Child, Adult, Senior
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
  Contacts and Locations
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
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
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
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 Submitted: February 13, 2014
First Posted: May 29, 2014
Last Update Posted: August 3, 2017
Last Verified: August 2017

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:
Death
Stillbirth
Perinatal Death
Maternal Death
Pathologic Processes
Fetal Death
Pregnancy Complications
Parental Death