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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02148952
Other study ID # HSPH OPP1017378
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 2014
Est. completion date July 18, 2017

Study information

Verified date October 2018
Source Harvard School of Public Health
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 157689
Est. completion date July 18, 2017
Est. primary completion date January 20, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility 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

Study Design


Intervention

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.

Locations

Country Name City State
India PSI Lucknow Uttar Pradesh

Sponsors (8)

Lead Sponsor Collaborator
Harvard School of Public Health 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

Country where clinical trial is conducted

India, 

Outcome

Type Measure Description Time frame Safety issue
Other Mean Number of 18 Essential Birth Practices Performed at 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 months post-intervention start
Other Count of Participants Where Essential Birth Practices Were Observed at Admission, 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. 2 months post-intervention start
Other Count of Participants Where Essential Birth Practices Were Observed Just Before Pushing, 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. 2 months post-intervention start
Other Count of Participants Where Essential Birth Practices Were Observed Within One Minute After Delivery, 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. 2 months post-intervention start
Other Count of Participants Where Essential Birth Practices Were Observed Within One Hour After Delivery, 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. 2 months post-intervention start
Other Count of Participants Where Essential Birth Practices Were Observed at Anytime During Delivery, 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. 2 months post-intervention start
Other Mean Number of 18 Essential Birth Practices Performed at 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. 12 months post-intervention start
Other Count of Participants Where Essential Birth Practices Were Observed at Admission, 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. 12 months post-intervention start
Other Count of Participants Where Essential Birth Practices Were Observed Just Before Pushing, 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 12 months post-intervention start
Other Count of Participants Where Essential Birth Practices Were Observed Within One Minute After Delivery, 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 12 months post-intervention start
Other Count of Participants Where Essential Birth Practices Were Observed Within One Hour After Delivery, 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 months post-intervention start
Other Count of Participants Where Essential Birth Practices Were Observed at Anytime, 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. 12 months post-intervention start
Primary Percentage of Participants With Composite Measure of Perinatal Death, Maternal Death, or Maternal Severe Complications Within 7 Days 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. 0-7 days after delivery
Secondary Percentage of Participants With Perinatal Death or Maternal Death Within 7 Days Percentage of participants with composite rate of perinatal death and maternal death within 7 days 0-7 days after delivery
Secondary Count of Participants With Perinatal Death Within 7 Days Count of participants with perinatal death within 7 days (combined stillbirth or neonatal death) 0-7 days
Secondary Count of Participants With Stillbirth Newborn outcome; rate of stillbirth 0-7 days after delivery
Secondary Count of Participants With Early Neonatal Death Newborn outcome; rate of early neonatal death 0-7 days after delivery
Secondary Count of Participants With Maternal Death Maternal outcome; rate of maternal death 0-7 days after delivery
Secondary Count of Participants With Severe Maternal Complications Maternal outcome; any severe maternal complication within 7 days 0-7 days after delivery
Secondary Count of Participants With Cesarean Section Rate of cesarean section Around the time of delivery during facility stay, an expected average of 2 days (although individual patients may vary)
Secondary Count of Participants With Maternal Referral, Before or After Delivery Maternal outcome; Rate of maternal inter-facility transfer 0-7 days after delivery
Secondary Count of Participants With Newborn Referral Newborn outcome; Newborn referral 0-7 days after delivery
Secondary Count of Participants With Hysterectomy Within 7 Days Rate of hysterectomy within 7 days 0-7 days after delivery
Secondary Count of Participants With Blood Transfusion Within 7 Days Rate of blood transfusion within 7 days 0-7 days after delivery
Secondary Count of Mothers Returning to Facility for a Health Problem Within 7 Days Maternal Outcome; Rate of need for follow-up care for Mother 0-7 days after delivery
Secondary Count of Newborns Returning to Facility for a Health Problem Within 7 Days Newborn outcome; Rate of need for follow-up care for newborn (or at least one newborn in case of twins) 0-7 days after delivery
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