BetterBirth: A Trial of the WHO Safe Childbirth Checklist Program

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Matched-pair, Cluster Randomized Trial to Measure the Efficacy of the WHO Safe Childbirth Checklist Program on Severe Maternal, Fetal and Newborn Harm

Conditions
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Maternal Death, Maternal Morbidity, Stillbirth, Neonatal Death

Intervention / Treatment
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* Behavioral: WHO Safe Childbirth Checklist Program


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Health Facility<br>WHO Safe Childbirth Checklist Program | Behavioral: WHO Safe Childbirth Checklist Program<br>* 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.<br>|
| No Intervention: Control Health Facility<br>Matched control facilities providing comparison for intervention facilities | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| Count of Participants With Stillbirth | Newborn outcome; rate of stillbirth | 0-7 days after delivery | 
| Count of Participants With Early Neonatal Death | Newborn outcome; rate of early neonatal death | 0-7 days after delivery | 
| Count of Participants With Maternal Death | Maternal outcome; rate of maternal death | 0-7 days after delivery | 
| Count of Participants With Severe Maternal Complications | Maternal outcome; any severe maternal complication within 7 days | 0-7 days after delivery | 
| 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) | 
| Count of Participants With Maternal Referral, Before or After Delivery | Maternal outcome; Rate of maternal inter-facility transfer | 0-7 days after delivery | 
| Count of Participants With Newborn Referral | Newborn outcome; Newborn referral | 0-7 days after delivery | 
| Count of Participants With Hysterectomy Within 7 Days | Rate of hysterectomy within 7 days | 0-7 days after delivery | 
| Count of Participants With Blood Transfusion Within 7 Days | Rate of blood transfusion within 7 days | 0-7 days after delivery | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Maternal Health, Maternal Death, Maternal Morbidity, Stillbirth, Neonatal Mortality, Quality Improvement, Resource Limited Settings, Checklist, Safe Childbirth