Assessment and Evaluation of the Safe Childbirth Checklist --Phase II

Not Applicable

Completed

• Conditions: Intrapartum Mortality
• Interventions: Behavioral: SCC

• Registration Number: NCT01994304
• Lead Sponsor: Public Health Foundation of India

Brief Summary

PHFI independently evaluated the effectiveness of the Safe Childbirth Checklist program in preventing stillbirths and early neonatal deaths. Evaluation used a quasi-experimental design with data collection from 34 facilities across six intervention districts and four control districts. The study with a sample of 137,000 births has 88% power to detect 15% reduction in intrapartum mortality. Data on this was collected over a period of 17 months (November 2013 to April 2015).

Detailed Description

The Safe Childbirth Checklist (SCC), a tool that provides reminders and is a job aid to health care providers is a new maternal and newborn care intervention that is being implemented by the Government of Rajasthan with technical support from Jhpeigo. SCC is thus expected to improve the quality of delivery care practices and was implemented in Community Health Centres (CHCs) and District Hospitals (DHs) across seven districts in Rajasthan over a two-year time period (2013 to 2015). PHFI independently evaluated the effectiveness and cost-effectiveness of the SCC in preventing intrapartum (stillbirths and very early neonatal deaths within 3-days after births). Data on 137,000 births was collected over a period of 17 months (November 2013 to April 2015) from 34 facilities with sick newborn care centres (SNC).

Facility records were main source of outcome data. Labor room provided data on stillbirths whereas information on very early neonatal deaths came from SNCs. All Data collection and management was done through software specifically developed for this purpose.

For a better understanding on how maternal and neonatal complications are diagnosed and managed at the facility, in-depth interviews were conducted with the service providers (specialists, physicians, labor room staff nurses, and pharmacists) from the District hospitals and CHCs. In addition, interviews focused on understanding the use, acceptability and feasibility of the SCC among various types of providers.

Cost of this intervention was estimated from a program perspective, and cost effectiveness in terms of cost per perinatal death prevented was calculated.

Preliminary analysis has found that SCC is significantly associated with a 11% reduction in intrapartum deaths.

Permission for this study and data collection has been obtained from the Department of Health and Family Welfare, Government of Rajasthan.

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2013-11-13
• Study First Submitted QC: 2013-11-19
• Study First Posted: 2013-11-25
• Primary Completion: 2015-09
• Study Completion: 2016-06
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-26
• Last Update Posted: 2016-09-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 200000

Inclusion Criteria

• All women who deliver at the District Hospitals (DHs), Sub-District Hospitals (SDHs) and Community Health Centres (CHCs)

Exclusion Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Safe Childbirth Checklist	SCC	The selected districts for SCC intervention include Alwar, Jalore, Sirohi, Sikar, Dausa, and Churu

Primary Outcome Measures

Name	Time	Method
Perinatal mortality	18 months (Nov-2013 to May-2015)	This evaluation will independently estimate the effectiveness of the Safe Childbirth Checklist in reduce perinatal mortality by 15% in the intervention areas

Secondary Outcome Measures

Name	Time	Method
Morbidity rates for infants and mothers	18 months (Nov-2013 to May-2015)	We determine checklist-related morbidity rates for infants and mothers at the intervention facilities by observing the following: 1. Level of Practices -use of partograph or recording of events; active management of third stage labor (AMTSL); early initiation of breast feeding; use of antihypertensives/magnesium sulphate for mothers and use of antibiotics for mother and neonate; 2. Levels of neonatal morbidity (low birth weight/prematurity, asphyxia, sepsis), maternal morbidity (Post partum haemorrhage, sepsis, eclampsia etc)

Trial Locations

Locations (1)

Public Health Foundation of India; 🇮🇳 New Delhi, India