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Trials / Completed

CompletedNCT01994304

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

Assessment and Evaluation of the Safe Childbirth Checklist --Phase II Rajasthan, India

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
200,000 (actual)
Sponsor
Public Health Foundation of India · Academic / Other
Sex
Female
Age
15 Years – 50 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALSCCThe intervention involves introducing and orienting health providers on the SCC, facilitating availability of a specific set of commodities and regular targeted supervision. These are expected to improve adherence to life saving interventions immediately before, during and after birth, and reduce intrapartum mortality (still births and very early neonatal deaths).

Timeline

Start date
2012-06-01
Primary completion
2015-09-01
Completion
2016-06-01
First posted
2013-11-25
Last updated
2016-09-27

Locations

1 site across 1 country: India

Source: ClinicalTrials.gov record NCT01994304. Inclusion in this directory is not an endorsement.