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

P

Public Health Foundation of India

Status

Completed

Conditions

Intrapartum Mortality

Treatments

Behavioral: SCC

Study type

Interventional

Funder types

Other

Identifiers

NCT01994304
SCC--P2

Details and patient eligibility

About

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).

Full 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.

Enrollment

200,000 patients

Sex

Female

Ages

15 to 50 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

Trial design

Primary purpose

Prevention

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

200,000 participants in 2 patient groups

No safe childbirth checklist
No Intervention group
Description:
The selected control districts include Bharatpur, Pali, Jhunjhunu, and Nagaur
Safe Childbirth Checklist
Active Comparator group
Description:
The selected districts for SCC intervention include Alwar, Jalore, Sirohi, Sikar, Dausa, and Churu
Treatment:
Behavioral: SCC

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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