Clinical trial NCT01994304: Assessment and Evaluation of the Safe Childbirth Checklist --Phase II
Official title: Assessment and Evaluation of the Safe Childbirth Checklist --Phase II Rajasthan, India
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intrapartum Mortality
Keywords: Safe Childbirth Checklist
Intrapartum mortality, Quality of Institutional delivery care
Maternal & newborn care practices
Lead sponsor: Public Health Foundation of India
Sponsor class: OTHER
Collaborators: name: UBS Optimus Foundation
name: The Children's Investment Fund Foundation
First posted: 2013-11-25
Enrollment: 200000
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

-

Primary outcomes:
measure: Perinatal mortality
timeFrame: 18 months (Nov-2013 to May-2015)
Secondary outcomes:
measure: Morbidity rates for infants and mothers
timeFrame: 18 months (Nov-2013 to May-2015)
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Public Health Foundation of India
Study officials:
affiliation: Public Health Foundation of India
name: Beena Varghese, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Varghese B, Copas A, Kumari S, Bandyopadhyay S, Sharma J, Saha S, Yadav V, Kumar S. Does the safe childbirth checklist (SCC) program save newborn lives? Evidence from a realistic quasi-experimental study, Rajasthan, India. Matern Health Neonatol Perinatol. 2019 Mar 1;5:3. doi: 10.1186/s40748-019-0098-4. eCollection 2019.