Assessment and Evaluation of the Safe Childbirth Checklist --Phase II
1 other identifier
interventional
200,000
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2012
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2012
CompletedFirst Submitted
Initial submission to the registry
November 13, 2013
CompletedFirst Posted
Study publicly available on registry
November 25, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedSeptember 27, 2016
September 1, 2016
3.3 years
November 13, 2013
September 26, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Perinatal mortality
This evaluation will independently estimate the effectiveness of the Safe Childbirth Checklist in reduce perinatal mortality by 15% in the intervention areas
18 months (Nov-2013 to May-2015)
Secondary Outcomes (1)
Morbidity rates for infants and mothers
18 months (Nov-2013 to May-2015)
Study Arms (2)
No safe childbirth checklist
NO INTERVENTIONThe selected control districts include Bharatpur, Pali, Jhunjhunu, and Nagaur
Safe Childbirth Checklist
ACTIVE COMPARATORThe selected districts for SCC intervention include Alwar, Jalore, Sirohi, Sikar, Dausa, and Churu
Interventions
The 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).
Eligibility Criteria
You may qualify if:
- All women who deliver at the District Hospitals (DHs), Sub-District Hospitals (SDHs) and Community Health Centres (CHCs)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Public Health Foundation of Indialead
- UBS Optimus Foundationcollaborator
- The Children's Investment Fund Foundationcollaborator
Study Sites (1)
Public Health Foundation of India
New Delhi, New Delhi, 110070, India
Related Publications (1)
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.
PMID: 30867935DERIVED
Related Links
Study Officials
- PRINCIPAL INVESTIGATOR
Beena Varghese, PhD
Public Health Foundation of India
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Sr. Health Economist and Additional Professor
Study Record Dates
First Submitted
November 13, 2013
First Posted
November 25, 2013
Study Start
June 1, 2012
Primary Completion
September 1, 2015
Study Completion
June 1, 2016
Last Updated
September 27, 2016
Record last verified: 2016-09