NCT01994304

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

November 13, 2013

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 25, 2013

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

September 27, 2016

Status Verified

September 1, 2016

Enrollment Period

3.3 years

First QC Date

November 13, 2013

Last Update Submit

September 26, 2016

Conditions

Keywords

Safe Childbirth ChecklistIntrapartum mortality, Quality of Institutional delivery careMaternal & newborn care practices

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 INTERVENTION

The selected control districts include Bharatpur, Pali, Jhunjhunu, and Nagaur

Safe Childbirth Checklist

ACTIVE COMPARATOR

The selected districts for SCC intervention include Alwar, Jalore, Sirohi, Sikar, Dausa, and Churu

Behavioral: SCC

Interventions

SCCBEHAVIORAL

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).

Safe Childbirth Checklist

Eligibility Criteria

Age15 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

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

Study Sites (1)

Public Health Foundation of India

New Delhi, New Delhi, 110070, India

Location

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.

Related Links

Study Officials

  • Beena Varghese, PhD

    Public Health Foundation of India

    PRINCIPAL INVESTIGATOR

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

Locations