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Study Overview

Title:
Facilitated participatory and action groups to improve maternal and newborn health at scale in Jharkhand, India
Study ID:
RIDIE-STUDY-ID-595f13a090784
Initial Registration Date:
07/06/2017
Last Update Date:
07/04/2017
Study Status:
In Development
Location(s):
India
Abstract:
Our study aims to evaluate the effect, at scale, of women’s groups taking part in a cycle of Participatory Learning and Action meetings to improve maternal and newborn health in Jharkhand, eastern India. In these meetings, women will come together to identify and prioritise common problems for pregnant women and newborn infants, discuss their causes, then prioritise, implement and evaluate activities to address their prioritised problems. Accredited Social Health Activists (ASHAs) and their supervisors will facilitate these meetings. We have purposively selected six districts for this evaluation. Three will begin women's group meetings in 2017. The remaining three will begin in March 2019. From March 2017 till September 2019 (including 6 months of baseline), community-based key informants will identify births and deaths to women of reproductive age, and report these to trained data collectors. Data collectors will conduct interviews around six weeks after every birth and death. We will compare neonatal mortality, home care practices and care-seeking between early and the delayed intervention districts using the difference in difference approach.
Categories:
Health, Nutrition, and Population
Additional Keywords:
India, maternal and child health, neonatal survival
Secondary ID Number(s):

Principal Investigator(s)

Name of First PI:
Audrey Prost
Affiliation:
University College London
Name of Second PI:
Affiliation:

Study Sponsor

Name:
Children's Investment Fund Foundation
Study Sponsor Location:
United Kingdom
Funding Proposal:

Research Partner

Name of Partner Institution:
Ekjut
Type of Organization:
NGO (local) or other civil society organization
Website:
http://www.ekjutindia.org
Location:
India
Intervention

Intervention Overview

Intervention:
The intervention being evaluated is a cycle of women's group meetings using a facilitated participatory learning and action approach to improve maternal and newborn health. Groups usually have around 20 members. Meetings are open to all community members but facilitators and members deliberately seek to attract pregnant women and new mothers. The participatory learning and action cycle consists of around 20 meetings divided into four phases. In the first phase, groups identify and prioritise problems commonly faced by women during pregnancy and the postnatal period. In the second phase, they analyse the immediate and underlying causes of their prioritised problems, then identify and prioritise locally feasible strategies to address these. In the third phase the groups implement their strategies, and in the fourth phase they evaluate the process. The intervention seeks to improve birth outcomes (reduce neonatal deaths, maternal deaths, perinatal deaths and stillbirths) by increasing the use of preventive practices at home, and appropriate care-seeking.
Theory of Change:
Multiple Treatment Arms Evaluated?
No

Implementing Agency

Name of Organization:
Jharkhand State Health Mission
Type of Organization:
Public Sector, e.g. Government Agency or Ministry

Program Funder

Name of Organization:
Children's Investment Fund Foundation
Type of Organization:
NGO (International)

Intervention Timing

Intervention or Program Started at time of Registration?
Yes
Start Date:
03/05/2017
End Date:
09/30/2019
Evaluation Method

Evaluation Method Overview

Primary (or First) Evaluation Method:
Difference in difference/fixed effects
Other (not Listed) Method:
Additional Evaluation Method (If Any):
Other (not Listed) Method:

Method Details

Details of Evaluation Approach:
The intervention’s impact will be assessed using a non-randomised controlled design in six districts purposively selected with the Jharkhand State Health Mission. Within these six districts, we have purposively select 20 blocks, and five data collection clusters of around 10,000 population each per block. We have sought cluster-level consent from village leaders to collect data in their areas and created 100 data collection clusters of around 10,000 population each. Three districts will receive the intervention in 2017, while the remaining three will begin in in 2019. This allocation has been decided purposively by the National Health Mission and is therefore non-random. The delayed intervention area clusters will serve as control clusters in the evaluation period of 2017-2019. We will collect quantitative data in our 100 surveillance clusters from 1st March 2017 until the 31st of August 2017 for the baseline period (6 months), and then from the 1st September 2017 till 31st August 2019 for the evaluation period (24 months). We will use a difference in difference approach to compare outcomes between early and delayed intervention adjusted for baseline differences.
Outcomes (Endpoints):
Primary endpoint: Neonatal mortality (neonatal deaths per 1000 live births) Secondary endpoints: 1. Maternal deaths 2. Stillbirths 3. Perinatal deaths 4. % Mothers who received at least three ANC consultations by a skilled provider 5. % Mothers who made plans for birth (transport, location, money) in pregnancy 6. % Mothers who sought skilled care for a problem in pregnancy 7. % Births with a skilled attendant 8. % Births in a health facility 9. % Home births where a clean delivery kit was used 10. % Infants wiped within 1 hour of birth 11. % Infants wrapped within 1 hour of birth 12. % Infants not given a bath in 1st 24 hours 13. % Infants given breastmilk within one hour 14. % Infants exclusively breastfed 15. % Mothers visited by ASHA three times in the first week 16. % Infants for whom skilled care is sought for a newborn health problems 17. % Mothers who receive a postpartum check-up from a skilled provider Other outcomes are listed in the protocol.
Measurement:
Unit of Analysis:
The main unit of analysis is the infant-mother pair.
Hypotheses:
We hypothesise that the intervention will lead to a 20% reduction in neonatal mortality (the primary endpoint). Hypotheses related to secondary endpoints are listed in the protocol linked to this registration.
Unit of Intervention or Assignment:
District
Number of Clusters in Sample:
Six districts (three intervention and three control)
Number of Individuals in Sample:
50,000 births
Size of Treatment, Control, or Comparison Subsamples:
25,000 births in each of the two arms

Supplementary Files

Analysis Plan:
Other Documents:
Evaluation protocol: FLAG_Protocol_5July2017.docx
Data

Outcomes Data

Description:
The data to be used to measure outcomes will come from our prospective surveillance of births and deaths in 100 clusters across the six study districts.
Data Already Collected?
No
Survey Name:
Data Previously Used?
Data Access:
Data Obtained by the Study Researchers?
Data Approval Process:
Approval Status:

Treatment Assignment Data

Participation or Assignment Information:
Yes
Description:
Data Obtained by the Study Researchers?
Data Previously Used?
Data Access:
Data Obtained by the Study Researchers?
Data Approval Process:
Approval Status:

Data Analysis

Data Analysis Status:

Study Materials

Upload Study Materials:

Registration Category

Registration Category:
Prospective, Category 1: Data for measuring impacts have not been collected
Completion

Completion Overview

Intervention Completion Date:
Data Collection Completion Date:
Unit of Analysis:
Clusters in Final Sample:
Total Observations in Final Sample:
Size of Treatment, Control, or Comparison Subsamples:

Findings

Preliminary Report:
Preliminary Report URL:
Summary of Findings:
Paper:
Paper Summary:
Paper Citation:

Data Availability

Data Availability (Primary Data):
Date of Data Availability:
Data URL or Contact:
Access procedure:

Other Materials

Survey:
Survey Instrument Links or Contact:
Program Files:
Program Files Links or Contact:
External Link:
External Link Description:
Description of Changes:

Study Stopped

Date:
Reason: