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Improving Maternal and Child Health in India: Evaluating Demand and Supply Side Strategies (IMATCHINE) (IMATCHINE)

Primary Purpose

Obstetric Labor Complications, Post-partum Hemorrhage, Sepsis

Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Experimental: Treatment 1
Experimental: Treatment 2
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Obstetric Labor Complications focused on measuring Institutional Deliveries, Maternal Health, Infant Health, Private Medical Providers, Provider Incentives, Randomized Control Trial

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Households with new mothers (one to three weeks after childbirth)
  • Rural private sector maternity care providers who are listed on the Karnataka government's legitimate provider list.

Exclusion Criteria:

  • Households without children
  • Households where mothers gave birth > 3 weeks ago
  • Public sector maternity care providers
  • Private sector maternity care providers serving in towns with large public providers such as Community Health Centers (CHCs)

Sites / Locations

  • Imatchine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Experimental

Experimental

No Intervention

Arm Label

Mothers at endline

Treatment 1

Treatment 2

Control

Arm Description

Data collected on new mothers (up to three weeks after childbirth) in 180 clusters with 100 mothers in each cluster at endline.

Data collected on new mothers (up to three weeks after childbirth) and on providers with incentives for clinical improvements in quality of maternity care in the providers' patient populations and the catchment areas served by the providers.

Data collected on new mothers (up to three weeks after childbirth) and on providers with incentives for improvement in maternal and infant health outcomes in the providers' patient populations and in the catchment areas served by the providers.

Data collected on new mothers (up to three weeks after childbirth) and providers with no incentives

Outcomes

Primary Outcome Measures

Increase institutional deliveries and improve maternal and infant health outcomes in the population.
Rates of deliveries in hospitals and maternal health complications such as obstetric fistulas, post-partum hemorrhage, sepsis, as well as neonatal outcomes.

Secondary Outcome Measures

Effectiveness of financial incentives to maternity care private providers for improvements in the clinical quality of services in the providers' patient populations and the catchment areas they serve.
Indicators of quality of services include monitoring of the fetal heartbeat, active management of labor, and monitoring of cervical dilation and effacement.
Effectiveness of financial incentives to maternity care private providers for improvements in maternal and infant health outcomes in the providers' patient populations and the catchment areas they serve.
Indicators of improvements in maternal and neonatal health outcomes include reduced incidence of maternal morbidity outcomes such as obstetric fistulas, excessive post partum bleeding, sepsis, hospital readmission, as well as neonatal outcomes.

Full Information

First Posted
November 8, 2011
Last Updated
December 14, 2015
Sponsor
Duke University
Collaborators
Stanford University, International Initiative for Impact Evaluation, Department for International Development, United Kingdom, Sambodhi Research and Communication Pvt., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01480544
Brief Title
Improving Maternal and Child Health in India: Evaluating Demand and Supply Side Strategies (IMATCHINE)
Acronym
IMATCHINE
Official Title
Improving Maternal and Child Health in India: Evaluating Demand and Supply Side Strategies
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
November 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
Stanford University, International Initiative for Impact Evaluation, Department for International Development, United Kingdom, Sambodhi Research and Communication Pvt., Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The study evaluates the impact of a new conditional cash transfer (CCT) program (Thayi Bhagya Yojana) to promote child birth in obstetric facilities in the state of Karnataka, India in order to determine its policy value and to guide efforts to improve maternal and infant health outcomes nationally. In addition, the study includes a large randomized evaluation of performance-based incentive payments to providers to improve quality of medical care provided during delivery and actual health improvement in the providers' patient populations and their catchment areas.
Detailed Description
The evaluation study will first provide new evidence on the effectiveness of demand-side strategies to increase institutional deliveries and improve childbirth outcomes. Second, the study will analyze one of the first implementations of direct rewards to providers for health improvement in a developing country. Third, the study will provide critical new insight into dynamics between demand and supply-side incentives in improving population health outcomes as either complements or substitutes. The study uses household survey to collect data from mothers on socio-economic, human capital, quality of life variables (including below poverty line [BPL] index components) and as well as information about deliveries, fertility histories, morbidity and mortality (for mothers, infants, and children), birth related complications, health service use and spending. Additionally, provider surveys will collect data on infrastructure, staffing, provider qualifications, provider knowledge and process measures of provider performance.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstetric Labor Complications, Post-partum Hemorrhage, Sepsis, Pre-eclampsia, Neonatal Mortality
Keywords
Institutional Deliveries, Maternal Health, Infant Health, Private Medical Providers, Provider Incentives, Randomized Control Trial

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
14990 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mothers at endline
Arm Type
No Intervention
Arm Description
Data collected on new mothers (up to three weeks after childbirth) in 180 clusters with 100 mothers in each cluster at endline.
Arm Title
Treatment 1
Arm Type
Experimental
Arm Description
Data collected on new mothers (up to three weeks after childbirth) and on providers with incentives for clinical improvements in quality of maternity care in the providers' patient populations and the catchment areas served by the providers.
Arm Title
Treatment 2
Arm Type
Experimental
Arm Description
Data collected on new mothers (up to three weeks after childbirth) and on providers with incentives for improvement in maternal and infant health outcomes in the providers' patient populations and in the catchment areas served by the providers.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Data collected on new mothers (up to three weeks after childbirth) and providers with no incentives
Intervention Type
Other
Intervention Name(s)
Experimental: Treatment 1
Intervention Description
Physicians will receive financial incentives for improving the quality of obstetric and neonatal care provided to mothers and newborns as reported by mothers during household interviews.
Intervention Type
Other
Intervention Name(s)
Experimental: Treatment 2
Intervention Description
Physicians will receive financial incentives for improving maternal and neonatal health outcomes as reported by mothers during household interviews.
Primary Outcome Measure Information:
Title
Increase institutional deliveries and improve maternal and infant health outcomes in the population.
Description
Rates of deliveries in hospitals and maternal health complications such as obstetric fistulas, post-partum hemorrhage, sepsis, as well as neonatal outcomes.
Time Frame
1 Year
Secondary Outcome Measure Information:
Title
Effectiveness of financial incentives to maternity care private providers for improvements in the clinical quality of services in the providers' patient populations and the catchment areas they serve.
Description
Indicators of quality of services include monitoring of the fetal heartbeat, active management of labor, and monitoring of cervical dilation and effacement.
Time Frame
1 Year
Title
Effectiveness of financial incentives to maternity care private providers for improvements in maternal and infant health outcomes in the providers' patient populations and the catchment areas they serve.
Description
Indicators of improvements in maternal and neonatal health outcomes include reduced incidence of maternal morbidity outcomes such as obstetric fistulas, excessive post partum bleeding, sepsis, hospital readmission, as well as neonatal outcomes.
Time Frame
1 Year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Households with new mothers (one to three weeks after childbirth) Rural private sector maternity care providers who are listed on the Karnataka government's legitimate provider list. Exclusion Criteria: Households without children Households where mothers gave birth > 3 weeks ago Public sector maternity care providers Private sector maternity care providers serving in towns with large public providers such as Community Health Centers (CHCs)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manoj Mohanan, PhD, MPH
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Imatchine
City
Bangalore
State/Province
Karnataka
Country
India

12. IPD Sharing Statement

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Improving Maternal and Child Health in India: Evaluating Demand and Supply Side Strategies (IMATCHINE)

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