NCT01480544

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
14,990

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 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

First Submitted

Initial submission to the registry

November 8, 2011

Completed
21 days until next milestone

First Posted

Study publicly available on registry

November 29, 2011

Completed
8 months until next milestone

Study Start

First participant enrolled

August 1, 2012

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

December 16, 2015

Status Verified

December 1, 2015

Enrollment Period

2.3 years

First QC Date

November 8, 2011

Last Update Submit

December 14, 2015

Conditions

Keywords

Institutional DeliveriesMaternal HealthInfant HealthPrivate Medical ProvidersProvider IncentivesRandomized Control Trial

Outcome Measures

Primary Outcomes (1)

  • 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.

    1 Year

Secondary Outcomes (2)

  • 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.

    1 Year

  • 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.

    1 Year

Study Arms (4)

Mothers at endline

NO INTERVENTION

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

Treatment 1

EXPERIMENTAL

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.

Other: Experimental: Treatment 1

Treatment 2

EXPERIMENTAL

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.

Other: Experimental: Treatment 2

Control

NO INTERVENTION

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

Interventions

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.

Treatment 1

Physicians will receive financial incentives for improving maternal and neonatal health outcomes as reported by mothers during household interviews.

Treatment 2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Imatchine

Bangalore, Karnataka, India

Location

MeSH Terms

Conditions

Obstetric Labor ComplicationsPostpartum HemorrhageSepsisPre-Eclampsia

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPuerperal DisordersUterine HemorrhageHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsInfectionsSystemic Inflammatory Response SyndromeInflammationHypertension, Pregnancy-Induced

Study Officials

  • Manoj Mohanan, PhD, MPH

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 8, 2011

First Posted

November 29, 2011

Study Start

August 1, 2012

Primary Completion

December 1, 2014

Study Completion

November 1, 2015

Last Updated

December 16, 2015

Record last verified: 2015-12

Locations