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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Duke University
Sponsor:
Collaborators:
Stanford University
International Initiative for Impact Evaluation (3ie)
Department for International Development, United Kingdom
Sambodhi Research and Communication Pvt., Ltd.
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01480544
First received: November 8, 2011
Last updated: August 5, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention
Obstetric Labor Complications
Post-partum Hemorrhage
Sepsis
Pre-eclampsia
Neonatal Mortality
Other: Experimental: Treatment 1
Other: Experimental: Treatment 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Improving Maternal and Child Health in India: Evaluating Demand and Supply Side Strategies

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Increase institutional deliveries and improve maternal and infant health outcomes in the population. [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
    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. [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
    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. [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 14990
Study Start Date: August 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Mothers at endline
Data collected on new mothers (up to three weeks after childbirth) in 180 clusters with 100 mothers in each cluster at endline.
Experimental: Treatment 1
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
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.
Experimental: Treatment 2
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
Physicians will receive financial incentives for improving maternal and neonatal health outcomes as reported by mothers during household interviews.
No Intervention: Control
Data collected on new mothers (up to three weeks after childbirth) and providers with no incentives

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01480544

Contacts
Contact: Manveen Kohli, MA 919-321-8111 manveen.kohli@duke.edu
Contact: Manoj Mohanan, PhD, MPH 919-613-6127 manoj.mohanan@duke.edu

Locations
India
Imatchine Recruiting
Bangalore, Karnataka, India
Principal Investigator: Manveen Kohli, MA         
Sponsors and Collaborators
Duke University
Stanford University
International Initiative for Impact Evaluation (3ie)
Department for International Development, United Kingdom
Sambodhi Research and Communication Pvt., Ltd.
Investigators
Principal Investigator: Manoj Mohanan, PhD, MPH Duke University
  More Information

No publications provided

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01480544     History of Changes
Other Study ID Numbers: Pro00031046
Study First Received: November 8, 2011
Last Updated: August 5, 2014
Health Authority: United States: Institutional Review Board
India: Society for the Promotion of Ethical Clinical Trials - Ethical Review Board (SPECT-ERB)

Keywords provided by Duke University:
Institutional Deliveries
Maternal Health
Infant Health
Private Medical Providers
Provider Incentives
Randomized Control Trial

Additional relevant MeSH terms:
Obstetric Labor Complications
Eclampsia
Hemorrhage
Postpartum Hemorrhage
Pre-Eclampsia
Sepsis
Hypertension, Pregnancy-Induced
Pregnancy Complications
Pathologic Processes
Puerperal Disorders
Uterine Hemorrhage
Infection
Systemic Inflammatory Response Syndrome
Inflammation

ClinicalTrials.gov processed this record on August 18, 2014