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

Sepsis Clinical Trial

— IMATCHINE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01480544
• Other study ID #: Pro00031046
• Status: Completed
• Phase: N/A
• First received: November 8, 2011
• Last updated: December 14, 2015
• Start date: August 2012
• Est. completion date: November 2015

Study information

• Verified date: December 2015
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardIndia: Society for the Promotion of Ethical Clinical Trials - Ethical Review Board (SPECT-ERB)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14990
• Est. completion date: November 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Neonatal Mortality
• Obstetric Labor Complications
• Post-partum Hemorrhage
• Postpartum Hemorrhage
• Pre-Eclampsia
• Sepsis

Intervention

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

Locations

Country	Name	City	State
India	Imatchine	Bangalore	Karnataka

Sponsors (5)

Lead Sponsor	Collaborator
Duke University	Department for International Development, United Kingdom, International Initiative for Impact Evaluation (3ie), Sambodhi Research and Communication Pvt., Ltd., Stanford University

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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.	1 Year	No
Secondary	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.	1 Year	No