Obstetric Labor ComplicationsIMATCHINENCT01480544
Improving Maternal and Child Health in India: Evaluating Demand and Supply Side Strategies (IMATCHINE)
A study testing Experimental: Treatment 1 and Experimental: Treatment 2 in people with Obstetric Labor Complications and Post-partum Hemorrhage, run by Duke University at 1 site in India.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstetric Labor Complications, Post-partum Hemorrhage, Sepsis
- What is being tested?
- Experimental: Treatment 1 and Experimental: Treatment 2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14,990 participants
- Where
- 1 siteIndia
- Study dates
- Aug 2012to Nov 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Improving Maternal and Child Health in India: Evaluating Demand and Supply Side Strategies
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.
Read the 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.
- Conditions
- Obstetric Labor Complications, Post-partum Hemorrhage, Sepsis, Pre-eclampsia, Neonatal Mortality
- Being tested
- Experimental: Treatment 1, Experimental: Treatment 2
- Keywords
- Institutional Deliveries, Maternal Health, Infant Health, Private Medical Providers, Provider Incentives, Randomized Control Trial
- Medical subject headings
- Obstetric Labor Complications, Postpartum Hemorrhage, Sepsis, Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental: Treatment 1Other
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 2Other
Physicians will receive financial incentives for improving maternal and neonatal health outcomes as reported by mothers during household interviews.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Experimental: Treatment 2 |
| Control | No intervention | Data collected on new mothers (up to three weeks after childbirth) and providers with no incentives |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Indicators of quality of services include monitoring of the fetal heartbeat, active management of labor, and monitoring of cervical dilation and effacement.
Measured: 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.
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.
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2011 (estimated)
- Study startAug 2012
- Primary completionDec 2014
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstetric Labor ComplicationsStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 14,990 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Stanford University, International Initiative for Impact Evaluation, Department for International Development, United Kingdom, Sambodhi Research and Communications Pvt. Ltd.
- Responsible party
- Sponsor
- Investigators
- Manoj Mohanan, PhD, MPH, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01480544
- Sponsor's protocol ID
- Pro00031046
- Acronym
- IMATCHINE
- Status last verified
- Dec 2015
- First submitted
- 8 Nov 2011
- Last updated
- 16 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Maternal and Child Health in India: Evaluating Demand and Supply Side Strategies
- ClinicalTrials.gov ID
- NCT01480544
- Acronym / sponsor ID
- IMATCHINE / Pro00031046
- Conditions
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14,990 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Stanford University, International Initiative for Impact Evaluation, Department for International Development, United Kingdom, Sambodhi Research and Communications Pvt. Ltd.
- Study start
- Aug 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 29 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Experimental: Treatment 1Data 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. |
| Treatment 2 | Experimental | Other: Experimental: Treatment 2Data 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. |
| Control | No intervention | –Data collected on new mothers (up to three weeks after childbirth) and providers with no incentives |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental: Treatment 1Physicians 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. | Other | Treatment 1 |
| Experimental: Treatment 2Physicians will receive financial incentives for improving maternal and neonatal health outcomes as reported by mothers during household interviews. | Other | Treatment 2 |
Primary outcome
Increase institutional deliveries and improve maternal and infant health outcomes in the population.
Time frame: 1 Year
Rates of deliveries in hospitals and maternal health complications such as obstetric fistulas, post-partum hemorrhage, sepsis, as well as neonatal outcomes.
2 secondary outcomes
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manoj Mohanan, PhD, MPH principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental: Treatment 1 and Experimental: Treatment 2 in people with Obstetric Labor Complications and Post-partum Hemorrhage, run by Duke University at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Increase institutional deliveries and improve maternal and infant health outcomes in the population. (time frame: 1 Year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2015.