- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04090762
Improving Perinatal Outcomes Using Conditional and Targeted Transfers (IMPACTT)
November 2, 2023 updated by: Edward Okeke, RAND
It has been estimated that increasing the use of skilled care during childbirth could prevent up to 1.5 million maternal and newborn deaths and stillbirths by 2025.
Conditional cash transfer programs, in which women receive cash payments conditioned on the use of maternal health services, are increasingly being used as a mechanism to increase uptake.
In this study, the investigators randomly assign households to receive varying cash amounts conditioned on uptake of recommended pregnancy and delivery care.
The investigators crosscut this with an intervention in which pregnant women receive information about their risk type.
This randomized trial will provide new evidence about the potential efficacy of targeting cash transfers by pregnancy risk.
This study will take place in 288 primary health service areas (HSAs) in Nigeria.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
36607
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Kano, Nigeria
- Aminu Kano Teaching Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
15 years to 49 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Pregnant women ages 15-49 who reside in the participating health service areas
Exclusion Criteria:
- none
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control
Women in the control arm will complete the baseline and follow up surveys but will not receive any intervention.
|
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Active Comparator: Risk information only
Women in the risk only arm who exhibit characteristics associated with a greater risk of a poor birth outcome will be informed that they possess these characteristics.
Risk characteristics (identified from the medical and epidemiological literature) include age, prior pregnancy and birth history (e.g., previous stillbirth).
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Pregnant women who exhibit characteristics associated with a greater risk of a poor birth outcome - these will be identified from the medical and epidemiological literature - will be informed that they possess these characteristics.
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Active Comparator: Conditional Cash Transfer only
Women in this arm will be eligible to receive conditional cash transfers.
To receive the transfer, pregnant women must attend prenatal care and give birth in a health facility.
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Pregnant women receive cash payments conditioned on their use of prenatal services and use of a health facility for child birth.
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Active Comparator: Conditional Cash Transfer and risk information
Women in this arm will be provided with risk information at the time of baseline survey administration AND be eligible to receive conditional cash transfers, pending attendance at prenatal care and delivery at a health facility.
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Pregnant women who exhibit characteristics associated with a greater risk of a poor birth outcome - these will be identified from the medical and epidemiological literature - will be informed that they possess these characteristics.
Pregnant women receive cash payments conditioned on their use of prenatal services and use of a health facility for child birth.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Probability of prenatal care
Time Frame: 3-4 months after anticipated childbirth/delivery date
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the probability of receiving prenatal care
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3-4 months after anticipated childbirth/delivery date
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Uptake of prenatal care
Time Frame: 3-4 months after anticipated childbirth/delivery date
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the number of prenatal visits completed
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3-4 months after anticipated childbirth/delivery date
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Uptake of health facility birth
Time Frame: 3-4 months after anticipated childbirth/delivery date
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probability of giving birth at a health facility
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3-4 months after anticipated childbirth/delivery date
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Child mortality - fetal loss
Time Frame: 3-4 months after anticipated childbirth/delivery date
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Child mortality - fetal loss
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3-4 months after anticipated childbirth/delivery date
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Child mortality - stillbirths
Time Frame: 3-4 months after anticipated childbirth/delivery date
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Child mortality - stillbirths
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3-4 months after anticipated childbirth/delivery date
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Child mortality - early infant death
Time Frame: 3-4 months after anticipated childbirth/delivery date
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Child mortality - early infant death
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3-4 months after anticipated childbirth/delivery date
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maternal health
Time Frame: 3-4 months after anticipated childbirth/delivery date
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delivery complications
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3-4 months after anticipated childbirth/delivery date
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Maternal mortality
Time Frame: 3-4 months after anticipated childbirth/delivery date
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maternal death
|
3-4 months after anticipated childbirth/delivery date
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Child weight
Time Frame: 3-4 months after anticipated childbirth/delivery date
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Child weight
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3-4 months after anticipated childbirth/delivery date
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Child length
Time Frame: 3-4 months after anticipated childbirth/delivery date
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Child length
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3-4 months after anticipated childbirth/delivery date
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Uptake of postnatal care
Time Frame: 3-4 months after anticipated childbirth/delivery date
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Probability of using postnatal care
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3-4 months after anticipated childbirth/delivery date
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Child vaccination
Time Frame: 3-4 months after anticipated childbirth/delivery date
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Probability of receiving recommended child immunizations
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3-4 months after anticipated childbirth/delivery date
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Maternal beliefs
Time Frame: 3-4 months after anticipated childbirth/delivery date
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Risk perceptions and beliefs assessed using a questionnaire
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3-4 months after anticipated childbirth/delivery date
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Pregnancy behavior - tetanus vaccination
Time Frame: 3-4 months after anticipated childbirth/delivery date
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Probability of receiving tetanus vaccination
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3-4 months after anticipated childbirth/delivery date
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Pregnancy behavior - malaria prophylaxis
Time Frame: 3-4 months after anticipated childbirth/delivery date
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Probability of receiving malaria prophylaxis
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3-4 months after anticipated childbirth/delivery date
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Pregnancy behavior - blood building products
Time Frame: 3-4 months after anticipated childbirth/delivery date
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Probability of receiving blood building products
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3-4 months after anticipated childbirth/delivery date
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Pregnancy behavior - dietary consumption
Time Frame: 3-4 months after anticipated childbirth/delivery date
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Probability of consuming nutrient-rich foods assessed using questionnaire
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3-4 months after anticipated childbirth/delivery date
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Quality of perinatal care
Time Frame: 3-4 months after anticipated childbirth/delivery date
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Quality score assessed using a questionnaire
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3-4 months after anticipated childbirth/delivery date
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Timely initiation of prenatal care
Time Frame: 3-4 months after anticipated childbirth/delivery date
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Probability of initiating prenatal care in the first trimester of pregnancy
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3-4 months after anticipated childbirth/delivery date
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Maternal work
Time Frame: 3-4 months after enrollment
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Hours worked in the last seven days
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3-4 months after enrollment
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maternal depression
Time Frame: 3-4 months after anticipated childbirth/delivery date
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Depression assessed using the Edinburgh Postnatal Depression Scale
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3-4 months after anticipated childbirth/delivery date
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Health facility choice
Time Frame: 3-4 months after anticipated childbirth/delivery date
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Probability of receiving care at a government or private hospital
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3-4 months after anticipated childbirth/delivery date
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Okeke EN, Abubakar IS, De Guttry R. In Nigeria, Stillbirths And Newborn Deaths Increased During The COVID-19 Pandemic. Health Aff (Millwood). 2021 Nov;40(11):1797-1805. doi: 10.1377/hlthaff.2021.00659. Epub 2021 Oct 20.
- Okeke EN. Playing defense? Health care in the era of Covid. J Health Econ. 2022 Sep;85:102665. doi: 10.1016/j.jhealeco.2022.102665. Epub 2022 Jul 25.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 8, 2019
Primary Completion (Actual)
June 30, 2021
Study Completion (Estimated)
April 30, 2024
Study Registration Dates
First Submitted
June 28, 2019
First Submitted That Met QC Criteria
September 12, 2019
First Posted (Actual)
September 16, 2019
Study Record Updates
Last Update Posted (Actual)
November 7, 2023
Last Update Submitted That Met QC Criteria
November 2, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- R01HD090231 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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