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Improving Perinatal Outcomes Using Conditional and Targeted Transfers (IMPACTT)

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ClinicalTrials.gov Identifier: NCT04090762
Recruitment Status : Recruiting
First Posted : September 16, 2019
Last Update Posted : September 16, 2019
Sponsor:
Information provided by (Responsible Party):
Edward Okeke, RAND

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Utilization, Health Care Birth Outcomes Behavioral: Conditional cash transfer Behavioral: Risk information provision Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 34560 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Improving Perinatal Outcomes Using Conditional and Targeted Transfers
Actual Study Start Date : July 8, 2019
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : June 30, 2021

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.
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).
Behavioral: Risk information provision
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.

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.
Behavioral: Conditional cash transfer
Pregnant women receive cash payments conditioned on their use of prenatal services and use of a health facility for child birth.

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.
Behavioral: Conditional cash transfer
Pregnant women receive cash payments conditioned on their use of prenatal services and use of a health facility for child birth.

Behavioral: Risk information provision
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.




Primary Outcome Measures :
  1. Probability of prenatal care [ Time Frame: 3-4 months after anticipated childbirth/delivery date ]
    the probability of receiving prenatal care

  2. Uptake of prenatal care [ Time Frame: 3-4 months after anticipated childbirth/delivery date ]
    the number of prenatal visits completed

  3. Uptake of health facility birth [ Time Frame: 3-4 months after anticipated childbirth/delivery date ]
    probability of giving birth at a health facility

  4. Child mortality - fetal loss [ Time Frame: 3-4 months after anticipated childbirth/delivery date ]
    infant mortality - fetal loss

  5. Child mortality - stillbirths [ Time Frame: 3-4 months after anticipated childbirth/delivery date ]
    infant mortality - stillbirths

  6. Child mortality - early infant death [ Time Frame: 3-4 months after anticipated childbirth/delivery date ]
    infant mortality - early infant death


Secondary Outcome Measures :
  1. Maternal health [ Time Frame: 3-4 months after anticipated childbirth/delivery date ]
    delivery complications

  2. Maternal mortality [ Time Frame: 3-4 months after anticipated childbirth/delivery date ]
    maternal death



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Ages Eligible for Study:   15 Years to 49 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Pregnant women ages 15-49 who reside in the participating health service areas

Exclusion Criteria:

  • none

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04090762


Contacts
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Contact: Edward N Okeke, MBBS, PhD 7034131100 eokeke@rand.org

Locations
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Nigeria
Aminu Kano Teaching Hospital Recruiting
Kano, Nigeria
Contact: Isa S Abubakar, MBBS FWACP       universalisah@gmail.com   
Sub-Investigator: Isa S Abubakar, MBBS FWACP         
Sponsors and Collaborators
RAND

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Responsible Party: Edward Okeke, Senior Policy Researcher, RAND
ClinicalTrials.gov Identifier: NCT04090762     History of Changes
Other Study ID Numbers: R01HD090231 ( U.S. NIH Grant/Contract )
First Posted: September 16, 2019    Key Record Dates
Last Update Posted: September 16, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No