IMPACTT: Improving Perinatal Outcomes Using Conditional and Targeted Transfers

Sponsor
RAND (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04090762
Collaborator
(none)
36,607
1
4
32.9
1113.1

Study Details

Study Description

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
  • Behavioral: Conditional cash transfer
  • Behavioral: Risk information provision
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
36607 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 :
Jul 8, 2019
Actual Primary Completion Date :
Jun 30, 2021
Anticipated Study Completion Date :
Apr 4, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Probability of prenatal care [3-4 months after anticipated childbirth/delivery date]

    the probability of receiving prenatal care

  2. Uptake of prenatal care [3-4 months after anticipated childbirth/delivery date]

    the number of prenatal visits completed

  3. Uptake of health facility birth [3-4 months after anticipated childbirth/delivery date]

    probability of giving birth at a health facility

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

    Child mortality - fetal loss

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

    Child mortality - stillbirths

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

    Child mortality - early infant death

Secondary Outcome Measures

  1. Maternal health [3-4 months after anticipated childbirth/delivery date]

    delivery complications

  2. Maternal mortality [3-4 months after anticipated childbirth/delivery date]

    maternal death

  3. Child weight [3-4 months after anticipated childbirth/delivery date]

    Child weight

  4. Child length [3-4 months after anticipated childbirth/delivery date]

    Child length

  5. Uptake of postnatal care [3-4 months after anticipated childbirth/delivery date]

    Probability of using postnatal care

  6. Child vaccination [3-4 months after anticipated childbirth/delivery date]

    Probability of receiving recommended child immunizations

  7. Maternal beliefs [3-4 months after anticipated childbirth/delivery date]

    Risk perceptions and beliefs assessed using a questionnaire

  8. Pregnancy behavior - tetanus vaccination [3-4 months after anticipated childbirth/delivery date]

    Probability of receiving tetanus vaccination

  9. Pregnancy behavior - malaria prophylaxis [3-4 months after anticipated childbirth/delivery date]

    Probability of receiving malaria prophylaxis

  10. Pregnancy behavior - blood building products [3-4 months after anticipated childbirth/delivery date]

    Probability of receiving blood building products

  11. Pregnancy behavior - dietary consumption [3-4 months after anticipated childbirth/delivery date]

    Probability of consuming nutrient-rich foods assessed using questionnaire

  12. Quality of perinatal care [3-4 months after anticipated childbirth/delivery date]

    Quality score assessed using a questionnaire

  13. Timely initiation of prenatal care [3-4 months after anticipated childbirth/delivery date]

    Probability of initiating prenatal care in the first trimester of pregnancy

  14. Maternal work [3-4 months after enrollment]

    Hours worked in the last seven days

Other Outcome Measures

  1. Maternal depression [3-4 months after anticipated childbirth/delivery date]

    Depression assessed using the Edinburgh Postnatal Depression Scale

  2. Health facility choice [3-4 months after anticipated childbirth/delivery date]

    Probability of receiving care at a government or private hospital

Eligibility Criteria

Criteria

Ages Eligible for Study:
15 Years to 49 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Pregnant women ages 15-49 who reside in the participating health service areas
Exclusion Criteria:
  • none

Contacts and Locations

Locations

Site City State Country Postal Code
1 Aminu Kano Teaching Hospital Kano Nigeria

Sponsors and Collaborators

  • RAND

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Edward Okeke, Senior Policy Researcher, RAND
ClinicalTrials.gov Identifier:
NCT04090762
Other Study ID Numbers:
  • R01HD090231
First Posted:
Sep 16, 2019
Last Update Posted:
Sep 22, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Sep 22, 2021