- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07819201
Improving Maternal and Neonatal Care-seeking Through a Video-informed Training Session During the Third Trimester of Pregnancy (Taabo T3)
Improving Maternal and Neonatal Care-Seeking Through a Video-Informed Training Session During the Third Trimester of Pregnancy
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Taabo, Côte d’Ivoire
- Centre Suisse de Recherches Scientifiques en Cote d'Ivoire
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Contact:
- Siaka Koné, PhD
- Phone Number: +2250749069627
- Email: Siaka.kone@csrs.ci
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria for Pregnant Women:
- Currently pregnant
- Aged 15 years or older
- Live in the area served by the Taabo Health & Demographic Surveillance System
- Estimated gestational age between 6 completed months of pregnancy and 8 completed months of pregnancy
Inclusion Criteria for Male Partners:
- Aged 15 or older
- Married to or currently the main romantic partner of a woman who is enrolled in the study
Study Plan
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 |
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No Intervention: Control group
This group will not receive any intervention.
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Experimental: Information Video and Planning Session group
This group will receive the study intervention, including an information video and planning session for the pregnant woman and her partner.
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The study intervention is a video-informed information and planning session for health care during the third trimester, childbirth, and the first six weeks postpartum.
In this intervention, a member of the study team will show information videos to pregnant women and her partner, summarizing key recommendations for health and health care seeking during the third trimester of pregnancy and the first six weeks following childbirth.
After showing the videos, the study team member will guide the pregnant woman and her partner in a short discussion about planning for care-seeking during the third trimester and early postpartum period.
This discussion will include quizzing on the content of the information videos and discussions of care-seeking plans together with the couple.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Number of health care contacts as reported by women during endline survey
Time Frame: From enrollment to 6 weeks postpartum (measured 6-8 weeks after the end of pregnancy)
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Number of health care contacts that women have between enrollment in the study and 6 weeks postpartum, including antenatal care visits, childbirth, and postpartum care visits
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From enrollment to 6 weeks postpartum (measured 6-8 weeks after the end of pregnancy)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Number of antenatal care visits as reported by women during endline survey
Time Frame: Between enrollment and the end of pregnancy (measured 6-8 weeks after the end of pregnancy)
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Number of antenatal care visits
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Between enrollment and the end of pregnancy (measured 6-8 weeks after the end of pregnancy)
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Facility-based childbirth as reported by women during endline survey
Time Frame: Measured 6-8 weeks after the end of pregnancy
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Proportion of women who gave birth in a health facility
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Measured 6-8 weeks after the end of pregnancy
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Number of postpartum visits as reported by women during endline survey
Time Frame: From the end of pregnancy to 6 weeks postpartum (measured 6-8 weeks after the end of pregnancy)
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Number of postpartum care visits between the end of pregnancy and 6 weeks postpartum
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From the end of pregnancy to 6 weeks postpartum (measured 6-8 weeks after the end of pregnancy)
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Fetal movement counting as reported by women during endline surveys
Time Frame: Measured 6-8 weeks after the end of pregnancy
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The proportion of pregnant women who report counting fetal movements at least once during the final month of their pregnancy
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Measured 6-8 weeks after the end of pregnancy
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Perinatal mortality as reported by women during endline surveys
Time Frame: Measured 6-8 weeks after end of pregnancy
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The proportion of women who experience a stillbirth or neonatal death in the first seven days of life (perinatal mortality)
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Measured 6-8 weeks after end of pregnancy
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Neonatal mortality as reported by women during endline surveys
Time Frame: Measured 6-8 weeks after end of pregnancy
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The proportion of women whose child dies in the first 28 days of life
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Measured 6-8 weeks after end of pregnancy
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Average care-seeking knowledge scores among pregnant women and their partners
Time Frame: Measured 6-8 weeks after the end of pregnancy
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Average scores (among pregnant women and their partners) on assessments of knowledge of care-seeking recommendations during the third trimester and the early postpartum period, as measured using five questions during endline surveys with pregnant women and their partners. We create a Care-Seeking Knowledge Scale as follows: Participants receive 1 point if they respond with 3 or more when asked how many postpartum visits women should have during the first 6 weeks after childbirth; 1 point if they correctly name at least 3 danger signs for women during pregnancy; 1 point if they correctly name at least 3 danger signs for women during the first six weeks after childbirth; and 1 point if they correctly name at least 3 danger signs for newborns. Scores range from 0 to 4 with higher scores representing greater knowledge. |
Measured 6-8 weeks after the end of pregnancy
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2026-19
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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