- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07430033
Effectiveness of Online-Based "Pregnant Women Care Cadres" Intervention on Husband Support in Early Detection of High Risk in Medan Maimun Area
The goal of this quasi-experimental study is to evaluate whether an online-based "Caring for Pregnant Women" intervention delivered through community health cadres can improve husband support in the early detection of high-risk pregnancies among pregnant women and their husbands in the Medan Maimun area.
The main questions it aims to answer are:
Does the online-based "Caring for Pregnant Women" intervention increase emotional support from husbands in the early detection of high-risk pregnancies?
Does the intervention increase informational support from husbands in the early detection of high-risk pregnancies?
Does the intervention increase practical support from husbands in the early detection of high-risk pregnancies?
This study does not include a comparison group.
Participants will:
Complete a pre-test questionnaire assessing emotional, informational, and practical support from husbands in the early detection of high-risk pregnancies
Participate in an online-based education program facilitated by trained health cadres for one month
Join a WhatsApp group involving husbands, pregnant women, and health cadres for education, monitoring, and communication related to high-risk pregnancy detection
Complete a post-test questionnaire after the intervention to measure changes in husband support
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Medan, Indonesia
- Universitas Sumatera Utara
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Pregnant women who lived with their families (husband/wife/children/inlaws)
- Women who were able to communicate verbally
- Registered in the Medan Maimun area with a Medan Maimun identity card
- Registered with the neighborhood association
- Had a health cadre responsible for the local area
Exclusion Criteria:
- Pregnant women living alone
- Unable to communicate verbally
- Not registered in Medan Maimun
- Without a Medan Maimun identity card
- Not registered with the neighborhood association
- Without an assigned health cadre
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Pregnant Women Care Cadres Intervention
|
The intervention consisted of an online-based educational program delivered by trained community health cadres.
Education was provided through WhatsApp groups once per week for four consecutive weeks, including information on early detection of high-risk pregnancy and husband support.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from Baseline in Husbands' Emotional, Informational, and Practical Support Score for Early Detection of High-Risk Pregnancy After 4 Weeks of Online-Based Intervention
Time Frame: From enrollment (baseline/pre-test) to the end of the online-based intervention at 4 weeks (post-test).
|
This outcome measures changes in husbands' emotional, informational, and practical support for early detection of high-risk pregnancy following a 4-week online-based "Caring for Pregnant Women" intervention delivered by trained health cadres.
Husbands' support was assessed using a Family Support Questionnaire developed based on Friedman's Family Support Theory and high-risk pregnancy concepts.
The questionnaire consists of 19 valid items covering emotional, informational, and practical support.
Emotional, informational, and practical support were assessed separately, each with scores ranging from 10 to 50.
Higher scores indicate greater support from husbands/families.
The instrument showed good reliability (Cronbach's alpha = 0.879).
The primary outcome was calculated as the difference between baseline (pre-intervention) and post-intervention scores at 4 weeks.
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From enrollment (baseline/pre-test) to the end of the online-based intervention at 4 weeks (post-test).
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Other Study ID Numbers
- No:22/KEPK/USU/2024
- 2837/UN5.1.R/SK/PPM/2023 (Other Grant/Funding Number: Talenta Universitas of Sumatera Utara 2837/UN5.1.R/SK/PPM/2023)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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