NCT05199935

Testing the Effectiveness of a Safety-promoting Intervention in Antenatal Care

A Randomized Controlled Trial Comparing the Effectiveness of a Safety-promoting Intervention With Standard Antenatal Care for Pregnant Women in Nepal

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,230 (actual)
• Sponsor: Norwegian University of Science and Technology · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Domestic violence during pregnancy can directly or indirectly cause maternal and fetal morbidity and even mortality. The investigators have validated the Abuse Assessment Screen to the Nepali context for use with a color-coded audio computer assisted self-interview method among pregnant women. This instrument will be used to identify women experiencing domestic violence during or shortly prior to their current pregnancy. In addition, an intervention video was developed. The aim of the video is to encourage women to take safety actions, in particular telling someone about the violence experienced. Women in the control group will watch a video on a healthy pregnancy and sign and symptoms of complications and what to to if these occur.The control video was chosen to increase blinding. This study aims to investigate the effect of the video compared to an intervention video.

Detailed description

This randomized controlled study is a two armed study, which will take place at two locations in Nepal. Eligible women will be invited to the study when attending routine antenatal care. Women agreeing to participate will be invited to first complete a questionnaire. Upon completion of this first questionnaire women will view either the intervention or control video, irrespective of their Domestic Violence (DV) Status. In the intervention arm all women will be shown the intervention video, irrespective of their DV status. In the control arm women view an intervention video. All women are asked to return to the study during the last two months of their pregnancy. All women will be asked to complete the second questionnaire. Upon completions all women will be offered to see the intervention video. For the intervention group this will be their second viewing, for the control group this will be the first viewing of the intervention video. All women will be followed up til birth. Data about their birth will be collected from their hospital records.

Conditions

• Domestic Violence

Interventions

Type	Name	Description
BEHAVIORAL	Video	Information on violence and safety behaviors. Women are encouraged to share their experience of domestic violence with others.
OTHER	Control	Control video on healthy pregnancy

Timeline

• Start date: 2023-01-29
• Primary completion: 2025-10-01
• Completion: 2025-10-01
• First posted: 2022-01-20
• Last updated: 2026-01-22

Locations

2 sites across 1 country: Nepal