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

Not Applicable

Recruiting

• Conditions: Domestic Violence
• Interventions: Behavioral: Video; Other: Control

• Registration Number: NCT05199935
• Lead Sponsor: Norwegian University of Science and Technology

Brief 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.

Study Timeline

• Study First Submitted: 2022-01-05
• Study First Submitted QC: 2022-01-19
• Study First Posted: 2022-01-20
• Study Start: 2023-01-29
• Status Verified: 2024-11
• Last Update Submitted: 2024-12-02
• Last Update Posted: 2024-12-05
• Primary Completion: 2025-03
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 2000

Inclusion Criteria

• between 12 to 20 weeks gestational age of pregnancy

Exclusion Criteria

• prior 12 weeks gestation
• after 20 weeks of pregnancy
• mentally unable to participate

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Video	Are shown the intervention video after filling out baseline questionnaire
Control	Control	Are shown a control at Time 0, baseline and the intervention video after main outcome data is collected at Time 1

Primary Outcome Measures

Name	Time	Method
Seeking support	12 to 24 weeks after intervention	A single question asking women if they have told anybody about the experience of domestic violence besides the person at the personal follow-up at Time 1 (baseline)

Secondary Outcome Measures

Name	Time	Method
Ways of Coping Checklist	12 to 24 weeks after intervention	Sub-scales seeking social support, avoidance and detachment, self-blame
Use of safety measures	12 to 24 weeks after intervention	Measures women can take to prepare for leaving or reduce violence

Trial Locations

Locations (2)

Dhulikhel Hospital; 🇳🇵 Dhulikhel, Nepal

Kathmandu Medical College; 🇳🇵 Kathmandu, Nepal