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

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.

Study Overview

• Status: Completed
• Conditions: Domestic Violence
• Intervention / Treatment: Behavioral: Video; Other: Control

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 Type: Interventional
• Enrollment (Actual): 2230
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Nepal
  • Dhulikhel, Nepal
    • Dhulikhel Hospital
  • Kathmandu, Nepal
    • Kathmandu Medical College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Are shown the intervention video after filling out baseline questionnaire	Behavioral: Video; Information on violence and safety behaviors. Women are encouraged to share their experience of domestic violence with others.
Other: Control; Are shown a control at Time 0, baseline and the intervention video after main outcome data is collected at Time 1	Other: Control; Control video on healthy pregnancy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Seeking support	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)	12 to 24 weeks after intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ways of Coping Checklist	Sub-scales seeking social support, avoidance and detachment, self-blame	12 to 24 weeks after intervention
Use of safety measures	Measures women can take to prepare for leaving or reduce violence	12 to 24 weeks after intervention
Change in Domestic Violence status	A change in domestic violence status from reporting not any experience of any domestic violence to reporting experience of any domestic violence, or the contrasting result going from reporting the experience of any domestic violence to reporting no experience of any domestic violence.	From baseline (questionnaire nr. 1) to time 1, questionnaire number 2.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hopkins Symptom Checklist - 10	Symptoms of depression and anxiety	12 to 24 weeks after intervention
Social Acceptance of Wife Abuse Scale	6 items from the Social Acceptance of Wife Abuse Scale (SAWAS). Minimum score is 0 (zero) and maximum score is 3. A higher score is a worse outcome.	12 to 24 weeks after intervention
Attitudes towards domestic violence	WHO set of questions	12 to 24 weeks after intervention

Collaborators and Investigators

• Sponsor: Norwegian University of Science and Technology
• Collaborators: Kathmandu Medical College and Teaching Hospital; Kathmandu University School of Medical Sciences; University of South-Eastern Norway
• Investigators: Principal Investigator: Schei Berit, PhD, Norwegian University of Science and Technology

Publications and helpful links

General Publications

• Chalise P, Manandhar P, Infanti JJ, Campbell J, Henriksen L, Joshi SK, Koju R, Pun KD, Rishal P, Simpson MR, Skovlund E, Swahnberg K, Schei B, Lukasse M. Addressing Domestic Violence in Antenatal Care Environments in Nepal (ADVANCE) - study protocol for a randomized controlled trial evaluating a video intervention on domestic violence among pregnant women. BMC Public Health. 2023 Sep 15;23(1):1794. doi: 10.1186/s12889-023-16685-6.

Study record dates

Study Major Dates

• Study Start (Actual): January 29, 2023
• Primary Completion (Actual): October 1, 2025
• Study Completion (Actual): October 1, 2025

Study Registration Dates

• First Submitted: January 5, 2022
• First Submitted That Met QC Criteria: January 19, 2022
• First Posted (Actual): January 20, 2022

Study Record Updates

• Last Update Posted (Actual): January 22, 2026
• Last Update Submitted That Met QC Criteria: January 20, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Pregnancy; Nepal
• Additional Relevant MeSH Terms: Technology, Industry, and Agriculture; Technology; Tape Recording; Audiovisual Aids; Educational Technology; Television; Videotape Recording
• Other Study ID Numbers: 178092

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No