NCT05199935

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,230

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2023

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 5, 2022

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 20, 2022

Completed
1 year until next milestone

Study Start

First participant enrolled

January 29, 2023

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
Last Updated

January 22, 2026

Status Verified

January 1, 2026

Enrollment Period

2.7 years

First QC Date

January 5, 2022

Last Update Submit

January 20, 2026

Conditions

Domestic Violence

Keywords

PregnancyNepal

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Ways of Coping Checklist

    12 to 24 weeks after intervention

  • Use of safety measures

    12 to 24 weeks after intervention

  • Change in Domestic Violence status

    From baseline (questionnaire nr. 1) to time 1, questionnaire number 2.

Other Outcomes (3)

  • Hopkins Symptom Checklist - 10

    12 to 24 weeks after intervention

  • Social Acceptance of Wife Abuse Scale

    12 to 24 weeks after intervention

  • Attitudes towards domestic violence

    12 to 24 weeks after intervention

Study Arms (2)

Intervention

EXPERIMENTAL

Are shown the intervention video after filling out baseline questionnaire

Behavioral: Video

Control

OTHER

Are shown a control at Time 0, baseline and the intervention video after main outcome data is collected at Time 1

Other: Control

Interventions

VideoBEHAVIORAL

Information on violence and safety behaviors. Women are encouraged to share their experience of domestic violence with others.

Intervention
ControlOTHER

Control video on healthy pregnancy

Control

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • between 12 to 20 weeks gestational age of pregnancy

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Dhulikhel Hospital

Dhulikhel, Nepal

Location

Kathmandu Medical College

Kathmandu, Nepal

Location

Related Publications (1)

  • 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.

    PMID: 37715147DERIVED

MeSH Terms

Interventions

Videotape Recording

Intervention Hierarchy (Ancestors)

Tape RecordingAudiovisual AidsEducational TechnologyTechnologyTechnology, Industry, and AgricultureTelevision

Study Officials

  • Schei Berit, PhD

    Norwegian University of Science and Technology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
All participants will view a video twice. At baseline (Time 0) one group will view the intervention video and the other group the control video. Both video are of the same length. Women are seated in such a way that they cannot view each others screens. All women will view the intervention video after the main outcome has been collected at time 1. Care providers will provide standard care and not know which group women in unless they specifically ask at which point the woman viewed a video and if she talked to someone in person after viewing the video. The data-set will be masked so that the statistician analyzing will not know the code for the two different groups.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: A two armed randomized controlled trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 5, 2022

First Posted

January 20, 2022

Study Start

January 29, 2023

Primary Completion

October 1, 2025

Study Completion

October 1, 2025

Last Updated

January 22, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

NE(2)