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

NCT ID: NCT05199935

Last Updated: 2026-01-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 2230 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-29
• Study Completion Date: 2025-10-01

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.

Conditions

Domestic Violence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Intervention

Are shown the intervention video after filling out baseline questionnaire

Group Type: EXPERIMENTAL

Video

Intervention Type: BEHAVIORAL

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

Control

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

Group Type: OTHER

Control

Intervention Type: OTHER

Control video on healthy pregnancy

Interventions

Video

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

Intervention Type: BEHAVIORAL

Control

Control video on healthy pregnancy

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Kathmandu Medical College and Teaching Hospital

OTHER

Sponsor Role: collaborator

Kathmandu University School of Medical Sciences

OTHER

Sponsor Role: collaborator

University of South-Eastern Norway

OTHER

Sponsor Role: collaborator

Norwegian University of Science and Technology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Schei Berit, PhD

Role: PRINCIPAL_INVESTIGATOR

Norwegian University of Science and Technology

Locations

Dhulikhel Hospital

Dhulikhel, , Nepal

Kathmandu Medical College

Kathmandu, , Nepal

Countries

Nepal

References

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.

Reference Type: DERIVED

PMID: 37715147 (View on PubMed)

Other Identifiers

178092

Identifier Type: -

Identifier Source: org_study_id