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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
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05199935
Enrollment
2230
Registered
2022-01-20
Start date
2023-01-29
Completion date
2025-10-01
Last updated
2026-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Domestic Violence

Keywords

Pregnancy, Nepal

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.

Interventions

BEHAVIORALVideo

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

OTHERControl

Control video on healthy pregnancy

Sponsors

Norwegian University of Science and Technology
Lead SponsorOTHER
Kathmandu Medical College and Teaching Hospital
CollaboratorOTHER
Kathmandu University School of Medical Sciences
CollaboratorOTHER
University of South-Eastern Norway
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Masking description

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.

Intervention model description

A two armed randomized controlled trial

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Seeking support12 to 24 weeks after interventionA 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

MeasureTime frameDescription
Ways of Coping Checklist12 to 24 weeks after interventionSub-scales seeking social support, avoidance and detachment, self-blame
Use of safety measures12 to 24 weeks after interventionMeasures women can take to prepare for leaving or reduce violence
Change in Domestic Violence statusFrom baseline (questionnaire nr. 1) to time 1, questionnaire number 2.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.

Countries

Nepal

Contacts

PRINCIPAL_INVESTIGATORSchei Berit, PhD

Norwegian University of Science and Technology

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026