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Completed

NCT Number: NCT05199935

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

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.

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Key information

Conditions

Domestic Violence

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Dhulikhel Hospital, Dhulikhel, Nepal

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Video

Behavioral

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

Control

Other

Control video on healthy pregnancy

Primary outcomes

  1. Seeking support

    Time frame: 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 outcomes

  1. Ways of Coping Checklist

    Time frame: 12 to 24 weeks after intervention

    Sub-scales seeking social support, avoidance and detachment, self-blame

  2. Use of safety measures

    Time frame: 12 to 24 weeks after intervention

    Measures women can take to prepare for leaving or reduce violence

  3. Change in Domestic Violence status

    Time frame: From 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.

Other outcomes

  1. Hopkins Symptom Checklist - 10

    Time frame: 12 to 24 weeks after intervention

    Symptoms of depression and anxiety

  2. Social Acceptance of Wife Abuse Scale

    Time frame: 12 to 24 weeks after intervention

    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.

  3. Attitudes towards domestic violence

    Time frame: 12 to 24 weeks after intervention

    WHO set of questions

Sponsors and collaborators

Lead sponsor

Norwegian University of Science and Technology

Other

Collaborators

  • Kathmandu Medical College and Teaching Hospital
  • Kathmandu University School of Medical Sciences
  • University of South-Eastern Norway

Registry information

Official study title

A Randomized Controlled Trial Comparing the Effectiveness of a Safety-promoting Intervention With Standard Antenatal Care for Pregnant Women in Nepal

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jan 20, 2022
Registry last updated
Jan 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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