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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Domestic Violence

Intervention / Treatment
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* Behavioral: Video
* Other: Control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A two armed randomized controlled trial
Masking: Triple


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pregnancy, Nepal