Clinical trial NCT05199935: Testing the Effectiveness of a Safety-promoting Intervention in Antenatal Care
Official title: A Randomized Controlled Trial Comparing the Effectiveness of a Safety-promoting Intervention With Standard Antenatal Care for Pregnant Women in Nepal
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Domestic Violence
Keywords: Pregnancy
Nepal
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: Kathmandu Medical College and Teaching Hospital
name: Kathmandu University School of Medical Sciences
name: University of South-Eastern Norway
First posted: 2022-01-20
Enrollment: 2000
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A two armed randomized controlled trial
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Seeking support
timeFrame: 12 to 24 weeks after intervention
Secondary outcomes:
measure: Ways of Coping Checklist
timeFrame: 12 to 24 weeks after intervention
measure: Use of safety measures
timeFrame: 12 to 24 weeks after intervention
Other outcomes:
measure: Hopkins Symptom Checklist - 10
timeFrame: 12 to 24 weeks after intervention
measure: Social Acceptance of Wife Abuse Scale
timeFrame: 12 to 24 weeks after intervention
measure: Attitudes towards domestic violence
timeFrame: 12 to 24 weeks after intervention
Locations:
city: Dhulikhel
country: Nepal
facility: Dhulikhel Hospital
city: Kathmandu
country: Nepal
facility: Kathmandu Medical College
Study officials:
affiliation: Norwegian University of Science and Technology
name: Schei Berit, PhD
role: PRINCIPAL_INVESTIGATOR
References: