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

Domestic Violence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05199935
• Other study ID #: 178092
• Status: Recruiting
• Phase: N/A
• Start date: January 29, 2023
• Est. completion date: December 2024

Study information

• Verified date: February 2023
• Source: Norwegian University of Science and Technology
• Contact: Mirjam Lukasse, PhD
• Phone: 004795771864
• Email: Mirjam.Lukasse[@]usn.no
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: December 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Domestic Violence

Intervention

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

Other:
• Control
Control video on healthy pregnancy

Locations

Country	Name	City	State
Nepal	Dhulikhel Hospital	Dhulikhel
Nepal	Kathmandu Medical College	Kathmandu

Sponsors (4)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	Kathmandu Medical College and Teaching Hospital, Kathmandu University School of Medical Sciences, University of South-Eastern Norway

Country where clinical trial is conducted

Nepal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Hopkins Symptom Checklist - 10	Symptoms of depression and anxiety	12 to 24 weeks after intervention
Other	Social Acceptance of Wife Abuse Scale	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.	12 to 24 weeks after intervention
Other	Attitudes towards domestic violence	WHO set of questions	12 to 24 weeks after intervention
Primary	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	Ways of Coping Checklist	Sub-scales seeking social support, avoidance and detachment, self-blame	12 to 24 weeks after intervention
Secondary	Use of safety measures	Measures women can take to prepare for leaving or reduce violence	12 to 24 weeks after intervention