A Randomized Controlled Trial Comparing the Effectiveness of a Safety-promoting Intervention With Standard Antenatal Care for Pregnant Women in Nepal
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,000
- 试验地点
- 2
- 主要终点
- Seeking support
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •between 12 to 20 weeks gestational age of pregnancy
排除标准
- •prior 12 weeks gestation
- •after 20 weeks of pregnancy
- •mentally unable to participate
研究组 & 干预措施
Intervention
Are shown the intervention video after filling out baseline questionnaire
干预措施: Video (Behavioral)
Control
Are shown a control at Time 0, baseline and the intervention video after main outcome data is collected at Time 1
干预措施: Control (Other)
结局指标
主要结局
Seeking support
时间窗: 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)
次要结局
- Ways of Coping Checklist(12 to 24 weeks after intervention)
- Use of safety measures(12 to 24 weeks after intervention)