NCT03469739

Brief Summary

This study uses data from 29,990 women from 12 different countries collected by the WHO multi-country study on women's health and domestic violence to capture the effect of different types, frequency and timing of IPV on self-reported health, symptoms and suicidal behaviours.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29,990

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2016

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

June 10, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
8 months until next milestone

First Posted

Study publicly available on registry

March 19, 2018

Completed
Last Updated

March 19, 2018

Status Verified

January 1, 2018

Enrollment Period

1.2 years

First QC Date

June 10, 2016

Last Update Submit

March 16, 2018

Conditions

Keywords

Intimate Partner Violence

Outcome Measures

Primary Outcomes (1)

  • Participant description of their current overall state of health

    Participant description of their current overall state of health- a choice of options- excellent, good, fair, poor or very poor.

    Preceding 4 weeks

Secondary Outcomes (4)

  • Participant reported health in the last 4 weeks- problems walking around, doing usual activities, pain or discomfort, problems with memory or concentration, dizziness or vaginal discharge. Measured by questionnaire.

    Preceding 4 weeks

  • Emotional distress. Measured by questionnaire of 20 different symptoms of emotional distress. SRQ-20 (score of 20 different symptoms of emotional distress with yes/no answers)

    Preceding 4 weeks

  • Participant reported ever suicidal thoughts or attempts; measured by questionnaire.

    Up to 49 years

  • Participant reported medication used for sleep/ pain; measured by questionnaire.

    Preceding 4 weeks

Eligibility Criteria

Age15 Years - 49 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

This study consists of further analysis of 29,990 interviews conducted with women in 12 different countries coordinated by the World Health Organisation. They report in most sites around 1500 women between 15 and 49 years old were interviewed. Countries included were Bangladesh, Brazil, Cambodia, Ethiopia, Japan, Maldives, Namibia, Peru, Samoa, Serbia and Montenegro, Thailand and the United Republic of Tanzania.

You may qualify if:

  • The WHO report that in most sites, a representative sample of women was obtained using a two-stage cluster sampling scheme to select households and then only one woman per household was randomly selected per household for interview.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Ellsberg M, Jansen HA, Heise L, Watts CH, Garcia-Moreno C; WHO Multi-country Study on Women's Health and Domestic Violence against Women Study Team. Intimate partner violence and women's physical and mental health in the WHO multi-country study on women's health and domestic violence: an observational study. Lancet. 2008 Apr 5;371(9619):1165-72. doi: 10.1016/S0140-6736(08)60522-X.

    PMID: 18395577BACKGROUND
  • Garcia-Moreno C, Jansen HA, Ellsberg M, Heise L, Watts CH; WHO Multi-country Study on Women's Health and Domestic Violence against Women Study Team. Prevalence of intimate partner violence: findings from the WHO multi-country study on women's health and domestic violence. Lancet. 2006 Oct 7;368(9543):1260-9. doi: 10.1016/S0140-6736(06)69523-8.

    PMID: 17027732BACKGROUND

Study Officials

  • Gene Feder, MD FRCGP

    University of Bristol

    STUDY DIRECTOR
  • Lucy C Potter, MB ChB

    University of Bristol

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 10, 2016

First Posted

March 19, 2018

Study Start

June 1, 2016

Primary Completion

August 1, 2017

Study Completion

August 1, 2017

Last Updated

March 19, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share