Intimate Partner Violence and Pregnancy, a Perinatal Care Intervention Study (MOM)

October 12, 2017 updated by: University Ghent

Intimate Partner Violence and Pregnancy, a Randomised Controlled Trial on the Effect of a Resource Card on the Incidence of Intimate Partner Violence

The study composes of two large parts, in particular a large scale prevalence/incidence study and a single-blind randomised controlled trial (RCT). The prevalence/incidence study aims to determine the prevalence/incidence of physical, psychological and sexual violence in a pregnant population. The study population is recruited through the prenatal consultation of more or less 15 hospitals in Belgium. The respondents fill out a questionnaire on the spot minimum one time during pregnancy. Based on this questionnaire, the investigators aim to recruit 150 victims of intimate partner violence (IPV) to participate in the second part of the study. The RCT aims to evaluate if there is a safe and effective way to reduce IPV within the perinatal care setting. The investigators hypothesise that screening pregnant women for violence in combination with handing out a resource card, has the potential of interrupting the IPV and increase help-seeking behaviour.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

199

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Aalst, Belgium
        • OLV Ziekenhuis Aalst
      • Antwerp, Belgium
        • UZA
      • Antwerp, Belgium
        • ZNA Middelheim Antwerpen
      • Brugge, Belgium
        • AZ Sint-Jan Brugge
      • Deurne, Belgium
        • AZ Monica Deurne
      • Genk, Belgium
        • ZOL Genk
      • Gent, Belgium
        • AZ Jan Palfijn Gent
      • Ghent, Belgium
        • Ghent University Hospital
      • Hasselt, Belgium
        • Virga Jesse Hasselt
      • Kortrijk, Belgium
        • AZ Groeninge Kortrijk
      • Waregem, Belgium
        • OLV van Lourdes ziekenhuis Waregem
      • Wilrijk, Belgium
        • AZ Sint-Augustinus Ziekenhuis Wilrijk

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Dutch-, French- or English speaking
  • Victim of intimate partner violence based on the questionnaire
  • Accessible through telephone and no safety problems

Exclusion Criteria:

  • Not Dutch-, French- or English speaking
  • Not a victim of intimate partner violence one year before or during pregnancy
  • Not accessible through telephone and/or safety problems

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: resource card group
The intervention group will receive an envelope with a gift voucher and a resource card (wallet size card with on the one side safety measures and on the other side contact details of resources for violence).
Other: resource card
the intervention group receives an envelop with resource card
Active Comparator: control group
The control group will receive the same envelop with a gift voucher and a letter of thanks.
Other: no resource card
the control group receives an envelop without resource card

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Impact of the resource card on the evolution of the partner violence within a sample of pregnant victims of partner violence
Time Frame: 6 months after receipt of the resource card
6 months after receipt of the resource card
Impact of the resource card on the evolution of the partner violence within a sample of pregnant victims of partner violence
Time Frame: 12 months after the receipt of the resource card
12 months after the receipt of the resource card

Secondary Outcome Measures

Outcome Measure
Time Frame
Impact of a resource card on the evolution of the help-seeking behaviour
Time Frame: 6 months after receipt of the resource card
6 months after receipt of the resource card
Impact of a resource card on the evolution of the help-seeking behaviour
Time Frame: 12 months after receipt of the resource card
12 months after receipt of the resource card

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Ghent

Collaborators

Fund for Scientific Research, Flanders, Belgium
International Centre for Reproductive Health, Belgium

Investigators

  • Principal Investigator: Marleen Temmerman, MD, PhD, Ghent University, Belgium

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2010

Primary Completion (Actual)

October 1, 2012

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

July 7, 2010

First Submitted That Met QC Criteria

July 7, 2010

First Posted (Estimate)

July 8, 2010

Study Record Updates

Last Update Posted (Actual)

October 13, 2017

Last Update Submitted That Met QC Criteria

October 12, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2010/093

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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