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

This study is currently recruiting participants.

Verified March 2012 by University Ghent

Sponsor:

Collaborators:

Fund for Scientific Research, Flanders, Belgium

International Centre for Reproductive Health, Belgium

Information provided by (Responsible Party):

University Ghent

ClinicalTrials.gov Identifier:

NCT01158690

First received: July 7, 2010

Last updated: March 23, 2012

Last verified: March 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

July 7, 2010

Last Updated Date

March 23, 2012

Start Date ^ICMJE

June 2010

Estimated Primary Completion Date

June 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

the impact of the resource card on the evolution of the partner violence and the help seeking behaviour of the pregnant victims of partner violence [ Time Frame: after 6 months ] [ Designated as safety issue: No ]
impact of the resource card will be measured by means of interview after 2 months and after 6 months
impact of the resource card on the evolution of the partner violence and the help seeking behaviour of the pregnant victims of partner violence [ Time Frame: after 2 months ] [ Designated as safety issue: No ]

Change History

Complete list of historical versions of study NCT01158690 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Impact of a resource card on the evolution of the help-seeking behaviour [ Time Frame: 6 months after receipt of the resource card ] [ Designated as safety issue: No ]
Impact of a resource card on the evolution of the help-seeking behaviour [ Time Frame: 12 months after receipt of the resource card ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

increase or decrease in the help-seeking behaviour [ Time Frame: after 6 months ] [ Designated as safety issue: No ]
increase or decrease in the help-seeking behaviour [ Time Frame: after 2 months ] [ Designated as safety issue: No ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Intimate Partner Violence and Pregnancy, a Perinatal Care Intervention Study

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)

Condition ^ICMJE

Intimate Partner Violence

Intervention ^ICMJE

Other: resource card
the intervention group receives an envelop with resource card
Other: no resource card
the control group receives an envelop without resource card

Study Arm (s)

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).

Intervention: Other: resource card
Active Comparator: control group
The control group will receive the same envelop with a gift voucher and a letter of thanks.

Intervention: Other: no resource card

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

150

Estimated Completion Date

March 2014

Estimated Primary Completion Date

June 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: An-Sofie Van Parys

ansofie.vanparys@ugent.be

Location Countries ^ICMJE

Belgium

Administrative Information

NCT Number ^ICMJE

NCT01158690

Other Study ID Numbers ^ICMJE

2010/093

Has Data Monitoring Committee

Responsible Party

University Ghent

Study Sponsor ^ICMJE

University Ghent

Collaborators ^ICMJE

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

Investigators ^ICMJE

Principal Investigator:

Marleen Temmerman, MD, PhD

Ghent University, Belgium

Information Provided By

University Ghent

Verification Date

March 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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