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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01158690
First Posted: July 8, 2010
Last Update Posted: October 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Fund for Scientific Research, Flanders, Belgium
International Centre for Reproductive Health, Belgium
Information provided by (Responsible Party):
University Ghent
  Purpose
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.

Condition Intervention
Intimate Partner Violence Other: resource card Other: no resource card

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Other
Official Title: Intimate Partner Violence and Pregnancy, a Randomised Controlled Trial on the Effect of a Resource Card on the Incidence of Intimate Partner Violence

Further study details as provided by University Ghent:

Primary Outcome Measures:
  • 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 ]
  • 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 ]

Secondary Outcome Measures:
  • Impact of a resource card on the evolution of the help-seeking behaviour [ Time Frame: 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 ]

Enrollment: 199
Actual Study Start Date: June 2010
Study Completion Date: September 2016
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01158690


Locations
Belgium
OLV Ziekenhuis Aalst
Aalst, Belgium
UZA
Antwerp, Belgium
ZNA Middelheim Antwerpen
Antwerp, Belgium
AZ Sint-Jan Brugge
Brugge, Belgium
AZ Monica Deurne
Deurne, Belgium
ZOL Genk
Genk, Belgium
AZ Jan Palfijn Gent
Gent, Belgium
Ghent University Hospital
Ghent, Belgium
Virga Jesse Hasselt
Hasselt, Belgium
AZ Groeninge Kortrijk
Kortrijk, Belgium
OLV van Lourdes ziekenhuis Waregem
Waregem, Belgium
AZ Sint-Augustinus Ziekenhuis Wilrijk
Wilrijk, Belgium
Sponsors and Collaborators
University Ghent
Fund for Scientific Research, Flanders, Belgium
International Centre for Reproductive Health, Belgium
Investigators
Principal Investigator: Marleen Temmerman, MD, PhD Ghent University, Belgium
  More Information

Responsible Party: University Ghent
ClinicalTrials.gov Identifier: NCT01158690     History of Changes
Other Study ID Numbers: 2010/093
First Submitted: July 7, 2010
First Posted: July 8, 2010
Last Update Posted: October 13, 2017
Last Verified: October 2017

Keywords provided by University Ghent:
Intimate partner violence