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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by University Ghent.
Recruitment status was  Recruiting
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
  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 Blind (Subject)
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 ] [ 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 ]

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 ] [ 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 ]

Estimated Enrollment: 150
Study Start Date: June 2010
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: June 2013 (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

Ages Eligible for Study:   18 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01158690

Contacts
Contact: An-Sofie Van Parys ansofie.vanparys@ugent.be

Locations
Belgium
OLV Ziekenhuis Aalst Active, not recruiting
Aalst, Belgium
UZA Active, not recruiting
Antwerp, Belgium
ZNA Middelheim Antwerpen Active, not recruiting
Antwerp, Belgium
AZ Sint-Jan Brugge Active, not recruiting
Brugge, Belgium
AZ Monica Deurne Completed
Deurne, Belgium
ZOL Genk Recruiting
Genk, Belgium
Principal Investigator: Wilfried Gyselaers, MD         
AZ Jan Palfijn Gent Active, not recruiting
Gent, Belgium
Ghent University Hospital Recruiting
Ghent, Belgium
Principal Investigator: Marleen Temmerman, MD, PhD         
Sub-Investigator: Hans Verstraelen, MD, PhD         
Sub-Investigator: An-Sofie Van Parys         
Virga Jesse Hasselt Recruiting
Hasselt, Belgium
Principal Investigator: Simon Boes, MD         
AZ Groeninge Kortrijk Recruiting
Kortrijk, Belgium
Principal Investigator: Bart De Keersmaecker, MD         
OLV van Lourdes ziekenhuis Waregem Recruiting
Waregem, Belgium
Principal Investigator: Monica Notermans, MD         
AZ Sint-Augustinus Ziekenhuis Wilrijk Active, not recruiting
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

No publications provided

Responsible Party: University Ghent
ClinicalTrials.gov Identifier: NCT01158690     History of Changes
Other Study ID Numbers: 2010/093
Study First Received: July 7, 2010
Last Updated: March 23, 2012
Health Authority: Belgium: Ethics Committee

Keywords provided by University Ghent:
Intimate partner violence

ClinicalTrials.gov processed this record on November 27, 2014