Intimate Partner Violence and Pregnancy, a Perinatal Care Intervention Study

Intimate Partner Violence Clinical Trial

— MOM  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01158690
• Other study ID #: 2010/093
• Status: Completed
• Phase: N/A
• First received: July 7, 2010
• Last updated: October 12, 2017
• Start date: June 2010
• Est. completion date: September 2016

Study information

• Verified date: October 2017
• Source: University Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 199
• Est. completion date: September 2016
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Intimate Partner Violence

Intervention

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

Locations

Country	Name	City	State
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

Sponsors (3)

Lead Sponsor	Collaborator
University Ghent	Fund for Scientific Research, Flanders, Belgium, International Centre for Reproductive Health, Belgium

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Impact of the resource card on the evolution of the partner violence within a sample of pregnant victims of partner violence		6 months after receipt of the resource card
Primary	Impact of the resource card on the evolution of the partner violence within a sample of pregnant victims of partner violence		12 months after the receipt of the resource card
Secondary	Impact of a resource card on the evolution of the help-seeking behaviour		6 months after receipt of the resource card
Secondary	Impact of a resource card on the evolution of the help-seeking behaviour		12 months after receipt of the resource card