Clinical trial NCT01158690: Intimate Partner Violence and Pregnancy, a Perinatal Care Intervention Study
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intimate Partner Violence
Keywords: Intimate partner violence
Lead sponsor: University Ghent
Sponsor class: OTHER
Collaborators: name: Fund for Scientific Research, Flanders, Belgium
name: International Centre for Reproductive Health, Belgium
First posted: 2010-07-08
Enrollment: 199
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility 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

Primary outcomes:
measure: Impact of the resource card on the evolution of the partner violence within a sample of pregnant victims of partner violence
timeFrame: 6 months after receipt of the resource card
measure: Impact of the resource card on the evolution of the partner violence within a sample of pregnant victims of partner violence
timeFrame: 12 months after the receipt of the resource card
Secondary outcomes:
measure: Impact of a resource card on the evolution of the help-seeking behaviour
timeFrame: 6 months after receipt of the resource card
measure: Impact of a resource card on the evolution of the help-seeking behaviour
timeFrame: 12 months after receipt of the resource card
Other outcomes:
Locations:
city: Aalst
country: Belgium
facility: OLV Ziekenhuis Aalst
city: Antwerp
country: Belgium
facility: UZA
city: Antwerp
country: Belgium
facility: ZNA Middelheim Antwerpen
city: Brugge
country: Belgium
facility: AZ Sint-Jan Brugge
city: Deurne
country: Belgium
facility: AZ Monica Deurne
city: Genk
country: Belgium
facility: ZOL Genk
city: Gent
country: Belgium
facility: AZ Jan Palfijn Gent
city: Ghent
country: Belgium
facility: Ghent University Hospital
city: Hasselt
country: Belgium
facility: Virga Jesse Hasselt
city: Kortrijk
country: Belgium
facility: AZ Groeninge Kortrijk
city: Waregem
country: Belgium
facility: OLV van Lourdes ziekenhuis Waregem
city: Wilrijk
country: Belgium
facility: AZ Sint-Augustinus Ziekenhuis Wilrijk
Study officials:
affiliation: University Ghent
name: Marleen Temmerman, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Van Parys AS, Deschepper E, Roelens K, Temmerman M, Verstraelen H. The impact of a referral card-based intervention on intimate partner violence, psychosocial health, help-seeking and safety behaviour during pregnancy and postpartum: a randomized controlled trial. BMC Pregnancy Childbirth. 2017 Oct 6;17(1):346. doi: 10.1186/s12884-017-1519-x.