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Intimate Partner Violence and Pregnancy, a Perinatal Care Intervention Study

NCT ID: NCT01158690

Last Updated: 2017-10-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

199 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2016-09-30

Brief Summary

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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

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Conditions

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Intimate Partner Violence

Keywords

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Intimate partner violence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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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).

Group Type EXPERIMENTAL

resource card

Intervention Type OTHER

the intervention group receives an envelop with resource card

control group

The control group will receive the same envelop with a gift voucher and a letter of thanks.

Group Type ACTIVE_COMPARATOR

no resource card

Intervention Type OTHER

the control group receives an envelop without resource card

Interventions

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resource card

the intervention group receives an envelop with resource card

Intervention Type OTHER

no resource card

the control group receives an envelop without resource card

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Fund for Scientific Research, Flanders, Belgium

OTHER

Sponsor Role collaborator

International Centre for Reproductive Health, Belgium

OTHER

Sponsor Role collaborator

University Ghent

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marleen Temmerman, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Ghent

Locations

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OLV Ziekenhuis Aalst

Aalst, , Belgium

Site Status

UZA

Antwerp, , Belgium

Site Status

ZNA Middelheim Antwerpen

Antwerp, , Belgium

Site Status

AZ Sint-Jan Brugge

Bruges, , Belgium

Site Status

AZ Monica Deurne

Deurne, , Belgium

Site Status

ZOL Genk

Genk, , Belgium

Site Status

AZ Jan Palfijn Gent

Ghent, , Belgium

Site Status

Ghent University Hospital

Ghent, , Belgium

Site Status

Virga Jesse Hasselt

Hasselt, , Belgium

Site Status

AZ Groeninge Kortrijk

Kortrijk, , Belgium

Site Status

OLV van Lourdes ziekenhuis Waregem

Waregem, , Belgium

Site Status

AZ Sint-Augustinus Ziekenhuis Wilrijk

Wilrijk, , Belgium

Site Status

Countries

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Belgium

References

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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.

Reference Type DERIVED
PMID: 28985722 (View on PubMed)

Other Identifiers

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2010/093

Identifier Type: -

Identifier Source: org_study_id