NCT01158690

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
199

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 7, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 8, 2010

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
3.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

October 13, 2017

Status Verified

October 1, 2017

Enrollment Period

2.3 years

First QC Date

July 7, 2010

Last Update Submit

October 12, 2017

Conditions

Intimate Partner Violence

Keywords

Intimate partner violence

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (2)

  • Impact of a resource card on the evolution of the help-seeking behaviour

    6 months after receipt of the resource card

  • Impact of a resource card on the evolution of the help-seeking behaviour

    12 months after receipt of the resource card

Study Arms (2)

resource card group

EXPERIMENTAL

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

control group

ACTIVE COMPARATOR

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

Other: no resource card

Interventions

resource cardOTHER

the intervention group receives an envelop with resource card

resource card group
no resource cardOTHER

the control group receives an envelop without resource card

control group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Dutch-, French- or English speaking
  • Victim of intimate partner violence based on the questionnaire
  • Accessible through telephone and no safety problems

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

OLV Ziekenhuis Aalst

Aalst, Belgium

Location

UZA

Antwerp, Belgium

Location

ZNA Middelheim Antwerpen

Antwerp, Belgium

Location

AZ Sint-Jan Brugge

Bruges, Belgium

Location

AZ Monica Deurne

Deurne, Belgium

Location

ZOL Genk

Genk, Belgium

Location

AZ Jan Palfijn Gent

Ghent, Belgium

Location

Ghent University Hospital

Ghent, Belgium

Location

Virga Jesse Hasselt

Hasselt, Belgium

Location

AZ Groeninge Kortrijk

Kortrijk, Belgium

Location

OLV van Lourdes ziekenhuis Waregem

Waregem, Belgium

Location

AZ Sint-Augustinus Ziekenhuis Wilrijk

Wilrijk, Belgium

Location

Related Publications (1)

  • 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.

    PMID: 28985722DERIVED

Study Officials

  • Marleen Temmerman, MD, PhD

    University Ghent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 7, 2010

First Posted

July 8, 2010

Study Start

June 1, 2010

Primary Completion

October 1, 2012

Study Completion

September 1, 2016

Last Updated

October 13, 2017

Record last verified: 2017-10

Locations

BE(12)