Intimate Partner ViolenceMOMNCT01158690
Intimate Partner Violence and Pregnancy, a Perinatal Care Intervention Study
A study testing resource card and no resource card in people with Intimate Partner Violence, run by University Ghent at 12 sites in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Intimate Partner Violence
- What is being tested?
- resource card and no resource card
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 199 participants
- Where
- 12 sitesBelgium
- Study dates
- Jun 2010to Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Dutch-, French- or English speaking
- Victim of intimate partner violence based on the questionnaire
- Accessible through telephone and no safety problems
Who cannot join
- 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
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Belgium12 sites
OLV Ziekenhuis Aalst
Aalst
UZA
Antwerp
ZNA Middelheim Antwerpen
Antwerp
AZ Sint-Jan Brugge
Bruges
AZ Monica Deurne
Deurne
ZOL Genk
Genk
AZ Jan Palfijn Gent
Ghent
Ghent University Hospital
Ghent
Virga Jesse Hasselt
Hasselt
AZ Groeninge Kortrijk
Kortrijk
OLV van Lourdes ziekenhuis Waregem
Waregem
AZ Sint-Augustinus Ziekenhuis Wilrijk
Wilrijk
About this 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
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.
- Conditions
- Intimate Partner Violence
- Being tested
- resource card, no resource card
- Keywords
- Intimate partner violence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
resource cardOther
the intervention group receives an envelop with resource card
no resource cardOther
the control group receives an envelop without resource card
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: resource card |
| control group | Active comparator | The control group will receive the same envelop with a gift voucher and a letter of thanks. Receives: Other: no resource card |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of the resource card on the evolution of the partner violence within a sample of pregnant victims of partner violence
Measured: 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
Measured: 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
Measured: 6 months after receipt of the resource card
Impact of a resource card on the evolution of the help-seeking behaviour
Measured: 12 months after receipt of the resource card
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2010 (estimated)
- Study startJun 2010
- Primary completionOct 2012
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intimate Partner ViolenceStudies of the same condition, open and under way.
- More trials run by University GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 199 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- Fund for Scientific Research, Flanders, Belgium, International Centre for Reproductive Health, Belgium
- Responsible party
- Sponsor
- Investigators
- Marleen Temmerman, MD, PhD, Principal investigator, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01158690
- Sponsor's protocol ID
- 2010/093
- Acronym
- MOM
- Status last verified
- Oct 2017
- First submitted
- 7 Jul 2010
- Last updated
- 13 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 28985722
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01158690
- Acronym / sponsor ID
- MOM / 2010/093
- Conditions
- Intimate Partner Violence
- Keywords
- Intimate partner violence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 199 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Collaborators
- Fund for Scientific Research, Flanders, Belgium, International Centre for Reproductive Health, Belgium
- Study start
- Jun 2010 (actual)
- Primary completion
- Oct 2012 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 8 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| resource card group | Experimental | Other: resource cardThe 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). |
| control group | Active comparator | Other: no resource cardThe control group will receive the same envelop with a gift voucher and a letter of thanks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Dutch-, French- or English speaking
- Victim of intimate partner violence based on the questionnaire
- Accessible through telephone and no safety problems
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| resource cardthe intervention group receives an envelop with resource card | Other | resource card group |
| no resource cardthe control group receives an envelop without resource card | Other | control group |
Primary outcome
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
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
2 secondary outcomes
Impact of a resource card on the evolution of the help-seeking behaviour
Time frame: 6 months after receipt of the resource card
Impact of a resource card on the evolution of the help-seeking behaviour
Time frame: 12 months after receipt of the resource card
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2017.
- Derived from this study: PubMed 28985722Van 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.
Related trials for Intimate Partner Violence
Recruiting
Adjunctive Motivational Alcohol Intervention to Prevent IPV
Alcohol Use and Intimate Partner Violence
Recruiting
SER Familia: A Family-Based Intervention Addressing Syndemic Conditions Among Latino Families
Substance Abuse, Intimate Partner Violence (IPV)
Recruiting
RISE Versus Advocacy-based Enhanced Care as Usual for Patients Experiencing IPV
Intimate Partner Violence (IPV)
Not yet recruiting
Metacognitive Interpersonal Therapy for Male Intimate Partner Violence Perpetrators With Personality Disorders
Intimate Partner Violence, Personality Disorders
Recruiting
Multifaceted Intervention to Restore Resilience and Overcome Risk
Military Sexual Trauma, Intimate Partner Violence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marleen Temmerman, MD, PhD principal investigator
University Ghent
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing resource card and no resource card in people with Intimate Partner Violence, run by University Ghent at 12 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01158690, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2017; AzTrials last refreshed its copy on 6 Nov 2026.