Pregnancy RelatedeIPVNCT04978064
E-health Psychological Intervention in Pregnant Women Exposed to Intimate Partner Violence (eIPV)
A study testing e-health psychological counselling in people with Pregnancy Related and Violence, Gender-Based, run by Universidad de Granada at 2 sites in 2 countries.
Trial summary
The investigators will assess the need and feasibility of randomising a sufficiently large number of women exposed to IPV during pregnancy in a full-scale future randomised trial. To achieve this, the investigators will: 1. Read more about this study
- Who is it for?
- Ages 16 years and older, women only
- Conditions the study is for
- Pregnancy Related, Violence, Gender-Based, Intimate Partner Violence
- What is being tested?
- e-health psychological counselling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 7 Oct 2021to 14 Nov 2022
- 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 16 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Pregnant women at <12 weeks gestation, who screen positive in IPV at the first antenatal visit and accept the e-health package.
Who cannot join
- Women who cannot be informed about the study without their partners or other family members knowing
- Women mentally or physically incapacity to participate in the study
- Women below 16 years in Spain or below 18 years in Denmark
- Inability to understand Danish/Spanish
- Lack of internet and electronic device
- Women with extreme severity of IPV. Women selected to participate in the trial in this situation will receive a danger assessment before randomisation and if the severity of IPV is confirmed, they will be routinely treated and supported according to the standard protocol in each country. Women who have same-sex partners will be screened, but their data will not be used for the purpose of this study.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: E-health Psychological Intervention in Pregnant Women Exposed to Intimate Partner Violence (eIPV): a Pilot Randomised Controlled Trial
The investigators will assess the need and feasibility of randomising a sufficiently large number of women exposed to IPV during pregnancy in a full-scale future randomised trial. To achieve this, the investigators will:
- estimate rates of consent to randomization, and the rates of adherence and dropout following randomization (for the use in sample size estimation)
- determine recruitment duration
- examine the women's perception about the benefit of the intervention
- determine the reasons for acceptability, non-adherence, and obstacles to recruitment, randomisation and consent through qualitative interviews
Read the detailed description
Introduction. Intimate partner violence (IPV) during pregnancy, a condition as common as obstetrics conditions like gestational diabetes, is associated with maternal and neonatal complications. Systematic detection of IPV is not well established in antenatal screening probably because the effectiveness of protective interventions has not been evaluated. Among mothers exposed to IPV, e-health interventions during pregnancy may be beneficial. Prior to performing a full-scale effectiveness trial for such an intervention, a pilot study is required to assess the need and feasibility of randomising a sufficiently large number of women at exposed to IPV during pregnancy.
Methods. The eIPV trial is a randomised pilot study nested within a cohort of consenting mothers at <12 weeks' gestation who screen positive for IPV in the first antenatal visit and accept an e-health package (psychological counselling by videoconference) in Spain and Denmark. Twenty eligible mothers from the above cohort will be randomised to either intervention or control. The intervention group will receive the e-health package as part of the cohort. The control group will be invited to accept a delay in the intervention (e-health package eight weeks later). After consenting to delay, the control group will provide comparative data without losing the opportunity of obtaining the intervention. The investigators will determine estimates of rates of informed consent to randomization, and the rates of adherence and dropout following randomization. Qualitative interviews will be conducted to examine the women's perception about the benefit of the intervention, reasons for acceptability and non-adherence, and obstacles to recruitment, randomisation and consent. The results will inform the feasibility and variance of key clinical outcome measures for estimation of sample size of the full-scale effectiveness trial.
Comment. The pilot study nested within the cohort study will allow us to obtain information about the rates of IPV in pregnancy, the acceptability of an e-health intervention and the availability of participants for randomisation into a large effectiveness trial.
- Being tested
- e-health psychological counselling
- Keywords
- pilot randomized controlled trial, pregnancy, intimate partner violence, e-health intervention, counselling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
e-health psychological counsellingBehavioural
Intervention group: Women positive for IPV who accept the e-Health intervention and who have been randomly allocated in the intervention group will receive the e-health package as the rest of the cohort, as well as the baseline and outcome measurements. The e-health package will include six video counselling sessions by trained providers and the access to a mobile application for designing security plans, an adapted version of the mobile application "My Plan". The content of the six individually tailored sessions will be based on the Dutton's Empowerment Model and the Psychosocial Readiness Model.
Control group: women positive in IPV who accept the e-Health intervention package will be asked for a second consent to receive a delayed intervention (8 weeks later) and to complete as the baseline and outcome measurements. Women can request to leave the control group at any time and to receive the intervention immediately (in which case they data will be part of the cohort study).
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Behavioral e-health psychological counselling Receives: Behavioral: e-health psychological counselling |
| Control group | Other | Usual care (delayed behavioral e-health psychological counselling) Receives: Behavioral: e-health psychological counselling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Consent rate for a future full-scale RCT trial
Rate of women who were positive in IPV, consent to receive e-health package and consent to randomization in the control group.
Measured: Three to nine months
Secondary outcomes (8)
Positivity rate of the cohort study (useful for planning the future full-scale randomised control trial):
Rate of women who were positive in IPV and consent to receive e-health package
Measured: Three to nine months
Completion rate in the intervention group a future full-scale RCT trial
Rate of women who were recruited to intervention group, and for whom complete outcomes were obtained.
Measured: Three to nine months
Completion rate in the control group a future full-scale RCT trial
Rate of women who were recruited to control group, and for whom complete outcomes were obtained.
Measured: Three to nine months
Recruitment duration for a future full-scale RCT trial
Recruitment duration (in days) to get the pilot sample (5 women for the intervention group and 5 women for the control group, in each country)
Measured: Three to nine months
Benefit of the intervention a future full-scale RCT trial
Perception of the intervention by women participating in the pilot through the information obtained in qualitative interviews.
Measured: Three to nine months
Perception about the delay of the intervention of the control group for a future full-scale RCT trial
Perception about the duration of delay of the intervention of women in the control group (provided in the qualitative interviews).
Measured: Three to nine months
Reasons for acceptability, non-adherence, and obstacles for a future full-scale RCT trial
Reasons for acceptability, non-adherence, and obstacles to recruitment, randomization, consent and follow-up (provided in the qualitative interviews).
Measured: Three to nine months
Follow up rate for a future full-scale RCT trial
Rate of failure to obtain data in the follow-up.
Measured: Three to nine months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2021
- Study start7 Oct 2021
- Primary completion14 Nov 2022
- Study completion14 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A pilot randomised controlled trial (RCT), co-designed by patient input using a modified Zelen's design with additional qualitative evaluation, will be nested within a cohort study.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de Granada
- Sponsor type
- University, hospital or other
- Collaborators
- University of Southern Denmark, Odense University Hospital
- Responsible party
- Principal investigator, Antonella Ludmila Zapata Calvente, Universidad de Granada
- Investigators
- Khalid S. Khan, Study director, Universidad de Granada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04978064
- Sponsor's protocol ID
- eIPV
- Other IDs
- 202167133116, 20212000-80
- Acronym
- eIPV
- Status last verified
- Jan 2023
- First submitted
- 4 Jul 2021
- Last updated
- 10 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will collaborate in an approved, registered Individual Participant Data metaanalysis
Publications
Martin-de-Las-Heras S, Velasco C, Luna-Del-Castillo JD, Khan KS. Breastfeeding avoidance following psychological intimate partner violence during pregnancy: a cohort study and multivariate analysis. BJOG. 2019 May;126(6):778-783. doi: 10.1111/1471-0528.15592. Epub 2019 Jan 24.
PubMed 30575266Roman-Galvez RM, Martin-Pelaez S, Martinez-Galiano JM, Khan KS, Bueno-Cavanillas A. Prevalence of Intimate Partner Violence in Pregnancy: An Umbrella Review. Int J Environ Res Public Health. 2021 Jan 15;18(2):707. doi: 10.3390/ijerph18020707.
PubMed 33467538Rasch V, Van TN, Nguyen HTT, Manongi R, Mushi D, Meyrowitsch DW, Gammeltoft T, Wu CS. Intimate partner violence (IPV): The validity of an IPV screening instrument utilized among pregnant women in Tanzania and Vietnam. PLoS One. 2018 Feb 1;13(2):e0190856. doi: 10.1371/journal.pone.0190856. eCollection 2018.
PubMed 29389954Zapata-Calvente AL, Bueno Cavanillas A, Andreasen K, Linde DS, Rasch V, Khan KS, Martin-de-Las-Heras S. E-health intervention in pregnant women exposed to intimate partner violence (eIPV): Results of a pilot randomised controlled trial. Contemp Clin Trials Commun. 2026 Mar 25;51:101634. doi: 10.1016/j.conctc.2026.101634. eCollection 2026 Jun.
PubMed 41969624
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- E-health Psychological Intervention in Pregnant Women Exposed to Intimate Partner Violence (eIPV): a Pilot Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT04978064
- Acronym / sponsor ID
- eIPV / eIPV
- Keywords
- pilot randomized controlled trial, pregnancy, intimate partner violence, e-health intervention, counselling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Universidad de GranadaUniversity, hospital or other
- Collaborators
- University of Southern Denmark, Odense University Hospital
- Study start
- 7 Oct 2021 (actual)
- Primary completion
- 14 Nov 2022 (actual)
- Study completion
- 14 Nov 2022 (actual)
- First posted
- 27 Jul 2021 (actual)
- 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 investigators will assess the need and feasibility of randomising a sufficiently large number of women exposed to IPV during pregnancy in a full-scale future randomised trial. To achieve this, the investigators will:
- estimate rates of consent to randomization, and the rates of adherence and dropout following randomization (for the use in sample size estimation)
- determine recruitment duration
- examine the women's perception about the benefit of the intervention
- determine the reasons for acceptability, non-adherence, and obstacles to recruitment, randomisation and consent through qualitative interviews
Detailed description
Introduction. Intimate partner violence (IPV) during pregnancy, a condition as common as obstetrics conditions like gestational diabetes, is associated with maternal and neonatal complications. Systematic detection of IPV is not well established in antenatal screening probably because the effectiveness of protective interventions has not been evaluated. Among mothers exposed to IPV, e-health interventions during pregnancy may be beneficial. Prior to performing a full-scale effectiveness trial for such an intervention, a pilot study is required to assess the need and feasibility of randomising a sufficiently large number of women at exposed to IPV during pregnancy.
Methods. The eIPV trial is a randomised pilot study nested within a cohort of consenting mothers at <12 weeks' gestation who screen positive for IPV in the first antenatal visit and accept an e-health package (psychological counselling by videoconference) in Spain and Denmark. Twenty eligible mothers from the above cohort will be randomised to either intervention or control. The intervention group will receive the e-health package as part of the cohort. The control group will be invited to accept a delay in the intervention (e-health package eight weeks later). After consenting to delay, the control group will provide comparative data without losing the opportunity of obtaining the intervention. The investigators will determine estimates of rates of informed consent to randomization, and the rates of adherence and dropout following randomization. Qualitative interviews will be conducted to examine the women's perception about the benefit of the intervention, reasons for acceptability and non-adherence, and obstacles to recruitment, randomisation and consent. The results will inform the feasibility and variance of key clinical outcome measures for estimation of sample size of the full-scale effectiveness trial.
Comment. The pilot study nested within the cohort study will allow us to obtain information about the rates of IPV in pregnancy, the acceptability of an e-health intervention and the availability of participants for randomisation into a large effectiveness trial.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- A pilot randomised controlled trial (RCT), co-designed by patient input using a modified Zelen's design with additional qualitative evaluation, will be nested within a cohort study.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: e-health psychological counsellingBehavioral e-health psychological counselling |
| Control group | Other | Behavioral: e-health psychological counsellingUsual care (delayed behavioral e-health psychological counselling) |
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Pregnant women at <12 weeks gestation, who screen positive in IPV at the first antenatal visit and accept the e-health package.
Key exclusion criteria (6 listed)
- Women who cannot be informed about the study without their partners or other family members knowing
- Women mentally or physically incapacity to participate in the study
- Women below 16 years in Spain or below 18 years in Denmark
- Inability to understand Danish/Spanish
- Lack of internet and electronic device
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 |
|---|---|---|
| e-health psychological counsellingIntervention group: Women positive for IPV who accept the e-Health intervention and who have been randomly allocated in the intervention group will receive the e-health package as the rest of the cohort, as well as the baseline and outcome measurements. The e-health package will include six video counselling sessions by trained providers and the access to a mobile application for designing security plans, an adapted version of the mobile application "My Plan". The content of the six individually tailored sessions will be based on the Dutton's Empowerment Model and the Psychosocial Readiness Model. Control group: women positive in IPV who accept the e-Health intervention package will be asked for a second consent to receive a delayed intervention (8 weeks later) and to complete as the baseline and outcome measurements. Women can request to leave the control group at any time and to receive the intervention immediately (in which case they data will be part of the cohort study). | Behavioural | Control group, Intervention group |
Primary outcome
Consent rate for a future full-scale RCT trial
Time frame: Three to nine months
Rate of women who were positive in IPV, consent to receive e-health package and consent to randomization in the control group.
8 secondary outcomes
Positivity rate of the cohort study (useful for planning the future full-scale randomised control trial):
Time frame: Three to nine months
Completion rate in the intervention group a future full-scale RCT trial
Time frame: Three to nine months
Completion rate in the control group a future full-scale RCT trial
Time frame: Three to nine months
Recruitment duration for a future full-scale RCT trial
Time frame: Three to nine months
Benefit of the intervention a future full-scale RCT trial
Time frame: Three to nine months
Perception about the delay of the intervention of the control group for a future full-scale RCT trial
Time frame: Three to nine months
Reasons for acceptability, non-adherence, and obstacles for a future full-scale RCT trial
Time frame: Three to nine months
Follow up rate for a future full-scale RCT trial
Time frame: Three to nine months
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 10 Jan 2023.
- Background: PubMed 30575266Martin-de-Las-Heras S, Velasco C, Luna-Del-Castillo JD, Khan KS. Breastfeeding avoidance following psychological intimate partner violence during pregnancy: a cohort study and multivariate analysis. BJOG. 2019 May;126(6):778-783. doi: 10.1111/1471-0528.15592. Epub 2019 Jan 24.
- Background: PubMed 33467538Roman-Galvez RM, Martin-Pelaez S, Martinez-Galiano JM, Khan KS, Bueno-Cavanillas A. Prevalence of Intimate Partner Violence in Pregnancy: An Umbrella Review. Int J Environ Res Public Health. 2021 Jan 15;18(2):707. doi: 10.3390/ijerph18020707.
- Background: PubMed 29389954Rasch V, Van TN, Nguyen HTT, Manongi R, Mushi D, Meyrowitsch DW, Gammeltoft T, Wu CS. Intimate partner violence (IPV): The validity of an IPV screening instrument utilized among pregnant women in Tanzania and Vietnam. PLoS One. 2018 Feb 1;13(2):e0190856. doi: 10.1371/journal.pone.0190856. eCollection 2018.
- Derived from this study: PubMed 41969624Zapata-Calvente AL, Bueno Cavanillas A, Andreasen K, Linde DS, Rasch V, Khan KS, Martin-de-Las-Heras S. E-health intervention in pregnant women exposed to intimate partner violence (eIPV): Results of a pilot randomised controlled trial. Contemp Clin Trials Commun. 2026 Mar 25;51:101634. doi: 10.1016/j.conctc.2026.101634. eCollection 2026 Jun.
- Individual participant dataSharing planned: Yes. We will collaborate in an approved, registered Individual Participant Data metaanalysis
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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.
Khalid S. Khan study director
Universidad de Granada
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing e-health psychological counselling in people with Pregnancy Related and Violence, Gender-Based, run by Universidad de Granada at 2 sites in 2 countries.
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 1 inclusion and 6 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 10 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark, Spain. 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?
Consent rate for a future full-scale RCT trial (time frame: Three to nine months). 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 NCT04978064, which also lists 4 linked publications.
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 10 Jan 2023.