Clinical trial NCT04978064: E-health Psychological Intervention in Pregnant Women Exposed to Intimate Partner Violence (eIPV)
Official title: E-health Psychological Intervention in Pregnant Women Exposed to Intimate Partner Violence (eIPV): a Pilot Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy Related
Violence, Gender-Based
Intimate Partner Violence
Keywords: pilot randomized controlled trial
pregnancy
intimate partner violence
e-health intervention
counselling
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
Collaborators: name: University of Southern Denmark
name: Odense University Hospital
First posted: 2021-07-27
Enrollment: 24
Sex: FEMALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

Brief 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. estimate rates of consent to randomization, and the rates of adherence and dropout following randomization (for the use in sample size estimation)
2. determine recruitment duration
3. examine the women's perception about the benefit of the intervention
4. 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.

Eligibility criteria: Inclusion Criteria:

• Pregnant women at \<12 weeks gestation, who screen positive in IPV at the first antenatal visit and accept the e-health package.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Consent rate for a future full-scale RCT trial
timeFrame: Three to nine months
Secondary outcomes:
measure: Positivity rate of the cohort study (useful for planning the future full-scale randomised control trial):
timeFrame: Three to nine months
measure: Completion rate in the intervention group a future full-scale RCT trial
timeFrame: Three to nine months
measure: Completion rate in the control group a future full-scale RCT trial
timeFrame: Three to nine months
measure: Recruitment duration for a future full-scale RCT trial
timeFrame: Three to nine months
measure: Benefit of the intervention a future full-scale RCT trial
timeFrame: Three to nine months
measure: Perception about the delay of the intervention of the control group for a future full-scale RCT trial
timeFrame: Three to nine months
measure: Reasons for acceptability, non-adherence, and obstacles for a future full-scale RCT trial
timeFrame: Three to nine months
measure: Follow up rate for a future full-scale RCT trial
timeFrame: Three to nine months
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Odense University Hospital
city: Granada
country: Spain
facility: University of Granada
Study officials:
affiliation: Universidad de Granada
name: Khalid S. Khan
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Roman-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.
citation: Rasch 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.