E-health Psychological Intervention in Pregnant Women Exposed to Intimate Partner Violence (eIPV)

University of Granada (UGR)

Status

Completed

Conditions

Pregnancy Related

Violence, Gender-Based

Intimate Partner Violence

Treatments

Behavioral: e-health psychological counselling

Study type

Interventional

Funder types

Other

Identifiers

NCT04978064

20212000-80 (Other Identifier)

eIPV

202167133116 (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment

24 patients

Sex

Female

Ages

16+ years old

Volunteers

No Healthy Volunteers

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.