E-health intervention in pregnant women exposed to intimate partner violence (eIPV): Results of a pilot randomised controlled trial

Abstract

Objective: To assess the feasibility of randomising a sufficiently large number of pregnant women who screen positive for intimate partner violence (IPV) to perform a full-scale effectiveness trial. Methods: This pilot randomised trial was nested within a cohort of IPV-positive pregnant women who accepted an e-health package in Spain and Denmark. This study was co-designed with patient input using a modified Zelen’s design and a qualitative evaluation. Eligible women were randomised to an intervention (received the e-health package) or to a control (received it with a delay). The primary outcome was the proportion of women screened positive for IPV who consented to be randomised to receive an e-health package with a delay. Results: Twenty-nine of the 51 women in the cohort were randomised. Of these, 12 were allocated to the control group, and 7 (58.3%) consented to receive the e-health package with a delay, i.e., 24.1% of the total randomised and 13.7% of the total cohort. The proportion of randomized women who adhered to treatment was 31.03% (9/29). Complete outcome data were obtained in 7/17 (41.17%) and 2/12 (16.66%) women in the intervention and control groups, respectively. Qualitative interviews indicated that the women perceived the intervention as beneficial and that delaying it was not acceptable. Conclusions: This pilot randomised trial indicated that a future full-scale randomised study would likely be unfeasible based on our a priori criteria to stop the trial. If a future large trial is launched, it should include an internal pilot with strict go/no-go criteria monitored by an independent committee.