UTAH: Using Telemedicine to improve early medical Abortion at Home: a protocol for a randomised controlled trial comparing face-to-face with telephone consultations for women seeking early medical abortion

Abstract

Introduction: Early medical abortion (EMA) is a two-stage process of terminating pregnancy using oral mifepristone (a progesterone-receptor antagonist) followed usually 1-2 days later by sublingual, vaginal or buccal misoprostol (a prostaglandin analogue). There are no published randomised controlled trials (RCTs) on the use of telemedicine for EMA. Our proposed research will determine if telephone consultations for EMA (the most common method of abortion in the UK) is non-inferior to standard face-to-face consultations with regard to the efficacy of EMA.

Methods and analysis: This study will be conducted as an RCT. The recruitment target is 1222 participants.The primary outcome is success of EMA (complete abortion rate). This will be determined based on a negative low-sensitivity urine pregnancy test result (2 weeks after misoprostol use) and absence of surgical intervention or diagnosis of ongoing pregnancy (within 6 weeks of misoprostol).Secondary outcomes include total time spent at a clinic appointment to receive EMA, self-reported preparedness for EMA, level of satisfaction with consultation and effective contraception uptake compared with when women attend for a face-to-face consultation.The main analysis will be a modified intention-to-treat analysis. This will include all randomised women (with a viable pregnancy) using EMA and follow-up for the main outcome. The study initiated on 13 January 2020 and is anticipated to finish in late 2021.

Ethics and dissemination: Ethical approval was given by the South East Scotland NHS Research Ethics Committee, reference: 19/SS/0111. Results will be published in peer-reviewed journals, presented at clinical and academic meetings, and shared with participants via the clinic website.

Trial registration number: NCT04139382.

Keywords: community gynaecology; gynaecology; public health; reproductive medicine; telemedicine.

Conflict of interest statement

Competing interests: Professor JN was Deputy Chair of the National Institute of Health Research (NIHR) Health Technology Assessment (HTA) General Funding Committee (2016-2019) and is currently Chair of the Medical Research Council (MRC)/NIHR Efficacy and Mechanisms Evaluation (EME) Funding Committee.

© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY. Published by BMJ.