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

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 prostaglandin analogue). There are no published randomised controlled trials (RCTs) on the use telemedicine for EMA. Our proposed research will determine if telephone consultations EMA (the most common method in UK) non-inferior to standard face-to-face with regard efficacy Methods and analysis This study be conducted as an RCT. The recruitment target 1222 participants. primary outcome success (complete rate). determined based negative low-sensitivity urine test result (2 weeks after use) absence surgical intervention diagnosis ongoing (within 6 misoprostol). Secondary outcomes include total time spent at clinic appointment receive EMA, self-reported preparedness level satisfaction consultation effective contraception uptake compared when women attend consultation. main modified intention-to-treat analysis. all (with viable pregnancy) follow-up outcome. initiated 13 January 2020 anticipated finish late 2021. Ethics dissemination Ethical approval was given South East Scotland NHS Research Committee, reference: 19/SS/0111. Results peer-reviewed journals, presented clinical academic meetings, shared participants via website. Trial registration number NCT04139382 .