Using telemedicine to improve early medical abortion at home (UTAH): a randomised controlled trial to compare telemedicine with in-person consultation for early medical abortion.

Autor:	Reynolds-Wright JJ; MRC Centre for Reproductive Health, Institute for Regeneration and Repair, University of Edinburgh, Edinburgh, UK john.reynolds-wright@ed.ac.uk.; Chalmers Centre for Sexual Health, NHS Lothian, Edinburgh, UK., Norrie J; Edinburgh Clinical Trials Unit, Usher Institute, University of Edinburgh, Bioquarter, Edinburgh, UK., Cameron ST; MRC Centre for Reproductive Health, Institute for Regeneration and Repair, University of Edinburgh, Edinburgh, UK.; Chalmers Centre for Sexual Health, NHS Lothian, Edinburgh, UK.; Obstetrics and Gynaecology, University of Edinburgh, Edinburgh, UK.
Jazyk:	angličtina
Zdroj:	BMJ open [BMJ Open] 2023 Sep 13; Vol. 13 (9), pp. e073630. Date of Electronic Publication: 2023 Sep 13.
DOI:	10.1136/bmjopen-2023-073630
Abstrakt:	Objectives: To compare telephone consultations with in-person consultations for the provision of medical abortion (using mifepristone 200 mg and misoprostol 800 µg). We hypothesised that telemedicine consultations would be non-inferior to in-person consultations with a non-inferiority limit of 3%. Design: Randomised controlled trial with 1:1 allocation. Setting: Community abortion service housed within an integrated sexual and reproductive health service in Edinburgh, UK. Participants: The trial began on 13 January 2020, but was stopped early due to COVID-19; recruitment was suspended on 31 March 2020, and was formally closed on 31 August 2021. A total of 125 participants were randomised, approximately 10% of the total planned, with 63 assigned to telemedicine and 62 to in-person consultation. Primary and Secondary Outcome Measures: Primary outcome: efficacy of medical abortion, defined as complete abortion without surgical intervention. Secondary Outcomes: satisfaction with consultation type, preparedness, unscheduled contact with care, complication rate, time spent in clinical contact and uptake of long-acting contraception. Results: Primary outcome was available for 115 participants (lost-to-follow-up telemedicine=2, in-person=8), secondary outcomes were available for 110 participants (n=5 and n=10 in telemedicine and in-person groups did not complete questionnaires). There were no significant differences between groups in treatment efficacy (telemedicine 57/63 (90.5%), in-person 48/62 (77.4%)). However, non-inferiority was not demonstrated (+3.3% in favour of telemedicine, CI -6.6% to +13.3%, lower than non-inferiority margin). There were no significant differences in most secondary outcomes, however, there was more unscheduled contact with care in the telemedicine group (12 (19%) vs 3 (5%), p=0.01). The overall time spent in clinical contact was statistically significantly lower in the telemedicine group (mean 94 (SD 24) vs 111 (24) min, p=0.0005). Conclusions: Telemedicine for medical abortion appeared to be effective, safe and acceptable to women, with less time spent in the clinic. However, due to the small sample size resulting from early cessation, the study was underpowered to confirm this conclusion. These findings warrant further investigation in larger scale studies. Trial Registration Number: NCT04139382. Competing Interests: Competing interests: JRW has received an educational grant from Gedeon Richter. STC and JN have no competing interests to declare. (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
Databáze:	MEDLINE
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