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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.


ABSTRACT:

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.

SUBMITTER: Reynolds-Wright JJ 

PROVIDER: S-EPMC10870195 | biostudies-literature | 2023 Sep

REPOSITORIES: biostudies-literature

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Publications

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.

Reynolds-Wright John Joseph JJ   Norrie John J   Cameron Sharon Tracey ST  

BMJ open 20230913 9


<h4>Objectives</h4>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%.<h4>Design</h4>Randomised controlled trial with 1:1 allocation.<h4>Setting</h4>Community abortion service housed within an integrated sexual and reproductive health service in Edinburgh, UK.<h4>P  ...[more]

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