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
| Autor: | John Norrie, John Joseph Reynolds-Wright, Sharon Cameron |
|---|---|
| Jazyk: | angličtina |
| Rok vydání: | 2021 |
| Předmět: |
medicine.medical_specialty
Telemedicine medicine.medical_treatment Reproductive medicine Abortion law.invention 03 medical and health sciences 0302 clinical medicine Randomized controlled trial law Pregnancy Utah medicine Humans 030212 general & internal medicine Misoprostol Referral and Consultation Randomized Controlled Trials as Topic Research ethics 030219 obstetrics & reproductive medicine business.industry gynaecology public health Abortion Induced General Medicine medicine.disease Medical abortion Telephone Scotland Family medicine Medicine Female Sexual Health community gynaecology business medicine.drug reproductive medicine |
| Zdroj: | BMJ Open, Vol 11, Iss 6 (2021) BMJ Open Reynolds-Wright, J J, Norrie, J & Cameron, S T 2021, ' 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 ', BMJ Open, vol. 11, no. 6 . https://doi.org/10.1136/bmjopen-2020-046628 |
| ISSN: | 2044-6055 |
| DOI: | 10.1136/bmjopen-2020-046628 |
| Popis: | IntroductionEarly 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 analysisThis 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 disseminationEthical 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 numberNCT04139382. |
| Databáze: | OpenAIRE |
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