Using Telemedicine to Improve Early Medical Abortion at Home (UTAH)
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|ClinicalTrials.gov Identifier: NCT04139382|
Recruitment Status : Suspended (Suspended during COVID-19 outbreak, aim to re-start 2021)
First Posted : October 25, 2019
Last Update Posted : December 9, 2020
The investigators plan a trial comparing telephone consultations for women requesting early medical abortion (EMA - under 10 weeks pregnant) to regular face-to-face consultations.
In Scotland, 7 out of 10 women having an abortion choose EMA. The clinic visit to discuss EMA is lengthy (2-3 hours). Much time is spent between having tests and waiting to consult a doctor or nurse. Women can struggle with time off work or childcare for lengthy daytime appointments.
There is some evidence from other countries that telephone consultations for EMA are a safe and acceptable alternative.
In this study, women seeking EMA will be randomised to face-to-face (standard care) or a planned telephone consultation (in advance of the clinic visit).
The investigators will determine the success of the EMA in both groups, women' satisfaction with the consultation and possible advantages and disadvantages. If telephone consultations prove to be effective and acceptable then this will change EMA provision throughout Scotland.
|Condition or disease||Intervention/treatment||Phase|
|Abortion Early Abortion in First Trimester||Other: Telephone Consultation Other: Face-to-Face Consultation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1222 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomised Controlled Trial|
|Masking:||None (Open Label)|
|Official Title:||Using Telemedicine to Improve Early Medical Abortion at Home|
|Actual Study Start Date :||January 13, 2020|
|Estimated Primary Completion Date :||October 31, 2021|
|Estimated Study Completion Date :||February 28, 2022|
Telephone Consultation for women requesting abortion
Other: Telephone Consultation
A telephone consultation comprising clinical history, contraception planning, explanation of medical method of abortion
Active Comparator: Control
Face-to-face consultation for women requesting abortion
Other: Face-to-Face Consultation
A face-to-face consultation comprising clinical history, contraception planning, explanation of medical method of abortion
- Efficacy of medical abortion [ Time Frame: 2 weeks after administration of abortion medications (via telephone) ]Complete abortion as assessed by self-performed low-sensitivity urinary pregnancy test
- Preparedness for medical abortion [ Time Frame: Within 1 week of randomisation (on day of clinic attendance) ]A Likert-scale rating of how prepared participant felt for medical abortion
- Satisfaction with consultation [ Time Frame: 2 weeks after administration of abortion medications (via telephone) ]A Likert-scale rating of how satisfied participant was with consultation for medical abortion
- Contraception [ Time Frame: Case note review at 2 weeks ]Rate of uptake of contraceptive methods following consultation
- Ineligibility for EMA [ Time Frame: Within 1 week of randomisation (on day of clinic attendance) ]Proportion of participants who are not eligible for early medical abortion when they attend clinic for confirmatory ultrasound
- Time taken [ Time Frame: Within 1 week of randomisation (on day of clinic attendance) ]Time taken in consultation and in clinic
- Unscheduled contact [ Time Frame: 4 weeks after administration of abortion medications ]Unscheduled contact with abortion service or hospital within 4 weeks of EMA for concern related to EMA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04139382
|Chalmers Centre for Sexual and Reproductive Health|
|Edinburgh, United Kingdom|
|Principal Investigator:||Sharon T Cameron, MD FRCOG||University of Edinburgh|