Using Telemedicine to Improve Early Medical Abortion at Home (UTAH)

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.

Study Overview

• Status: Terminated
• Conditions: Abortion in First Trimester; Abortion Early
• Intervention / Treatment: Other: Telephone Consultation; Other: Face-to-Face Consultation

Detailed Description

This study is a randomised controlled trial comparing telephone consultation to face-to-face consultation prior to early medical abortion at home (EMA).

The majority of patients seeking abortion care in NHS Lothian will self-refer by telephone to the Lothian Abortion Referral Service (LARS).

Routinely, patients are asked the date of their last menstrual period (LMP) by administrative staff. They then collect basic contact information and book an appointment to come to clinic within 5-7 days.

For all women who self report an LMP that is less than 10 weeks to the date of the appointment they are offered, the administrative staff at LARS will read a short statement describing the project and ask if the patient is happy to be contacted by a member of the research team to discuss further. If they agree, they will also be directed to the LARS webpage where a copy of the Participant Information Sheet (PIS) will be available. The patient's contact details will be passed to the research nurse or doctor who will then call the patient back.

At call back, the researcher will confirm that the patient has read the PIS and answer any questions and give further information as required. If the patient wishes to participate, verbal consent will be obtained using a standard form.

The patient (now participant) will then be randomised to either the intervention arm (telephone consultation) or standard of care (face-to-face consultation).

For participants in the standard of care arm:

They will attend clinic as usual at the appointment already issued by LARS. After the consultation, they will be asked to complete a questionnaire (either self-administered or researcher-administered) about their preparedness for EMA.

14-20 days later a follow-up questionnaire will be completed with the researcher via telephone, internet or post to assess completion of abortion (using the outcome of a low sensitivity urinary pregnancy test, the standard method used at the abortion service), overall acceptability of consultation and EMA process and what method of contraception they have selected.

For participants in the intervention arm:

They will have a telephone consultation either immediately after they have been randomised or at another point up to the evening before they are due to attend clinic, depending on their preference. The content of the consultation will be identical to that of a face-to-face consultation.

They will attend clinic as planned at their allocated appointment time for an ultrasound scan to confirm gestation, to have standard blood tests and infection screen, complete consent paperwork for their abortion care procedure (as per standard care) and receive their medications.

Before leaving the department, they will be asked to complete a questionnaire (either self-administered or researcher-administered) about their preparedness for EMA.

14-20 days later a follow-up questionnaire will be completed with the researcher via telephone, internet or post to assess completion of abortion (using the outcome of a low sensitivity urinary pregnancy test, the standard method used at the abortion service), overall acceptability of consultation and EMA process and what method of contraception they have selected.

• Study Type: Interventional
• Enrollment (Actual): 125
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Edinburgh, United Kingdom
    • Chalmers Centre for Sexual and Reproductive Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Self-reported last menstrual period (LMP) less than 10 weeks on day of appointment
• Self-referral to Lothian Abortion Referral Service (LARS)
• Aged 16 or over at the time of procedure
• Preference for EMA
• Ability to give informed consent

Exclusion Criteria:

• Requires interpreter
• Patient preference for surgical method of abortion

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy of medical abortion	Complete abortion as assessed by self-performed low-sensitivity urinary pregnancy test	2 weeks after administration of abortion medications (via telephone)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Preparedness for medical abortion	A Likert-scale rating of how prepared participant felt for medical abortion	Within 1 week of randomisation (on day of clinic attendance)
Satisfaction with consultation	A Likert-scale rating of how satisfied participant was with consultation for medical abortion	2 weeks after administration of abortion medications (via telephone)
Contraception	Rate of uptake of contraceptive methods following consultation	Case note review at 2 weeks
Ineligibility for EMA	Proportion of participants who are not eligible for early medical abortion when they attend clinic for confirmatory ultrasound	Within 1 week of randomisation (on day of clinic attendance)
Time taken	Time taken in consultation and in clinic	Within 1 week of randomisation (on day of clinic attendance)
Unscheduled contact	Unscheduled contact with abortion service or hospital within 4 weeks of EMA for concern related to EMA	4 weeks after administration of abortion medications

Collaborators and Investigators

• Sponsor: NHS Lothian
• Collaborators: University of Edinburgh
• Investigators: Principal Investigator: Sharon T Cameron, MD FRCOG, University of Edinburgh

Publications and helpful links

General Publications

• Reynolds-Wright JJ, Norrie J, Cameron ST. 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. 2021 Jun 16;11(6):e046628. doi: 10.1136/bmjopen-2020-046628.

Study record dates

Study Major Dates

• Study Start (Actual): January 13, 2020
• Primary Completion (Actual): August 31, 2021
• Study Completion (Actual): August 31, 2021

Study Registration Dates

• First Submitted: October 21, 2019
• First Submitted That Met QC Criteria: October 23, 2019
• First Posted (Actual): October 25, 2019

Study Record Updates

• Last Update Posted (Actual): October 18, 2022
• Last Update Submitted That Met QC Criteria: October 14, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Telemedicine; Telephone; Remote
• Additional Relevant MeSH Terms: Pregnancy Complications; Abortion, Spontaneous
• Other Study ID Numbers: AC19076; IRAS (Other Identifier: 332422)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: We cannot share individual level data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No