NCT04139382

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
125

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 21, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 25, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

January 13, 2020

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2021

Completed
Last Updated

October 18, 2022

Status Verified

October 1, 2022

Enrollment Period

1.6 years

First QC Date

October 21, 2019

Last Update Submit

October 14, 2022

Conditions

Abortion EarlyAbortion in First Trimester

Keywords

TelemedicineTelephoneRemote

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Preparedness for medical abortion

    Within 1 week of randomisation (on day of clinic attendance)

  • Satisfaction with consultation

    2 weeks after administration of abortion medications (via telephone)

  • Contraception

    Case note review at 2 weeks

  • Ineligibility for EMA

    Within 1 week of randomisation (on day of clinic attendance)

  • Time taken

    Within 1 week of randomisation (on day of clinic attendance)

  • +1 more secondary outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

Telephone Consultation for women requesting abortion

Other: Telephone Consultation

Control

ACTIVE COMPARATOR

Face-to-face consultation for women requesting abortion

Other: Face-to-Face Consultation

Interventions

Telephone ConsultationOTHER

A telephone consultation comprising clinical history, contraception planning, explanation of medical method of abortion

Intervention
Face-to-Face ConsultationOTHER

A face-to-face consultation comprising clinical history, contraception planning, explanation of medical method of abortion

Control

Eligibility Criteria

Age16 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Requires interpreter
  • Patient preference for surgical method of abortion

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chalmers Centre for Sexual and Reproductive Health

Edinburgh, United Kingdom

Location

Related Publications (2)

  • Reynolds-Wright JJ, Norrie J, Cameron ST. 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. BMJ Open. 2023 Sep 13;13(9):e073630. doi: 10.1136/bmjopen-2023-073630.

    PMID: 37709327DERIVED

  • 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.

    PMID: 34135047DERIVED

Study Officials

  • Sharon T Cameron, MD FRCOG

    University of Edinburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomised Controlled Trial
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 21, 2019

First Posted

October 25, 2019

Study Start

January 13, 2020

Primary Completion

August 31, 2021

Study Completion

August 31, 2021

Last Updated

October 18, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

We cannot share individual level data

Locations

GB(1)