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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Collaborator:
University of Edinburgh
Information provided by (Responsible Party):
NHS Lothian

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.


Condition or disease Intervention/treatment Phase
Abortion Early Abortion in First Trimester Other: Telephone Consultation Other: Face-to-Face Consultation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1222 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomised Controlled Trial
Masking: None (Open Label)
Primary Purpose: Treatment
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

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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. Contraception [ Time Frame: Case note review at 2 weeks ]
    Rate of uptake of contraceptive methods following consultation

  4. 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

  5. Time taken [ Time Frame: Within 1 week of randomisation (on day of clinic attendance) ]
    Time taken in consultation and in clinic

  6. 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



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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

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


Locations
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United Kingdom
Chalmers Centre for Sexual and Reproductive Health
Edinburgh, United Kingdom
Sponsors and Collaborators
NHS Lothian
University of Edinburgh
Investigators
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Principal Investigator: Sharon T Cameron, MD FRCOG University of Edinburgh
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: NHS Lothian
ClinicalTrials.gov Identifier: NCT04139382    
Other Study ID Numbers: AC19076
IRAS ( Other Identifier: 264265 )
First Posted: October 25, 2019    Key Record Dates
Last Update Posted: December 9, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We cannot share individual level data

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by NHS Lothian:
Telemedicine
Telephone
Remote
Additional relevant MeSH terms:
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Abortion, Spontaneous
Pregnancy Complications