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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

Tracking Information
First Submitted Date  ICMJE October 21, 2019
First Posted Date  ICMJE October 25, 2019
Last Update Posted Date December 9, 2020
Actual Study Start Date  ICMJE January 13, 2020
Estimated Primary Completion Date October 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 23, 2019)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 23, 2019)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Using Telemedicine to Improve Early Medical Abortion at Home
Official Title  ICMJE Using Telemedicine to Improve Early Medical Abortion at Home
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.

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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Randomised Controlled Trial
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Abortion Early
  • Abortion in First Trimester
Intervention  ICMJE
  • Other: Telephone Consultation
    A telephone consultation comprising clinical history, contraception planning, explanation of medical method of abortion
  • Other: Face-to-Face Consultation
    A face-to-face consultation comprising clinical history, contraception planning, explanation of medical method of abortion
Study Arms  ICMJE
  • Experimental: Intervention
    Telephone Consultation for women requesting abortion
    Intervention: Other: Telephone Consultation
  • Active Comparator: Control
    Face-to-face consultation for women requesting abortion
    Intervention: Other: Face-to-Face Consultation
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Suspended
Estimated Enrollment  ICMJE
 (submitted: October 23, 2019)
1222
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 28, 2022
Estimated Primary Completion Date October 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 16 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04139382
Other Study ID Numbers  ICMJE AC19076
IRAS ( Other Identifier: 264265 )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: We cannot share individual level data
Responsible Party NHS Lothian
Study Sponsor  ICMJE NHS Lothian
Collaborators  ICMJE University of Edinburgh
Investigators  ICMJE
Principal Investigator: Sharon T Cameron, MD FRCOG University of Edinburgh
PRS Account NHS Lothian
Verification Date December 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP