Abortion EarlyUTAHNCT04139382
Using Telemedicine to Improve Early Medical Abortion at Home
A study testing Telephone Consultation and Face-to-Face Consultation in people with Abortion Early and Abortion in First Trimester, run by NHS Lothian at 1 site in United Kingdom.
Trial 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). Read more about this study
- Who is it for?
- Ages 16 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Abortion Early, Abortion in First Trimester
- What is being tested?
- Telephone Consultation and Face-to-Face Consultation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 13 Jan 2020to 31 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Requires interpreter
- Patient preference for surgical method of abortion
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Chalmers Centre for Sexual and Reproductive Health
Edinburgh
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Abortion Early, Abortion in First Trimester
- Being tested
- Telephone Consultation, Face-to-Face Consultation
- Keywords
- Telemedicine, Telephone, Remote
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telephone ConsultationOther
A telephone consultation comprising clinical history, contraception planning, explanation of medical method of abortion
Face-to-Face ConsultationOther
A face-to-face consultation comprising clinical history, contraception planning, explanation of medical method of abortion
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Telephone Consultation for women requesting abortion Receives: Other: Telephone Consultation |
| Control | Active comparator | Face-to-face consultation for women requesting abortion Receives: Other: Face-to-Face Consultation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of medical abortion
Complete abortion as assessed by self-performed low-sensitivity urinary pregnancy test
Measured: 2 weeks after administration of abortion medications (via telephone)
Secondary outcomes (6)
Preparedness for medical abortion
A Likert-scale rating of how prepared participant felt for medical abortion
Measured: 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
Measured: 2 weeks after administration of abortion medications (via telephone)
Contraception
Rate of uptake of contraceptive methods following consultation
Measured: 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
Measured: Within 1 week of randomisation (on day of clinic attendance)
Time taken
Time taken in consultation and in clinic
Measured: 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
Measured: 4 weeks after administration of abortion medications
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2019
- Study start13 Jan 2020
- Primary completion31 Aug 2021
- Study completion31 Aug 2021
Why it stopped: Study suspended on 31 March 2020 due to COVID-19 pandemic. Aimed to restart study early 2021, but decision taken to formally terminate the study on 31st August 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Abortion EarlyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised Controlled Trial
- Masking
- None (open label)
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- NHS Lothian
- Sponsor type
- Other government
- Collaborators
- University of Edinburgh
- Responsible party
- Sponsor
- Investigators
- Sharon T Cameron, MD FRCOG, Principal investigator, University of Edinburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04139382
- Sponsor's protocol ID
- AC19076
- Other IDs
- IRAS
- Acronym
- UTAH
- Status last verified
- Oct 2022
- First submitted
- 21 Oct 2019
- Last updated
- 18 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We cannot share individual level data
Publications
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.
PubMed 37709327Reynolds-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.
PubMed 34135047
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Telemedicine to Improve Early Medical Abortion at Home
- ClinicalTrials.gov ID
- NCT04139382
- Acronym / sponsor ID
- UTAH / AC19076
- Conditions
- Abortion Early, Abortion in First Trimester
- Keywords
- Telemedicine, Telephone, Remote
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study suspended on 31 March 2020 due to COVID-19 pandemic. Aimed to restart study early 2021, but decision taken to formally terminate the study on 31st August 2021
- Enrolment
- 125 participants (actual)
- Lead sponsor
- NHS LothianOther government
- Collaborators
- University of Edinburgh
- Study start
- 13 Jan 2020 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 31 Aug 2021 (actual)
- First posted
- 25 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomised Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Telephone ConsultationTelephone Consultation for women requesting abortion |
| Control | Active comparator | Other: Face-to-Face ConsultationFace-to-face consultation for women requesting abortion |
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Requires interpreter
- Patient preference for surgical method of abortion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telephone ConsultationA telephone consultation comprising clinical history, contraception planning, explanation of medical method of abortion | Other | Intervention |
| Face-to-Face ConsultationA face-to-face consultation comprising clinical history, contraception planning, explanation of medical method of abortion | Other | Control |
Primary outcome
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
6 secondary outcomes
Preparedness for medical abortion
Time frame: Within 1 week of randomisation (on day of clinic attendance)
Satisfaction with consultation
Time frame: 2 weeks after administration of abortion medications (via telephone)
Contraception
Time frame: Case note review at 2 weeks
Ineligibility for EMA
Time frame: Within 1 week of randomisation (on day of clinic attendance)
Time taken
Time frame: Within 1 week of randomisation (on day of clinic attendance)
Unscheduled contact
Time frame: 4 weeks after administration of abortion medications
Results and safety
The study was stopped early (reason given: Study suspended on 31 March 2020 due to COVID-19 pandemic. Aimed to restart study early 2021, but decision taken to formally terminate the study on 31st August 2021). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2022.
- Derived from this study: PubMed 37709327Reynolds-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.
- Derived from this study: PubMed 34135047Reynolds-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.
- Individual participant dataSharing planned: No. We cannot share individual level data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sharon T Cameron, MD FRCOG principal investigator
University of Edinburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telephone Consultation and Face-to-Face Consultation in people with Abortion Early and Abortion in First Trimester, run by NHS Lothian at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Study suspended on 31 March 2020 due to COVID-19 pandemic. Aimed to restart study early 2021, but decision taken to formally terminate the study on 31st August 2021). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of medical abortion (time frame: 2 weeks after administration of abortion medications (via telephone)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04139382, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2022.