Clinical Trial Details
— Status: Terminated
Administrative data
| NCT number |
NCT04139382 |
| Other study ID # |
AC19076 |
| Secondary ID |
IRAS |
| Status |
Terminated |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 13, 2020 |
| Est. completion date |
August 31, 2021 |
Study information
| Verified date |
October 2022 |
| Source |
NHS Lothian |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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). 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.
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.
