Delivery of Audiovisual Information on Early Medical Abortion (EMAVID)

March 12, 2019 updated by: John Reynolds-Wright, NHS Lothian

Delivery of Audiovisual Information on Early Medical Abortion to Women in Europe Via Digital Technology: is it Acceptable and Informative?

The majority of abortions in the United Kingdom (UK) are performed before 9 weeks (63 days) gestation using a method known as Early Medical Abortion (EMA). EMA involves an assessment visit and provision of two types of medication .

The assessment visit usually involves Ultrasound to confirm gestation, detailed personal history, safeguarding assessment and contraception planning, before arranging treatment and follow up.

The process is long and lots of information is given to women attending the service. In NHS Lothian (National Health Service, Lothian Health Board), the average appointment length for combined assessment and provision of the first part of treatment is 3 hours.

Despite how common abortion is ( 1 in 3), many women presenting for abortion care are not aware of what the procedure will involve. This may in part to the social stigma surrounding abortion and unintended pregnancy in general. This stigma can in turn result in feelings of anxiety and shame about the decision to terminate a pregnancy.

There is evidence that short videos shown to patients prior to abortion or contraception consultations can improve their ability to recall information and can make them feel more confident about the procedure.

Additionally, abortion care providers have found patients who have seen videos to be better prepared and informed and this allows consultations to progress more easily and allow greater time for discussion of contraceptive methods.

We have prepared a video approximately 3 minutes in length to provide information about EMA. It summarises the process described above using simple language and animated characters. The video has been translated into French, Portuguese and Swedish and has been adapted to reflect subtle differences in practice and law in these countries. We have partners in services in these three countries who will be conducting the trial there in accordance with this protocol and their own local ethics and clinical governance requirements.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Despite abortion being a common medical procedure, many women do not have access to good quality, reliable information about it. This may stem from the stigma and shame surrounding the procedure leading to less community knowledge and experience sharing compared to other medical conditions, for example diabetes or heart disease.

Lack of knowledge and understanding about a medical procedure can cause anxiety, distress and confusion when seeing a healthcare professional, which in turn can prolong consultations.

By introducing the short video animation, we are hoping that this will give the women attending the service a basic level of knowledge about Early Medical Abortion, reduce the anxiety and worry they are experiencing by informing them, and make them feel more confident and clear during their consultations.

It has been shown in other studies that short videos in contraception and abortion consultations can have this impact, but a randomised control trial methodology has never been applied to this intervention.

In a standard initial Early Medical Abortion visit a patient will experience the following Patient Journey:

  1. Arrival and registration
  2. Waiting for appointment in waiting room
  3. Ultrasound scan to determine gestation
  4. Self taken vulvovaginal swab for Chlamydia and Gonorrhoea screening
  5. Blood tests for : HIV, Syphilis, Full Blood Count, Blood Group
  6. Return to the waiting room
  7. Assessment consultation with healthcare professional (i.e. Specialist Nurse or Doctor)
  8. Return to the waiting room
  9. Treatment Consultation: to receive 'first part' of treatment i.e. Mifepristone and dates for 'second part' 24-48 hours later.
  10. Leave department

In the study, the above will happen, however patients will be given a participant information sheet (at step 1 above )when they arrive in department to register. At Step 6, when the patient has returned to the waiting room, eligible patients will be approached and asked if they would like to participate and if so will be randomised to 'standard of care' or 'intervention' (i.e. the video). They will resume the Patient Journey above and will again be approached at Step 8 or Step 10 to complete the short questionnaire.

For the questionnaire: a single researcher will record, on a standard proforma, what information the subject had taken from the consultation and its accuracy, and the overall acceptability of the consultation using a Likert scale to quantify descriptors such as 'helpful', 'informative', 'understandable', 'impersonal', 'sympathetic' 'unsympathetic' etc.

The number of women declining to participate in the study would be recorded .

Study Type

Interventional

Enrollment (Actual)

174

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France
        • Assistance Publique Hopitaux de Paris
  • Sweden
      • Stockholm, Sweden
        • Karolinska University Hospital
  • United Kingdom
      • Edinburgh, United Kingdom
        • Chalmers Centre for Sexual and Reproductive Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Female
  2. Pregnant
  3. Presenting for Termination of Pregnancy
  4. Aged 16 years or over
  5. Able to understand English (the video is in English, and whilst translations are available, their content has been altered to reflect abortion laws in other countries)
  6. Gestation of 9 weeks (63 days) or less on ultrasound scan
  7. Able to provide consent

Exclusion Criteria:

  1. Non pregnant
  2. Pregnancy of Unknown Location
  3. Uncertain of decision or wishing to continue pregnancy
  4. 15 years old or younger
  5. Unable to understand English
  6. Gestation 9 weeks and 1 day (64 days) or greater on ultrasound scan.
  7. Unable to provide consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Animation
Animation describing process of early medical abortion, what to expect, how to take medicines. This is prior to consultation.
Other: Animation
3 minute video describing and explaining early medical abortion, followed by questionnaire
No Intervention: Standard
Standard of Care - no animation ,standard consultation only.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Is the recall of key information about EMA similar after watching the video compared to following face to face contact with a clinician?
Time Frame: Immediately during questionnaire
The patient will be asked to recall any facts that they learned from watching the video/from the consultation and this will be compared to a list held by the researcher. A numerical score for points recalled will be generated for each patient.
Immediately during questionnaire

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
What place/ role do women who watch the video feel that it has (if any)?
Time Frame: Immediately during questionnaire
Open ended questions in the questionnaire to ask participants their thoughts on video and when/where it could be viewed in relation to their treatment. The participant can select an answer from a list of options or volunteer their own.
Immediately during questionnaire
Do women find it acceptable to receive information about Early Medical Abortion (EMA) via an animated video?
Time Frame: Immediately during questionnaire
Likert Scale completed with researcher around a series of different statements relating to their acceptability of the video. Positive responses will be grouped and an overall result of 'acceptable' or 'not acceptable' will be assigned per case.
Immediately during questionnaire

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NHS Lothian

Investigators

  • Study Director: Sharon T Cameron, FRCOG, NHS Lothian

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 5, 2018

Primary Completion (Actual)

March 12, 2019

Study Completion (Actual)

March 12, 2019

Study Registration Dates

First Submitted

January 24, 2018

First Submitted That Met QC Criteria

January 24, 2018

First Posted (Actual)

January 31, 2018

Study Record Updates

Last Update Posted (Actual)

March 13, 2019

Last Update Submitted That Met QC Criteria

March 12, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AC17102
  • 235487 (Other Identifier: IRAS ID (UK))
  • 2018/0060 (Other Identifier: NHS Lothian R&D)
  • 18/NS/0016 (Other Identifier: South East Scotland Research Ethics Committee)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Only anonymised responses to questionnaire will be shared between sites.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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