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Delivery of Audiovisual Information on Early Medical Abortion (EMAVID)

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: NCT03417362
Recruitment Status : Completed
First Posted : January 31, 2018
Last Update Posted : March 13, 2019
Sponsor:
Information provided by (Responsible Party):
John Reynolds-Wright, NHS Lothian

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Abortion Early Abortion in First Trimester Other: Animation Not Applicable

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 .

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 174 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Delivery of Audiovisual Information on Early Medical Abortion to Women in Europe Via Digital Technology: is it Acceptable and Informative?
Actual Study Start Date : March 5, 2018
Actual Primary Completion Date : March 12, 2019
Actual Study Completion Date : March 12, 2019

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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:

  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

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): NCT03417362


Locations
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France
Assistance Publique Hopitaux de Paris
Paris, France
Sweden
Karolinska University Hospital
Stockholm, Sweden
United Kingdom
Chalmers Centre for Sexual and Reproductive Health
Edinburgh, United Kingdom
Sponsors and Collaborators
NHS Lothian
Investigators
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Study Director: Sharon T Cameron, FRCOG NHS Lothian
Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: John Reynolds-Wright, Community Sexual and Reproductive Healthcare Trainee, NHS Lothian
ClinicalTrials.gov Identifier: NCT03417362    
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 )
First Posted: January 31, 2018    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Only anonymised responses to questionnaire will be shared between sites.

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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 John Reynolds-Wright, NHS Lothian:
education
audiovisual
information
acceptability
Additional relevant MeSH terms:
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Abortion, Spontaneous
Pregnancy Complications