Abortion in First Trimester Clinical Trial
— EMAVIDOfficial title:
Delivery of Audiovisual Information on Early Medical Abortion to Women in Europe Via Digital Technology: is it Acceptable and Informative?
Verified date | March 2019 |
Source | NHS Lothian |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 174 |
Est. completion date | March 12, 2019 |
Est. primary completion date | March 12, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 16 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
France | Assistance Publique Hopitaux de Paris | Paris | |
Sweden | Karolinska University Hospital | Stockholm | |
United Kingdom | Chalmers Centre for Sexual and Reproductive Health | Edinburgh |
Lead Sponsor | Collaborator |
---|---|
NHS Lothian |
France, Sweden, United Kingdom,
Michie L, Cameron ST, Glasier A, Johnstone A. Giving information about the contraceptive implant using a DVD: is it acceptable and informative? A pilot randomised study. J Fam Plann Reprod Health Care. 2016 Jul;42(3):194-200. doi: 10.1136/jfprhc-2015-101186. Epub 2015 Aug 6. — View Citation
Powell-Jackson R, Glasier A, Cameron ST. Benefits of using a digital video disk for providing information about abortion to women requesting termination of pregnancy. Contraception. 2010 Jun;81(6):537-41. doi: 10.1016/j.contraception.2010.01.015. Epub 2010 Feb 19. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Is the recall of key information about EMA similar after watching the video compared to following face to face contact with a clinician? | 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 | What place/ role do women who watch the video feel that it has (if any)? | 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 | |
Secondary | Do women find it acceptable to receive information about Early Medical Abortion (EMA) via an animated video? | 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 |
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