Delivery of Audiovisual Information on Early Medical Abortion

NCT03417362 | Completed DMC

• 4 other identifiers: AC171022354872018/006018/NS/0016
• Study Type: interventional
• Target: 174
• Locations: 3 countries
• Sites: 3

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.

Conditions

Abortion Early; Abortion in First Trimester

Keywords

education; audiovisual; information; acceptability

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• What place/ role do women who watch the video feel that it has (if any)?

  Immediately during questionnaire

• Do women find it acceptable to receive information about Early Medical Abortion (EMA) via an animated video?

  Immediately during questionnaire

Study Arms (2)

Animation

OTHER

Animation describing process of early medical abortion, what to expect, how to take medicines. This is prior to consultation.

Other: Animation

Standard

NO INTERVENTION

Standard of Care - no animation ,standard consultation only.

Interventions

Animation OTHER

3 minute video describing and explaining early medical abortion, followed by questionnaire

Animation

Eligibility Criteria

• Age: 16 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Female
• Pregnant
• Presenting for Termination of Pregnancy
• Aged 16 years or over
• 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)
• Gestation of 9 weeks (63 days) or less on ultrasound scan
• Able to provide consent

You may not qualify if:

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

Sponsors & Collaborators

• NHS Lothian: lead

Study Sites (3)

Assistance Publique Hopitaux de Paris

Paris, France

Location

Karolinska University Hospital

Stockholm, Sweden

Location

Chalmers Centre for Sexual and Reproductive Health

Edinburgh, United Kingdom

Location

Related Publications (3)

• 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.

  PMID: 26250853 BACKGROUND

• 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.

  PMID: 20472123 BACKGROUND

• Reynolds-Wright JJ, Belleuvre F, Daberius A, Faucher P, Gemzell-Danielsson K, Cameron ST. Information on early medical abortion for women using an audiovisual animation vs face-to-face consultation: A consortium randomized and quasi-randomized trial. Acta Obstet Gynecol Scand. 2020 Dec;99(12):1611-1617. doi: 10.1111/aogs.13944. Epub 2020 Jul 12.

  PMID: 32573767 DERIVED

Related Links

• NHS Scotland Information and Statistics Division. Sexual Health. Abortion activity in 2016

Study Officials

• Sharon T Cameron, FRCOG

  NHS Lothian

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Community Sexual and Reproductive Healthcare Trainee

Study Record Dates

• First Submitted: January 24, 2018
• First Posted: January 31, 2018
• Study Start: March 5, 2018
• Primary Completion: March 12, 2019
• Study Completion: March 12, 2019
• Last Updated: March 13, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1); SE (1); FR (1)