Abortion EarlyEMAVIDNCT03417362
Delivery of Audiovisual Information on Early Medical Abortion
A study testing Animation in people with Abortion Early and Abortion in First Trimester, run by NHS Lothian at 3 sites in 3 countries.
Trial 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 . Read more about this study
- Who is it for?
- Ages 16 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Abortion Early, Abortion in First Trimester
- What is being tested?
- Animation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 174 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 5 Mar 2018to 12 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Non pregnant
- Pregnancy of Unknown Location
- Uncertain of decision or wishing to continue pregnancy
- 15 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
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
United Kingdom1 site
Chalmers Centre for Sexual and Reproductive Health
Edinburgh
About this study
Official title: 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.
Read more
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.
Read the 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:
- Arrival and registration
- Waiting for appointment in waiting room
- Ultrasound scan to determine gestation
- Self taken vulvovaginal swab for Chlamydia and Gonorrhoea screening
- Blood tests for : HIV, Syphilis, Full Blood Count, Blood Group
- Return to the waiting room
- Assessment consultation with healthcare professional (i.e. Specialist Nurse or Doctor)
- Return to the waiting room
- Treatment Consultation: to receive 'first part' of treatment i.e. Mifepristone and dates for 'second part' 24-48 hours later.
- 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 .
- Conditions
- Abortion Early, Abortion in First Trimester
- Being tested
- Animation
- Keywords
- education, audiovisual, information, acceptability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AnimationOther
3 minute video describing and explaining early medical abortion, followed by questionnaire
| Study group | Role | What they receive |
|---|---|---|
| Animation | Other | Animation describing process of early medical abortion, what to expect, how to take medicines. This is prior to consultation. Receives: Other: Animation |
| Standard | No intervention | Standard of Care - no animation ,standard consultation only. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Immediately during questionnaire
Secondary outcomes (2)
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.
Measured: Immediately during questionnaire
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.
Measured: Immediately during questionnaire
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2018
- Study start5 Mar 2018
- Primary completion12 Mar 2019
- Study completion12 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Abortion EarlyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 174 participants (actual)
Sponsor and investigators
- Lead sponsor
- NHS Lothian
- Sponsor type
- Other government
- Responsible party
- Principal investigator, John Reynolds-Wright, NHS Lothian
- Investigators
- Sharon T Cameron, FRCOG, Study director, NHS Lothian
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03417362
- Sponsor's protocol ID
- AC17102
- Other IDs
- 235487, 2018/0060, 18/NS/0016
- Acronym
- EMAVID
- Status last verified
- Mar 2019
- First submitted
- 24 Jan 2018
- Last updated
- 13 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only anonymised responses to questionnaire will be shared between sites.
Publications
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.
PubMed 26250853Powell-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.
PubMed 20472123Reynolds-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.
PubMed 32573767
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Delivery of Audiovisual Information on Early Medical Abortion to Women in Europe Via Digital Technology: is it Acceptable and Informative?
- ClinicalTrials.gov ID
- NCT03417362
- Acronym / sponsor ID
- EMAVID / AC17102
- Conditions
- Abortion Early, Abortion in First Trimester
- Keywords
- education, audiovisual, information, acceptability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 174 participants (actual)
- Lead sponsor
- NHS LothianOther government
- Study start
- 5 Mar 2018 (actual)
- Primary completion
- 12 Mar 2019 (actual)
- Study completion
- 12 Mar 2019 (actual)
- First posted
- 31 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- Arrival and registration
- Waiting for appointment in waiting room
- Ultrasound scan to determine gestation
- Self taken vulvovaginal swab for Chlamydia and Gonorrhoea screening
- Blood tests for : HIV, Syphilis, Full Blood Count, Blood Group
- Return to the waiting room
- Assessment consultation with healthcare professional (i.e. Specialist Nurse or Doctor)
- Return to the waiting room
- Treatment Consultation: to receive 'first part' of treatment i.e. Mifepristone and dates for 'second part' 24-48 hours later.
- 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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Animation | Other | Other: AnimationAnimation describing process of early medical abortion, what to expect, how to take medicines. This is prior to consultation. |
| Standard | No intervention | –Standard of Care - no animation ,standard consultation only. |
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (7 listed)
- Non pregnant
- Pregnancy of Unknown Location
- Uncertain of decision or wishing to continue pregnancy
- 15 years old or younger
- Unable to understand English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Animation3 minute video describing and explaining early medical abortion, followed by questionnaire | Other | Animation |
Primary outcome
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.
2 secondary outcomes
What place/ role do women who watch the video feel that it has (if any)?
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2019.
- Background: PubMed 26250853Michie 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.
- Background: PubMed 20472123Powell-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.
- Derived from this study: PubMed 32573767Reynolds-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.
- NHS Scotland Information and Statistics Division. Sexual Health. Abortion activity in 2016Link provided by the sponsor.
- Individual participant dataSharing planned: No. Only anonymised responses to questionnaire will be shared between sites.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sharon T Cameron, FRCOG study director
NHS Lothian
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Animation in people with Abortion Early and Abortion in First Trimester, run by NHS Lothian at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France, Sweden, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03417362, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2019.