Abortion EarlyVEMASCOTNCT03989869
Very Early Medical Abortion
A study testing Immediate treatment in people with Abortion Early, run by NHS Lothian at 1 site in United Kingdom.
Trial summary
The research question begin addressed by this study is "Is Very Early Medical Abortion (VEMA - before a pregnancy is visible on ultrasound scan) as effective as medical abortion when performed later and an intrauterine pregnancy can be visualised with ultrasound?". 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
- What is being tested?
- Immediate treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 4 Sep 2019to 20 Jun 2023
- 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
- Women 18 years old or above opting for medical abortion with a pregnancy estimated by gynaecological history and Last Menstrual Period (LMP - if known) to be less than 6 weeks
- No signs of ectopic pregnancy, miscarriage or other pathological pregnancy
- Transvaginal ultrasound (part of the clinical protocol at the abortion visit) shows no confirmed Intrauterine Pregnancy (IUP see definitions below)
- Willing and able to return to the clinic for possible delayed treatment and at 1 to 2 weeks after the start of treatment for follow up
- Capable of giving their informed consent to participate.
Who cannot join
- Women with visible (confirmed) IUP
- Women with contraindications to medical abortion including diagnosed pathological pregnancy at the initial examination.
- Inability to give informed consent.
- The following definitions will be used according to the consensus statement on nomenclature, definitions and outcomes in pregnancy of unknown location (Barnhart et al, Fertil Steril. 2011;95:857-66):
- Confirmed IUP: Ultrasound shows an intrauterine yolk sac or fetal structure with or without cardiac echo.
- Not confirmed IUP: This group includes cases where:
- ultrasound shows an empty uterine cavity (frequently referred to as PUL: Pregnancy of Unknown Location) or
- ultrasound shows a gestational sac, or sac like structure, but without a yolk sac.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Chalmers Centre for Sexual and Reproductive Health
Edinburgh
About this study
Official title: Very Early Medical Abortion - a Randomised Controlled Trial
The research question begin addressed by this study is "Is Very Early Medical Abortion (VEMA - before a pregnancy is visible on ultrasound scan) as effective as medical abortion when performed later and an intrauterine pregnancy can be visualised with ultrasound?".
This is important to patients and public, because delays to abortion care can cause mental distress, and pain and bleeding are worse at later gestations.
Read more
The study is examining whether earlier or delayed administration of abortion medications affects the efficacy and side effects of the medical abortion process, in women with very early pregnancies.
Any women who had a positive pregnancy test, requesting abortion, but did not have a visible pregnancy on ultrasound scan could take part in the study. Women with signs, symptoms or ultrasound findings suggesting ectopic pregnancy would not be included.
This study will be conducted at a community sexual and reproductive health centre that provides abortion care.
The participants will be involved in the study for a maximum period of 4 weeks. They will be randomly allocated to either immediate abortion care or delayed abortion care. In each arm of the study they will receive clinical care that they would otherwise routinely receive. In addition to this, they will receive a telephone call follow up with a short questionnaire to complete over the phone.
This study is being conducted in Scotland but the results will be combined with findings from similar research groups across Europe as part of a consortium of researchers. This consortium is coordinated by the Karolinska Institutet in Sweden under the EuDRACT ID: 2018-003675-35
- Conditions
- Abortion Early
- Being tested
- Immediate treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate treatmentOther
Early Medical Abortion treatment, when ultrasound does not yet have conclusive signs of intrauterine pregnancy
| Study group | Role | What they receive |
|---|---|---|
| VEMA | Experimental | Immediate medical abortion treatment Receives: Other: Immediate treatment |
| Standard of Care | No intervention | Delayed care until an intrauterine pregnancy has been confirmed with ultrasound. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Abortion Rate (efficacy)
Rate of complete abortion without surgical intervention, as reported by patients using a self-administered low-sensitivity pregnancy test at 2 weeks after treatment. This will be collected via telephone questionnaire.
Measured: Within 30 days of treatment initiation
Secondary outcomes (4)
Complication Rate
Rate of complications including ectopic pregnancy, infection.
Measured: Within 30 days of treatment initiation
Duration of post-abortion bleeding
Number of days bleeding following treatment
Measured: Within 30 days of treatment initiation
Acceptability of method
Preference for delay or immediate treatment
Measured: Within 30 days of treatment initiation
Visual Analogue Pain score
Visual Analogue Scale of pain experienced during abortion. Mean will be reported and range of scale from 0-10.
Measured: Within 30 days of treatment initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2019
- Study start4 Sep 2019
- Primary completion20 Jun 2023
- Study completion20 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- NHS Lothian
- Sponsor type
- Other government
- Collaborators
- Karolinska Institutet, University of Edinburgh
- Responsible party
- Principal investigator, John Reynolds-Wright, University of Edinburgh
- Investigators
- John J Reynolds-Wright, MBChB, Principal investigator, NHS Lothian and University of Edinburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03989869
- Sponsor's protocol ID
- AC19007
- Other IDs
- 257387
- Acronym
- VEMASCOT
- Status last verified
- Jun 2023
- First submitted
- 17 Jun 2019
- Last updated
- 5 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be shared with our collaborators at Karolinska Institutet but not publically available.
Publications
Gyllenberg F, Brandell K, Jar-Allah T, Kallner HK, Reynolds-Wright J, Boerma C, Cameron S, Hognert H, Heikinheimo O, Kaislasuo J, Gemzell-Danielsson K. Differences in pain, bleeding, and satisfaction during medical abortion at very early gestations. Acta Obstet Gynecol Scand. 2025 Sep;104(9):1665-1671. doi: 10.1111/aogs.15177. Epub 2025 Jul 2.
PubMed 40600383Brandell K, Jar-Allah T, Reynolds-Wright J, Kopp Kallner H, Hognert H, Gyllenberg F, Kaislasuo J, Tamang A, Tuladhar H, Boerma C, Schimanski K, Gibson G, Lokeland M, Teleman P, Bixo M, Mandrup Kjaer M, Kallfa E, Bring J, Heikinheimo O, Cameron S, Gemzell-Danielsson K; VEMA (Very Early Medication Abortion) Study Group. Randomized Trial of Very Early Medication Abortion. N Engl J Med. 2024 Nov 7;391(18):1685-1695. doi: 10.1056/NEJMoa2401646.
PubMed 39504520
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Very Early Medical Abortion - a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT03989869
- Acronym / sponsor ID
- VEMASCOT / AC19007
- Conditions
- Abortion Early
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- NHS LothianOther government
- Collaborators
- Karolinska Institutet, University of Edinburgh
- Study start
- 4 Sep 2019 (actual)
- Primary completion
- 20 Jun 2023 (actual)
- Study completion
- 20 Jun 2023 (actual)
- First posted
- 18 Jun 2019 (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 research question begin addressed by this study is "Is Very Early Medical Abortion (VEMA - before a pregnancy is visible on ultrasound scan) as effective as medical abortion when performed later and an intrauterine pregnancy can be visualised with ultrasound?".
This is important to patients and public, because delays to abortion care can cause mental distress, and pain and bleeding are worse at later gestations.
The study is examining whether earlier or delayed administration of abortion medications affects the efficacy and side effects of the medical abortion process, in women with very early pregnancies.
Any women who had a positive pregnancy test, requesting abortion, but did not have a visible pregnancy on ultrasound scan could take part in the study. Women with signs, symptoms or ultrasound findings suggesting ectopic pregnancy would not be included.
This study will be conducted at a community sexual and reproductive health centre that provides abortion care.
The participants will be involved in the study for a maximum period of 4 weeks. They will be randomly allocated to either immediate abortion care or delayed abortion care. In each arm of the study they will receive clinical care that they would otherwise routinely receive. In addition to this, they will receive a telephone call follow up with a short questionnaire to complete over the phone.
This study is being conducted in Scotland but the results will be combined with findings from similar research groups across Europe as part of a consortium of researchers. This consortium is coordinated by the Karolinska Institutet in Sweden under the EuDRACT ID: 2018-003675-35
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VEMA | Experimental | Other: Immediate treatmentImmediate medical abortion treatment |
| Standard of Care | No intervention | –Delayed care until an intrauterine pregnancy has been confirmed with ultrasound. |
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Women 18 years old or above opting for medical abortion with a pregnancy estimated by gynaecological history and Last Menstrual Period (LMP - if known) to be less than 6 weeks
- No signs of ectopic pregnancy, miscarriage or other pathological pregnancy
- Transvaginal ultrasound (part of the clinical protocol at the abortion visit) shows no confirmed Intrauterine Pregnancy (IUP see definitions below)
- Willing and able to return to the clinic for possible delayed treatment and at 1 to 2 weeks after the start of treatment for follow up
- Capable of giving their informed consent to participate.
Key exclusion criteria (8 listed)
- Women with visible (confirmed) IUP
- Women with contraindications to medical abortion including diagnosed pathological pregnancy at the initial examination.
- Inability to give informed consent.
- The following definitions will be used according to the consensus statement on nomenclature, definitions and outcomes in pregnancy of unknown location (Barnhart et al, Fertil Steril. 2011;95:857-66):
- Confirmed IUP: Ultrasound shows an intrauterine yolk sac or fetal structure with or without cardiac echo.
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 |
|---|---|---|
| Immediate treatmentEarly Medical Abortion treatment, when ultrasound does not yet have conclusive signs of intrauterine pregnancy | Other | VEMA |
Primary outcome
Complete Abortion Rate (efficacy)
Time frame: Within 30 days of treatment initiation
Rate of complete abortion without surgical intervention, as reported by patients using a self-administered low-sensitivity pregnancy test at 2 weeks after treatment. This will be collected via telephone questionnaire.
4 secondary outcomes
Complication Rate
Time frame: Within 30 days of treatment initiation
Duration of post-abortion bleeding
Time frame: Within 30 days of treatment initiation
Acceptability of method
Time frame: Within 30 days of treatment initiation
Visual Analogue Pain score
Time frame: Within 30 days of treatment initiation
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 5 Jul 2023.
- Derived from this study: PubMed 40600383Gyllenberg F, Brandell K, Jar-Allah T, Kallner HK, Reynolds-Wright J, Boerma C, Cameron S, Hognert H, Heikinheimo O, Kaislasuo J, Gemzell-Danielsson K. Differences in pain, bleeding, and satisfaction during medical abortion at very early gestations. Acta Obstet Gynecol Scand. 2025 Sep;104(9):1665-1671. doi: 10.1111/aogs.15177. Epub 2025 Jul 2.
- Derived from this study: PubMed 39504520Brandell K, Jar-Allah T, Reynolds-Wright J, Kopp Kallner H, Hognert H, Gyllenberg F, Kaislasuo J, Tamang A, Tuladhar H, Boerma C, Schimanski K, Gibson G, Lokeland M, Teleman P, Bixo M, Mandrup Kjaer M, Kallfa E, Bring J, Heikinheimo O, Cameron S, Gemzell-Danielsson K; VEMA (Very Early Medication Abortion) Study Group. Randomized Trial of Very Early Medication Abortion. N Engl J Med. 2024 Nov 7;391(18):1685-1695. doi: 10.1056/NEJMoa2401646.
- Individual participant dataSharing planned: No. Data will be shared with our collaborators at Karolinska Institutet but not publically available.
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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.
John J Reynolds-Wright, MBChB principal investigator
NHS Lothian and University of Edinburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immediate treatment in people with Abortion Early, run by NHS Lothian at 1 site in United Kingdom.
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 5 inclusion and 8 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 5 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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?
Complete Abortion Rate (efficacy) (time frame: Within 30 days of treatment initiation). 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 NCT03989869, which also lists 2 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 5 Jul 2023.