Very Early Medical Abortion

NCT03989869 | Completed

• 2 other identifiers: AC19007257387
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief 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?". 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

Conditions

Abortion Early

Outcome Measures

Primary Outcomes (1)

• 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.

  Within 30 days of treatment initiation

Secondary Outcomes (4)

• Complication Rate

  Within 30 days of treatment initiation

• Duration of post-abortion bleeding

  Within 30 days of treatment initiation

• Acceptability of method

  Within 30 days of treatment initiation

• Visual Analogue Pain score

  Within 30 days of treatment initiation

Study Arms (2)

VEMA

EXPERIMENTAL

Immediate medical abortion treatment

Other: Immediate treatment

Standard of Care

NO INTERVENTION

Delayed care until an intrauterine pregnancy has been confirmed with ultrasound.

Interventions

Immediate treatment OTHER

Early Medical Abortion treatment, when ultrasound does not yet have conclusive signs of intrauterine pregnancy

VEMA

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:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• NHS Lothian: lead
• Karolinska Institutet: collaborator
• University of Edinburgh: collaborator

Study Sites (1)

Chalmers Centre for Sexual and Reproductive Health

Edinburgh, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 40600383 DERIVED

• Brandell 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.

  PMID: 39504520 DERIVED

Study Officials

• John J Reynolds-Wright, MBChB

  NHS Lothian and University of Edinburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Research Fellow

Study Record Dates

• First Submitted: June 17, 2019
• First Posted: June 18, 2019
• Study Start: September 4, 2019
• Primary Completion: June 20, 2023
• Study Completion: June 20, 2023
• Last Updated: July 5, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)