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Completed

NCT Number: NCT03989869

Very Early Medical Abortion

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

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Key information

Conditions

Abortion Early

Age range

16 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Chalmers Centre for Sexual and Reproductive Health

Edinburgh, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Immediate treatment

Other

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Complication Rate

    Time frame: Within 30 days of treatment initiation

    Rate of complications including ectopic pregnancy, infection.

  2. Duration of post-abortion bleeding

    Time frame: Within 30 days of treatment initiation

    Number of days bleeding following treatment

  3. Acceptability of method

    Time frame: Within 30 days of treatment initiation

    Preference for delay or immediate treatment

  4. Visual Analogue Pain score

    Time frame: Within 30 days of treatment initiation

    Visual Analogue Scale of pain experienced during abortion. Mean will be reported and range of scale from 0-10.

Sponsors and collaborators

Lead sponsor

NHS Lothian

Other Gov

Collaborators

  • Karolinska Institutet
  • University of Edinburgh

Registry information

Official study title

Very Early Medical Abortion - a Randomised Controlled Trial

Acronym: VEMASCOT

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Jun 18, 2019
Registry last updated
Jul 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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