Very Early Medical Abortion (VEMASCOT)

  • STATUS
    Recruiting
  • End date
    Dec 31, 2023
  • participants needed
    150
  • sponsor
    NHS Lothian
Updated on 29 April 2022
Accepts healthy volunteers

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.

Details
Condition Abortion Early
Treatment Immediate treatment
Clinical Study IdentifierNCT03989869
SponsorNHS Lothian
Last Modified on29 April 2022

Eligibility

Yes No Not Sure

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
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How to participate?

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What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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