Very Early Medical Abortion (VEMASCOT)

NHS Lothian

Status: Completed

Conditions: Abortion Early

Treatments: Other: Immediate treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT03989869

AC19007

257387 (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 39 patients

Sex: Female

Ages: 16+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. 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
2. No signs of ectopic pregnancy, miscarriage or other pathological pregnancy
3. Transvaginal ultrasound (part of the clinical protocol at the abortion visit) shows no confirmed Intrauterine Pregnancy (IUP see definitions below)
4. 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
5. Capable of giving their informed consent to participate.

Exclusion criteria

1. Women with visible (confirmed) IUP
2. Women with contraindications to medical abortion including diagnosed pathological pregnancy at the initial examination.
3. 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):

1. Confirmed IUP: Ultrasound shows an intrauterine yolk sac or fetal structure with or without cardiac echo.

2. Not confirmed IUP: This group includes cases where:

   1. ultrasound shows an empty uterine cavity (frequently referred to as PUL: Pregnancy of Unknown Location) or
   2. ultrasound shows a gestational sac, or sac like structure, but without a yolk sac.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

39 participants in 2 patient groups

VEMA

Experimental group

Description:

Immediate medical abortion treatment

Treatment:

Other: Immediate treatment

Standard of Care

No Intervention group

Description:

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