Clinical trial NCT03989869: Very Early Medical Abortion
Official title: Very Early Medical Abortion - a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Abortion Early
Lead sponsor: NHS Lothian
Sponsor class: OTHER_GOV
Collaborators: name: Karolinska Institutet
name: University of Edinburgh
First posted: 2019-06-18
Enrollment: 39
Sex: FEMALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Complete Abortion Rate (efficacy)
timeFrame: Within 30 days of treatment initiation
Secondary outcomes:
measure: Complication Rate
timeFrame: Within 30 days of treatment initiation
measure: Duration of post-abortion bleeding
timeFrame: Within 30 days of treatment initiation
measure: Acceptability of method
timeFrame: Within 30 days of treatment initiation
measure: Visual Analogue Pain score
timeFrame: Within 30 days of treatment initiation
Other outcomes:
Locations:
city: Edinburgh
country: United Kingdom
facility: Chalmers Centre for Sexual and Reproductive Health
Study officials:
affiliation: NHS Lothian and University of Edinburgh
name: John J Reynolds-Wright, MBChB
role: PRINCIPAL_INVESTIGATOR
References: