Very Early Medical Abortion (VEMASCOT)

Very Early Medical Abortion - a Randomised Controlled Trial

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

Study Overview

• Status: Completed
• Conditions: Abortion Early
• Intervention / Treatment: Other: Immediate treatment

• Study Type: Interventional
• Enrollment (Actual): 39
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: John J Reynolds-Wright, MBChB; Phone Number: 01315362137; Email: john.reynolds-wright@nhslothian.scot.nhs.uk

Study Locations

• United Kingdom
  • Edinburgh, United Kingdom
    • Chalmers Centre for Sexual and Reproductive Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VEMA; Immediate medical abortion treatment	Other: Immediate treatment; Early Medical Abortion treatment, when ultrasound does not yet have conclusive signs of intrauterine pregnancy
No Intervention: Standard of Care; Delayed care until an intrauterine pregnancy has been confirmed with ultrasound.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complication Rate	Rate of complications including ectopic pregnancy, infection.	Within 30 days of treatment initiation
Duration of post-abortion bleeding	Number of days bleeding following treatment	Within 30 days of treatment initiation
Acceptability of method	Preference for delay or immediate treatment	Within 30 days of treatment initiation
Visual Analogue Pain score	Visual Analogue Scale of pain experienced during abortion. Mean will be reported and range of scale from 0-10.	Within 30 days of treatment initiation

Collaborators and Investigators

• Sponsor: NHS Lothian
• Collaborators: Karolinska Institutet; University of Edinburgh
• Investigators: Principal Investigator: John J Reynolds-Wright, MBChB, NHS Lothian and University of Edinburgh

Study record dates

Study Major Dates

• Study Start (Actual): September 4, 2019
• Primary Completion (Actual): June 20, 2023
• Study Completion (Actual): June 20, 2023

Study Registration Dates

• First Submitted: June 17, 2019
• First Submitted That Met QC Criteria: June 17, 2019
• First Posted (Actual): June 18, 2019

Study Record Updates

• Last Update Posted (Actual): July 5, 2023
• Last Update Submitted That Met QC Criteria: June 30, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: AC19007; 257387 (Other Identifier: IRAS (NHS Ethics))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data will be shared with our collaborators at Karolinska Institutet but not publically available.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No