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Very Early Medical Abortion

NCT03989869 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2023-07-05

No results posted yet for this study

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

Conditions

  • Abortion Early

Interventions

OTHER

Immediate treatment

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

Sponsors & Collaborators

  • Karolinska Institutet

    collaborator OTHER

  • University of Edinburgh

    collaborator OTHER

  • NHS Lothian

    lead OTHER_GOV

Principal Investigators

  • John J Reynolds-Wright, MBChB · NHS Lothian and University of Edinburgh

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-09-04
Primary Completion
2023-06-20
Completion
2023-06-20

Countries

  • United Kingdom

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03989869 on ClinicalTrials.gov