NCT03989869

Very Early Medical Abortion

Very Early Medical Abortion - a Randomised Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: NHS Lothian · Other Government
• Sex: Female
• Age: 16 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
OTHER	Immediate treatment	Early Medical Abortion treatment, when ultrasound does not yet have conclusive signs of intrauterine pregnancy

Timeline

• Start date: 2019-09-04
• Primary completion: 2023-06-20
• Completion: 2023-06-20
• First posted: 2019-06-18
• Last updated: 2023-07-05

Locations

1 site across 1 country: United Kingdom