O04
Conditions
Interventions
Group 1: No sonographic evidence of RPOC (homogeneous, three-layered endometrium) 3 weeks after mifepristone administration
follow-up phone call after 12 weeks.
Group 2: Sonographic suspicion of RPOC 3 weeks after mifepristone administration
further sonographic follow-up after the first menstrual period or after 6 weeks at the latest
depending on the course of events surgery or follow-up phone call after 12 weeks.
Sponsors
Kepler Universitätsklinikum
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: o Abortion with 600 mg of mifepristone and 800 µg of misoprostol for an intrauterine pregnancy confirmed by transvaginal ultrasound, with a maximum CRL of 20 mm o Follow-up appointment scheduled for 3 weeks later (18–25 days after mifepristone) o Of legal age (=18 years) o Sufficient knowledge of German
Exclusion criteria
Exclusion criteria: o Multiple pregnancy o Known uterine malformation o Early intervention (medical or surgical) between mifepristone administration and the 3-week follow-up o Persistent intrauterine gestational sac 3 weeks after mifepristone o Presence of an intrauterine foreign body
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary aim of the study is to identify differences in the sonographic morphology of RPOC following medical abortion with mifepristone/misoprostol between patients with and without RPOC later confirmed histologically. The aim is to determine whether ultrasound features can reliably predict the presence of persistent RPOC and serve as potential indicators for early surgical intervention. | — |
Secondary
| Measure | Time frame |
|---|---|
| • To determine the prevalence of sonographic findings suggestive of RPOC following medical termination of pregnancy. • To evaluate whether serum hCG levels 3 weeks after administration of Mifegyne or at subsequent follow-up visits correlate with symptom severity, the sonomorphological appearance of RPOC, or the need for surgical intervention. | — |
Countries
Austria
Contacts
Public ContactSimon-Hermann Enzelsberger
Kepler Universitätsklinikum
Outcome results
None listed