About this trial
A prospective cohort study to explore the optimal time interval between mifepristone and misoprostol administration for medical management of early pregnancy loss. Participants will be followed to assess treatment success, satisfaction, and side effects.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Able to participate in the informed consent process and provide a signed and dated consent form.
Stated willingness to comply with all study procedures.
Access to device with text or email capability.
Able to read and understand English.
Disqualifiers
Incomplete or inevitable abortion.
Contraindication or allergy to mifepristone or misoprostol
Unable to return for clinic-based follow-up.
Trial design
Single group
Treatments tested in this trial
200mg mifepristone and 800mg misoprostol
DrugParticipants will take 200mg of mifepristone by mouth and will be instructed to administer misoprostol any time between 4- and 24-hours post-mifepristone.
Treatment groups
Trial outcomes
Primary outcomes
Treatment success
Gestational sac expulsion by first follow-up visit (as indicated by transvaginal ultrasound), with one dose of misoprostol and no additional need for medical/surgical intervention; comparison of this outcome between patient chosen intervals.
Secondary outcomes
Adverse Events
Number of serious adverse events related to study procedures, particularly hemorrhage resulting in blood transfusion and pelvic infection, as collected from chart review and participant self-report.
Treatment acceptability
Participants' overall assessment of the treatment measured on a 3-point scale.
Treatment satisfaction
Participants' overall assessment of the treatment measured on a 3-point scale.
Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: