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.
This is a prospective trial to establish the optimal time interval between mifepristone and misoprostol administration for the management of early pregnancy loss. Participants will be followed to assess treatment success, side effects, and satisfaction with the misoprostol interval. Patients will be invited to participate if they are clinically eligible for medical management of early pregnancy loss. After consent is obtained, eligibility will be confirmed by a designated study investigator. Participants will take 200mg of mifepristone by mouth and will be instructed to administer misoprostol any time between 4- and 24-hours post-mifepristone. They will receive instructions for vaginal misoprostol administration. Participants will be prompted to report the time of medication administration via text, email, or portal message. Participants will follow up as clinically indicated. At the clinical follow-up visit, participants will complete a brief survey to collect preliminary adverse event information, and then the study staff will review adverse events and concomitant medications with participants. Study staff will remind participants when they took mifepristone and misoprostol and ask participants what influenced their decision to administer misoprostol at their chosen time. Study staff will follow up 42 days after study enrollment to review adverse events and concomitant medications and to administer a satisfaction and acceptability survey. Medical records will also be reviewed for any additional clinical intervention or adverse event since enrollment. Clinicians performing the follow-up transvaginal ultrasound will be blinded to the participant's misoprostol administration timing.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
1,000
Participants will take 200mg of mifepristone by mouth and will be instructed to administer misoprostol any time between 4- and 24-hours post-mifepristone.
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.
Time frame: 17 days
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.
Time frame: 42 days
Treatment acceptability
Participants' overall assessment of the treatment measured on a 3-point scale.
Time frame: 42 days
Treatment satisfaction
Participants' overall assessment of the treatment measured on a 3-point scale.
Time frame: 42 days
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