Optimal Time Interval Between Mifepristone and Misoprostol Administration for Early Pregnancy Loss

Optimal Time Interval Between Mifepristone and Misoprostol Administration for Early Pregnancy Loss

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.

Inclusion Criteria:

• 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.
• Confirmed diagnosis of intrauterine embryonic/fetal demise or anembryonic gestation (ultrasound examination demonstrates a fetal pole without cardiac activity measuring between 5.3 and 40mm or an abnormal growth pattern diagnostic of early pregnancy loss.

Exclusion Criteria:

• Incomplete or inevitable abortion.
• Contraindication or allergy to mifepristone or misoprostol
• Unable to return for clinic-based follow-up.