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

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
AgeNot listed
SponsorUniversity of Pennsylvania

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 volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • 200mg mifepristone and 800mg misoprostol

    Drug

    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 groups

1,000 Participants
are divided into 1 treatment group
Group A: Mifepristone and MisoprostolExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

Treatment acceptability

Participants' overall assessment of the treatment measured on a 3-point scale.

Time frame
42 days
3

Treatment satisfaction

Participants' overall assessment of the treatment measured on a 3-point scale.

Time frame
42 days

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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