Early Pregnancy Loss
Conditions
Keywords
early pregnancy loss, miscarriage
Brief summary
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.
Detailed description
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.
Interventions
DRUG200mg mifepristone and 800mg misoprostol
Participants will take 200mg of mifepristone by mouth and will be instructed to administer misoprostol any time between 4- and 24-hours post-mifepristone.
Sponsors
University of Pennsylvania
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment success | 17 days | 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
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | 42 days | 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 | 42 days | Participants' overall assessment of the treatment measured on a 3-point scale. |
| Treatment satisfaction | 42 days | Participants' overall assessment of the treatment measured on a 3-point scale. |
Contacts
CONTACTCourtney Schreiber
Outcome results
None listed