Letrozole and Misoprostol for Early Pregnancy Loss Management
Letrozole and Misoprostol for Early Pregnancy Loss Management: A Prospective Pilot Cohort Study
University of Pennsylvania
30 participants
Aug 22, 2024
INTERVENTIONAL
Summary
A pilot cohort study to preliminarily investigate the efficacy of pretreatment with letrozole 10 mg daily for three consecutive days followed by treatment with misoprostol 800 mcg vaginally for medical management of early pregnancy loss in a US population. Patients will be followed to assess efficacy of this treatment regimen, as well as additional interventions needed, side effects, adverse events, and patient acceptability.
Eligibility
Inclusion Criteria6
- Able to participate in the informed consent process and provide a signed and dated consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Access to working mobile phone
- English-speaking
- Age 18 years or older
- Confirmed diagnosis of intrauterine embryonic/fetal demise or anembryonic gestation (ultrasound examination demonstrates a fetal pole without cardiac activity measuring between 5.3 and 40 mm or an abnormal growth pattern diagnostic of early pregnancy failure)
Exclusion Criteria4
- Incomplete or inevitable abortion
- Contraindication of allergy to letrozole or misoprostol
- Unable to return for clinic-based follow-up
- Twin or multiple pregnancy
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Interventions
Letrozole 10 mg orally daily for three consecutive days
Misoprostol 800 mcg vaginally within 24 hours of final letrozole dose
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06452719