Letrozole and Misoprostol for Early Pregnancy Loss Management (LeMi)
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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.
Enrollment
Sex
Ages
Volunteers
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 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 criteria
- Incomplete or inevitable abortion
- Contraindication of allergy to letrozole or misoprostol
- Unable to return for clinic-based follow-up
- Twin or multiple pregnancy
Trial design
Primary purpose
Allocation
Interventional model
Masking
30 participants in 1 patient group
Trial contacts and locations
Loading...
Central trial contact
Arden McAllister, MPH
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal