Letrozole and Misoprostol for Early Pregnancy Loss Management
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Letrozole, Misoprostol.
- Who it may be relevant to
- Registry conditions: Early Pregnancy Loss, Miscarriage in First Trimester, Miscarriage. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Letrozole and Misoprostol for Early Pregnancy Loss Management: A Prospective Pilot Cohort Study
Overview
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.
Interventions
- Drug Letrozole
Letrozole 10 mg orally daily for three consecutive days - Drug Misoprostol
Misoprostol 800 mcg vaginally within 24 hours of final letrozole dose
Primary outcome measures
- Treatment Efficacy [Time frame: Visit 2 (Days 10-11)]
Secondary outcome measures (1)
- Acceptability [Time frame: 30 days]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- PEACE / Penn Medicine — Philadelphia
Identifiers
NCT: NCT06452719 · 855835