Letrozole and Misoprostol for Early Pregnancy Loss Management

Phase 2RecruitingNCT06452719

University of Pennsylvania30 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Early Pregnancy Loss Miscarriage in First Trimester Miscarriage

Interventions

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Treatment Efficacy

Absence of gestational sac on transvaginal ultraound

Time frame: Visit 2 (Days 10-11)

Secondary Outcomes

Acceptability

Participant assessment of treatment (Positive / Neutral / Negative), Likelihood to recommend this method of treatment to a friend (Yes / No)

Time frame: 30 days