Letrozole and Misoprostol for Early Pregnancy Loss Management

Description

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.

Conditions

Early Pregnancy Loss, Miscarriage in First Trimester, Miscarriage

Study Overview

Study Details

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.

Letrozole and Misoprostol for Early Pregnancy Loss Management: A Prospective Pilot Cohort Study

Letrozole and Misoprostol for Early Pregnancy Loss Management

Condition
Early Pregnancy Loss
Intervention / Treatment

-

Contacts and Locations

Philadelphia

PEACE / Penn Medicine, Philadelphia, Pennsylvania, United States, 19104

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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)
  • * Incomplete or inevitable abortion
  • * Contraindication of allergy to letrozole or misoprostol
  • * Unable to return for clinic-based follow-up
  • * Twin or multiple pregnancy

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Pennsylvania,

Study Record Dates

2025-07-15