RECRUITING

Letrozole and Misoprostol for Early Pregnancy Loss Management

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-08-22
Study Completion:2025-07-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06452719

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Able to participate in the informed consent process and provide a signed and dated consent form
  2. * Stated willingness to comply with all study procedures and availability for the duration of the study
  3. * Access to working mobile phone
  4. * English-speaking
  5. * Age 18 years or older
  6. * 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)
  1. * Incomplete or inevitable abortion
  2. * Contraindication of allergy to letrozole or misoprostol
  3. * Unable to return for clinic-based follow-up
  4. * Twin or multiple pregnancy

Contacts and Locations

Study Contact

Arden McAllister, MPH
CONTACT
215-785-8030
arden.mcallister@pennmedicine.upenn.edu

Study Locations (Sites)

PEACE / Penn Medicine
Philadelphia, Pennsylvania, 19104
United States

Collaborators and Investigators

Sponsor: University of Pennsylvania

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-22
Study Completion Date2025-07-15

Study Record Updates

Study Start Date2024-08-22
Study Completion Date2025-07-15

Terms related to this study

Additional Relevant MeSH Terms

  • Early Pregnancy Loss
  • Miscarriage in First Trimester
  • Miscarriage