Using letrozole and misoprostol to manage early pregnancy loss
Letrozole and Misoprostol for Early Pregnancy Loss Management: A Prospective Pilot Cohort Study
This study is testing if a combination of letrozole and misoprostol can help women manage early pregnancy loss more effectively.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University of Pennsylvania Academic / other |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Trial ID | NCT06452719 on ClinicalTrials.gov |
What this trial studies
This pilot cohort study aims to evaluate the effectiveness of a treatment regimen involving letrozole followed by misoprostol for managing early pregnancy loss. Participants will receive letrozole at a dosage of 10 mg daily for three days, followed by a vaginal administration of misoprostol at 800 mcg. The study will monitor the efficacy of this approach, any additional interventions required, side effects, adverse events, and overall patient acceptability. The goal is to provide a new medical management option for women experiencing early pregnancy loss.
Who should consider this trial
Good fit: Ideal candidates include English-speaking women aged 18 and older with a confirmed diagnosis of early pregnancy loss.
Not a fit: Patients with incomplete or inevitable abortion, allergies to the study medications, or those unable to attend follow-up appointments may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer a more effective and acceptable option for women experiencing early pregnancy loss.
How similar studies have performed: While this approach is novel, similar studies have explored medical management of early pregnancy loss, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Philadelphia, Pennsylvania
- PEACE / Penn Medicine — Philadelphia, Pennsylvania, United States (Recruiting)
Study contacts
- Study coordinator: Arden McAllister, MPH
- Email: arden.mcallister@pennmedicine.upenn.edu
- Phone: 215-785-8030
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.