Comparing Letrozole and Mifepristone for Early Miscarriage Management
COMPARATIVE STUDY OF EFFECTS BETWEEN LETROZOLE PLUS MISOPROSTOL AND MIFEPRISTONE PLUS MISOPROSTOL IN TERMINATING NON-VIABLE FIRST TRIMESTER PREGNANCIES
This study is testing whether letrozole works better than mifepristone for managing early miscarriages to help women through this difficult time.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | Female |
| Sponsor | Calcutta National Medical College and Hospital Government |
| Locations | 1 site (Kolkata, West Bengal) |
| Trial ID | NCT05304273 on ClinicalTrials.gov |
What this trial studies
This interventional study aims to compare the effectiveness of letrozole versus mifepristone in the medical management of first trimester miscarriages. Participants with confirmed missed abortions will be randomly assigned to receive either mifepristone followed by misoprostol or letrozole followed by misoprostol. The primary outcomes include the mean duration from induction to expulsion and the rate of complete abortion in both groups. This study seeks to determine if letrozole can provide a more effective alternative to the conventional treatment.
Who should consider this trial
Good fit: Ideal candidates are women over 18 years old with a confirmed missed abortion in the first trimester.
Not a fit: Patients with hemodynamic instability or significant underlying health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could offer a more effective medical option for women experiencing first trimester miscarriages.
How similar studies have performed: While the use of mifepristone is well-established, the application of letrozole in this context is relatively novel and has not been extensively tested in similar studies.
Eligibility criteria
Show full inclusion / exclusion criteria
INCLUSION CRITERIA : * Women older than 18years who will give consent regarding medical management of missed abortion * First trimester pregnancy (gestational age less than equal to 12weeks) with missed abortion confirmed by ultrasonography * Hemoglobin level more than 12mg/dl EXCLUSION CRITERIA : * Hemodynamically unstable patient * Abnormalities in blood tests including complete blood count (CBC), prothrombin time(PT), internationalised normalized ratio(INR) and fibrinogen * History or clinical evidence of any thromboembolic impairment or deep venous thrombosis * Having intra-uterine device * Present or previous use of corticosteroids * History of any malignancy * Existing cardiovascular disease contraindicating misoprostol
Where this trial is running
Kolkata, West Bengal
- Calcutta National Medical College and Hospital — Kolkata, West Bengal, India (Recruiting)
Study contacts
- Study coordinator: Jhuma Biswas
- Email: drjhumabiswas78@gmail.com
- Phone: +91 9433019780
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.