Comparing Letrozole with Misoprostol to Misoprostol Alone for Early Pregnancy Loss
Comparison of Rate of Complete Abortion Between Letrozole Plus Misoprostol vs Misoprostol Alone in First Trimester Pregnancy
NA · Queen Savang Vadhana Memorial Hospital, Thailand · NCT05940233
This study is testing if adding Letrozole to Misoprostol helps women who have early pregnancy loss complete the process better than using Misoprostol alone.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Sex | Female |
| Sponsor | Queen Savang Vadhana Memorial Hospital, Thailand (other) |
| Locations | 1 site (Bangkok, Yannawa) |
| Trial ID | NCT05940233 on ClinicalTrials.gov |
What this trial studies
This clinical trial compares the effectiveness of Letrozole combined with Misoprostol versus Misoprostol alone in achieving complete abortion in women experiencing early pregnancy loss during the first trimester. A total of 70 patients will be randomly assigned to either the intervention group receiving Letrozole followed by Misoprostol or the control group receiving Misoprostol alone. The primary outcome is the rate of complete abortion, while secondary outcomes include side effects of Letrozole and the time taken to induce abortion. Follow-up will occur on day 7 to assess the outcomes using transvaginal ultrasound.
Who should consider this trial
Good fit: Ideal candidates are women diagnosed with early pregnancy loss up to 14 weeks gestation who meet specific health criteria.
Not a fit: Patients with contraindications such as allergies to the medications, ectopic pregnancy, or severe liver disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve the rate of complete abortion in women experiencing early pregnancy loss.
How similar studies have performed: While this approach is being tested in this trial, similar studies have shown varying results, indicating the need for further investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diafnoed Early pregnancy loss by TVS according to ACOG Practice bulletin 2018 * GA \<= 14 weeks * Os open \<= 1 cm and no conceptus per os * Hematicrit \>= 30 * Systolic blood pressure \>= 95 mmHg * Informed consent done and can follow up and comunicate in Thai language Exclusion Criteria: * Allerguc to Letrozole or Misoprostol * Intrauterine contraceptive device use * Breast feeding * Diagnoed with ectopic pregnancy or undiagnoed adnexal mass * Severe or recurrent liver disease or AST or ALT more than or equal to 3 times of upper normal limit * Multiple pregnancy * Myoma uteri that involves the endometrium ex. Submucous myoma uteri * Thromboembolism or has a history of thromboembolism * Serum creatinine \>= 2
Where this trial is running
Bangkok, Yannawa
- Sutinee Srimahachota — Bangkok, Yannawa, Thailand (RECRUITING)
Study contacts
- Study coordinator: Sutinee Srimahachota, M.D.
- Email: srimahachota@gmail.com
- Phone: 0847202666
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.
Conditions: Medical, Abortion, Fetus