Letrozole before misoprostol to help pass a missed or anembryonic miscarriage
Comparison Between the Use of Aromatase Inhibitor Before Misoprostol and Use of Misoprostol Alone in Medical Termination of Miscarriage
This will test whether taking letrozole before misoprostol helps people with a missed or anembryonic miscarriage pass the pregnancy more effectively.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | Aswan University Academic / other |
| Drugs / interventions | methotrexate |
| Locations | 1 site (Aswān) |
| Trial ID | NCT07109947 on ClinicalTrials.gov |
What this trial studies
This interventional protocol gives participants letrozole (2.5 mg) prior to administration of misoprostol to encourage evacuation of retained pregnancy tissue. Eligible participants have a missed or anembryonic pregnancy confirmed by ultrasound between 4 and 26 weeks, a closed cervix, and hemoglobin over 9 g/dL. Key exclusions include molar pregnancy, significant uterine abnormalities, an intrauterine device in place, prior termination attempts, major cardiac/renal/bleeding disorders, or BMI over 35 kg/m2. Outcomes are based on whether the pregnancy tissue is expelled with medical treatment and whether surgical intervention is avoided, as determined by clinical follow-up and ultrasound.
Who should consider this trial
Good fit: People with a missed or anembryonic pregnancy from 4 to 26 weeks by ultrasound, a closed cervix, hemoglobin >9 g/dL, BMI ≤35 kg/m2, and no major medical disorders would be ideal candidates.
Not a fit: Patients with molar pregnancy, an intrauterine device in place, abnormal uterine lesions, prior termination attempts, an open cervix, BMI >35 kg/m2, or significant cardiac/renal/bleeding disorders are excluded and unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this approach could increase the chance of completing a miscarriage with medication alone and reduce the need for surgical procedures.
How similar studies have performed: Previous studies combining letrozole and misoprostol for induced abortion of live pregnancies have reported improved success rates, but the approach is less well studied specifically for missed or anembryonic miscarriage.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Missed or anembryonic pregnancy. * Gestational age from 4 weeks to 26 weeks of pregnancy (confirmed by ultrasound scanning on first day of admittance). * Hemoglobin level more than 9g/l. * Closed cervix. * No product of conception in the cervical canal. Exclusion Criteria: * Previous attempt to terminate the pregnancy. * Molar pregnancy * Abnormal uterine lesions such as fibroids or congenital mal formations. * Pregnancy despite of intrauterine contraceptive device. * Medical disorders as cardiac, renal or hemorrhagic diseases. * BMI more than 35 kg/m2. * Known hypersensitivity to any of the medication used.
Where this trial is running
Aswān
- Aswan University Hospital — Aswān, Egypt (Recruiting)
Study contacts
- Study coordinator: Arwa Ashraf Saeed, MSC
- Email: Arwa170439@aswu.edu.eg
- Phone: +201013302339
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.