Comparing local and systemic methotrexate for treating uterine ectopic pregnancy
Local Versus Systemic Methotrexate in Management of Uterine Ectopic Pregnancy: A Randomized Trial
This study is testing whether giving methotrexate directly to the uterus works better than giving it through the bloodstream for treating women with ectopic pregnancies.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 34 (estimated) |
| Ages | 20 Years to 40 Years |
| Sex | Female |
| Sponsor | Tanta University Academic / other |
| Drugs / interventions | methotrexate |
| Locations | 1 site (Tanta, El-Gharbia) |
| Trial ID | NCT06554470 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of local versus systemic administration of methotrexate in managing uterine ectopic pregnancies. It focuses on measuring the duration of beta human chorionic gonadotropin (hCG) clearance and the necessity for additional treatment options. By utilizing methotrexate, an antimetabolite drug, the study seeks to determine which method provides better outcomes for patients diagnosed with this condition. The study includes women aged 20 to 40 with specific criteria related to gestational age and hCG levels.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 20 to 40 with uterine ectopic pregnancies under 9 weeks gestation and specific hCG levels.
Not a fit: Patients with contraindications to methotrexate or those experiencing severe complications such as significant bleeding or hemodynamic instability may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for women experiencing uterine ectopic pregnancies.
How similar studies have performed: While there is ongoing research in this area, the comparative approach of local versus systemic methotrexate in this specific context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age from 20 to 40 years. * Women with uterine ectopic pregnancy (interstitial pregnancy, cervical pregnancy, or cesarean scar pregnancy). * Gestational age is less than 9 weeks, the embryo size is smaller than 10 mm, and the serum beta-human chorionic gonadotropin (β-hCG) levels are less than 10,000 mIU/mL. Exclusion Criteria: * Patients with basal beta hCG levels less than 1500 mIU/Ml. * Any contraindications to MTX as a hepatic disorder, renal disorder and thrombocytopenia * Diabetes mellitus. * Severe vaginal bleeding or hemodynamic changes or hemoperitoneum. * History of cancer. * Ascites. * Pleural effusion.
Where this trial is running
Tanta, El-Gharbia
- Tanta University — Tanta, El-Gharbia, Egypt (Recruiting)
Study contacts
- Study coordinator: Mai N Ageez, MD
- Email: mai.ageez@med.tanta.edu.eg
- Phone: 00201062388870
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.