Actively Recruiting
Local Versus Systemic Methotrexate in Management of Uterine Ectopic Pregnancy: A Randomized Trial
Led by Tanta University · Updated on 2024-08-16
34
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of local versus systemic methotrexate in managing uterine ectopic pregnancy, a life-threatening condition diagnosed early thanks to medical advances. This study focuses on comparing how long it takes for beta human chorionic gonadotropin (hCG) levels to clear and whether additional treatment is needed. Methotrexate works by inhibiting an enzyme involved in cell growth, making it a treatment option for this condition. Participants will be randomly assigned to receive either systemic methotrexate through an intramuscular injection dosed at 50 mg per square meter of body weight or a local methotrexate injection at a fixed dose of 25 mg. The study will track outcomes over three months following the intervention, with additional monitoring of hospitalization time within 15 days post-treatment. During the study, participants will have their serum beta-hCG levels measured regularly to determine the time to remission, along with assessments of the disappearance of the uterine mass. Hospitalization duration will also be recorded. These evaluations help researchers understand treatment success and monitor safety. The total follow-up for primary outcomes is three months after treatment.
CONDITIONS
Brief Title
Local vs Systemic Methotrexate in Management of Uterine Ectopic Pregnancy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age from 20 to 40 years.
- Women with uterine ectopic pregnancy (interstitial pregnancy, cervical pregnancy, or cesarean scar pregnancy).
- Gestational age less than 9 weeks.
- Embryo size smaller than 10 mm.
- Serum beta-human chorionic gonadotropin (β-hCG) levels less than 10,000 mIU/mL.
You will not qualify if you...
- Basal beta hCG levels less than 1500 mIU/mL.
- Contraindications to methotrexate such as hepatic disorder, renal disorder, or thrombocytopenia.
- Diabetes mellitus.
- Severe vaginal bleeding, hemodynamic changes, or hemoperitoneum.
- History of cancer.
- Ascites.
- Pleural effusion.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 15 days after intervention
Participants receive either systemic or local methotrexate to manage uterine ectopic pregnancy.
1 intervention visit and several follow-up visits during 15 days
Duration - 3 months post intervention
Participants are monitored for serum b-hCG remission and uterine mass disappearance after treatment.
Periodic visits during 3 months
Trial Site Locations
Total: 1 location
1
Tanta University
Tanta, El-Gharbia, Egypt, 31527
Actively Recruiting
Research Team
M
Mai N Ageez, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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