Local vs Systemic Methotrexate in Management of Uterine Ectopic Pregnancy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Systemic Methotrexate, Local Methotrexate.
- Who it may be relevant to
- Registry conditions: Local, Systemic, Methotrexate, Uterine Ectopic Pregnancy. Basic parameters: 20 years — 40 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Local Versus Systemic Methotrexate in Management of Uterine Ectopic Pregnancy: A Randomized Trial
Overview
This study aims to compare local and systemic methotrexate in the management of uterine ectopic pregnancy regarding the duration of beta human chorionic gonadotropin (hCG) clearance and need for further management options.
Detailed description
Ectopic pregnancy is considered a life-threatening condition which requires immediate intervention. Owing to the advancements in medical technology, ectopic pregnancy can now be diagnosed in the early stages.
Methotrexate (MTX) is an antimetabolite drug showing a competitive reversible binding concerning natural dihydrofolates and acting as an inhibitor of the dihydrofolate-reductase (DHFR), a key enzyme synthesizing the tetrahydrofolates needed for the synthesis of purine and pyrimidine rings.
Interventions
- Drug Systemic Methotrexate
Patients will receive systemic methotrexate (intramuscular; 50 mg/m2 body weight). - Drug Local Methotrexate
Patients will receive local methotrexate (25 mg methotrexate as a fixed dose).
Primary outcome measures
- Time for serum b-hCG remission [Time frame: Post intervention for 3 months]
Secondary outcome measures (3)
- Success rate [Time frame: Post intervention for 3 months]
- Time for uterine-mass disappearance [Time frame: Post intervention for 3 months]
- Hospitalization time [Time frame: 15 days after intervention]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Tanta University — Tanta
Identifiers
NCT: NCT06554470 · 36264PR751/7/24