Local vs Systemic Methotrexate in Management of Uterine Ectopic Pregnancy

Not Applicable

Recruiting

• Conditions: Local; Systemic; Methotrexate; Uterine Ectopic Pregnancy
• Interventions: Drug: Systemic Methotrexate; Drug: Local Methotrexate

• Registration Number: NCT06554470
• Lead Sponsor: Tanta University

Brief Summary

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.

Study Timeline

• Status Verified: 2024-08
• Study First Submitted: 2024-08-11
• Study First Submitted QC: 2024-08-14
• Study Start: 2024-08-15
• Study First Posted: 2024-08-15
• Last Update Submitted: 2024-08-15
• Last Update Posted: 2024-08-16
• Primary Completion: 2025-07-01
• Study Completion: 2025-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 34

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Systemic Methotrexate	Systemic Methotrexate	Patients will receive systemic methotrexate (intramuscular; 50 mg/m2 body weight).
Local Methotrexate	Local Methotrexate	Patients will receive local methotrexate (25 mg methotrexate as a fixed dose).

Primary Outcome Measures

Name	Time	Method
Time for serum b-hCG remission	Post intervention for 3 months	Time for serum b-hCG remission will be recorded to be less than 20 iu/ml.

Secondary Outcome Measures

Name	Time	Method
Success rate	Post intervention for 3 months	Success rate will be recorded.
Time for uterine-mass disappearance	Post intervention for 3 months	Time for uterine-mass disappearance will be recorded.
Hospitalization time	15 days after intervention	Hospitalization time will be recorded from admission till discharge from hospital.

Trial Locations

Locations (1)

Tanta University; 🇪🇬 Tanta, El-Gharbia, Egypt