Local vs Systemic Methotrexate in Management of Uterine Ectopic Pregnancy

NCT ID: NCT06554470

Last Updated: 2024-08-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-15
• Study Completion Date: 2025-07-01

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.

Conditions

Local; Systemic; Methotrexate; Uterine Ectopic Pregnancy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Systemic Methotrexate

Patients will receive systemic methotrexate (intramuscular; 50 mg/m2 body weight).

Group Type: EXPERIMENTAL

Systemic Methotrexate

Intervention Type: DRUG

Patients will receive systemic methotrexate (intramuscular; 50 mg/m2 body weight).

Local Methotrexate

Patients will receive local methotrexate (25 mg methotrexate as a fixed dose).

Group Type: EXPERIMENTAL

Local Methotrexate

Intervention Type: DRUG

Patients will receive local methotrexate (25 mg methotrexate as a fixed dose).

Interventions

Systemic Methotrexate

Patients will receive systemic methotrexate (intramuscular; 50 mg/m2 body weight).

Intervention Type: DRUG

Local Methotrexate

Patients will receive local methotrexate (25 mg methotrexate as a fixed dose).

Intervention Type: DRUG

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Tanta University

OTHER

Sponsor Role: lead

Responsible Party

Mai Nabil Ageez

Lecturer of Obstetrics and Gynecology, Faculty of Medicine, Tanta University, Tanta, Egypt.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Tanta University

Tanta, El-Gharbia, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Mai N Ageez, MD

Role: CONTACT

mai.ageez@med.tanta.edu.eg

00201062388870

Facility Contacts

Mai N Ageez, MD

Role: primary

mai.ageez@med.tanta.edu.eg

00201062388870

Other Identifiers

36264PR751/7/24

Identifier Type: -

Identifier Source: org_study_id