Local vs Systemic Methotrexate in Management of Uterine Ectopic Pregnancy

Tanta University

Status: Enrolling

Conditions: Systemic; Methotrexate; Uterine Ectopic Pregnancy; Local

Treatments: Drug: Systemic Methotrexate; Drug: Local Methotrexate

Study type: Interventional

Funder types: Other

Identifiers

NCT06554470

36264PR751/7/24

Details and patient eligibility

About

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.

Full 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.

Enrollment: 34 estimated patients

Sex: Female

Ages: 20 to 40 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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34 participants in 2 patient groups

Systemic Methotrexate

Experimental group

Description:

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

Treatment:

Drug: Systemic Methotrexate

Local Methotrexate

Experimental group

Description:

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

Treatment:

Drug: Local Methotrexate