Local vs Systemic Methotrexate in Management of Uterine Ectopic Pregnancy

Local Versus Systemic Methotrexate in Management of Uterine Ectopic Pregnancy: A Randomized Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Methotrexate; Systemic; Local; Uterine Ectopic Pregnancy
• Intervention / Treatment: Drug: Systemic Methotrexate; Drug: Local Methotrexate

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 Type: Interventional
• Enrollment (Estimated): 34
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mai N Ageez, MD; Phone Number: 00201062388870; Email: mai.ageez@med.tanta.edu.eg

Study Locations

• Egypt
  • El-Gharbia
    • Tanta, El-Gharbia, Egypt, 31527
      • Recruiting
      • Tanta University
      • Contact: Mai N Ageez, MD; Phone Number: 00201062388870; Email: mai.ageez@med.tanta.edu.eg
      • Principal Investigator: Amr A Habib, MD
      • Principal Investigator: Shereef L Elshwaikh, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Systemic Methotrexate; Patients will receive systemic methotrexate (intramuscular; 50 mg/m2 body weight).	Drug: Systemic Methotrexate; Patients will receive systemic methotrexate (intramuscular; 50 mg/m2 body weight).
Experimental: Local Methotrexate; Patients will receive local methotrexate (25 mg methotrexate as a fixed dose).	Drug: Local Methotrexate; Patients will receive local methotrexate (25 mg methotrexate as a fixed dose).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time for serum b-hCG remission	Time for serum b-hCG remission will be recorded to be less than 20 iu/ml.	Post intervention for 3 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2024
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: August 11, 2024
• First Submitted That Met QC Criteria: August 14, 2024
• First Posted (Actual): August 15, 2024

Study Record Updates

• Last Update Posted (Actual): August 16, 2024
• Last Update Submitted That Met QC Criteria: August 15, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pregnancy, Ectopic; Cardiac Complexes, Premature; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Antirheumatic Agents; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Dermatologic Agents; Reproductive Control Agents; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Folic Acid Antagonists; Methotrexate
• Other Study ID Numbers: 36264PR751/7/24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
• IPD Sharing Time Frame: After the end of study for one year.
• IPD Sharing Access Criteria: The data will be available upon a reasonable request from the corresponding author.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No