Local vs Systemic Methotrexate in Management of Uterine Ectopic Pregnancy

NCT06554470 | Recruiting

• 1 other identifier: 36264PR751/7/24
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Local; Systemic; Methotrexate; Uterine Ectopic Pregnancy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Success rate

  Post intervention for 3 months

• Time for uterine-mass disappearance

  Post intervention for 3 months

• Hospitalization time

  15 days after intervention

Study Arms (2)

Systemic Methotrexate

EXPERIMENTAL

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

Drug: Systemic Methotrexate

Local Methotrexate

EXPERIMENTAL

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

Drug: Local Methotrexate

Interventions

Systemic Methotrexate DRUG

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

Systemic Methotrexate

Local Methotrexate DRUG

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

Local Methotrexate

Eligibility Criteria

• Age: 20 Years - 40 Years
• Gender Eligibility Details: Women with uterine ectopic pregnancy
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, El-Gharbia, 31527, Egypt

RECRUITING

Central Study Contacts

Mai N Ageez, MD

CONTACT

00201062388870; mai.ageez@med.tanta.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Obstetrics and Gynecology, Faculty of Medicine, Tanta University, Tanta, Egypt.

Study Record Dates

• First Submitted: August 11, 2024
• First Posted: August 15, 2024
• Study Start: August 15, 2024
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: August 16, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)