Methotrexate Treatment in Cases of Ectopic Pregnancy With Relative Contraindications

NCT07186127 | Recruiting

• 1 other identifier: 2025/05/01/044
• Study Type: observational
• Target: 230
• Locations: 1 country
• Sites: 1

Brief Summary

Study Description (For Patients, Families, and Healthcare Providers) Purpose: The aim of this study is to evaluate the effectiveness and safety of methotrexate treatment in women with ectopic pregnancy who belong to a group for whom this treatment is relatively contraindicated. Background: Methotrexate is a medication commonly used in the treatment of ectopic pregnancy (a pregnancy that occurs outside the uterus, usually in the fallopian tube). However, in certain conditions - such as kidney or liver dysfunction - methotrexate use may carry increased risks. These situations are known as relative contraindications. This study will retrospectively examine treatment outcomes in this specific patient population. Method: The study will analyze medical records of patients who were previously treated with methotrexate for ectopic pregnancy. No new interventions will be performed. The analysis will be based solely on existing clinical data. Why Is This Important? The findings of this study may help us better understand the safety limits of methotrexate therapy and guide healthcare providers in managing similar cases in the future.

Conditions

Ectopic Pregnancy

Keywords

Ectopic Pregnancy; Relative Contraindication; Methotrexate; Laparoscopic surgery

Outcome Measures

Primary Outcomes (1)

• Change in serum β-hCG levels (IU/L)

  Serum beta-human chorionic gonadotropin levels measured via blood test on days 0, 4, and 7 of methotrexate treatment.

  Days 0, 4, and 7 after methotrexate administration

Secondary Outcomes (2)

• Hospital stay duration (days)

  The duration from treatment initiation to discharge for each patient.

• endometrial thickness (mm), ectopic focus size (mm), and douglas pouch fluid (mm)

  DAY 1

Study Arms (1)

group 1 and group 2

Group 1 with indication for MTX treatment and group 2 with relative indication for MTX treatment

Drug: Drug: Methotrexate (MTX) Patients received methotrexate treatment according to institutional protocols. Dosage and administration routes were recorded retrospectively. For patients who did not respond

Interventions

Drug: Methotrexate (MTX) Patients received methotrexate treatment according to institutional protocols. Dosage and administration routes were recorded retrospectively. For patients who did not respond DRUG

MTX medical treatment Laparoscopic salpingectomy Laparoscopic salpingostomy

Also known as: surgical treatment

group 1 and group 2

Eligibility Criteria

• Age: 18 Years - 48 Years
• Gender Eligibility Details: This study includes only pregnant women.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with ectopic pregnancy and treated with methotrexate

You may qualify if:

• Diagnosed with ectopic pregnancy
• Received methotrexate (MTX) treatment
• Underwent surgical treatment due to lack of response to MTX therapy
• Compliant with treatment follow-up

You may not qualify if:

• Participants with contraindications to methotrexate (MTX) treatment
• Participants non-compliant with follow-up

Sponsors & Collaborators

• Bagcilar Training and Research Hospital: lead

Study Sites (1)

University of Health Sciences, Training and Research Hospital

Istanbul, Türkiye, 34200, Turkey (Türkiye)

RECRUITING

Related Publications (1)

• Cohen A, Bar-On S, Cohen Y, Sandel O, Fouks Y, Michaan N, Tzur T, Levin I. Ruptured ectopic pregnancies following methotrexate treatment: clinical course and predictors for improving patient counseling. Reprod Sci. 2022 Apr;29(4):1209-1214. doi: 10.1007/s43032-022-00881-7. Epub 2022 Feb 14.

  PMID: 35157263 RESULT

MeSH Terms

Conditions

Pregnancy, Ectopic

Interventions

Methotrexate; Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• gülhan özüm, md

  Sağlık Bilimleri Üniversitesi, Bağcılar Eğitim ve Araştırma Hastanesi

  PRINCIPAL INVESTIGATOR

Central Study Contacts

gülhan özüm, md

CONTACT

+905355784928; gulhanozum86@gmail.com

gülhan özüm

CONTACT

05355784928; gulhanozum86@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2025
• First Posted: September 22, 2025
• Study Start: May 1, 2025
• Primary Completion: September 30, 2025
• Study Completion: May 1, 2026
• Last Updated: September 22, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: 01.05.2025-01.05.2026
• Access Criteria: Individual participant data (IPD) will be shared upon reasonable request after publication, following institutional and ethical guidelines. They can be accessed by contacting the principal investigator.

Locations

TU (1)