Surgical Evacuation Versus Methotrexate Injection in Treatment of Caesarean Scar Pregnancy [Clinical Trial ]

December 15, 2025 updated by: Badr Atef Abd Allah Moussa, Minia University

Ultrasound Guided Surgical Evacuation Versus Combined Local and Systemic Methotrexate Injection for Management of Caesarean Scar Pregnancy [Clinical Trial ]

The aim of the study is to compare the effectiveness and the complications of Ultrasound guided surgical evacuation versus using combined local and systemic methotrexate injection for management of caesarean scar pregnancy.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

42

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Gestation age Less than 12 weeks. Hemodynamically stable patient with un ruptured CSP. Non disturbed scar pregnancy . Acceptance of possible prolonged follow up, repeated HCG tests, the need for additional treatment doses and possible bleeding and subsequent hysterectomy.

-

Exclusion Criteria:

  • Patient refuse TOP. Gestation age More than 12 weeks . Hemodynamically unstable patient with ruptured CSP. Contraindication for methotrexate as hepatic disorders, renal disorders ,hypersensitivity to the drug and autoimmune diseases.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ultrasound surgical evacuation
Procedure: Surgical evacuation and methotrexate injection
Surgical evacuation of the scar pregnancy using ultrasound and local and systemic methotrexate injection
Active Comparator: Local and systemic methotrexate injection
Procedure: Surgical evacuation and methotrexate injection
Surgical evacuation of the scar pregnancy using ultrasound and local and systemic methotrexate injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Success rate of treatment either by surgical evacuation or by methotrexate injection
Time Frame: Up to 8 weeks post -intervention
The proportion of participants achieving complete resolution of caesarean scar pregnancy without the need of additional intervention
Up to 8 weeks post -intervention

Secondary Outcome Measures

Outcome Measure
Time Frame
Bleeding during the procedure
Time Frame: Up to 8 weeks post -intervention
Up to 8 weeks post -intervention
The need for additional intervention
Time Frame: Up to 8 weeks post -intervention
Up to 8 weeks post -intervention
Time for serum-hCG normalisation (days).
Time Frame: Up to 8 weeks post -intervention
Up to 8 weeks post -intervention
Hospital stay (days).
Time Frame: Up to 8 weeks post -intervention
Up to 8 weeks post -intervention
Uterine perforation.
Time Frame: Up to 8 weeks post -intervention
Up to 8 weeks post -intervention
Occurrence of drug complications
Time Frame: Up to 8 weeks post -intervention
Up to 8 weeks post -intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Minia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 20, 2026

Primary Completion (Estimated)

January 20, 2027

Study Completion (Estimated)

February 1, 2027

Study Registration Dates

First Submitted

December 15, 2025

First Submitted That Met QC Criteria

December 15, 2025

First Posted (Actual)

December 17, 2025

Study Record Updates

Last Update Posted (Actual)

December 17, 2025

Last Update Submitted That Met QC Criteria

December 15, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSP-MTX-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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