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

M

Minia University

Status and phase

Not yet enrolling
Phase 2

Conditions

Caesarean Scar Pregnancy

Treatments

Procedure: Surgical evacuation and methotrexate injection

Study type

Interventional

Funder types

Other

Identifiers

NCT07288307
CSP-MTX-01

Details and patient eligibility

About

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.

Enrollment

42 estimated patients

Sex

Female

Ages

18 to 45 years old

Volunteers

No Healthy Volunteers

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.

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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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

42 participants in 2 patient groups

Ultrasound surgical evacuation
Experimental group
Treatment:
Procedure: Surgical evacuation and methotrexate injection
Local and systemic methotrexate injection
Active Comparator group
Treatment:
Procedure: Surgical evacuation and methotrexate injection

Trial contacts and locations

0

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Central trial contact

Badr Atef AbdAllah, MD

Data sourced from clinicaltrials.gov

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