Outcome After MTX & Transvaginal Surgery or UAE & Uterine Curettage in Patients With Cesarean Scar Pregnancy

NCT ID: NCT03218059

Last Updated: 2017-07-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-15
• Study Completion Date: 2018-12-31

Brief Summary

Cesarean scar pregnancy (CSP)is one of the more serious complications of pregnancies that occur after a prior cesarean delivery. No clinical guidelines have been issued for the management of CSP. More than 30 treatment methods are reported to be used in managing CSP. However, which management can achieve better clinical effects remains unknown. Therefore, this prospective study is designed to compare the outcome between MTX + transvaginal surgery and UAE + D&C in the treatment of CSP.

Conditions

Cesarean Scar Pregnancy; Menstruation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Methotrexate Combined With Transvaginal Surgery

The methods of treatment of CSP

Intervention Type: PROCEDURE

Other Intervention Names

Uterine Artery Embolization Combined With Uterine Curettage

Eligibility Criteria

Inclusion Criteria

Increased levels of serum β-hCG and ultrasonography findings. The criteria for diagnosis by ultrasonography was the presence of the following: (1) an empty uterine cavity and endocervical canal; (2) detection of the placenta and/or a gestational sac embedded in the hysterectomy scar; (3) the presence of the gestation sac with or without a fetal pole and with or without fetal cardiac activity (depending on the gestational age) in the anterior part of the uterine isthmus; and (4) a thin (1-3 mm) or absent myometrial layer between the gestational sac and the bladder. All patients had taken Magnetic Resonance Imaging (MRI) to clarify the diagnosis . Pregnancy tissues were identified by histopathology examinations of the surgical tissues.

Exclusion Criteria

All enrolled patients had no contraindications for transvaginal surgery or UAE, including renal failure, active pelvic infection, clotting disorders, or known allergy to the contrast material.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Shanghai First Maternity and Infant Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xipeng Wang

Role: STUDY_CHAIR

Department of Gynecology, Shanghai First Maternity and Infant Hospital, affiliated to Tongji University

Locations

Department of Gynecology, Shanghai First Maternity and Infant Hospital, affiliated to Tongji University

Shanghai, Shanghai Municipality, China

Countries

China

Central Contacts

Xipeng Wang

Role: CONTACT

xipengwang@hotmail.com

0086-13817806602

Huihui Chen

Role: CONTACT

huihui78505@hotmail.com

0086-13916278505

Facility Contacts

Xipeng Wang

Role: primary

xipengwang@hotmail.com

0086-13817806602

Other Identifiers

ShanghaiFMIH-CSP Treatment

Identifier Type: -

Identifier Source: org_study_id