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

NCT03218059 | Unknown

• 1 other identifier: ShanghaiFMIH-CSP Treatment
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Keywords

Cesarean Scar Pregnancy

Outcome Measures

Primary Outcomes (3)

• Duration of menstruation by questionnaire

  Duration of menstruation

  six months after treatment

• Endocrine level by blood examination

  FSH in IU/L

  six months after treatment

• Volume of menstruation by questionnaire

  in pictorial blood loss score

  six months after treatment

Secondary Outcomes (2)

• The length of the CSD by MRI

  six months after treatment

• The depth of the CSD by MRI

  six months after treatment

Interventions

Methotrexate Combined With Transvaginal Surgery PROCEDURE

The methods of treatment of CSP

Also known as: Uterine Artery Embolization Combined With Uterine Curettage

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai First Maternity and Infant Hospital: lead

Study Sites (1)

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

Shanghai, Shanghai Municipality, 201204, China

Location

Study Officials

• Xipeng Wang

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

  STUDY CHAIR

Central Study Contacts

Xipeng Wang

CONTACT

0086-13817806602; xipengwang@hotmail.com

Huihui Chen

CONTACT

0086-13916278505; huihui78505@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2017
• First Posted: July 14, 2017
• Study Start: July 15, 2017
• Primary Completion: June 1, 2018
• Study Completion: December 1, 2018
• Last Updated: July 14, 2017

Record last verified: 2017-01

Locations

CN (1)