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

Primary Purpose

Cesarean Scar Pregnancy, Menstruation

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Methotrexate Combined With Transvaginal Surgery
Sponsored by
Shanghai First Maternity and Infant Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cesarean Scar Pregnancy focused on measuring Cesarean Scar Pregnancy

Eligibility Criteria

20 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

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

Outcomes

Primary Outcome Measures

Duration of menstruation by questionnaire
Duration of menstruation
Endocrine level by blood examination
FSH in IU/L
Volume of menstruation by questionnaire
in pictorial blood loss score

Secondary Outcome Measures

The length of the CSD by MRI
millimeter
The depth of the CSD by MRI
millimeter

Full Information

First Posted
March 12, 2017
Last Updated
July 12, 2017
Sponsor
Shanghai First Maternity and Infant Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03218059
Brief Title
Outcome After MTX & Transvaginal Surgery or UAE & Uterine Curettage in Patients With Cesarean Scar Pregnancy
Official Title
Outcome After MTX & Transvaginal Surgery or UAE & Uterine Curettage in Patients With Cesarean Scar Pregnancy
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Unknown status
Study Start Date
July 15, 2017 (Anticipated)
Primary Completion Date
June 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai First Maternity and Infant Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cesarean Scar Pregnancy, Menstruation
Keywords
Cesarean Scar Pregnancy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Methotrexate Combined With Transvaginal Surgery
Other Intervention Name(s)
Uterine Artery Embolization Combined With Uterine Curettage
Intervention Description
The methods of treatment of CSP
Primary Outcome Measure Information:
Title
Duration of menstruation by questionnaire
Description
Duration of menstruation
Time Frame
six months after treatment
Title
Endocrine level by blood examination
Description
FSH in IU/L
Time Frame
six months after treatment
Title
Volume of menstruation by questionnaire
Description
in pictorial blood loss score
Time Frame
six months after treatment
Secondary Outcome Measure Information:
Title
The length of the CSD by MRI
Description
millimeter
Time Frame
six months after treatment
Title
The depth of the CSD by MRI
Description
millimeter
Time Frame
six months after treatment

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xipeng Wang
Phone
0086-13817806602
Email
xipengwang@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Huihui Chen
Phone
0086-13916278505
Email
huihui78505@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xipeng Wang
Organizational Affiliation
Department of Gynecology, Shanghai First Maternity and Infant Hospital, affiliated to Tongji University
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Gynecology, Shanghai First Maternity and Infant Hospital, affiliated to Tongji University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
201204
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xipeng Wang
Phone
0086-13817806602
Email
xipengwang@hotmail.com

12. IPD Sharing Statement

Learn more about this trial

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

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