Fertility After Transvaginal Surgery or Uterine Artery Embolization Combined With Uterine Curettage in Patients With Cesarean Scar Pregnancy

October 12, 2016 updated by: Shanghai First Maternity and Infant Hospital
To investigate the fertility in patients after treatment by transvaginal surgery or uterine artery embolization combined with uterine curettage

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 201204
        • Department of Gynecology, Shanghai First Maternity and Infant Hospital, affiliated to Tongji University

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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(24). 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.

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: Single Group Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: CSP；transvaginal surgery；UAE and D&C
Cesarean scar pregnancy (CSP) refers to the implantation of a gestational sac with the myometrium at the site of a previous cesarean scar
Procedure: transvaginal surgery；UAE and D&C
For cesarean scar pregnancy treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Duration of menstruation by questionnaire (days)
Time Frame: six months after treatment
six months after treatment
Endocrine level by blood examination (FSH in IU/L)
Time Frame: six months after treatment
six months after treatment
Volume of menstruation by questionnaire (in pictorial blood loss score)
Time Frame: six months after treatment
six months after treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
The length of the CSD by MRI (millimeter)
Time Frame: six months after treatment
six months after treatment
The width of the CSD by MRI (millimeter)
Time Frame: six months after treatment
six months after treatment
The depth of the CSD by MRI (millimeter)
Time Frame: six months after treatment
six months after treatment

Collaborators and Investigators

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

Sponsor

Shanghai First Maternity and Infant Hospital

Investigators

  • Study Chair: Xipeng Wang, Department of Gynecology, Shanghai First Maternity and Infant Hospital, affiliated to Tongji University

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

November 1, 2016

Primary Completion (Anticipated)

August 1, 2018

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

August 9, 2016

First Submitted That Met QC Criteria

October 12, 2016

First Posted (Estimate)

October 14, 2016

Study Record Updates

Last Update Posted (Estimate)

October 14, 2016

Last Update Submitted That Met QC Criteria

October 12, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • ShanghaiFMIH-CSP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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