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The Efficacy and Safety of Disposable Balloon Uterine Stent in Patients With Asherman Syndrome

Primary Purpose

Intrauterine Adhesion

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
disposable balloon uterine stent
Foley catheter
Sponsored by
Beijing Obstetrics and Gynecology Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Intrauterine Adhesion focused on measuring Asherman syndrome, disposable balloon uterine stent, hysteroscopy, Foley catheter

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • age 20-40 years;
  • Moderate to severe intrauterine adhesion (AFS score ≥5）;
  • complains of menstruation disorder and reproductive dysfunction
  • Agreement to have second-look hysteroscopy
  • informed consent

Exclusion Criteria:

  • ovarian failure
  • patients who did not proceed to second-look hysteroscopy within the specified time frame
  • Contraindication of hormone

Sites / Locations

  • Beijing Obstetrics and Gynecology Hospital，Capital Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Foley catheter

Disposable balloon uterine stent

Arm Description

After the completion of hysteroscopic adhesiolysis, Foley catheter was inserted and inflated with normal saline which was removed on the 7th day after surgery.

After the completion of hysteroscopic adhesiolysis, disposable balloon uterine stent was inserted and inflated with normal saline which was removed on the 7th day after surgery.

Outcomes

Primary Outcome Measures

second diagnostic hysteroscopy
AFS score（The American Fertility Society classifications）

Secondary Outcome Measures

Menstruation Pattern
Improvement or No Significant Change
Number of participants with pregnancy
Number of biochemical pregnancies and clinical pregnancies

Full Information

First Posted
October 18, 2017
Last Updated
October 31, 2017
Sponsor
Beijing Obstetrics and Gynecology Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03330873
Brief Title
The Efficacy and Safety of Disposable Balloon Uterine Stent in Patients With Asherman Syndrome
Official Title
Randomized, Controlled Trial to Assess the Efficacy of Disposable Balloon Uterine Stent and Foley Catheter in the Prevention of Adhesion Reformation After Hysteroscopic Adhesiolysis
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Unknown status
Study Start Date
October 23, 2017 (Actual)
Primary Completion Date
August 20, 2018 (Anticipated)
Study Completion Date
October 20, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beijing Obstetrics and Gynecology Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Asherman's syndrome is characterized by the presence of intrauterine adhesions (IUA) as well as symptoms such as amenorrhea, hypomenorrhea, pelvic pain, and infertility. The gold standard for the treatment of intrauterine adhesions is hysteroscopic intrauterine adhesions. The recurrence of intrauterine adhesions is a major challenge in clinical practice. The isolation of barriers in the uterine cavity may be a measure to reduce postoperative re adhesion, but the effect of different devices is different. Therefore, this study was conducted.
Detailed Description
The Foley catheter is usually inserted into the uterine after a hysteroscopic adhesiolysis and removed after on the 5-7th day after surgery. Several investigators demonstrated its favorable effect in the recurrence of adhesion after the treatment of intrauterine adhesion. Disposable balloon uterine stent is specially designed to fit into the cavity of the uterus, and usually removed on the 7th day after surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intrauterine Adhesion
Keywords
Asherman syndrome, disposable balloon uterine stent, hysteroscopy, Foley catheter

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Foley catheter
Arm Type
Experimental
Arm Description
After the completion of hysteroscopic adhesiolysis, Foley catheter was inserted and inflated with normal saline which was removed on the 7th day after surgery.
Arm Title
Disposable balloon uterine stent
Arm Type
Experimental
Arm Description
After the completion of hysteroscopic adhesiolysis, disposable balloon uterine stent was inserted and inflated with normal saline which was removed on the 7th day after surgery.
Intervention Type
Device
Intervention Name(s)
disposable balloon uterine stent
Intervention Description
The disposable balloon uterine stent is heart-shaped that resembled the shape of the uterine cavity and could fully separate the two sides of the uterine wall and the corners of the uterus compare to Foley catheter
Intervention Type
Device
Intervention Name(s)
Foley catheter
Intervention Description
Foley catheter can partly separate the sides of uterus wall.
Primary Outcome Measure Information:
Title
second diagnostic hysteroscopy
Description
AFS score（The American Fertility Society classifications）
Time Frame
Within the first 3 months after surgery
Secondary Outcome Measure Information:
Title
Menstruation Pattern
Description
Improvement or No Significant Change
Time Frame
Within the first 3 months after surgery
Title
Number of participants with pregnancy
Description
Number of biochemical pregnancies and clinical pregnancies
Time Frame
one year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: age 20-40 years; Moderate to severe intrauterine adhesion (AFS score ≥5）; complains of menstruation disorder and reproductive dysfunction Agreement to have second-look hysteroscopy informed consent Exclusion Criteria: ovarian failure patients who did not proceed to second-look hysteroscopy within the specified time frame Contraindication of hormone
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhu Ru, MD
Phone
+8613966636438
Email
zhuru19790202@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Wang Sha, MD
Phone
+8615201556908
Email
wangsha1020@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Duan Hua, PhD
Organizational Affiliation
Beijing Obstetrics and Gynecology Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Beijing Obstetrics and Gynecology Hospital，Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100006
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liu Zhen
Phone
+8613718210767
Email
fcyykyb@163.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The Efficacy and Safety of Disposable Balloon Uterine Stent in Patients With Asherman Syndrome

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