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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03330873
Recruitment Status : Unknown
Verified October 2017 by Beijing Obstetrics and Gynecology Hospital.
Recruitment status was:  Recruiting
First Posted : November 6, 2017
Last Update Posted : November 6, 2017
Sponsor:
Information provided by (Responsible Party):
Beijing Obstetrics and Gynecology Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Intrauterine Adhesion Device: disposable balloon uterine stent Device: Foley catheter Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
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
Actual Study Start Date : October 23, 2017
Estimated Primary Completion Date : August 20, 2018
Estimated Study Completion Date : October 20, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Adhesions

Arms and Interventions
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Arm Intervention/treatment
Experimental: Foley catheter
After the completion of hysteroscopic adhesiolysis, Foley catheter was inserted and inflated with normal saline which was removed on the 7th day after surgery.
 Device: Foley catheter
Foley catheter can partly separate the sides of uterus wall.
Experimental: Disposable balloon uterine stent
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.
 Device: disposable balloon uterine stent
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


Outcome Measures
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Primary Outcome Measures :
  1. second diagnostic hysteroscopy [ Time Frame: Within the first 3 months after surgery ]
    AFS score（The American Fertility Society classifications）


Secondary Outcome Measures :
  1. Menstruation Pattern [ Time Frame: Within the first 3 months after surgery ]
    Improvement or No Significant Change

  2. Number of participants with pregnancy [ Time Frame: one year ]
    Number of biochemical pregnancies and clinical pregnancies


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03330873


Contacts
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Contact: Zhu Ru, MD +8613966636438 zhuru19790202@163.com
Contact: Wang Sha, MD +8615201556908 wangsha1020@163.com

Locations
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China, Beijing
Beijing Obstetrics and Gynecology Hospital，Capital Medical University Recruiting
Beijing, Beijing, China, 100006
Contact: Liu Zhen    +8613718210767    fcyykyb@163.com   
Sponsors and Collaborators
Beijing Obstetrics and Gynecology Hospital
Investigators
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Study Chair: Duan Hua, PhD Beijing Obstetrics and Gynecology Hospital
More Information
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Responsible Party: Beijing Obstetrics and Gynecology Hospital
ClinicalTrials.gov Identifier: NCT03330873    
Other Study ID Numbers: No.3-20140601
First Posted: November 6, 2017    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Beijing Obstetrics and Gynecology Hospital:
Asherman syndrome
disposable balloon uterine stent
hysteroscopy
Foley catheter
Additional relevant MeSH terms:
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Tissue Adhesions
Cicatrix
Fibrosis
Pathologic Processes