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

October 31, 2017 updated by: Beijing Obstetrics and Gynecology Hospital

Randomized, Controlled Trial to Assess the Efficacy of Disposable Balloon Uterine Stent and Foley Catheter in the Prevention of Adhesion Reformation After Hysteroscopic Adhesiolysis

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

80

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 Contact

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100006
        • Recruiting
        • Beijing Obstetrics and Gynecology Hospital,Capital Medical University
        • Contact:

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

18 years to 38 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
second diagnostic hysteroscopy
Time Frame: Within the first 3 months after surgery
AFS score（The American Fertility Society classifications）
Within the first 3 months after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Menstruation Pattern
Time Frame: Within the first 3 months after surgery
Improvement or No Significant Change
Within the first 3 months after surgery
Number of participants with pregnancy
Time Frame: one year
Number of biochemical pregnancies and clinical pregnancies
one year

Collaborators and Investigators

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

Sponsor

Beijing Obstetrics and Gynecology Hospital

Investigators

  • Study Chair: Duan Hua, PhD, Beijing Obstetrics and Gynecology Hospital

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 (Actual)

October 23, 2017

Primary Completion (Anticipated)

August 20, 2018

Study Completion (Anticipated)

October 20, 2018

Study Registration Dates

First Submitted

October 18, 2017

First Submitted That Met QC Criteria

October 31, 2017

First Posted (Actual)

November 6, 2017

Study Record Updates

Last Update Posted (Actual)

November 6, 2017

Last Update Submitted That Met QC Criteria

October 31, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • No.3-20140601

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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