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

NCT ID: NCT03330873

Last Updated: 2017-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-23

Study Completion Date

2018-10-20

Brief Summary

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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

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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.

Conditions

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Intrauterine Adhesion

Keywords

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Asherman syndrome disposable balloon uterine stent hysteroscopy Foley catheter

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Foley catheter

Intervention Type DEVICE

Foley catheter can partly separate the sides of uterus wall.

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.

Group Type EXPERIMENTAL

disposable balloon uterine stent

Intervention Type DEVICE

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

Interventions

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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

Intervention Type DEVICE

Foley catheter

Foley catheter can partly separate the sides of uterus wall.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Beijing Obstetrics and Gynecology Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Duan Hua, PhD

Role: STUDY_CHAIR

Beijing Obstetrics and Gynecology Hospital

Locations

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Beijing Obstetrics and Gynecology Hospital，Capital Medical University

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Zhu Ru, MD

Role: CONTACT

Phone: +8613966636438

Email: [email protected]

Wang Sha, MD

Role: CONTACT

Phone: +8615201556908

Email: [email protected]

Facility Contacts

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Liu Zhen

Role: primary

Other Identifiers

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No.3-20140601

Identifier Type: -

Identifier Source: org_study_id