The Efficacy and Safety of Disposable Balloon Uterine Stent in Patients With Asherman Syndrome
Randomized, Controlled Trial to Assess the Efficacy of Disposable Balloon Uterine Stent and Foley Catheter in the Prevention of Adhesion Reformation After Hysteroscopic Adhesiolysis
1 other identifier
interventional
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 18, 2017
CompletedStudy Start
First participant enrolled
October 23, 2017
CompletedFirst Posted
Study publicly available on registry
November 6, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 20, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
October 20, 2018
CompletedNovember 6, 2017
October 1, 2017
10 months
October 18, 2017
October 31, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
second diagnostic hysteroscopy
AFS score（The American Fertility Society classifications）
Within the first 3 months after surgery
Secondary Outcomes (2)
Menstruation Pattern
Within the first 3 months after surgery
Number of participants with pregnancy
one year
Study Arms (2)
Foley catheter
EXPERIMENTALAfter the completion of hysteroscopic adhesiolysis, Foley catheter was inserted and inflated with normal saline which was removed on the 7th day after surgery.
Disposable balloon uterine stent
EXPERIMENTALAfter 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.
Interventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- ovarian failure
- patients who did not proceed to second-look hysteroscopy within the specified time frame
- Contraindication of hormone
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Beijing Obstetrics and Gynecology Hospital，Capital Medical University
Beijing, Beijing Municipality, 100006, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Duan Hua, PhD
Beijing Obstetrics and Gynecology Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 18, 2017
First Posted
November 6, 2017
Study Start
October 23, 2017
Primary Completion
August 20, 2018
Study Completion
October 20, 2018
Last Updated
November 6, 2017
Record last verified: 2017-10
Data Sharing
- IPD Sharing
- Will not share