Intrauterine Adhesion
Conditions
Keywords
Asherman syndrome, disposable balloon uterine stent, hysteroscopy, Foley catheter
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.
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
DEVICEFoley catheter
Foley catheter can partly separate the sides of uterus wall.
Sponsors
Beijing Obstetrics and Gynecology Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| second diagnostic hysteroscopy | Within the first 3 months after surgery | AFS score（The American Fertility Society classifications） |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Menstruation Pattern | Within the first 3 months after surgery | Improvement or No Significant Change |
| Number of participants with pregnancy | one year | Number of biochemical pregnancies and clinical pregnancies |
Countries
China
Contacts
Primary ContactZhu Ru, MD
Backup ContactWang Sha, MD
Outcome results
None listed