An interventional study of disposable balloon uterine stent and Foley catheter in Intrauterine Adhesion, sponsored by Beijing Obstetrics and Gynecology Hospital. Status unknown at 1 site in China. Open to female participants aged 20 Years to 40 Years. Per ClinicalTrials.gov, last updated 2017-11-06.
Sponsored by Beijing Obstetrics and Gynecology Hospital · Not applicable, Interventional, and Prevention
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.
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.
99 studies on the registry are indexed under Gynatresia; 23 are open to participants now.
This study's planned enrollment of 80 is below the median of 100 across 87 interventional studies indexed under Gynatresia.
Browse Gynatresia studies →Beijing Obstetrics and Gynecology Hospital is the lead sponsor of 8 studies on the registry; 2 are open to participants now.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
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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
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
Foley catheter can partly separate the sides of uterus wall.
second diagnostic hysteroscopy
AFS score（The American Fertility Society classifications）
Time frame: Within the first 3 months after surgery
Menstruation Pattern
Improvement or No Significant Change
Time frame: Within the first 3 months after surgery
Number of participants with pregnancy
Number of biochemical pregnancies and clinical pregnancies
Time frame: one year
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.
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Beijing Obstetrics and Gynecology Hospital