The Efficacy and Safety of Disposable Balloon Uterine Stent in Patients With Asherman Syndrome
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|ClinicalTrials.gov Identifier: NCT03330873|
Recruitment Status : Unknown
Verified October 2017 by Beijing Obstetrics and Gynecology Hospital.
Recruitment status was: Recruiting
First Posted : November 6, 2017
Last Update Posted : November 6, 2017
|Condition or disease||Intervention/treatment||Phase|
|Intrauterine Adhesion||Device: disposable balloon uterine stent Device: Foley catheter||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Randomized, Controlled Trial to Assess the Efficacy of Disposable Balloon Uterine Stent and Foley Catheter in the Prevention of Adhesion Reformation After Hysteroscopic Adhesiolysis|
|Actual Study Start Date :||October 23, 2017|
|Estimated Primary Completion Date :||August 20, 2018|
|Estimated Study Completion Date :||October 20, 2018|
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
- second diagnostic hysteroscopy [ Time Frame: Within the first 3 months after surgery ]AFS score（The American Fertility Society classifications）
- Menstruation Pattern [ Time Frame: Within the first 3 months after surgery ]Improvement or No Significant Change
- Number of participants with pregnancy [ Time Frame: one year ]Number of biochemical pregnancies and clinical pregnancies
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03330873
|Contact: Zhu Ru, MDfirstname.lastname@example.org|
|Contact: Wang Sha, MDemail@example.com|
|Beijing Obstetrics and Gynecology Hospital，Capital Medical University||Recruiting|
|Beijing, Beijing, China, 100006|
|Contact: Liu Zhen +8613718210767 firstname.lastname@example.org|
|Study Chair:||Duan Hua, PhD||Beijing Obstetrics and Gynecology Hospital|