Clinical Trials Logo

Clinical Trial Summary

To use Cook balloon uterine stent to prevent intrauterine adhesion (IUA), and to see if leaving it in the uterus will cause uterine infection.


Clinical Trial Description

Background:Intrauterine adhesion (IUA) can cause infertility. Hysteroscopic surgery can effectively treat most IUA. In order to prevent adhesion reformation after surgery, most gynecologists will prescribe high-dose estrogen to stimulate endometrial growth, and leave an IUD or a Foley catheter in uterus for 1-3 months. But neither IUD nor Foley catheter conform to the uterine cavity. The Cook balloon uterine stent was designed to fit into the uterine cavity. But it was designed to tamponade the uterus to prevent post-operative uterine bleeding. It's not known if it can be left in the uterus for 30 days.

Study Design:Uterine culture was done before hysteroscopic surgery, and 30 days later. The study group comprise patients with uterine stent; the control group comprise patients who undergo hysteroscopic surgeries but without uterine stent.

Method:Immediately before hysteroscopic surgery, a culture tip is inserted into the uterine cavity and sent for culture. Another culture was done 30 days later, and a second-look hysteroscope is done to evaluate the healing of uterine cavity. The removed uterine stent was sent for bacterial culture too. The same procedures are done for patients with and without uterine stent. The bacterial counts will be compared before and after hysterosocpic surgeries, and between the two groups of patients.

Effect:If leaving the uterine stent in the uterus up to 30 days does not cause bacteria to grow, we can be confident to leave the stent for 30 days. ;


Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01167296
Study type Interventional
Source Shin Kong Wu Ho-Su Memorial Hospital
Contact
Status Completed
Phase Phase 4
Start date July 2010
Completion date December 2011

See also
  Status Clinical Trial Phase
Recruiting NCT04972032 - Efficacy of Estrogen-intrauterine Stent System After Intrauterine Adhesiolysis N/A
Recruiting NCT03381807 - Human Amniotic Epithelial Stem Cell in Treatment of Refractory Severe Intrauterine Adhesion Early Phase 1
Recruiting NCT03329898 - Comparing the Efficacy of Two Methods for the Therapy of Uterine Adhesion N/A
Completed NCT03724617 - Clinical Study of Umbilical Cord Mesenchymal Stem Cells Combined With Collagen Scaffold in the Treatment of Thin Endometrium N/A
Recruiting NCT03330873 - The Efficacy and Safety of Disposable Balloon Uterine Stent in Patients With Asherman Syndrome N/A
Completed NCT02220621 - Efficacy and Safety of Crosslinked Hyaluronan Gel for Preventing Intrauterine Adhesion N/A
Active, not recruiting NCT04963179 - PREvention of Intrauterine Adhesion After Adhesiolysis With Novel Tri-block deGradable Polymer Film. N/A
Recruiting NCT03351205 - The Efficacy of Estrogen Therapy Against Adhesion Reformation After Hysteroscopic Adhesiolysis N/A
Completed NCT04381728 - PREvention of Intrauterine Adhesion After Hysteroscopic Surgery With Novel deGradable Film N/A
Recruiting NCT03346317 - Comparing the Efficacy of Two Methods in the Prevention of Adhesion Reformation After Hysteroscopic Adhesiolysis N/A
Completed NCT05414760 - Evaluate Formation of IUAs After Third-generation Endometrial Ablation, With and Without Intrauterine Adhesion Barrier N/A
Completed NCT04166500 - Early Outpatient Hysteroscopy Can Prevent Intrauterine Adhesion After Induced Abortion N/A
Recruiting NCT03171454 - Immediate and Delayed Intrauterine Balloon in the Prevention of Adhesion Reformation After Hysteroscopic Adhesiolysis N/A
Recruiting NCT03169478 - Intrauterine Balloon Dilatation Therapy in the Prevention of Adhesion Formation After Hysteroscopic Myomectomy N/A
Recruiting NCT05003869 - Clinical and Basic Research on the Necessity of Scar Tissue Resection During Intrauterine Adhesions N/A
Completed NCT02744716 - Effects of Aspirin on Uterine Endometrial Repair Severe Intrauterine Adhesion N/A
Completed NCT03131596 - Postoperative Intermittent Intrauterine Balloon Dilatation Therapy. N/A
Completed NCT04824430 - Assessment of Uterine Access, Uterine Patency and Intrauterine Adhesions Following Endometrial Ablation
Completed NCT03578172 - HMG Stimulation Versus HRT for Endometrial Preparation Prior to Blastocyst Transfer in Moderate to Severe IUA Patients N/A
Recruiting NCT04930913 - Three-dimensional Ultrasound Applying in Assessment of Intrauterine Adhesions