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Safety of Leaving Cook Balloon Uterine Stent in Uterus for One Month

Primary Purpose

Intrauterine Adhesion

Status
Completed
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
Cook balloon uterine stent
Sponsored by
Shin Kong Wu Ho-Su Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intrauterine Adhesion focused on measuring Intrauterine adhesion, Cook balloon uterine stent

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • intrauterine adhesion women

Exclusion Criteria:

  • allergic to Cook balloon uterine stent

Sites / Locations

  • Department of Obstetrics and Gynecology, Shin-Kong Wu-Ho-Su Memerial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Cook balloon uterine stent

without Cook balloon uterine stent

Arm Description

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.removed uterine stent was sent for bacterial culture too.

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.

Outcomes

Primary Outcome Measures

intrauterine bacteria count

Secondary Outcome Measures

intrauterine adhesion

Full Information

First Posted
July 21, 2010
Last Updated
June 7, 2013
Sponsor
Shin Kong Wu Ho-Su Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01167296
Brief Title
Safety of Leaving Cook Balloon Uterine Stent in Uterus for One Month
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shin Kong Wu Ho-Su Memorial Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intrauterine Adhesion
Keywords
Intrauterine adhesion, Cook balloon uterine stent

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cook balloon uterine stent
Arm Type
Active Comparator
Arm Description
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.removed uterine stent was sent for bacterial culture too.
Arm Title
without Cook balloon uterine stent
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Cook balloon uterine stent
Intervention Description
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.
Primary Outcome Measure Information:
Title
intrauterine bacteria count
Time Frame
one year
Secondary Outcome Measure Information:
Title
intrauterine adhesion
Time Frame
one year

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: intrauterine adhesion women Exclusion Criteria: allergic to Cook balloon uterine stent
Facility Information:
Facility Name
Department of Obstetrics and Gynecology, Shin-Kong Wu-Ho-Su Memerial Hospital
City
Taipei
ZIP/Postal Code
111
Country
Taiwan

12. IPD Sharing Statement

Citations:
PubMed Identifier
25467040
Citation
Lin YH, Jang TN, Hwang JL, Huang LW, Seow KM, Hsieh BC, Huang CH. Bacterial colonization with balloon uterine stent placement in the uterus for 30 days: a randomized controlled clinical trial. Fertil Steril. 2015 Feb;103(2):513-8.e2. doi: 10.1016/j.fertnstert.2014.10.032. Epub 2014 Nov 20.
Results Reference
derived

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Safety of Leaving Cook Balloon Uterine Stent in Uterus for One Month

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