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Adjuvant Therapy for Intrauterine Adhesions Between Two Groups

Primary Purpose

Asherman Syndrome

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Intrauterine balloon
Intrauterine Contraceptive Device Plus Foley Catheter
Sponsored by
Wenzhou Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asherman Syndrome focused on measuring intrauterine balloon, Intrauterine Device Plus Foley Balloon Catheter, Asherman Syndrome

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Moderate to severe intrauterine adhesion (AFS score ≥5）
  • Agreement to have a second-look hysteroscopy
  • no previous history of hysteroscopic adhesiolysis

Exclusion Criteria:

  • Minimal adhesion (AFS score<5)
  • Previous hysteroscopic adhesiolysis

Sites / Locations

  • the 1st Affiliated Hospital of Wenzhou Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Intrauterine balloon

intrauterine device Plus Foley Catheter

Arm Description

The heart-shaped intrauterine balloon is designed to fit into the cavity of the uterus,and removed on the 7th day after surgery. And hysteroscopy was taken out again after two or three months to re-evaluate the uterine adhesions.

Intrauterine Contraceptive Device Plus Foley Catheter are inserted into the uterine after hysteroscopic adhesiolysis. Foley Catheter is removed after three days while intrauterine device is removed at the second hysteroscopy. Uterine adhesions are judged again at the second hysteroscopy.

Outcomes

Primary Outcome Measures

the AFS Score at Second-look Hysteroscopy
The AFS score is based on the American Fertility Society (AFS) Classification of Intra-uterine adhesions( 1988 version)The total range of AFS score is from 0 to 12, and the higher the score is, the worse the outcome is.

Secondary Outcome Measures

Full Information

First Posted
April 11, 2016
Last Updated
December 15, 2019
Sponsor
Wenzhou Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT02867202
Brief Title
Adjuvant Therapy for Intrauterine Adhesions Between Two Groups
Official Title
A Randomized Clinical Trial to Assess the Efficacy of Intrauterine Balloon Compared to Intrauterine Contraceptive Device Plus Foley Catheter in the Therapy for Uterine Adhesion After Hysteroscopic Adhesiolysis
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
June 2015 (undefined)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wenzhou Medical University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study was taken out to compare two mechanical devices (intrauterine balloon and Intrauterine Contraceptive Device Plus Foley Catheter) in the therapy for intrauterine adhesions after hysteroscopic adhesiolysis. Participates were assigned into two groups by randomly.
Detailed Description
Intrauterine balloon and Intrauterine Contraceptive Device Plus Foley Catheter are both effective in the therapy for intrauterine adhesion. The Intrauterine Contraceptive Device Plus Foley Catheter are usually inserted into the uterine after hysteroscopic adhesiolysis. Foley Catheter is removed after three days while intrauterine device is removed two or three month later. The heart-shaped intrauterine balloon is designed to fit into the cavity of the uterus, and usually removed on the 7th day after surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asherman Syndrome
Keywords
intrauterine balloon, Intrauterine Device Plus Foley Balloon Catheter, Asherman Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
171 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intrauterine balloon
Arm Type
Experimental
Arm Description
The heart-shaped intrauterine balloon is designed to fit into the cavity of the uterus,and removed on the 7th day after surgery. And hysteroscopy was taken out again after two or three months to re-evaluate the uterine adhesions.
Arm Title
intrauterine device Plus Foley Catheter
Arm Type
Experimental
Arm Description
Intrauterine Contraceptive Device Plus Foley Catheter are inserted into the uterine after hysteroscopic adhesiolysis. Foley Catheter is removed after three days while intrauterine device is removed at the second hysteroscopy. Uterine adhesions are judged again at the second hysteroscopy.
Intervention Type
Device
Intervention Name(s)
Intrauterine balloon
Other Intervention Name(s)
Cook balloon
Intervention Description
After the completion of hysteroscopic adhesiolysis, intrauterine balloon was inserted and inflated with 3-5 mL normal saline which was removed after 1 week.
Intervention Type
Device
Intervention Name(s)
Intrauterine Contraceptive Device Plus Foley Catheter
Other Intervention Name(s)
Intrauterine Device Plus Foley Catheter
Intervention Description
After the completion of hysteroscopic adhesiolysis, Intrauterine Contraceptive Device Plus Foley Catheter were inserted into the uterine cavity. Foley Catheter was removed after three days and Intrauterine Device was removed at the second time of hysteroscopy.
Primary Outcome Measure Information:
Title
the AFS Score at Second-look Hysteroscopy
Description
The AFS score is based on the American Fertility Society (AFS) Classification of Intra-uterine adhesions( 1988 version)The total range of AFS score is from 0 to 12, and the higher the score is, the worse the outcome is.
Time Frame
2 or 3 months after the surgery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Moderate to severe intrauterine adhesion (AFS score ≥5） Agreement to have a second-look hysteroscopy no previous history of hysteroscopic adhesiolysis Exclusion Criteria: Minimal adhesion (AFS score<5) Previous hysteroscopic adhesiolysis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Feng Lin, MD
Organizational Affiliation
the 1st Affiliated Hospital of Wenzhou Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
the 1st Affiliated Hospital of Wenzhou Medical University
City
Wenzhou
State/Province
Zhejiang
ZIP/Postal Code
325000
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25936237
Citation
Lin XN, Zhou F, Wei ML, Yang Y, Li Y, Li TC, Zhang SY. Randomized, controlled trial comparing the efficacy of intrauterine balloon and intrauterine contraceptive device in the prevention of adhesion reformation after hysteroscopic adhesiolysis. Fertil Steril. 2015 Jul;104(1):235-40. doi: 10.1016/j.fertnstert.2015.04.008. Epub 2015 Apr 30.
Results Reference
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PubMed Identifier
23933351
Citation
Johary J, Xue M, Zhu X, Xu D, Velu PP. Efficacy of estrogen therapy in patients with intrauterine adhesions: systematic review. J Minim Invasive Gynecol. 2014 Jan-Feb;21(1):44-54. doi: 10.1016/j.jmig.2013.07.018. Epub 2013 Aug 9.
Results Reference
background
PubMed Identifier
23932377
Citation
Lin X, Wei M, Li TC, Huang Q, Huang D, Zhou F, Zhang S. A comparison of intrauterine balloon, intrauterine contraceptive device and hyaluronic acid gel in the prevention of adhesion reformation following hysteroscopic surgery for Asherman syndrome: a cohort study. Eur J Obstet Gynecol Reprod Biol. 2013 Oct;170(2):512-6. doi: 10.1016/j.ejogrb.2013.07.018. Epub 2013 Aug 7.
Results Reference
background

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Adjuvant Therapy for Intrauterine Adhesions Between Two Groups

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