Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Adjuvant Therapy for Intrauterine Adhesions Between Two Groups

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02867202
Recruitment Status : Completed
First Posted : August 15, 2016
Results First Posted : January 2, 2020
Last Update Posted : January 2, 2020
Sponsor:
Information provided by (Responsible Party):
Feng Lin, Wenzhou Medical University

Tracking Information
First Submitted Date  ICMJE April 11, 2016
First Posted Date  ICMJE August 15, 2016
Results First Submitted Date  ICMJE December 27, 2017
Results First Posted Date  ICMJE January 2, 2020
Last Update Posted Date January 2, 2020
Study Start Date  ICMJE June 2015
Actual Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 15, 2019)
the AFS Score at Second-look Hysteroscopy [ Time Frame: 2 or 3 months after the surgery ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: August 10, 2016)
The change of AFS score (The American Fertility Society classifications)in two menstrual cycles [ Time Frame: baseline and two months ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Adjuvant Therapy for Intrauterine Adhesions Between Two Groups
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Asherman Syndrome
Intervention  ICMJE
  • Device: Intrauterine balloon
    After the completion of hysteroscopic adhesiolysis, intrauterine balloon was inserted and inflated with 3-5 mL normal saline which was removed after 1 week.
    Other Name: Cook balloon
  • Device: Intrauterine Contraceptive Device Plus Foley Catheter
    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.
    Other Name: Intrauterine Device Plus Foley Catheter
Study Arms  ICMJE
  • Experimental: Intrauterine balloon
    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.
    Intervention: Device: Intrauterine balloon
  • Experimental: intrauterine device Plus Foley Catheter
    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: Device: Intrauterine Contraceptive Device Plus Foley Catheter
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 15, 2019)
171
Original Estimated Enrollment  ICMJE
 (submitted: August 10, 2016)
200
Actual Study Completion Date  ICMJE December 2017
Actual Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02867202
Other Study ID Numbers  ICMJE Wenzhou MC
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Feng Lin, Wenzhou Medical University
Study Sponsor  ICMJE Wenzhou Medical University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Feng Lin, MD the 1st Affiliated Hospital of Wenzhou Medical University
PRS Account Wenzhou Medical University
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP