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Adjuvant Therapy for Intrauterine Adhesions Between Two Groups

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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Asherman Syndrome Device: Intrauterine balloon Device: Intrauterine Contraceptive Device Plus Foley Catheter Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 171 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : June 2015
Actual Primary Completion Date : December 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Adhesions

Arms and Interventions
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Arm Intervention/treatment
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.
 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
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.
 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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

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): NCT02867202


Locations
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China, Zhejiang
the 1st Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China, 325000
Sponsors and Collaborators
Wenzhou Medical University
Investigators
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Principal Investigator: Feng Lin, MD the 1st Affiliated Hospital of Wenzhou Medical University
  Study Documents (Full-Text)

Documents provided by Feng Lin, Wenzhou Medical University:
Statistical Analysis Plan  [PDF] December 1, 2017
Study Protocol  [PDF] December 1, 2017

More Information
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Publications:

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Responsible Party: Feng Lin, attending doctor, Wenzhou Medical University
ClinicalTrials.gov Identifier: NCT02867202    
Other Study ID Numbers: Wenzhou MC
First Posted: August 15, 2016    Key Record Dates
Results First Posted: January 2, 2020
Last Update Posted: January 2, 2020
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Feng Lin, Wenzhou Medical University:
intrauterine balloon
Intrauterine Device Plus Foley Balloon Catheter
Asherman Syndrome
Additional relevant MeSH terms:
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Gynatresia
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs