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Postoperative Intermittent Intrauterine Balloon Dilatation Therapy.

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ClinicalTrials.gov Identifier: NCT03131596
Recruitment Status : Completed
First Posted : April 27, 2017
Results First Posted : September 13, 2019
Last Update Posted : September 13, 2019
Sponsor:
Information provided by (Responsible Party):
Xiaoyu Shi, Fu Xing Hospital, Capital Medical University

Brief Summary:
In this prospective, randomized, controlled study, the investigators wish to determine the efficacy of intrauterine balloon (IUB) dilatation in the prevention of adhesion reformation when compared with the conventional management.

Condition or disease Intervention/treatment Phase
Intrauterine Adhesion Procedure: IUB dilatation therapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Masking Description: Both surgeons conducting the hysteroscopic surgery and follow-up hysteroscopy were blinded to the patient group allocation.
Primary Purpose: Prevention
Official Title: Prevention of Postoperative Adhesion Reformation by Intrauterine Balloon Therapy: a Randomized Controlled Trial
Actual Study Start Date : May 15, 2017
Actual Primary Completion Date : November 15, 2017
Actual Study Completion Date : November 15, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Adhesions Aneurysms

Arm Intervention/treatment
Experimental: IUB dilatation therapy
The patient will have Foley-catheter intrauterine balloon dilatation 2 weeks and 6 weeks after hysteroscopic adhesiolysis. A second-look hysteroscopy will be carried out in the early proliferative phase 4 weeks after the surgery and third-look hysteroscopy will be carried out 8 weeks after the surgery.
Procedure: IUB dilatation therapy
A Foley catheter (size 14fr) will be prepared by cutting the excess catheter tip protruding beyond the balloon prior to insertion into the uterine cavity. Once the catheter has reached the fundus, 3-4.5mls of saline will be slowly introduced into the balloon under ultrasound guidance, in order to directly visualize the distention of the cavity and division of any intrauterine adhesions, if present.

No Intervention: control group
Patient will not undergo any balloon therapy. A second-look hysteroscopy will be carried out in the early proliferative phase 4 weeks after the surgery and third-look hysteroscopy will be carried out 8 weeks after the surgery.



Primary Outcome Measures :
  1. Number of Participants With Adhesion Reformation (American Fertility Society Score of Greater Than 0) 8 Weeks Later After the Index Surgery [ Time Frame: at 8 weeks post-operation ]
    The American Fertility Society (AFS) score ranges from 0-12, while represented the severity of the adhesions. Mild 1-4, Moderate 5-8, Severe 9-12. The lower the AFS score is, the better the prognosis the patient is. When the surgery was finished the AFS score should be 0. The reformation of intrauterine adhesions was evaluated by third-look hysteroscopy, if the score was greater than 0, a adhesion reformation was considered.

  2. The American Fertility Society Score 8 Weeks After Operation [ Time Frame: at 8 weeks post-operation ]
    The American Fertility Society(AFS) score of each group was evaluated again at third-look hysteroscopy in order to reflect the efficacy of the treatment. The original AFS score was recorded in baseline characteristics part. The AFS score ranges from 0-12, while represented the severity of the adhesions. Mild 1-4, Moderate 5-8, Severe 9-12. The lower the AFS score is, the better the prognosis the patient is. When the surgery was finished the AFS score score should be 0.

  3. Pictorial Blood Loss Assessment Chart Score 8 Weeks After Operation [ Time Frame: at 8 weeks post-operation ]

    The Pictorial Blood Loss Assessment Chart (PBAC) score was used to represent the menstrual flow volume of the patient. The PBAC score was evaluated again at 8 weeks after surgery. A higher PBAC score after hysteroscopic adhesiolysis means a better outcome.The PBAC score of a normal women usually range from 30-100 points.

    The minium value of PBAC score is 0, which means the patient is amenorrhea. The maximum value of PBAC score is 1000.

    We measured the score before and 8 weeks after the operation in order to assess if there was any improvement (higher than before) in menstrual flow.



Secondary Outcome Measures :
  1. Pregnancy Outcome Within 12 Months Follow-up After Third Look Hysteroscopy [ Time Frame: within 12 months after third look hysteroscopy(8 weeks post-operation) ]
    number of patients who have pregnancy, miscarriage and ectopic pregnancy within12 months follow-up



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. women aged 18-40 years;
  2. moderate to severe intrauterine adhesion (AFS score≥5);
  3. no previous history of hysteroscopic adhesiolysis in our hospital;
  4. written consent obtained
  5. agreement to have second-look and third-look hysteroscopy.

Exclusion Criteria:

  1. minimal adhesion (AFS score <5);
  2. previous hysteroscopic adhesiolysis in our hospital.

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): NCT03131596


Locations
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China, Beijing
Fu Xing Hospital
Beijing, Beijing, China, 100038
Sponsors and Collaborators
Fu Xing Hospital, Capital Medical University
Investigators
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Study Chair: Tinchiu Li Fuxing Hospital,Capital Medical University,China
  Study Documents (Full-Text)

Documents provided by Xiaoyu Shi, Fu Xing Hospital, Capital Medical University:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Xiaoyu Shi, principal investigator, Fu Xing Hospital, Capital Medical University
ClinicalTrials.gov Identifier: NCT03131596    
Other Study ID Numbers: 2016FXHEC-KY036
First Posted: April 27, 2017    Key Record Dates
Results First Posted: September 13, 2019
Last Update Posted: September 13, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Xiaoyu Shi, Fu Xing Hospital, Capital Medical University:
Intrauterine Adhesion
Hysteroscopy
Intrauterine balloon
Reformation
Prevention
Additional relevant MeSH terms:
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Tissue Adhesions
Cicatrix
Fibrosis
Pathologic Processes