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Effectiveness of Hyaluronic Acid Gel in the Prevention of Intrauterine Adhesions After Second Trimester Abortion

Primary Purpose

Placenta Retained, Uterine Diseases

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
intrauterine self-cross-linked hyaluronic acid gel
Sponsored by
Istanbul University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Placenta Retained

Eligibility Criteria

18 Years - 39 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Subject has curettage for retained product after second trimester abortion

Exclusion Criteria:

  • History of curettage or other intrauterine surgery
  • History of post-abortion complication or infection

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    No Intervention

    Arm Label

    Group 1

    Group 2

    Arm Description

    The patients who are having curettage for retained product after second trimester abortion will also receive an intervention of intrauterine self-cross-linked hyaluronic acid gel after the procedure

    The patients who are having curettage for retained product after second trimester abortion will receive no intervention

    Outcomes

    Primary Outcome Measures

    The presence of de-novo post-curettage adhesions
    In 2 months following the curettage, Hysteroscopy will perform to observe of whether there is any intrauterine adhesion

    Secondary Outcome Measures

    The characteristic of the intrauterine adhesions
    If any intrauterine adhesion is detected during the Hysteroscopy, American Fertility Society/American Society for Reproductive Medicine classification of intrauterine adhesions will be used to describe to the characteristic of the intrauterine adhesions

    Full Information

    First Posted
    August 10, 2016
    Last Updated
    August 14, 2016
    Sponsor
    Istanbul University
    Collaborators
    Bilar Medikal, Turkey
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02868437
    Brief Title
    Effectiveness of Hyaluronic Acid Gel in the Prevention of Intrauterine Adhesions After Second Trimester Abortion
    Official Title
    Effectiveness of Self-cross-linked Hyaluronic Acid Gel in the Prevention of Intrauterine Adhesions After Second Trimester Abortion
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 2016 (undefined)
    Primary Completion Date
    January 2017 (Anticipated)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Istanbul University
    Collaborators
    Bilar Medikal, Turkey

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This prospective, randomized, controlled study evaluates the efficacy of self-crosslinked hyaluronic acid gel to prevent the development of de-novo intrauterine adhesions following curettage for retained product after second trimester abortion. One group of participants will underwent curettage plus intrauterine application of self-crosslinked hyaluronic acid gel while the other group will underwent curettage alone (control group).
    Detailed Description
    Intrauterine adhesions are the major long-term complication of curettage for retained products of conception. The risk of adhesion is higher after second trimester abortion. This complication may result in infertility, recurrent miscarriages and irregular periods with dysmenorrhea and pelvic pain. They have been reported that the intrauterine application of auto-crosslinked hyaluronic acid gel following hysteroscopic adhesiolysis or hysteroscopic surgery significantly reduces the formation of post-operative intrauterine adhesions. The aim of this prospective, randomized, controlled study is to evaluate the efficacy of self-crosslinked hyaluronic acid gel in the reduction of development of de-novo post-curettage adhesions at 2 months follow-up.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Placenta Retained, Uterine Diseases

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Group 1
    Arm Type
    Active Comparator
    Arm Description
    The patients who are having curettage for retained product after second trimester abortion will also receive an intervention of intrauterine self-cross-linked hyaluronic acid gel after the procedure
    Arm Title
    Group 2
    Arm Type
    No Intervention
    Arm Description
    The patients who are having curettage for retained product after second trimester abortion will receive no intervention
    Intervention Type
    Device
    Intervention Name(s)
    intrauterine self-cross-linked hyaluronic acid gel
    Intervention Description
    intrauterine self-cross-linked hyaluronic acid gel will apply after curettage for retained product after second trimester abortion
    Primary Outcome Measure Information:
    Title
    The presence of de-novo post-curettage adhesions
    Description
    In 2 months following the curettage, Hysteroscopy will perform to observe of whether there is any intrauterine adhesion
    Time Frame
    2 months
    Secondary Outcome Measure Information:
    Title
    The characteristic of the intrauterine adhesions
    Description
    If any intrauterine adhesion is detected during the Hysteroscopy, American Fertility Society/American Society for Reproductive Medicine classification of intrauterine adhesions will be used to describe to the characteristic of the intrauterine adhesions
    Time Frame
    2 months

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    39 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Subject has curettage for retained product after second trimester abortion Exclusion Criteria: History of curettage or other intrauterine surgery History of post-abortion complication or infection
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Sultan Can, M.D.
    Phone
    +90 212 4142000
    Ext
    31687
    Email
    sltncn89@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Gamze Yilmaz, M.D.
    Phone
    +90 212 4142000
    Email
    gmzylmz89@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ozlem Dural, M.D.
    Organizational Affiliation
    Istanbul University School Of Medicine, Department of Obstetrics and Gynecology
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    24082042
    Citation
    Hooker AB, Lemmers M, Thurkow AL, Heymans MW, Opmeer BC, Brolmann HA, Mol BW, Huirne JA. Systematic review and meta-analysis of intrauterine adhesions after miscarriage: prevalence, risk factors and long-term reproductive outcome. Hum Reprod Update. 2014 Mar-Apr;20(2):262-78. doi: 10.1093/humupd/dmt045. Epub 2013 Sep 29.
    Results Reference
    result
    PubMed Identifier
    15105384
    Citation
    Guida M, Acunzo G, Di Spiezio Sardo A, Bifulco G, Piccoli R, Pellicano M, Cerrota G, Cirillo D, Nappi C. Effectiveness of auto-crosslinked hyaluronic acid gel in the prevention of intrauterine adhesions after hysteroscopic surgery: a prospective, randomized, controlled study. Hum Reprod. 2004 Jun;19(6):1461-4. doi: 10.1093/humrep/deh238. Epub 2004 Apr 22.
    Results Reference
    result

    Learn more about this trial

    Effectiveness of Hyaluronic Acid Gel in the Prevention of Intrauterine Adhesions After Second Trimester Abortion

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