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Hemostatic Effect of Intrauterine Instillation Of Tranexamic Acid In Hysteroscopic Myomectomy

Primary Purpose

Surgical Blood Loss, Fibroid

Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Topical application Tranexamic acid
Placebo (Normal saline)
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Surgical Blood Loss

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. Subjects must be able to understand, and read and sign the study specific informed consent after fully explanation the nature of the study .
  2. Subjects exhibit submucous myoma that are completely within the endometrial cavity or extend less than 50 percent into the myometrium (type 0,i)according to European Society Of Hysteroscopy (ESH).
  3. The submucous myoma are less than 4 cm in diameter

Exclusion Criteria:

  1. Pregnancy
  2. Active Pelvic Infection
  3. Present or History of Cervical or Uterine Caner
  4. Bleeding Diathesis or patient on anticoagulant
  5. Contraindication and /or allergy to medication specified in the treatment protocol
  6. History of ischemic heart disease
  7. Patient with Cardiopulmonary, Hepatic , and renal diseases
  8. Patient with metabolic disorders including diabetes
  9. Patients with uterine septum or structural abnormality

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    Tranexamic acid (TXA) Group

    Normal Saline (control group)

    Arm Description

    Subjects in the Tranexamic acd (TXA) group will receive intrauterine instillation of 500 mg (100mg/ml) Tranexamic acid per 500 ml normal salin (distention medium) during Hysteroscopic Myomectomy.

    Subjects in the control group will receive 500 ml intrauterine instillation of normal saline with the distention medium (normal saline) during Hysteroscopic Myomectomy.

    Outcomes

    Primary Outcome Measures

    Estimated blood loss by comparing changes in hemoglobin level
    Estimated blood loss by comparing changes in hemoglobin level before hysteroscopic myomectomy (preoperative) and 24 hours after hysteroscopic myomectomy (postoperative) in Tranexamic acid group comparing to the control group
    Estimated blood loss by comparing changes in hematocrit level
    Estimated blood loss by comparing changes in hematocrit level before hysteroscopic myomectomy (preoperative) and 24 hours after hysteroscopic myomectomy (postoperative) in the Tranexamic acid group comparing to the control group

    Secondary Outcome Measures

    Full Information

    First Posted
    March 6, 2017
    Last Updated
    June 27, 2017
    Sponsor
    Ain Shams University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03122782
    Brief Title
    Hemostatic Effect of Intrauterine Instillation Of Tranexamic Acid In Hysteroscopic Myomectomy
    Official Title
    Hemostatic Effect of Intrauterine Instillation Of Tranexamic Acid In Hysteroscopic Myomectomy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    August 1, 2017 (Anticipated)
    Primary Completion Date
    August 2017 (Anticipated)
    Study Completion Date
    January 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Ain Shams University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No

    5. Study Description

    Brief Summary
    Study Design: Randomized Controlled Clinical Trial. Study Population: The study population will be a consecutive series of participants attending the Early Cancer Detection Unit (ECDU) at Ain Shams University Maternity Hospital. 80 women who are scheduled to undergo a hysteroscopic myomectomy will be included and will be randomized into two groups: Group A: women will undergo a hysteroscopic myomectomy with the use of (TXA) Kapron in the distention medium Group B: women will undergo hysteroscopic myomectomy with the use of placebo(normal saline in the distention medium). Randomization will be performed using a Computer-generated randomization system. The allocated groups will be concealed in serially-numbered sealed opaque envelopes that will only be opened after recruitment. Patient allocation will be performed prior to the induction of anesthesia by an independent person, who will not otherwise be involved in this study. The trial will be appropriately blinded; the participants, outcome assessors and the surgeon performing the procedure will be blinded to the medication type, which will be used inside the distention medium. Therefore, this study will be a randomized double blind prospective clinical Methodology: Informed written consent obtained from the participant. History Personal history Menstrual history Detailed obstetric history Surgical intervention especially uterine surgeries and any post-operative complication History of drug intake, especially hormonal treatment or anticoagulant therapy. Routine preoperative investigations in addition to a serum pregnancy test if pregnancy is suspected. Physical examination including general, abdominal and pelvic examination. Hysteroscopy will be performed in the early proliferative phase using normal saline as a distention medium. Only in intervention group (TXA group) KAPRON (Tranexamic acid) will be added to the injected media. In intervention group 500 mg of Kapron for every 500 ml of distending media will be added. In the control group, placebo .i.e. ,normal saline in the same form will be injected inside every 500 ml of the distention medium. The trial will be appropriately blinded; the participants, outcome assessors and the surgeon performing the procedure will be blinded to the medication type, which will be used inside the distention medium. Therefore, our study will be a randomized double blind prospective clinical trial. Intraoperative bleeding and quality of view will be observed. A blood sample will be taken from each participant in both groups after 24 hours from the end of the operation for both hemoglobin and hematocrit levels. Types of outcome measures: Primary outcome measures: Estimated Blood loss defined as comparing the hematocrit and hemoglobin at base line (preoperative ) and 24 hours after surgery with the Tranexamic acid compared to the control group. Secondary outcome measures: The quality of view, duration of surgery, the volume of injected media, intraoperative complications and the success of the completion of the operation will be secondary outcomes.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Surgical Blood Loss, Fibroid

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    80 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Tranexamic acid (TXA) Group
    Arm Type
    Active Comparator
    Arm Description
    Subjects in the Tranexamic acd (TXA) group will receive intrauterine instillation of 500 mg (100mg/ml) Tranexamic acid per 500 ml normal salin (distention medium) during Hysteroscopic Myomectomy.
    Arm Title
    Normal Saline (control group)
    Arm Type
    Placebo Comparator
    Arm Description
    Subjects in the control group will receive 500 ml intrauterine instillation of normal saline with the distention medium (normal saline) during Hysteroscopic Myomectomy.
    Intervention Type
    Drug
    Intervention Name(s)
    Topical application Tranexamic acid
    Other Intervention Name(s)
    KAPRON (AMOUN Pharmaceutical co.)
    Intervention Description
    Tranexamic acid (TXA) will be injected to distinction media during hysteroscopy in myomectomy
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo (Normal saline)
    Intervention Description
    5ml of normal saline will be added to every 500 ml of distension media
    Primary Outcome Measure Information:
    Title
    Estimated blood loss by comparing changes in hemoglobin level
    Description
    Estimated blood loss by comparing changes in hemoglobin level before hysteroscopic myomectomy (preoperative) and 24 hours after hysteroscopic myomectomy (postoperative) in Tranexamic acid group comparing to the control group
    Time Frame
    24 Hours
    Title
    Estimated blood loss by comparing changes in hematocrit level
    Description
    Estimated blood loss by comparing changes in hematocrit level before hysteroscopic myomectomy (preoperative) and 24 hours after hysteroscopic myomectomy (postoperative) in the Tranexamic acid group comparing to the control group
    Time Frame
    24 hours

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Subjects must be able to understand, and read and sign the study specific informed consent after fully explanation the nature of the study . Subjects exhibit submucous myoma that are completely within the endometrial cavity or extend less than 50 percent into the myometrium (type 0,i)according to European Society Of Hysteroscopy (ESH). The submucous myoma are less than 4 cm in diameter Exclusion Criteria: Pregnancy Active Pelvic Infection Present or History of Cervical or Uterine Caner Bleeding Diathesis or patient on anticoagulant Contraindication and /or allergy to medication specified in the treatment protocol History of ischemic heart disease Patient with Cardiopulmonary, Hepatic , and renal diseases Patient with metabolic disorders including diabetes Patients with uterine septum or structural abnormality
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Radwa Ali Rasheedy, MD
    Phone
    01283492979
    Email
    Radwaebed@yahoo.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ahmed Khairyy Makled, MD
    Organizational Affiliation
    Ain Shams University
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Amgad Said Abu-Gamra, MD
    Organizational Affiliation
    Ain Shams University
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Radwa Ali Rasheedy, MD
    Organizational Affiliation
    Ain Shams University
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Hajer Giuma Soliman, M.B.B.CH
    Organizational Affiliation
    Ain Shams University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    Hemostatic Effect of Intrauterine Instillation Of Tranexamic Acid In Hysteroscopic Myomectomy

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