search
Back to results

Topical Tranexamic Acid for the Prevention of Postpartum Hemorrhage in Women With Twin Pregnancy

Primary Purpose

Cesarean Section Complications

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Topical tranexamic acid
normal saline
Sponsored by
Aswan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cesarean Section Complications

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Women With Twin Pregnancy Undergoing Cesarean Section

Exclusion Criteria:

  • Patients with cardiac, hepatic, renal, or thromboembolic disease. ,
  • patients with a high possibility of the morbid adherent placenta,
  • known coagulopathy and
  • those presented with severe antepartum hemorrhage
  • refuse to participate

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Topical tranexamic acid

    normal saline

    Arm Description

    temporary uterine packing with gauze of the dimensions soaked with 2 gm tranexamic diluted in 60ml saline acid

    temporary uterine packing with gauze of the dimensions soaked with 2 gm placebo to tranexamic diluted in 60ml saline acid

    Outcomes

    Primary Outcome Measures

    intraoperative blood loss
    measurement the intraoperative blood loss by direct and gravimetric methods

    Secondary Outcome Measures

    postoperative blood loss
    measurement the intraoperative blood loss by direct and gravimetric methods
    need of blood transfusion
    number of unites of blood transfusion
    need of uterotonic
    misoprostol, oxytocin etc
    change in hemoglobin
    change in hemoglobin

    Full Information

    First Posted
    September 29, 2021
    Last Updated
    September 29, 2021
    Sponsor
    Aswan University Hospital
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05072873
    Brief Title
    Topical Tranexamic Acid for the Prevention of Postpartum Hemorrhage in Women With Twin Pregnancy
    Official Title
    The Adjunctive Role of Temporary Uterine Packing Combined With Topical Tranexamic Acid for the Prevention of Postpartum Hemorrhage in Women With Twin Pregnancy Undergoing Cesarean Section: A Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2021
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 1, 2021 (Anticipated)
    Primary Completion Date
    October 31, 2023 (Anticipated)
    Study Completion Date
    November 30, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Aswan University Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    twin pregnant women requesting cesarean section, the effectiveness and safety of temporary uterine packing coupled with topical tranexamic acid as an adjuvant for decreasing blood loss during delivery were compared to placebo.
    Detailed Description
    The most common cause of postpartum hemorrhage (PPH) is uterine atony, which accounts for up to 80% of PPH occurrences. PPH is the main cause of maternal morbidity and mortality, accounting for up to 28% of all maternal deaths globally. As a result, generating a fast and efficient uterine contraction after birth is critical. Obesity, White or Hispanic race/ethnicity, polyhydramnios, preeclampsia, anemia, and chorioamnionitis, as well as a twin pregnancy, are all risk factors for uterine atony.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cesarean Section Complications

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    a double-blind randomized controlled study
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Masking Description
    a double-blind randomized controlled study
    Allocation
    Randomized
    Enrollment
    150 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Topical tranexamic acid
    Arm Type
    Experimental
    Arm Description
    temporary uterine packing with gauze of the dimensions soaked with 2 gm tranexamic diluted in 60ml saline acid
    Arm Title
    normal saline
    Arm Type
    Placebo Comparator
    Arm Description
    temporary uterine packing with gauze of the dimensions soaked with 2 gm placebo to tranexamic diluted in 60ml saline acid
    Intervention Type
    Drug
    Intervention Name(s)
    Topical tranexamic acid
    Other Intervention Name(s)
    experimental
    Intervention Description
    temporary uterine packing with gauze of the dimensions soaked with 2 gm tranexamic diluted in 60ml saline acid
    Intervention Type
    Other
    Intervention Name(s)
    normal saline
    Other Intervention Name(s)
    Placebo Comparator
    Intervention Description
    temporary uterine packing with gauze of the dimensions soaked with 2 gm placebo to tranexamic diluted in 60ml saline acid
    Primary Outcome Measure Information:
    Title
    intraoperative blood loss
    Description
    measurement the intraoperative blood loss by direct and gravimetric methods
    Time Frame
    30 minutes
    Secondary Outcome Measure Information:
    Title
    postoperative blood loss
    Description
    measurement the intraoperative blood loss by direct and gravimetric methods
    Time Frame
    12 hours
    Title
    need of blood transfusion
    Description
    number of unites of blood transfusion
    Time Frame
    24 hours
    Title
    need of uterotonic
    Description
    misoprostol, oxytocin etc
    Time Frame
    24 hours
    Title
    change in hemoglobin
    Description
    change in hemoglobin
    Time Frame
    24 hours

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Gender Eligibility Description
    Women With Twin Pregnancy Undergoing Cesarean Section
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Women With Twin Pregnancy Undergoing Cesarean Section Exclusion Criteria: Patients with cardiac, hepatic, renal, or thromboembolic disease. , patients with a high possibility of the morbid adherent placenta, known coagulopathy and those presented with severe antepartum hemorrhage refuse to participate

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Topical Tranexamic Acid for the Prevention of Postpartum Hemorrhage in Women With Twin Pregnancy

    We'll reach out to this number within 24 hrs