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Determination of Blood Loss After CS

Primary Purpose

Effect of Drug

Status
Unknown status
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
Tranexamic acid
Oxytocin
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Effect of Drug

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  1. Age : 20-40 year

    • 2- Gestational age is between 37-41weeks

3- Delivery by uncomplicated elective CS

Exclusion Criteria:

  • 1- Risk factors for uterine atony such as polyhydramnios or fetal macrosomia. 2- Grandmultiparity 3- Past history of postpartum hemorrhage either atonic or traumatic 4- Previous history of retained placenta 5- Pre-eclampsia or gestational hypertension/ Maternal DM 6- Abnormal placentation 7- Contraindications to the use of tranexamic acid 8- Hypersensitivity to tranexamic acid. 9- Women receiving anticoagulant therapy. 10- having underlying disease (heart, liver, kidney, pulmonary, etc.),

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    group A

    group B

    Arm Description

    will receive oxytocin

    will receive tranexamic acid plus oxytocin

    Outcomes

    Primary Outcome Measures

    amount of blood loss
    comparison between effect of oxytocin alone and tranexamic acid and oxytocin in reducing blood loss after CS

    Secondary Outcome Measures

    maternal and neonatal complication
    blood transfusion ,surgical injuries ,

    Full Information

    First Posted
    September 9, 2020
    Last Updated
    September 14, 2020
    Sponsor
    Ain Shams University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04549012
    Brief Title
    Determination of Blood Loss After CS
    Official Title
    Tranexamic Acid Plus Oxytocin Versus Oxtocin Only in Reducing Blood Loss After Cesarean Section
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 2020 (Anticipated)
    Primary Completion Date
    September 2021 (Anticipated)
    Study Completion Date
    October 2021 (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

    5. Study Description

    Brief Summary
    Comparing betweeen tranexamic acid plus oxytocin and oxytocin alone in their efficacy in reducing blood loss following CS
    Detailed Description
    tranexamic acid plus oxytocin versus oxytocin only in reducing blood loss following CS

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Effect of Drug

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Early Phase 1
    Interventional Study Model
    Parallel Assignment
    Model Description
    Group (A) will receive oxytocin only Group (B)will receive oxytocin plus tranexamic acid
    Masking
    ParticipantCare ProviderInvestigator
    Masking Description
    women will be given serial number ,randomization will be done through a computer generated system
    Allocation
    Randomized
    Enrollment
    130 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    group A
    Arm Type
    Active Comparator
    Arm Description
    will receive oxytocin
    Arm Title
    group B
    Arm Type
    Active Comparator
    Arm Description
    will receive tranexamic acid plus oxytocin
    Intervention Type
    Drug
    Intervention Name(s)
    Tranexamic acid
    Other Intervention Name(s)
    oxytocin
    Intervention Description
    comparison between effect of oxytocin alone and tranexamic acid and oxytocin in reducing blood loss after CS
    Intervention Type
    Drug
    Intervention Name(s)
    Oxytocin
    Intervention Description
    Oxytocin
    Primary Outcome Measure Information:
    Title
    amount of blood loss
    Description
    comparison between effect of oxytocin alone and tranexamic acid and oxytocin in reducing blood loss after CS
    Time Frame
    baseline
    Secondary Outcome Measure Information:
    Title
    maternal and neonatal complication
    Description
    blood transfusion ,surgical injuries ,
    Time Frame
    baseline

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Age : 20-40 year 2- Gestational age is between 37-41weeks 3- Delivery by uncomplicated elective CS Exclusion Criteria: 1- Risk factors for uterine atony such as polyhydramnios or fetal macrosomia. 2- Grandmultiparity 3- Past history of postpartum hemorrhage either atonic or traumatic 4- Previous history of retained placenta 5- Pre-eclampsia or gestational hypertension/ Maternal DM 6- Abnormal placentation 7- Contraindications to the use of tranexamic acid 8- Hypersensitivity to tranexamic acid. 9- Women receiving anticoagulant therapy. 10- having underlying disease (heart, liver, kidney, pulmonary, etc.),
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    noha abu shata
    Phone
    01000287839
    Email
    mhmwdnhy44@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    tamer Borg
    Phone
    01001457437
    Email
    tamerborg1975@gmail.com

    12. IPD Sharing Statement

    Learn more about this trial

    Determination of Blood Loss After CS

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