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Tranexamic Acid and Ethamsylate For Preventing PPH in Patient Undergoing LSCS at High Risk For PPH

Primary Purpose

Postpartum Hemorrhage

Status
Unknown status
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Tranexamic Acid and Ethamsylate
Sponsored by
Ahmed Alanwar
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postpartum Hemorrhage

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  1. Women undergoing elective caesarean section

  2. Patient having one or more risk factor for PPH

    • Multiple pregnancy
    • Polyhydramnios (AFI >25cm)
    • Macrocosmic baby (>4.5 Kg)
    • Prolonged , augmented and obstructed labour
    • Obese patients(BMI >30)
    • Premature rapture of membranes
    • Previous history of PPH
  3. Age ≥18 years
  4. Gestational Age ≥ 35 Weeks
  5. Informed Oral Consent From The Patient

Exclusion Criteria:

  1. History of venous thrombosis (DVT and/or Pulmonary embolism) OR arterial thrombosis (angina pectoris , myocardial infarction, stroke)
  2. History of epilepsy or seizure
  3. Any Known Cardiovascular , renal or liver Disease
  4. Autoimmune Diseases
  5. Sickle Cell Disease
  6. Severe hemorrhagic Disease
  7. Placenta Previa.
  8. Morbidly adherent Placenta
  9. Abruptio placenta
  10. Eclampsia, hemolysis, elevated liver enzymes, and low platelet count syndrome
  11. Administration Of low molecular weight heparin or Anti platelets the week before delivery .

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    tanexamic acid and Ethamsylate

    placebo

    Arm Description

    10 ml of the study drugs (1 gm Tranexamic acid and 1 gm Ethamsylate ) slowly (over 30-60 sec ) in the 2 minutes after birth

    10 ml normal saline will be administered intravenously just after birth

    Outcomes

    Primary Outcome Measures

    PPH defined as blood loss ≥500 cc
    measured by pads placed under women buttocks

    Secondary Outcome Measures

    severe PPH (>1000 cc), .

    Full Information

    First Posted
    November 12, 2015
    Last Updated
    November 27, 2015
    Sponsor
    Ahmed Alanwar
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02604719
    Brief Title
    Tranexamic Acid and Ethamsylate For Preventing PPH in Patient Undergoing LSCS at High Risk For PPH
    Official Title
    Tranexamic Acid and Ethamsylate For Preventing Post Partum Hemorrhage in Patient Undergoing LSCS at High Risk For Post PartumHemorrhage : A Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2015
    Overall Recruitment Status
    Unknown status
    Study Start Date
    November 2015 (undefined)
    Primary Completion Date
    May 2016 (Anticipated)
    Study Completion Date
    July 2016 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Ahmed Alanwar

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The aim of this study is to compare the effect of low dose of Tranexamic acid (1gm) and Ethamsylate (1gm) after prophylactic oxytocin administration versus placebo with prophylactic oxytocin given in the 2 minutes after child delivery in patient undergoing LSCS at high risk for post partum hemorrhage
    Detailed Description
    Research Question: Is the combination of Tranexamic acid and Ethamsylate is more effective than oxytocin alone for preventing postpartum hemorrhage if they are given after delivery of the fetus ?

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Postpartum Hemorrhage

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    64 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    tanexamic acid and Ethamsylate
    Arm Type
    Experimental
    Arm Description
    10 ml of the study drugs (1 gm Tranexamic acid and 1 gm Ethamsylate ) slowly (over 30-60 sec ) in the 2 minutes after birth
    Arm Title
    placebo
    Arm Type
    Placebo Comparator
    Arm Description
    10 ml normal saline will be administered intravenously just after birth
    Intervention Type
    Drug
    Intervention Name(s)
    Tranexamic Acid and Ethamsylate
    Other Intervention Name(s)
    kapron and dycinon
    Intervention Description
    The intervention will be the intravenous administration of 10 ml blinded vial of the study drugs (either 1 gmTranexamic acid and 1 gm Ethamsylate or placebo according to randomization group) slowly (over 30-60 sec ) in the 2 minutes after birth and the routine prophylactic oxytocin and after the cord has been clamped , all generally by the anesthesiologist or obstetrician then a pad will be placed under women buttocks then weighting the pads to allow objective measurement of blood loss.
    Primary Outcome Measure Information:
    Title
    PPH defined as blood loss ≥500 cc
    Description
    measured by pads placed under women buttocks
    Time Frame
    the first 24hours
    Secondary Outcome Measure Information:
    Title
    severe PPH (>1000 cc), .
    Time Frame
    first 24 hours

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    35 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Women undergoing elective caesarean section Patient having one or more risk factor for PPH Multiple pregnancy Polyhydramnios (AFI >25cm) Macrocosmic baby (>4.5 Kg) Prolonged , augmented and obstructed labour Obese patients(BMI >30) Premature rapture of membranes Previous history of PPH Age ≥18 years Gestational Age ≥ 35 Weeks Informed Oral Consent From The Patient Exclusion Criteria: History of venous thrombosis (DVT and/or Pulmonary embolism) OR arterial thrombosis (angina pectoris , myocardial infarction, stroke) History of epilepsy or seizure Any Known Cardiovascular , renal or liver Disease Autoimmune Diseases Sickle Cell Disease Severe hemorrhagic Disease Placenta Previa. Morbidly adherent Placenta Abruptio placenta Eclampsia, hemolysis, elevated liver enzymes, and low platelet count syndrome Administration Of low molecular weight heparin or Anti platelets the week before delivery .
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    ahmed Dr alanwar, MD
    Phone
    +201111486669
    Ext
    0020
    Email
    eladwar@hotmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    ahmed Dr kotb, MD
    Phone
    +201008681999
    Ext
    0020
    Email
    ahmedmkotp@hotmail.com

    12. IPD Sharing Statement

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    Tranexamic Acid and Ethamsylate For Preventing PPH in Patient Undergoing LSCS at High Risk For PPH

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