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

Sponsor
Ahmed Alanwar (Other)
Overall Status
Unknown status
CT.gov ID
NCT02604719
Collaborator
(none)
64
Enrollment
2
Arms
8
Duration (Months)

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Tranexamic Acid and Ethamsylate
 Phase 1/Phase 2

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 ?

Study Design

Study Type:
Interventional
Anticipated Enrollment :
64 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
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 Start Date :
Nov 1, 2015
Anticipated Primary Completion Date :
May 1, 2016
Anticipated Study Completion Date :
Jul 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: tanexamic acid and Ethamsylate

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

Drug: Tranexamic Acid and Ethamsylate
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.
Other Names:
  • kapron and dycinon

    		•
    Placebo Comparator: placebo

    10 ml normal saline will be administered intravenously just after birth

    Drug: Tranexamic Acid and Ethamsylate
    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.
    Other Names:
  • kapron and dycinon

    		•

    Outcome Measures

    Primary Outcome Measures

    1. PPH defined as blood loss ≥500 cc [the first 24hours]

      measured by pads placed under women buttocks

    Secondary Outcome Measures

    1. severe PPH (>1000 cc), . [first 24 hours]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 35 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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

    1. Age ≥18 years

    2. Gestational Age ≥ 35 Weeks

    3. 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 .

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Ahmed Alanwar

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ahmed Alanwar, dr.ahmed alanwar, Ain Shams University
    ClinicalTrials.gov Identifier:
    NCT02604719
    Other Study ID Numbers:
    • TXA&Ethamsylate-PPH
    First Posted:
    Nov 13, 2015
    Last Update Posted:
    Nov 30, 2015
    Last Verified:
    Nov 1, 2015
    Additional relevant MeSH terms:
    Postpartum Hemorrhage
    Hemorrhage
    Tranexamic Acid
    Ethamsylate

    Study Results

    No Results Posted as of Nov 30, 2015