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Tranexamic Acid for Preventing Postpartum Haemorrhage Following a Vaginal Delivery (TRAAP)

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ClinicalTrials.gov Identifier: NCT02302456
Recruitment Status : Completed
First Posted : November 27, 2014
Last Update Posted : September 6, 2017
Sponsor:
Collaborator:
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by (Responsible Party):
University Hospital, Angers

Brief Summary:
The purpose of this study is to assess whether the administration of a low dose of tranexamic acid just after vaginal delivery can reduce the incidence of immediate postpartum hemorrhage, in women who receive a prophylactic administration of oxytocin.

Condition or disease Intervention/treatment Phase
Immediate Postpartum Hemorrhage Drug: Tranexamic Acid Drug: Placebo Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4079 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Tranexamic Acid for Preventing Postpartum Haemorrhage Following a Vaginal Delivery: a Multicenter Randomised Double Blind Placebo Controlled Trial
Actual Study Start Date : February 2015
Actual Primary Completion Date : January 2017
Actual Study Completion Date : April 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: TXA
Intravenous administration of 1g of tranexamic acid within 2 minutes after birth and prophylactic oxytocin administration
Drug: Tranexamic Acid
Intravenous administration of a 10 mL solution containing 1g of tranexamic acid within 2 minutes of birth and routine prophylactic IV injection of oxytocin

Placebo Comparator: Placebo
Intravenous administration of placebo within 2 minutes after birth and prophylactic oxytocin administration
Drug: Placebo
Intravenous administration of 10 mL of 0.9% sodium chloride solution within 2 minutes of birth and routine prophylactic IV injection of oxytocin




Primary Outcome Measures :
  1. Incidence of PPH [ Time Frame: 24 hours after birth ]
    Incidence of PPH defined by blood loss ≥ 500 ml, measured with a graduated collector bag


Secondary Outcome Measures :
  1. Mean blood loss at 15 minutes after birth [ Time Frame: 15 minutes after birth ]
    Measured with a collector bag left in place at least 15 minutes to have one measure of blood loss at the same time point in all women

  2. Mean total blood loss [ Time Frame: Up to 24 hours after birth ]
    Measured at collector bag removal

  3. Incidence of severe PPH [ Time Frame: 24 hours after birth ]
    Incidence of PPH defined by blood loss ≥ 1000 ml, measured with a graduated collector bag

  4. Need for supplementary uterotonic treatment [ Time Frame: 24 hours after birth ]
    Proportion of women requiring supplementary uterotonic treatment including sulprostone

  5. Postpartum transfusion [ Time Frame: Duration of postpartum hospital stay, an expected average of 3 days ]
    Proportion of women transfused in postpartum

  6. Need for invasive second-line procedures for PPH [ Time Frame: Duration of postpartum hospital stay, an expected average of 3 days ]
    Any of the following: arterial embolization, pelvic arterial ligation, uterine compression suture, hysterectomy

  7. Hemoglobin peripartum delta [ Time Frame: 2 days postpartum ]
    Mean difference between the hemoglobin values before delivery and on the 2nd day postpartum in the absence of a transfusion of packed red blood cells.

  8. Hematocrit peripartum delta [ Time Frame: 2 days postpartum ]
    Mean difference between the hematocrit values before delivery and on the 2nd day postpartum in the absence of a transfusion of packed red blood cells

  9. Hemodynamic tolerance [ Time Frame: 15, 30, 45, 60 and 120 minutes after delivery ]
    Heart rate, blood pressure

  10. Mild adverse effects [ Time Frame: Stay in labor ward, an expected average of 2 hours ]
    Nausea, vomiting, phosphenes, dizziness

  11. Tolerance lab tests [ Time Frame: Day 2 postpartum ]
    Urea, creatinemia, prothrombin time, active prothrombin time, fibrinogenemia, aspartate and alanine transaminase, total bilirubin

  12. Severe adverse effects [ Time Frame: Up to 12 weeks after delivery ]
    Deep venous thrombosis, pulmonary embolism, myocardial infarction, renal failure needing dialysis


Other Outcome Measures:
  1. Women's satisfaction [ Time Frame: Day 2 postpartum ]
    self-questionnaire

  2. Psychological status [ Time Frame: 2 months postpartum ]
    self questionnaire



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age≥ 18 years
  • Planned vaginal delivery
  • Term ≥ 35 weeks of gestation
  • Singleton pregnancy
  • Informed consent form signed

Exclusion Criteria:

  • History of venous (deep vein thrombosis and/or pulmonary embolism) or arterial (angina pectoris, myocardial infarction, stroke) thrombosis.
  • History of epilepsy or seizure
  • Any known cardiovascular, renal, liver disorders
  • Auto-immune disease
  • Sickle cell disease
  • Severe hemorrhagic disease
  • Placenta previa
  • Abnormally invasive placenta (placenta accreta/increta/percreta)
  • Abruptio placentae
  • Eclampsia; hemolysis, elevated liver enzymes, low platelet count (HELLP) syndrome
  • Multiple pregnancy
  • In utero foetal death
  • Administration of Low-Molecular-Weight Heparin or antiplatelet agents seven days before delivery
  • Poor understanding of the French language

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02302456


Locations
France
Angers University Hospital
Angers, France, 49933
Sponsors and Collaborators
University Hospital, Angers
Institut National de la Santé Et de la Recherche Médicale, France
Investigators
Principal Investigator: Loic SENTILHES, MD PhD Department of Obstetrics, Angers University Hospital Center
Study Director: Catherine DENEUX-THARAUX, MD PhD Institut National de la Santé Et de la Recherche Médicale, France

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University Hospital, Angers
ClinicalTrials.gov Identifier: NCT02302456     History of Changes
Other Study ID Numbers: PHRC 2013-01
First Posted: November 27, 2014    Key Record Dates
Last Update Posted: September 6, 2017
Last Verified: September 2017

Keywords provided by University Hospital, Angers:
Immediate postpartum hemorrhage
tranexamic acid
prevention

Additional relevant MeSH terms:
Hemorrhage
Postpartum Hemorrhage
Pathologic Processes
Obstetric Labor Complications
Pregnancy Complications
Puerperal Disorders
Uterine Hemorrhage
Oxytocin
Tranexamic Acid
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants