Status:
COMPLETED
Tranexamic Acid for Preventing Postpartum Haemorrhage Following a Vaginal Delivery
Lead Sponsor:
University Hospital, Angers
Collaborating Sponsors:
Institut National de la Santé Et de la Recherche Médicale, France
Conditions:
Immediate Postpartum Hemorrhage
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
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...
Detailed Description
Postpartum hemorrhage (PPH) is a major cause of maternal mortality, accounting for one quarter of all maternal deaths worldwide. Its incidence estimates in the literature vary widely, from 3% to 15% o...
Eligibility Criteria
Inclusion
- Age≥ 18 years
- Planned vaginal delivery
- Term ≥ 35 weeks of gestation
- Singleton pregnancy
- Informed consent form signed
Exclusion
- 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
Key Trial Info
Start Date :
February 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2017
Estimated Enrollment :
4079 Patients enrolled
Trial Details
Trial ID
NCT02302456
Start Date
February 1 2015
End Date
April 1 2017
Last Update
September 6 2017
Active Locations (1)
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1
Angers University Hospital
Angers, France, 49933