Status:
COMPLETED
TRAnexamic Acid for Preventing Postpartum Hemorrhage Following a Cesarean Delivery
Lead Sponsor:
University Hospital, Bordeaux
Collaborating Sponsors:
Ministry of Health, France
Conditions:
Postpartum Hemorrhage
Eligibility:
FEMALE
18-64 years
Phase:
PHASE3
Brief Summary
The aim is to assess the impact of tranexamic acid (TXA) for preventing postpartum hemorrhage (PPH) following a cesarean section (CS).
Detailed Description
Regarding the prevention of PPH, recent randomized controlled trials (RCTs) of unclear quality have suggested that TXA may reduce blood loss and maternal morbidity, while a Cochrane Collaboration revi...
Eligibility Criteria
Inclusion
- : adult women admitted for a cesarean delivery before or during labor, at a term ≥ 34 weeks,
- hemoglobin level at the last blood sample \>9g/dl,
- available blood test for Hb and Ht within one week before caesarean delivery,
- informed signed consent
Exclusion
- previous thrombotic event or preexisting pro-thrombotic disease,
- epileptic state or history of seizures,
- presence of any chronic or active cardiovascular disease outside hypertension,
- any chronic or active renal disease and chronic or active liver disease at risk thrombotic or hemorrhagic, autoimmune disease,
- sickle cell disease,
- placenta praevia,
- placenta accreta/increta/percreta,
- abruption placentae,
- eclampsia,
- HELLP syndrome,
- significant hemorrhage before cesarean section
- in utero fetal death,
- administration of low-molecular-weight heparin or antiplatelet agents during the week before delivery,
- planned general anesthesia,
- hypersensitivity to tranexamic acid or concentrated hydrochloric acid,
- instrumental extraction failure,
- multiple pregnancy with vaginal delivery of the first child,
- poor understanding of the French language.
Key Trial Info
Start Date :
March 3 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 8 2020
Estimated Enrollment :
4574 Patients enrolled
Trial Details
Trial ID
NCT03431805
Start Date
March 3 2018
End Date
April 8 2020
Last Update
April 29 2020
Active Locations (26)
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1
CHU Angers
Angers, France, 49033
2
CHU Jean Minjoz
Besançon, France, 25000
3
CHU Bordeaux
Bordeaux, France, 33076
4
CHRU Côte de Nacre
Caen, France, 14033