TRAnexamic Acid for Preventing Postpartum Hemorrhage Following a Cesarean Delivery

PHASE3CompletedINTERVENTIONAL
Enrollment

4,574

Participants

Timeline

Start Date

March 3, 2018

Primary Completion Date

January 14, 2020

Study Completion Date

April 8, 2020

Conditions
Postpartum Hemorrhage
Interventions
DRUG

Tranexamic Acid Injectable Solution

After the routine and prophylactic administration of a uterotonic , the intervention will be the IV administration of a 10-ml blinded ampoule of the study drug (either TXA or placebo according to the randomisation sequence) to the woman within 3 minutes after birth, slowly (over 30-60 seconds), once the cord has been clamped.

DRUG

Sodium Chloride 0.9%

After a routine and prophylactic administration of a uterotonic , the intervention will be the IV administration of a 10-ml blinded ampoule of the study drug (either TXA or placebo according to the randomisation sequence) to the patient within 3 minutes afterbirth), slowly (over 30-60 seconds), once the cord has been clamped.

Trial Locations (26)

13008

Hôpital Saint Joseph Marseille, Marseille

13915

Hopital Nord, Marseille

14033

CHRU Côte de Nacre, Caen

25000

CHU Jean Minjoz, Besançon

30900

CHU Nîmes, Nîmes

31059

Hôpital Paule de Viguier CHU Toulouse, Toulouse

33076

CHU Bordeaux, Bordeaux

34295

CHU de Montpellier, Montpellier

35033

CHU Rennes, Rennes

37044

CHU Tours, Tours

42270

CHU Saint Etienne, Saint-Etienne

44093

CHU Nantes, Nantes

49033

CHU Angers, Angers

54000

CHRU de Nancy, Nancy

63001

CHU Estain, Clermont-Ferrand

67098

CHU Strasbourg, Strasbourg

75012

Hôpital Trousseau, Paris

75014

Hôpital Saint Joseph Paris, Paris

Maternité de Port-Royal Paris, Paris

75015

Hôpital universitaire Necker-Enfants malades, Paris

75019

Hôpital universitaire Robert Debré, Paris

76000

CHU Charles Nicolle, Rouen

78303

Centre Hospitalier Intercommunal Poissy-Saint Germain, Poissy

94270

Hôpital universitaire Kremlin-Bicètre, Paris

Unknown

Centre Hospitalier Intercommunal de Créteil, Créteil

CH de Pau, Pau

All Listed Sponsors
collaborator

Ministry of Health, France

OTHER_GOV

lead

University Hospital, Bordeaux

OTHER

NCT03431805 - TRAnexamic Acid for Preventing Postpartum Hemorrhage Following a Cesarean Delivery | Biotech Hunter | Biotech Hunter