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COMPLETED
NCT03431805
PHASE3

TRAnexamic Acid for Preventing Postpartum Hemorrhage Following a Cesarean Delivery

Sponsor: University Hospital, Bordeaux

View on ClinicalTrials.gov

Summary

The aim is to assess the impact of tranexamic acid (TXA) for preventing postpartum hemorrhage (PPH) following a cesarean section (CS).

Official title: TRAnexamic Acid for Preventing Postpartum Hemorrhage Following a Cesarean Delivery :a Multicenter Randomised, Double Blind Placebo Controlled Trial (TRAAP2)

Key Details

Gender

FEMALE

Age Range

18 Years - 64 Years

Study Type

INTERVENTIONAL

Enrollment

4574

Start Date

2018-03-03

Completion Date

2020-04-08

Last Updated

2026-05-12

Healthy Volunteers

No

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.

Locations (26)

CHU Angers

Angers, France

CHU Jean Minjoz

Besançon, France

CHU Bordeaux

Bordeaux, France

CHRU Côte de Nacre

Caen, France

CHU Estain

Clermont-Ferrand, France

Centre Hospitalier Intercommunal de Créteil

Créteil, France

Hôpital Saint Joseph Marseille

Marseille, France

Hopital Nord

Marseille, France

CHU de Montpellier

Montpellier, France

CHRU de Nancy

Nancy, France

CHU Nantes

Nantes, France

CHU Nîmes

Nîmes, France

Hôpital Trousseau

Paris, France

Hôpital Saint Joseph Paris

Paris, France

Maternité de Port-Royal Paris

Paris, France

Hôpital universitaire Necker-Enfants malades

Paris, France

Hôpital universitaire Robert Debré

Paris, France

Hôpital universitaire Kremlin-Bicètre

Paris, France

CH de Pau

Pau, France

Centre Hospitalier Intercommunal Poissy-Saint Germain

Poissy, France

CHU Rennes

Rennes, France

CHU Charles Nicolle

Rouen, France

CHU Saint Etienne

Saint-Etienne, France

CHU Strasbourg

Strasbourg, France

Hôpital Paule de Viguier CHU Toulouse

Toulouse, France

CHU Tours

Tours, France