TRAnexamic Acid for Preventing Postpartum Hemorrhage Following a Cesarean Delivery

NCT03431805 | Completed Phase 3

• 1 other identifier: CHUBX 2015/41
• Study Type: interventional
• Target: 4,574
• Locations: 1 country
• Sites: 26

Brief Summary

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

Conditions

Postpartum Hemorrhage

Keywords

Randomized; double blind placebo controlled trial; prevention; tranexamic acid; postpartum hemorrhage; cesarean

Outcome Measures

Primary Outcomes (1)

• postpartum hemorrhage

  Incidence of PPH defined by a calculated blood loss \> 1000mL \[Calculated estimated blood loss = estimated blood volume × (preoperative Ht - postoperative Ht)/preoperative Ht (where estimated blood volume (mL) = weight (Kg) × 85)\] or red blood cell transfusion up to day 2 postpartum. Preoperative Ht will be the most recent Ht within one week before delivery. Postoperative Ht will be measured at D2

  day 2

Secondary Outcomes (43)

• mean calculated blood loss > 500mL

  day 2

• mean calculated blood loss > 1500mL

  day 2

• total mean calculated blood loss

  day 2

• mean gravimetrically estimated blood loss

  6 hours

• incidence of postpartum transfusion

  day 2

Study Arms (2)

Tranexamic acid

EXPERIMENTAL

intravenous administration of 10-mL of tranexamic acid (EXACYL® 1 g/10 ml I.V., solution injectable)

Drug: Tranexamic Acid Injectable Solution

Chloride solution

PLACEBO COMPARATOR

sodium intravenous administration of 10-mL of chloride solution (0.9% -10mL).

Drug: Sodium Chloride 0.9%

Interventions

Tranexamic Acid Injectable Solution DRUG

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.

Tranexamic acid

Sodium Chloride 0.9% DRUG

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.

Chloride solution

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• : 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

You may not qualify if:

• 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,

Sponsors & Collaborators

• University Hospital, Bordeaux: lead
• Ministry of Health, France: collaborator

Study Sites (26)

CHU Angers

Angers, 49033, France

Location

CHU Jean Minjoz

Besançon, 25000, France

Location

CHU Bordeaux

Bordeaux, 33076, France

Location

CHRU Côte de Nacre

Caen, 14033, France

Location

CHU Estain

Clermont-Ferrand, 63001, France

Location

Centre Hospitalier Intercommunal de Créteil

Créteil, France

Location

Hôpital Saint Joseph Marseille

Marseille, 13008, France

Location

Hopital Nord

Marseille, 13915, France

Location

CHU de Montpellier

Montpellier, 34295, France

Location

CHRU de Nancy

Nancy, 54000, France

Location

CHU Nantes

Nantes, 44093, France

Location

CHU Nîmes

Nîmes, 30900, France

Location

Hôpital Trousseau

Paris, 75012, France

Location

Hôpital Saint Joseph Paris

Paris, 75014, France

Location

Maternité de Port-Royal Paris

Paris, 75014, France

Location

Hôpital universitaire Necker-Enfants malades

Paris, 75015, France

Location

Hôpital universitaire Robert Debré

Paris, 75019, France

Location

Hôpital universitaire Kremlin-Bicètre

Paris, 94270, France

Location

CH de Pau

Pau, France

Location

Centre Hospitalier Intercommunal Poissy-Saint Germain

Poissy, 78303, France

Location

CHU Rennes

Rennes, 35033, France

Location

CHU Charles Nicolle

Rouen, 76000, France

Location

CHU Saint Etienne

Saint-Etienne, 42270, France

Location

CHU Strasbourg

Strasbourg, 67098, France

Location

Hôpital Paule de Viguier CHU Toulouse

Toulouse, 31059, France

Location

CHU Tours

Tours, 37044, France

Location

Related Publications (3)

• Sentilhes L, Benard A, Madar H, Froeliger A, Petit S, Deneux-Tharaux C; TRAAP2 study group. Tranexamic acid for reduction of blood loss after Caesarean delivery: a cost-effectiveness analysis of the TRAAP2 trial. Br J Anaesth. 2023 Nov;131(5):893-900. doi: 10.1016/j.bja.2023.07.028. Epub 2023 Sep 9.

  PMID: 37690946 DERIVED

• Sentilhes L, Senat MV, Le Lous M, Winer N, Rozenberg P, Kayem G, Verspyck E, Fuchs F, Azria E, Gallot D, Korb D, Desbriere R, Le Ray C, Chauleur C, de Marcillac F, Perrotin F, Parant O, Salomon LJ, Gauchotte E, Bretelle F, Sananes N, Bohec C, Mottet N, Legendre G, Letouzey V, Haddad B, Vardon D, Madar H, Mattuizzi A, Daniel V, Regueme S, Roussillon C, Benard A, Georget A, Darsonval A, Deneux-Tharaux C; Groupe de Recherche en Obstetrique et Gynecologie. Tranexamic Acid for the Prevention of Blood Loss after Cesarean Delivery. N Engl J Med. 2021 Apr 29;384(17):1623-1634. doi: 10.1056/NEJMoa2028788.

  PMID: 33913639 DERIVED

• Sentilhes L, Daniel V, Deneux-Tharaux C; TRAAP2 Study Group and the Groupe de Recherche en Obstetrique et Gynecologie (GROG). TRAAP2 - TRAnexamic Acid for Preventing postpartum hemorrhage after cesarean delivery: a multicenter randomized, doubleblind, placebo- controlled trial - a study protocol. BMC Pregnancy Childbirth. 2020 Jan 31;20(1):63. doi: 10.1186/s12884-019-2718-4.

  PMID: 32005192 DERIVED

MeSH Terms

Conditions

Postpartum Hemorrhage

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double blind
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2018
• First Posted: February 13, 2018
• Study Start: March 3, 2018
• Primary Completion: January 14, 2020
• Study Completion: April 8, 2020
• Last Updated: April 29, 2020

Record last verified: 2020-04

Locations

FR (26)