TRAnexamic Acid for Preventing Postpartum Hemorrhage Following a Cesarean Delivery
- Conditions
- Postpartum Hemorrhage
- Interventions
- Registration Number
- NCT03431805
- Lead Sponsor
- University Hospital, Bordeaux
- 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 review has concluded, that "TXA (in addition to uterotonic medications) decreases postpartum blood loss and prevents PPH and blood transfusions following vaginal birth and CS in women at low risk of PPH based on studies of mixed quality. Further investigations are needed on efficacy and safety of this regimen for preventing PPH.
Treatment, that is a 10-mL blinded vial of the study drug (either 1g TXA or placebo according to the randomization sequence), will be administered intravenously to the participant women during the third stage of labor of cesarean delivery.
The follow-up visit will take place in the postpartum ward of the maternity unit, on D2 postpartum. This stage will include a venous blood sample to measure plasma concentrations of Hb and Ht, urea and creatinemia, prothrombin time (PT), active prothrombin time (aPTT), aspartate and alanine transaminase, total bilirubin and fibrinogen, and the completion of a self-questionnaire about satisfaction by the women, as well as the assessment of the adverse events.
At 8 weeks postpartum, a self-questionnaire assessing psychological status and well-being will be sent to the women. At 12 weeks postpartum, all participants will be contacted by phone to assess the incidence of thrombotic and any other significant events.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 4574
- : 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Tranexamic acid Tranexamic Acid Injectable Solution intravenous administration of 10-mL of tranexamic acid (EXACYL® 1 g/10 ml I.V., solution injectable) Chloride solution Sodium Chloride 0.9% sodium intravenous administration of 10-mL of chloride solution (0.9% -10mL).
- Primary Outcome Measures
Name Time Method postpartum hemorrhage day 2 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
- Secondary Outcome Measures
Name Time Method mean calculated blood loss > 500mL day 2 mean calculated blood loss > 1500mL day 2 heart rate 15, 30, 45, 60 and 120 minutes after delivery bpm
systolic blood pressure 15, 30, 45, 60 and 120 minutes after delivery mmHg
gravimetrically estimated blood loss > 1000 mL day 2 mean gravimetrically estimated blood loss at the end of the cesarean delivery incidence of postpartum transfusion day 2 diastolic blood pressure 15, 30, 45, 60 and 120 minutes after delivery mmHg
number of participants with phosphenes reported by caregivers 6 hours aspartate transaminase day 2 IU/L
total fibrinogen day 2 g/L
women's satisfaction day 2 and weeks 8 postpartum assessed by a self-administered questionnaire
total mean calculated blood loss day 2 Mean or median number of units of red blood cells transfused day 2 mean peripartum change in haemoglobin day 2 difference between the most recent Hb within one week before delivery and at day 2 postpartum
number of participants with nausea reported by caregivers 6 hours number of participants with vomiting reported by caregivers 6 hours number of participants with deep venous thrombosis confirmed by paraclinical exams within twelve weeks after the delivery number of participants with myocardial infarction confirmed by paraclinical exams within twelve weeks after the delivery renal failure within twelve weeks after the delivery defined by the need for dialysis
Hb drop > 2g/DL day 2 Active prothrombin time (aPTT) day 2 mean peripartum change in hematocrit day 2 difference between the most recent Ht within one week before delivery and at day 2 postpartum
number of participants with dizziness reported by caregivers 6 hours creatinemia day 2 micromol/L
number of participants with pulmonary embolism confirmed by paraclinical exams within twelve weeks after the delivery alanine transaminase > 2N (day 2) day 2 supplementary uterotonic treatment day 2 proportion of women requiring supplementary uterotonic treatment
incidence of arterial embolisation or emergency surgery for PPH 3 months prothrombin time (PT) day 2 seizure within twelve weeks after the delivery Provider-assessed clinically significant PPH day 2 aspartate transaminase > 2N day 2 gravimetrically estimated blood loss > 500mL day 2 Shock day 2 Death from any cause 42 days postpartum urea day 2 g/L
alanine transaminase day 2 IU/L
total bilirubin day 2 micromol/L
number of participants with any thrombotic event confirmed by paraclinical exams within twelve weeks after the delivery Transfer to Intensive Care Unit twelve weeks after delivery iron sucrose perfusion discharge from hospital incidence of iron sucrose perfusion
Trial Locations
- Locations (26)
CHU Bordeaux
🇫🇷Bordeaux, France
Hôpital Saint Joseph Marseille
🇫🇷Marseille, France
CHU Charles Nicolle
🇫🇷Rouen, France
CHU Strasbourg
🇫🇷Strasbourg, France
Hôpital universitaire Necker-Enfants malades
🇫🇷Paris, France
CHU Jean Minjoz
🇫🇷Besançon, France
CHRU Côte de Nacre
🇫🇷Caen, France
Centre Hospitalier Intercommunal de Créteil
🇫🇷Créteil, France
CHU de Montpellier
🇫🇷Montpellier, France
CHU Angers
🇫🇷Angers, France
CHRU de Nancy
🇫🇷Nancy, France
CHU Nantes
🇫🇷Nantes, France
Centre Hospitalier Intercommunal Poissy-Saint Germain
🇫🇷Poissy, France
CHU Saint Etienne
🇫🇷Saint Etienne, France
Hôpital universitaire Robert Debré
🇫🇷Paris, France
CHU Estain
🇫🇷Clermont Ferrand, France
CHU Nîmes
🇫🇷Nîmes, France
Hôpital Paule de Viguier CHU Toulouse
🇫🇷Toulouse, France
Hopital Nord
🇫🇷Marseille, France
CH de Pau
🇫🇷Pau, France
Hôpital Saint Joseph Paris
🇫🇷Paris, France
Maternité de Port-Royal Paris
🇫🇷Paris, France
Hôpital universitaire Kremlin-Bicètre
🇫🇷Paris, France
CHU Rennes
🇫🇷Rennes, France
CHU Tours
🇫🇷Tours, France
Hôpital Trousseau
🇫🇷Paris, France