TRAnexamic Acid for Preventing Postpartum Hemorrhage Following a Cesarean Delivery

University Hospital, Bordeaux4,574 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

4,574

Conditions

Postpartum Hemorrhage

Interventions

Tranexamic Acid Injectable SolutionDRUG

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.

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.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 64 Years

Medical Language ↔ Plain English

Inclusion Criteria: * : 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 Criteria: * 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.

Locations (26)

CHU Angers

Angers, France

CHU Jean Minjoz

Outcomes

Primary Outcomes

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

Time frame: day 2

Secondary Outcomes

mean calculated blood loss > 500mL

Time frame: day 2

mean calculated blood loss > 1500mL

Time frame: day 2

total mean calculated blood loss

Time frame: day 2

mean gravimetrically estimated blood loss

by measuring the suction volume and swab weight; proportion of women requiring supplementary uterotonic treatment including sulprostone

Time frame: 6 hours

incidence of postpartum transfusion

Time frame: day 2

Mean or median number of units of red blood cells transfused

Time frame: day 2

incidence of arterial embolisation or emergency surgery for PPH

Time frame: 3 months

mean peripartum change in haemoglobin

difference between the most recent Hb within one week before delivery and at day 2 postpartum

Time frame: day 2

Data from ClinicalTrials.gov

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