TRAnexamic Acid for Preventing Postpartum Hemorrhage Following a Cesarean Delivery :a Multicenter Randomised, Double Blind Placebo Controlled Trial (TRAAP2)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 4,574
- 试验地点
- 50
- 主要终点
- postpartum hemorrhage
研究概览
简要总结
The aim is to assess the impact of tranexamic acid (TXA) for preventing postpartum hemorrhage (PPH) following a cesarean section (CS).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
盲法说明
Double blind
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •: 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
排除标准
- •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.
研究组 & 干预措施
Chloride solution
sodium intravenous administration of 10-mL of chloride solution (0.9% -10mL).
干预措施: Sodium Chloride 0.9% (Drug)
Tranexamic acid
intravenous administration of 10-mL of tranexamic acid (EXACYL® 1 g/10 ml I.V., solution injectable)
干预措施: Tranexamic Acid Injectable Solution (Drug)
结局指标
主要结局
postpartum hemorrhage
时间窗: 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
次要结局
- 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)
- systolic blood pressure(15, 30, 45, 60 and 120 minutes after delivery)
- 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)
- number of participants with phosphenes reported by caregivers(6 hours)
- aspartate transaminase(day 2)
- total fibrinogen(day 2)
- 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)
- 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)
- Hb drop > 2g/DL(day 2)
- Active prothrombin time (aPTT)(day 2)
- mean peripartum change in hematocrit(day 2)
- number of participants with dizziness reported by caregivers(6 hours)
- creatinemia(day 2)
- 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)
- 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)
- alanine transaminase(day 2)
- total bilirubin(day 2)
- 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)
- women's satisfaction(day 2 and weeks 8 postpartum)