Many RCT(randomized controlled trial) studies reported that tranexamic acid reduced blood loss in women who had elective cesareans. However, most of these elective cesareans are without high-risk factors of postpartum hemorrhage, such as placenta previa. The prophylactic use of tranexamic acid in the placenta previa is not clear. studies had poor quality and lacked adequate power to assess severe adverse events.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
1,732
Intravenous administration of 10 mL (1 g of tranexamic acid), diluted in 40 ml of normal saline, over 10 minutes after umbilical-cord clamping, the routine prophylactic uterotonic administration
Intravenous administration of 10 mL placebo(0.9% sodium chloride), diluted in 40 ml of normal saline, over 10 minutes after umbilical-cord clamping, the routine prophylactic uterotonic administration
Incidence of PPH
defined by a calculated estimated blood loss \> 1000 mL \[Calculated estimated blood loss = estimated blood volume × (preoperative hematocrit - postoperative hematocrit)/preoperative hematocrit (where estimated blood volume (mL) = weight (Kg) × 85)\] or red blood cell (RBC) transfusion before day 2 postpartum .
Time frame: Day 2
mean total calculated blood loss
Calculated estimated blood loss = estimated blood volume × (preoperative hematocrit - postoperative hematocrit)/preoperative hematocrit (where estimated blood volume (mL) = weight (Kg) × 85)\] or red blood cell (RBC) transfusion before day 2 postpartum
Time frame: Day 2
mean gravimetrically estimated blood loss
estimated blood loss = (weight of materials used + materials not used - weight of all materials before surgery)/ 1.05 + volume included in the suction container
Time frame: postpartum 24 hours
Number of Participants with additional uterotonic agents treatment
additional uterotonic agents include oxytocin, carbetocin, carboprost, misoprostol, ergonovine et al
Time frame: baseline
incidence of postpartum transfusion
include RBC, plasma, platelet, cryo et al
Time frame: baseline
incidence of postpartum iron perfusion
Time frame: baseline
incidence of hypovolemic shock related to PPH
Time frame: baseline
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Department of Obstetrics and Gynecology, The Third Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Peking Union Medical College
Beijing, China
Peking University First Hospital
Beijing, China
Women and Children's Hospital of Chongqing Medical University
Chongqing, China
Dalian Women and Children's Medical Group
Dalian, China
Dongguan Maternal and Child Health Care Hospital
Dongguan, China
The Tenth Affiliated Hospital of Southern Medical University; Dongguan People's Hospital
Dongguan, China
Foshan Women and Children Hospital
Foshan, China
Boai Hospital of Zhongshan
Guangzhou, China
Huadu District People's Hospital of Guangzhou
Guangzhou, China
...and 17 more locations
incidence of interventional therapy
include arterial embolization, abdominal aortic balloon, internal iliac artery/common iliac artery balloon et al
Time frame: baseline
incidence of transfer to intensive care unit
Time frame: baseline
Number of Participants with additional operations performed outside cesarean section
Additional operations include B-Lnych, uterine artery suture, partial hysterectomy, hysterectomy et al
Time frame: baseline
incidence of maternal death from any cause
Time frame: week 6
incidence of hospital readmission
Time frame: baseline
mean peripartum change in hemoglobin
the difference between the hemoglobin levels before delivery and at D2
Time frame: Day 2
mean peripartum change in hematocrit levels
the difference between the hematocrit levels before delivery and at D2
Time frame: Day 2
incidence of infectious complications
include endometritis, surgical-site infection, or pelvic abscess within 6 weeks post partum
Time frame: week 6
incidence of maternal thromboembolic events
including venous, arterial, or ischemic stroke or myocardial infarction within 6 weeks post partum
Time frame: week 6