TRAPP: Tranexamic Acid for the Prevention of Postpartum Hemorrhage in Pregnant Women With Placenta Previa
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: study group Intravenous administration of 10 mL (1 g of tranexamic acid), slowly (over 30- 60 s), in the 3 min after birth, the routine prophylactic uterotonic administration, all generally by the obstetricians |
Drug: Tranexamic acid
Intravenous administration of 10 mL (1 g of tranexamic acid), slowly (over 30- 60 s), in the 3 min after birth, the routine prophylactic uterotonic administration, all generally by the obstetricians
|
| Placebo Comparator: control group Intravenous administration of 10 mL placebo(0.9% sodium chloride), slowly (over 30- 60 s), in the 3 min after birth, the routine prophylactic uterotonic administration, all generally by the obstetricians |
Other: 0.9% sodium chloride
Intravenous administration of 10 mL placebo(0.9% sodium chloride), slowly (over 30- 60 s), in the 3 min after birth, the routine prophylactic uterotonic administration, all generally by the obstetricians
|
Outcome Measures
Primary Outcome Measures
- Incidence of PPH [Day 1]
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 .
Secondary Outcome Measures
- mean total calculated blood loss [Day 1]
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
- calculated blood loss > 500 mL [Day 1]
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.
- calculated blood loss > 1500 mL [Day 1]
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.
- mean gravimetrically estimated blood loss [intraoperative]
estimated blood loss = (weight of materials used + materials not used - weight of all materials before surgery)/ 1.05 + volume included in the suction container
- gravimetrically estimated blood loss >500 mL [intraoperative]
estimated blood loss = (weight of materials used + materials not used - weight of all materials before surgery)/ 1.05 + volume included in the suction container
- gravimetrically estimated blood loss > 1000 mL [intraoperative]
description: estimated blood loss = (weight of materials used + materials not used - weight of all materials before surgery)/ 1.05 + volume included in the suction container
- gravimetrically estimated blood loss > 1500 mL [intraoperative]
description: estimated blood loss = (weight of materials used + materials not used - weight of all materials before surgery)/ 1.05 + volume included in the suction
- Number of Participants with additional uterotonic agents treatment [intraoperative]
additional uterotonic agents include oxytocin, carbetocin, carboprost, misoprostol, ergonovine et al
- incidence of postpartum transfusion [up to 2 weeks]
include RBC, plasma, platelet, cryo et al
- incidence of postpartum iron perfusion [up to 2 weeks]
- incidence of hypovolemic shock related to PPH [up to 2 weeks]
- incidence of interventional therapy [up to 2 weeks]
include arterial embolization, abdominal aortic balloon, internal iliac artery/common iliac artery balloon et al
- incidence of transfer to intensive care unit [up to 2 weeks]
- Number of Participants with additional operations performed outside cesarean section [up to 2 weeks]
Additional operations include B-Lnych, uterine artery suture, partial hysterectomy, hysterectomy et al
- incidence of maternal death from any cause [up to 2 weeks]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Age 18-55 years old with a singleton
-
Diagnosed with Placenta previa before cesarean delivery by ultrasound（Placenta previa defined by a placental edge below 20mm from internal cervical os diagnosed at the most recent transvaginal ultrasound examination before delivery）
-
Gestational age ≥ 34 weeks
-
Available venous hematocrit value in the week before the cesarean
-
Prenatal hemoglobin level in the week before the cesarean > 90 g/l
-
Planned cesarean delivery
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Signed informed consent
Exclusion Criteria:
-
Known hypersensitivity to tranexamic acid or 0.95% sodium chloride
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History of venous (deep vein thrombosis and/or pulmonary embolism) or arterial (angina pectoris, myocardial infarction, or stroke) thrombosis
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History of epilepsy or seizure
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Any known active cardiovascular, renal, or liver disorders
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Autoimmune disease
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Sickle cell disease
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Severe hemorrhagic disease
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Administration of low-molecular-weight heparin or antiplatelet agents in the week before delivery
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Severe thrombin dysfunction, or prothrombin time and/or activated partial thrombin time exceeding the upper limit of normal, or platelet count < 80*10^9/L
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placental abruption
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In-utero fetal death
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Failed vaginal birth
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Planned general anesthesia
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gestational hypertension disease or HELLP syndrome
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Acquired color vision deficiency
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Significant bleeding (estimated blood loss>500ml) within 12 hours before cesarean delivery
-
multiple pregnancies
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Participated in other clinical studies within 3 months prior to inclusion
-
Intraoperative placenta retention in situ or direct uterine subtotal/total excision without attempting to expulsion the placenta
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of Obstetrics and Gynecology, The Third Affiliated Hospital of Guangzhou Medical University | Guangzhou | Guangdong | China | 510150 |
Sponsors and Collaborators
- Guangzhou Medical University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- GYSYTRAPP