Tranexamic Acid for the Prevention of Postpartum Hemorrhage in Pregnant Women With Placenta Previa

Department of Obstetrics and Gynecology, The Third Affiliated Hospital of Guangzhou Medical University, Guangzhou, PR China

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05811676

Acronym

TRAPP

Enrollment

1732

Registered

2023-04-13

Start date

2023-07-12

Completion date

2025-03-23

Last updated

2025-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemorrhage, Postpartum, Placenta Previa

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.

Interventions

DRUGTranexamic acid

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

OTHER0.9% sodium chloride

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

* Age of 18 years or older * 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 * Undergoing cesarean delivery * Signed informed consent

Exclusion criteria

* Known hypersensitivity to tranexamic acid or concentrated hydrochloric acid * History of venous (deep vein thrombosis and/or pulmonary embolism) or arterial thrombosis (angina pectoris, myocardial infarction, or stroke) * History of epilepsy or seizure * Any known active cancer, active cardiovascular, renal, or liver disorders * Autoimmune diseases such as lupus, rheumatoid arthritis, Sjogren's disease, and inflammatory bowel disease * Sickle cell disease * Severe hemorrhagic disease * Administration of low-molecular-weight heparin or antiplatelet agents within one week prior to delivery * Severe coagulation disorders with prothrombin time or activated partial thromboplastin time exceeding the upper limit of normal, or platelet count less than 80×109/L * placenta abruption * In-utero fetal death * Eclampsia or HELLP syndrome * Acquired color vision deficiency or subarachnoid hemorrhage * Severe bleeding with estimated blood loss exceeding 500 ml, within 12 hours before cesarean delivery * Known congenital or acquired thrombophilias, including antiphospholipid antibody syndrome * Participation in another intervention study where the primary outcome includes postpartum bleeding or thromboembolism or the study intervention potentially affects postpartum bleeding or thromboembolism

Design outcomes

Primary

Measure	Time frame	Description
Incidence of PPH	Day 2	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

Measure	Time frame	Description
mean gravimetrically estimated blood loss	postpartum 24 hours	estimated blood loss = (weight of materials used + materials not used - weight of all materials before surgery)/ 1.05 + volume included in the suction container
Number of Participants with additional uterotonic agents treatment	baseline	additional uterotonic agents include oxytocin, carbetocin, carboprost, misoprostol, ergonovine et al
incidence of postpartum transfusion	baseline	include RBC, plasma, platelet, cryo et al
incidence of postpartum iron perfusion	baseline	—
incidence of hypovolemic shock related to PPH	baseline	—
incidence of interventional therapy	baseline	include arterial embolization, abdominal aortic balloon, internal iliac artery/common iliac artery balloon et al
incidence of transfer to intensive care unit	baseline	—
mean total calculated blood loss	Day 2	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
incidence of maternal death from any cause	week 6	—
incidence of hospital readmission	baseline	—
mean peripartum change in hemoglobin	Day 2	the difference between the hemoglobin levels before delivery and at D2
mean peripartum change in hematocrit levels	Day 2	the difference between the hematocrit levels before delivery and at D2
incidence of infectious complications	week 6	include endometritis, surgical-site infection, or pelvic abscess within 6 weeks post partum
incidence of maternal thromboembolic events	week 6	including venous, arterial, or ischemic stroke or myocardial infarction within 6 weeks post partum
Number of Participants with additional operations performed outside cesarean section	baseline	Additional operations include B-Lnych, uterine artery suture, partial hysterectomy, hysterectomy et al

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 15, 2026