Efficacy of preoperative tranexamic acid administration for intraoperative blood loss reduction in high-risk cesarean delivery: A randomized controlled trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

TCTR

Registry ID

TCTR20241127006

Enrollment

Registered

2024-11-27

Start date

2023-09-20

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

To evaluate the efficacy of preoperative tranexamic acid (TXA) in reducing intraoperative blood loss in high-risk cesarean deliveries. Tranexamic acid, cesarean delivery, postpartum hemorrhage

Interventions

1 gm tranexamic acid ,0.9% sodium chloride solution (NSS)

Experimental Drug,Placebo Comparator Drug

tranexamic acid (TXA),Placebo

Eligibility

Sex/Gender

Female

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.pregnant women 2.18 years or older 3.GA 34th week or later of pregnancy 4.scheduled for cesarean delivery (either elective or emergency) 5.undergoing spinal anesthesia 6.one or more high-risk factors for postpartum hemorrhage (PPH) included previous cesarean delivery, transverse presentation, fetal macrosomia (estimated fetal weight exceeding 4.0 kg as determined by ultrasound), multiple gestation, placenta previa or low-lying placenta, prenatal anemia (hemoglobin levels below 9.9 g/dL), polyhydramnios (amniotic fluid index exceeding 24 cm or a deep vertical pocket exceeding 8 cm), or a previous history of PPH.

Exclusion criteria

Exclusion criteria: 1.medical conditions affecting the heart, liver, or kidneys, brain disorders, blood disorders 2.known sensitivity to TXA 3.a history of or present venous or arterial thromboembolism 4.intrauterine fetal death 5.major fetal anomalies

Design outcomes

Primary

Measure	Time frame
measurement of intraoperative blood loss from the time of placental delivery until skin closure gravimetric method	—

Secondary

Measure	Time frame
intraoperative blood loss more than 1,000 mL from the time of placental delivery until skin closure gravimetric method,hemoglobin level change 24 hours after CD 24 hours after delivery Complete blood count ,operative time skin incision to skin closure Stopwatch,intraoperative or postoperative blood transfusion within 24 hours within 24 hours after delivery Volume of blood (unit),additional uterotonic agents within 24 hours within 24 hours after delivery methylergonovine , misoprostol and carboprost tromethamine,adverse effects of tranexamic acid within 24 hours after delivery Nausea/Vomit, Dizziness, Headache, Chest discomfort, Rash and Other ,length of hospital stay (LOS) time at admission to discharge Day of discharge minus day of admission	—

Measure

Time frame

intraoperative blood loss more than 1,000 mL from the time of placental delivery until skin closure gravimetric method,hemoglobin level change 24 hours after CD 24 hours after delivery Complete blood count ,operative time skin incision to skin closure Stopwatch,intraoperative or postoperative blood transfusion within 24 hours within 24 hours after delivery Volume of blood (unit),additional uterotonic agents within 24 hours within 24 hours after delivery methylergonovine , misoprostol and carboprost tromethamine,adverse effects of tranexamic acid within 24 hours after delivery Nausea/Vomit, Dizziness, Headache, Chest discomfort, Rash and Other ,length of hospital stay (LOS) time at admission to discharge Day of discharge minus day of admission

—

Countries

Thailand

Contacts

Public ContactNid Wongjariyakul

Khon Kaen Hospital

nidwongjariyakul@gmail.com0853224725

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026