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NCT Number: NCT07078942

Prophylactic Intravenous Tranexamic Acid on Perioperative Blood Loss in Pregnant Women Undergoing Cesarean Section

The purpose of this study is to asses the effect of preoperative prophylactic intravenous tranexamic acid on perioperative blood loss in pregnant women undergoing cesarean section

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Key information

Conditions

Pregnant Women Undergoing Cesarean Delivery Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Department of Obstetrics and Gynecology, Faculty of Medicine, Chulalongkorn University

Bangkok, 10330, Thailand

Location contact

Thawit Suesakulpaisal, M.D.

PRINCIPAL_INVESTIGATOR

Vorapong Phupong, M.D.

CONTACT

[email protected]

026492115

Vorapong Phupong, M.D.

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • pregnant women with gestational age 37-42 weeks
  • undergoing cesarean delivery with indication as follows: placenta previa, severe preeclampsia, myoma uteri, fetal macrosomia, polyhydramnios, grand multiparity ≥ 5 deliveries, prolonged labor, etc.

Exclusion criteria

  • history of allergy to tranexamic acid
  • history of venous thromboembolism (Deep vein thrombosis, Pulmonary embolism)
  • history of arterial thrombosis (Myocardial infarction, Stroke)
  • history of seizure, convulsion
  • have underlying of cardiovascular, renal or liver disease
  • using of antiplatelet or anticoagulant within 1 week before operation
  • placenta accreta spectrum
  • abruptio placenta
  • Eclampsia or HELLP (Hemolysis Elevated Liver Low Platelet) syndrome
  • Failed operative vaginal delivery
  • Multifetal gestation

Treatment and study plan

Tranexamic Acid

Drug

Tranexamic Acid 1 g intravenous preoperation

Placebo

Other

normal saline 20 ml intravenous preoperation

Primary outcomes

  1. Blood loss

    Time frame: From enrollment to the end of operation

    blood loss in ml

Secondary outcomes

  1. early postpartum hemorrhage

    Time frame: From starting operation to 24-hour postoperation

    percentage of early postpartum hemorrhage

  2. delayed postpartum hemorrhage

    Time frame: From starting operation to 6 weeks postpartum

    percentage of delayed postpartum hemorrhage

  3. Adverse effects

    Time frame: from enrollment to 6 weeks postpartum

    percentage of adverse effects

  4. Neonatal outcomes

    Time frame: from starting operation to 10 minutes after birth

    Apgar scores (0 is the minimum value and 10 is maximum value, and higher scores mean a better outcome)

Study contacts

Contact information is provided by the study sponsor or research team.

Thawit Suesakulpaisal, M.D.

CONTACT

[email protected]

026492115

Vorapong Phupong, M.D.

CONTACT

[email protected]

+6626492115

Sponsors and collaborators

Lead sponsor

Chulalongkorn University

Other

Registry information

Official study title

Effect of Preoperative Prophylactic Intravenous Tranexamic Acid on Perioperative Blood Loss in Pregnant Women Undergoing Cesarean Section : A Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 22, 2025
Registry last updated
Jul 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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