Prevention of Postpartum Hemorrhage With Tranexamic Acid

Launched by INOVA HEALTH CARE SERVICES · May 6, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the use of a medication called Tranexamic Acid (TXA) to prevent heavy bleeding (postpartum hemorrhage) after childbirth, especially during cesarean sections. In the first part of the study, researchers tested different doses of TXA in pregnant women who were scheduled for a cesarean delivery. They are now moving to the second part, where they will compare how well TXA works when given in different ways (through an IV or an injection) right before the baby is delivered. The goal is to find the best way to administer TXA to help ensure mothers don't experience excessive bleeding after giving birth.

To be eligible for this trial, women must be between 18 and 50 years old and either be having an elective cesarean section after 34 weeks of pregnancy, a vaginal delivery after 34 weeks, or be morbidly obese with a body mass index (BMI) over 50. Participants can expect to receive TXA just before the birth and will be monitored for how well the medication works. It's important to note that women with certain health conditions, such as active blood clotting disorders or liver issues, cannot participate in the study. This trial aims to improve care for mothers during delivery and reduce the risk of serious bleeding.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Women who are scheduled to under medically indicated cesarean section at greater than 34+0 weeks gestation or women who are scheduled to undergo an elective cesarean section at 39+0 weeks gestation in accordance with recommendations from the American Congress of Obstetricians and Gynecologists
• • Women who are indicated to have a vaginal delivery at \> 34+0 weeks gestation.
• • Pregnant women with normal serum creatinine (serum creatinine \< 0.9) within 2 weeks of estimated/scheduled delivery
• • Women between the ages of 18 and 50 years old
• • Ability to understand and the willingness to sign a written informed consent form and HIPAA Authorization.
• Exclusion Criteria:
• • active thrombotic or thromboembolic disease
• • a history of arterial or venous thromboembolic event
• • inherited thrombophilia or preexisting conditions that predisposes them to thromboembolic events (i.e. lupus, antiphospholipid syndrome, thrombocytosis or thrombophilic thrombocytopathy)
• • a subarachnoid hemorrhage
• • acquired defective color vision
• • history of seizure disorder
• • known renal dysfunction (serum creatinine = or \>0.9)
• • multiple gestations (twin or triplet pregnancies)
• • hypersensitivity to Tranexamic acid or anti-fibrinolytic therapy
• • history of liver dysfunction at the discretion of the investigator