Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:26 AM
Ignite Modification Date:
2025-12-25 @ 4:26 AM
NCT ID:
NCT05370820
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
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT05370820
Study Brief:
Protocol Section:
NCT05370820