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Prevention study for Post Partum Hemorrhage
Official title Prevention of Postpartum Hemorrhage With Tranexamic Acid
ClinicalTrials.gov ID: NCT05370820
What this study is testing
What is Tranexamic acid?
Tranexamic acid is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for post partum hemorrhage.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- In part 1 of the study, the investigators conducted a prospective, open-label, dose finding pharmacokinetic (PK) study in 43 pregnant 3rd trimester women scheduled for non-emergent cesarean section. The investigators administered three doses of the drug (5 mg/kg, 10 mg/kg and 15 mg/kg) in an escalating fashion by cohort with the lowest dose first.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 50, women only. Healthy volunteers may be eligible.
You may be able to join if
- 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...
- 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.
You likely can't join if
- 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...
- a subarachnoid hemorrhage
- acquired defective color vision
- history of seizure disorder
See the full eligibility 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...
- 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.
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Washington D.C., District of Columbia, United States
- Falls Church, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 50 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Washington D.C., District of Columbia, United States; Falls Church, Virginia, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.