Prevention of Postpartum Hemorrhage With Tranexamic Acid

Recruiting Phase 2 Interventional Study
Post Partum Hemorrhage
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial. Healthy Volunteers Welcome You do not need to have the condition being studied to take part.
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At a Glance
Age
18 – 50
Sex
Female
Trial phase
Phase 2
Study type
Interventional
Purpose
Prevention
Participants needed
120 (estimated)
Sponsor
Inova Health Care Services · Other
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About This Trial
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. The drug was administered intravenously at the ti…
Trial Locations
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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 …
Contacts

Homa K Ahmadzia, MD

706-776-6650

homa.ahmadzia@inova.org

CONTACT

Jaclyn Phillips

CONTACT