Prevention of Postpartum Hemorrhage With Tranexamic Acid
| Status: | Recruiting |
|---|---|
| Conditions: | Women's Studies |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | 18 - 49 |
| Updated: | 11/16/2018 |
| Start Date: | January 2, 2018 |
| End Date: | September 1, 2020 |
| Contact: | Alexandra North, BS |
| Email: | anorth@mfa.gwu.edu |
| Phone: | (202)741-2592 |
Prevention of Postpartum Hemorrhage: Identifying Pregnant Women at Risk and Determining the Safe and Effective Use of Tranexamic Acid Using State-of-the-art Pharmacokinetic/Pharmacodynamics Modeling
Postpartum hemorrhage is a significant contributor to maternal morbidity and mortality and is
worldwide. TXA has recently been proven to reduce mortality when given to women in setting of
diagnosed PPH. US obstetricians and anesthesiologists are hesitant to use TXA in the
peripartum period especially for prevention of PPH due to uncertainty of an optimal dose and
safety profile. The purpose of this study is to characterize the pharmacokinetics of TXA when
given prophylactically at time of delivery. In addition investigators will determine the
pharmacodynamics of TXA in the peripartum period.
worldwide. TXA has recently been proven to reduce mortality when given to women in setting of
diagnosed PPH. US obstetricians and anesthesiologists are hesitant to use TXA in the
peripartum period especially for prevention of PPH due to uncertainty of an optimal dose and
safety profile. The purpose of this study is to characterize the pharmacokinetics of TXA when
given prophylactically at time of delivery. In addition investigators will determine the
pharmacodynamics of TXA in the peripartum period.
Conduct a prospective, open-label, dose finding PK study in 30 pregnant 3rd trimester women
scheduled for non-emergent cesarean section who are at risk for hemorrhage. Three doses of
the drug will be administered in an escalating fashion by cohort with the lowest dose first.
A maximum of 1 gram will be administered. TXA serum levels at several time points after
delivery will be assayed. A PK model will be constructed for determining the optimal TXA dose
administered at parturition.
scheduled for non-emergent cesarean section who are at risk for hemorrhage. Three doses of
the drug will be administered in an escalating fashion by cohort with the lowest dose first.
A maximum of 1 gram will be administered. TXA serum levels at several time points after
delivery will be assayed. A PK model will be constructed for determining the optimal TXA dose
administered at parturition.
Inclusion Criteria:
- Women who are undergoing medically indicated cesarean section at greater than 34+0
weeks gestation or women undergoing elective cesarean section at 39+0 weeks gestation
in accordance with recommendations from the American Congress of Obstetricians and
Gynecologists
- Pregnant women with normal serum creatinine (serum creatinine < 0.9)
- Women between the ages of 18 and 50 years old
Exclusion Criteria:
- Patients younger than 18 or older than 50
- women with active thrombotic or thromboembolic disease
- Women with a history of arterial or venous thromboembolic event
- Women with inherited thrombophilia or preexisting conditions that predisposes them to
thromboembolic events (i.e. lupus, antiphospholipid syndrome)
- Women with a subarachnoid hemorrhage
- Women with acquired defective color vision
- history of seizure disorder
- known renal dysfunction
- multiple gestations (Twin or triplet pregnancies)
- Hypersensitivity to Tranexamic acid or anti-fibrinolytic therapy
- History of liver dysfunction
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