Post Partum HemorrhagePhase 2Optimum OB-TXANCT05370820
Prevention of Postpartum Hemorrhage With Tranexamic Acid
A Phase 2 study testing Tranexamic acid in people with Post Partum Hemorrhage, run by Inova Health Care Services at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Post Partum Hemorrhage
- What is being tested?
- Tranexamic acid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesUnited States
- Study dates
- 28 Dec 2022to 1 Apr 2028
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Jaclyn Phillips contact
United States2 sites, 2 recruiting
- Recruiting
Inova Fairfax Medical Campus
Falls Church, Virginia, 22042
Homa Ahmadzia, MD, 706-776-6650, homa.ahmadzia@inova.org
Homa Ahmadzia, MD
- Recruiting
George Washington University Hospital
Washington D.C., District of Columbia, 20037
Jaclyn Phillips, MD, 202-741-2500, japhillips@mfa.gwu.edu
Homa K Ahmadzia, MD
About this study
Official title: Prevention of Postpartum Hemorrhage: Pharmacokinetics (PK) Abd Pharmacodynamics (PD) of Tranexamic Acid
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 time of umbilical cord clamping for a non-emergent cesarean section. A maximum of 1 g was administered. TXA serum levels at several time points after delivery were assayed to see if they reach the target plasma concentration of 10 ug/mL. A PK model was constructed for determining the optimal TXA dose administered at parturition.
In part 2 of the study, the investigators aim to compare PKPD endpoints using prophylactic TXA via IV and IM routes administered pre-cord clamp. The investigators will administer 1 g TXA within 10 minutes of skin incision via intravenous infusion (up to n=15), intravenous bolus < 2 minutes (up to n=15) and intramuscular injection (up to n=15). The investigators will target women undergoing scheduled cesarean delivery > 34 weeks gestation, women undergoing vaginal delivery > 34 weeks of gestation and morbidly obese women (BMI>=40) undergoing either a vaginal or cesarean delivery. The investigators will use advanced modeling techniques to determine time to achieve PKPD targets and duration remaining at those targets. The goal will be to determine how the optimal dose may vary if route of administration is modified. The investigators plan to enroll 45 patients in addition to the 43 that were enrolled during part 1. Our goal is to 30 participants, but the investigators will enroll 45 to account for lost to follow-up. The investigators also aim to enroll 30 patients undergoing vaginal delivery and 30 morbidly obese women (BMI >= 40) undergoing either a vaginal or cesarean delivery but the investigators will enroll 45 patients for each of these groups to account for loss to follow up. In addition, the investigators will enroll 30 pregnant patients receiving no medication acting as the control group, but the investigators will enroll 45 to account for loss to follow up.
Read the detailed description
The study will enroll 45 additional third trimester pregnant women scheduled for nonemergent cesarean sections. The investigators plan to enroll 30, but to account for lost to follow-up, the investigators will enroll 45. The investigators will also enroll 30 pregnant patients > 34 weeks of gestation undergoing vaginal delivery, and 30 morbidly obese (BMI >= 40) pregnant patients undergoing either vaginal or cesarean delivery. However, the investigators will enroll 45 patients in each of these two groups to account for loss to follow up. The investigators will also enroll 45 patients as a control group that will not receive TXA. The total number of enrolled patients will thus be 223.
A total of 1 g of TXA will be administered to patients prior to fetal delivery via three different routes of administration: IV infusion, IV push, and IM injection. The subjects in each group will be divided into three subgroups:
Group 1: Up to 15 subjects, TXA dose: 1 g, Route: IV infusion over 10 minutes Group 2: Up to 15 subjects, TXA dose: 1 g, Route: IV Push for <2 minutes Group 3: Up to 15 subjects, TXA dose: 1 g, Route: IM Injection
Plasma sampling: Timing of samples will be relative to the end of drug administration (t = 0) and include: Pre-drug administration, 5-10 minutes, 30-60 minutes, 60-90 minutes, 1.5-3 hours, 3-4 hours, 4-5 hours, 7-8 hours, and 10-18 hours. Each volume of blood draw will be approximately 7-9 mL. Actual times of plasma sampling will be documented. A second IV will be required for participating in the study. Citrated plasma samples will be centrifuged and supernatant will be stored at -80 degree Celsius. Breast milk sampling of no more than 2 mL per time point will occur at time points coinciding with maternal feedings.
- Conditions
- Post Partum Hemorrhage
- Being tested
- Tranexamic acid, No intervention
- Medical subject headings
- Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic acidDrug
Tranexamic Acid 1000 mg administered intravenously via infusion over 10 minutes.
Tranexamic acidDrug
Tranexamic Acid 1000 mg administered intravenously via push over 2 minutes.
Tranexamic acidDrug
Tranexamic Acid 1000 mg administered intramuscularly.
No interventionOther
Control group with no administration of Tranexamic Acid.
| Study group | Role | What they receive |
|---|---|---|
| Cesarean Delivery | Experimental | Not described Receives: Drug: Tranexamic acid; Other: No intervention |
| Vaginal Delivery | Experimental | Not described Receives: Drug: Tranexamic acid; Other: No intervention |
| Morbidly Obese | Experimental | Not described Receives: Drug: Tranexamic acid; Other: No intervention |
| No TXA | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
PK Model Parameter Estimates
Data obtained from assays of TXA in blood, dose group and patient characteristics; parameter estimates in 2 compartment model includes the clearance of the drug (L/hr).
Measured: Different time points ranging from surgery (T0) to 1 day postpartum.
Pharmacodynamics of Tranexamic Acid
PD model parameters included concentration of TXA causing 50% of maximal fractional inhibition (IC50).
Measured: Different time points ranging from surgery (T0) to 1 day postpartum.
Secondary outcomes (2)
Estimated Blood Loss
Intraoperative blood loss
Measured: During surgery
Safety Parameters
Safety parameters such as adverse events (including nausea/vomiting) and serious adverse events
Measured: During surgery, after surgery while in hospital, 2 weeks and 6 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2022
- Study start28 Dec 2022
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Partum HemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inova Health Care Services
- Sponsor type
- University, hospital or other
- Collaborators
- George Washington University, University of Maryland, University of North Carolina, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Homa Ahmadzia, MD, Inova Health Care Services
- Investigators
- Homa K Ahmadzia, MD, Principal investigator, Inova Health Care Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05370820
- Sponsor's protocol ID
- INOVA-2024-39
- Other IDs
- R01HD110109
- Acronym
- Optimum OB-TXA
- Status last verified
- Oct 2026
- First submitted
- 22 Apr 2022
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided