Status:
COMPLETED
ROTEM® Obstetric Hemorrhage Pilot Study
Lead Sponsor:
Ohio State University
Conditions:
High Risk Postpartum Hemorrhage (PPH)
Eligibility:
FEMALE
18+ years
Brief Summary
This is a prospective observational study among women at high-risk of postpartum hemorrhage, in their third trimester who are admitted to Labor \&Delivery in spontaneous labor, for induction of labor,...
Eligibility Criteria
Inclusion
- Age ≥ 18 years and able to provide consent
- Gestational age ≥ 34 weeks
- ≥ 1 High-risk of postpartum hemorrhage criteria defined as either of:
- Nulliparous women admitted for induction of labor with unfavorable cervix (Bishop's score \<5)
- Prior uterine surgery (\> 1 prior cesarean or myomectomy)
- Patients undergoing trial of labor after cesarean delivery
- History of postpartum hemorrhage
- ≥4 previous vaginal deliveries
- Multiple gestation
- The presence of \> 2 uterine fibroids or fibroid \> 5 cm on any ultrasound during the pregnancy
- Planned magnesium sulfate use
- Placenta previa/accreta/increta/percreta
Exclusion
- Receipt of anticoagulation (prophylactic anticoagulation stopped 24 hours prior to sample collection is not an exclusion)
- Antepartum hemorrhage present on admission (\>500cc Estimated Blood Loss (EBL))
- Coagulation defects
- Thrombocytopenia with platelets count \<100,000
- Enrolled in the "Tranexamic Acid for the Prevention of Obstetrical Hemorrhage After Cesarean (TXA)" (NCT03364491) study or planned receipt of Tranexamic Acid (TXA) prior to enrollment.
Key Trial Info
Start Date :
July 27 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 1 2022
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04409015
Start Date
July 27 2020
End Date
March 1 2022
Last Update
September 21 2022
Active Locations (1)
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1
The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine
Columbus, Ohio, United States, 43210