ROTEM® Obstetric Hemorrhage Pilot Study

Ohio State University60 enrolled

Overview

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, or for scheduled cesarean section.

Study Type

OBSERVATIONAL

Enrollment

Conditions

High Risk Postpartum Hemorrhage (PPH)

Interventions

ROTEM - rotation thromboelastometry testingDEVICE

The ROTEM® is a simple blood test that provides information about specific components involved in blood clotting and stopping hemorrhage.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age ≥ 18 years and able to provide consent 2. Gestational age ≥ 34 weeks 3. ≥ 1 High-risk of postpartum hemorrhage criteria defined as either of: 1. Nulliparous women admitted for induction of labor with unfavorable cervix (Bishop's score \<5) 2. Prior uterine surgery (\> 1 prior cesarean or myomectomy) 3. Patients undergoing trial of labor after cesarean delivery 4. History of postpartum hemorrhage 5. ≥4 previous vaginal deliveries 6. Multiple gestation 7. The presence of \> 2 uterine fibroids or fibroid \> 5 cm on any ultrasound during the pregnancy 8. Planned magnesium sulfate use 9. Placenta previa/accreta/increta/percreta Exclusion Criteria: 1. Receipt of anticoagulation (prophylactic anticoagulation stopped 24 hours prior to sample collection is not an exclusion) 2. Antepartum hemorrhage present on admission (\>500cc Estimated Blood Loss (EBL)) 3. Coagulation defects 4. Thrombocytopenia with platelets count \<100,000 5. 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.

Locations (1)

The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine

Columbus, Ohio, United States

Outcomes

Primary Outcomes

Evaluating degrees of Fibrin polymerization (FIBTEM) ROTEM in the immediate postpartum period.

Time frame: After delivery through study completion, an average of 2 years