ROTEM® Obstetric Hemorrhage Pilot Study

The Ohio State University

Status: Completed

Conditions: High Risk Postpartum Hemorrhage (PPH)

Treatments: Device: ROTEM - rotation thromboelastometry testing

Study type: Observational

Funder types: Other

Identifiers

NCT04409015

2020H0119

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.