CompletedNot Applicable

ROTEM® Obstetric Hemorrhage Pilot Study

United States60 participantsStarted 2020-07-27

Plain-language 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, or for scheduled cesarean section.

Who can participate

Age range18 Years

SexFEMALE

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Inclusion criteria

✓. 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

Exclusion criteria

✕. 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.

What they're measuring

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

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

Trial details

NCT IDNCT04409015

SponsorOhio State University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2021-01-30

View on ClinicalTrials.gov More High Risk Postpartum Hemorrhage (PPH) trials