Rotational Thromboelastometry for the Transfusion Management of Postpartum Hemorrhage After Vaginal or Cesarean Delivery
Postpartum Hemorrhage
About this trial
This is an interventional treatment trial for Postpartum Hemorrhage
Eligibility Criteria
Inclusion Criteria:
American Society of Anesthesiologists (ASA) II or III health status (minimal to no systemic disease), age between 18 and 50 yrs, singleton pregnancies admitted for labor and delivery anticipated or actual PPH, or anticipated transfusion of blood products. This will be defined by one or more of the following eligibility criteria:
- Cesarean delivery with moderate or high risk for PPH (see below).
- Cesarean delivery with acute PPH of > 1000 mL and blood products ordered from the blood bank.
- Vaginal delivery with acute PPH of > 500 mL and blood products ordered from the blood bank.
For criterion #1, moderate risk for PPH is defined by one or more of the following features:
- prior cesarean delivery in labor
- prior cesarean delivery with known adhesive disease of the placenta
- multiple gestation
- >4 previous vaginal births
- chorioamnionitis with maternal temperature > 101 degrees Fahrenheit
- history of previous PPH
- large uterine fibroids (> 5 cm)
- second stage of labor (10cm cervical dilation to delivery) > 3 hours
High risk for postpartum hemorrhage is defined by one or more of the following features:
- suspected placenta accreta by pre-delivery ultrasound findings
- placenta previa (current or resolved within 4 weeks of delivery) or low-lying placenta
- active bleeding on admission prior to delivery
Exclusion Criteria:
- known coagulation defect prior to delivery including inherited (hemophilia A, von Willebrand disease, thrombocytopenia, other) or iatrogenic causes (anticoagulation therapy), refusal to accept blood transfusion (Jehovah's Witness, other).
Sites / Locations
- Brigham and Women's Hospital
Arms of the Study
Arm 1
Arm 2
No Intervention
Experimental
Control
ROTEM
Patients who experience postpartum hemorrhage will receive standard of care for labor and delivery, cesarean delivery, and postpartum care. Transfusion will be based on standard of care utilizing clinical criteria of hemodynamics (noninvasive blood pressure, heart rate, arterial line if deemed clinically useful) and coagulation labs (PT, activated partial thromboplastin time (aPTT), fibrinogen, complete blood count). In addition to standard of care, additional ROTEM blood assays will be performed at any time routine coagulation labs are sent. Providers in the control group will be blinded to ROTEM results.
Patients will receive standard of care for labor and delivery, cesarean delivery, and postpartum care. Transfusion will be based on standard of care utilizing clinical criteria of hemodynamics (noninvasive blood pressure, heart rate, arterial line if deemed clinically useful) and coagulation labs (PT, aPTT, fibrinogen, complete blood count). In addition to standard of care, additional ROTEM blood assays will be performed at any time routine coagulation labs are sent. Providers in the ROTEM group will receive real-time ROTEM results and a previously validated ROTEM-based transfusion algorithm for PPH.