ROTEM® Obstetric Hemorrhage Pilot Study

Study Overview
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Brief Summary
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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.

Official Title
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ROTEM® Obstetric Hemorrhage Pilot Study

Conditions
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High Risk Postpartum Hemorrhage (PPH)

Intervention / Treatment
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* Device: ROTEM - rotation thromboelastometry testing


Participation Criteria
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Eligibility Criteria
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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 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 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: ROTEM - rotation thromboelastometry testing|The ROTEM® is a simple blood test that provides information about specific components involved in blood clotting and stopping hemorrhage.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluating degrees of Fibrin polymerization (FIBTEM) ROTEM in the immediate postpartum period. |  | After delivery through study completion, an average of 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluating INTEM, EXTEM and APTEM Clotting time in pre and post-delivery. |  | Pre and post-delivery through study completion, an average of 2 years | 
| Evaluating volume of estimated and quantitative blood loss |  | Pre and post-delivery through study completion, an average of 2 years | 
| Evaluating change in hemoglobin/hematocrit ratio between values on admission for delivery (or in the last 4 weeks prior to delivery) and at 24 (+/-4) hours postpartum |  | Pre and post-delivery through study completion, an average of 2 years | 
| Evaluating amount of Postpartum hemorrhage defined as Quantitative Blood Loss >500ml for vaginal delivery and >1000ml for cesarean delivery |  | Pre and post-delivery through study completion, an average of 2 years | 
| Evaluating frequency of blood transfusion and related morbidities |  | Pre and post-delivery through study completion, an average of 2 years | 
| Evaluating number of severe maternal morbidity (including admission to ICU, intubation, shock) |  | Pre and post-delivery through study completion, an average of 2 years | 
| Evaluating incidence of need for surgical and non-surgical interventions to manage Postpartum hemorrhage (PPH) |  | Pre and post-delivery through study completion, an average of 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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High risk Postpartum hemorrhage (PPH), ROTEM, pregnant women