High Risk Postpartum Hemorrhage (PPH)
Conditions
Keywords
High risk Postpartum hemorrhage (PPH), ROTEM, pregnant women
Brief 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.
Interventions
DEVICEROTEM - rotation thromboelastometry testing
The ROTEM® is a simple blood test that provides information about specific components involved in blood clotting and stopping hemorrhage.
Sponsors
Ohio State University
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| 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 INTEM, EXTEM and APTEM Clotting time in pre and post-delivery. | 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 |
| Evaluating frequency of blood transfusion and related morbidities | Pre and post-delivery through study completion, an average of 2 years |
Countries
United States
Outcome results
None listed