Clinical trial NCT04409015: ROTEM® Obstetric Hemorrhage Pilot Study
Official title: ROTEM® Obstetric Hemorrhage Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: High Risk Postpartum Hemorrhage (PPH)
Keywords: High risk Postpartum hemorrhage (PPH)
ROTEM
pregnant women
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2020-06-01
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women with high risk of postpartum hemorrhage

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Evaluating degrees of Fibrin polymerization (FIBTEM) ROTEM in the immediate postpartum period.
timeFrame: After delivery through study completion, an average of 2 years
Secondary outcomes:
measure: Evaluating INTEM, EXTEM and APTEM Clotting time in pre and post-delivery.
timeFrame: Pre and post-delivery through study completion, an average of 2 years
measure: Evaluating volume of estimated and quantitative blood loss
timeFrame: Pre and post-delivery through study completion, an average of 2 years
measure: 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
timeFrame: Pre and post-delivery through study completion, an average of 2 years
measure: Evaluating amount of Postpartum hemorrhage defined as Quantitative Blood Loss >500ml for vaginal delivery and >1000ml for cesarean delivery
timeFrame: Pre and post-delivery through study completion, an average of 2 years
measure: Evaluating frequency of blood transfusion and related morbidities
timeFrame: Pre and post-delivery through study completion, an average of 2 years
measure: Evaluating number of severe maternal morbidity (including admission to ICU, intubation, shock)
timeFrame: Pre and post-delivery through study completion, an average of 2 years
measure: Evaluating incidence of need for surgical and non-surgical interventions to manage Postpartum hemorrhage (PPH)
timeFrame: Pre and post-delivery through study completion, an average of 2 years
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine
state: Ohio
Study officials:
References: