ROTEM® Obstetric Hemorrhage Pilot Study

Completed

• Conditions: High Risk Postpartum Hemorrhage (PPH)

• Registration Number: NCT04409015
• Lead Sponsor: Ohio State University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-05-26
• Study First Submitted QC: 2020-05-26
• Study First Posted: 2020-06-01
• Study Start: 2020-07-27
• Primary Completion: 2021-01-30
• Study Completion: 2022-03-01
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-19
• Last Update Posted: 2022-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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 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 frequency of blood transfusion and related morbidities	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

Trial Locations

Locations (1)

The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine; 🇺🇸 Columbus, Ohio, United States