ROTEM® Obstetric Hemorrhage Pilot Study

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.

Study Overview

• Status: Completed
• Conditions: High Risk Postpartum Hemorrhage (PPH)
• Intervention / Treatment: Device: ROTEM - rotation thromboelastometry testing

• Study Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Pregnant women with high risk of postpartum hemorrhage

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Ohio State University

Study record dates

Study Major Dates

• Study Start (Actual): July 27, 2020
• Primary Completion (Actual): January 30, 2021
• Study Completion (Actual): March 1, 2022

Study Registration Dates

• First Submitted: May 26, 2020
• First Submitted That Met QC Criteria: May 26, 2020
• First Posted (Actual): June 1, 2020

Study Record Updates

• Last Update Posted (Actual): September 21, 2022
• Last Update Submitted That Met QC Criteria: September 19, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: pregnant women; ROTEM; High risk Postpartum hemorrhage (PPH)
• Additional Relevant MeSH Terms: Pathologic Processes; Pregnancy Complications; Obstetric Labor Complications; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Postpartum Hemorrhage
• Other Study ID Numbers: 2020H0119

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No