ROTEM® Obstetric Hemorrhage Pilot Study

NCT ID: NCT04409015

Last Updated: 2022-09-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-27

Study Completion Date

2022-03-01

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.

Detailed Description

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Conditions

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High Risk Postpartum Hemorrhage (PPH)

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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ROTEM - rotation thromboelastometry testing

The ROTEM® is a simple blood test that provides information about specific components involved in blood clotting and stopping hemorrhage.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Ohio State University

OTHER

Sponsor Role lead

Responsible Party

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Michael Cackovic

MD, Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine

Columbus, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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2020H0119

Identifier Type: -

Identifier Source: org_study_id

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