ROTEM® Obstetric Hemorrhage Pilot Study

September 19, 2022 updated by: Michael Cackovic, Ohio State University
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Evaluating degrees of Fibrin polymerization (FIBTEM) ROTEM in the immediate postpartum period.
Time Frame: After delivery through study completion, an average of 2 years
After delivery through study completion, an average of 2 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Evaluating INTEM, EXTEM and APTEM Clotting time in pre and post-delivery.
Time Frame: Pre and post-delivery through study completion, an average of 2 years
Pre and post-delivery through study completion, an average of 2 years
Evaluating volume of estimated and quantitative blood loss
Time Frame: Pre and post-delivery through study completion, an average of 2 years
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
Time Frame: Pre and post-delivery through study completion, an average of 2 years
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
Time Frame: Pre and post-delivery through study completion, an average of 2 years
Pre and post-delivery through study completion, an average of 2 years
Evaluating frequency of blood transfusion and related morbidities
Time Frame: Pre and post-delivery through study completion, an average of 2 years
Pre and post-delivery through study completion, an average of 2 years
Evaluating number of severe maternal morbidity (including admission to ICU, intubation, shock)
Time Frame: Pre and post-delivery through study completion, an average of 2 years
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)
Time Frame: Pre and post-delivery through study completion, an average of 2 years
Pre and post-delivery through study completion, an average of 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ohio State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 27, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 30, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 26, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 26, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 1, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 21, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 19, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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Dietary Supplements

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