Improving Management of Post-partum Haemorrhage With Quantra® System (Quantralab)

April 13, 2022 updated by: GRENIE, University Hospital, Montpellier

Use of Quantra® System in Clinical Practice to Improve Management of Post-partum Haemorrhage : a Prospective Study

Post partum haemorrhage is a concerning situation in maternity wards, though it is not the first cause of maternal mortality anymore.

It has been already shown that low fibrinogen level is a major predictive factor of massive bleeding after delivery.

In this situation, the early knowledge of fibrinogen level could enhance care of women experiencing post partum haemorrhage.

In a cohort of women suffering from post partum haemorrhage, this study will evaluate whether assessing fibrinogen level would be faster using the Quantra® system than the standard coagulation test.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

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 Contact

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women ≥ 18 years old experiencing post partum haemorrhage ≥ 500 mL

Description

Inclusion Criteria:

Women ≥ 18 years old Experiencing post partum haemorrhage ≥ 500 mL Within 24 hours after delivery

Exclusion Criteria:

  • Previous anemia ≤ 7g/dL
  • Known bleeding disorders
  • Ongoing antiplatelets treatment
  • Ongoing anticoagulant treatment

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: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of delay in obtaining Quantra Fibrinogen Clot Stiffness result to standard fibrinogen level result
Time Frame: When post partum haemorrhage occurred, within 24 hours after delivery
Comparison of delay in obtaining Quantra Fibrinogen Clot Stiffness result to standard fibrinogen level result
When post partum haemorrhage occurred, within 24 hours after delivery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of level of fibrinogen assessed by Quantra Fibrinogen Clot Stiffness to level of fibrinogen assessed by standard coagulation test
Time Frame: When post partum haemorrhage occurred, within 24 hours after delivery
Fibrinogen level assessed by Quantra and standard coagulation tests
When post partum haemorrhage occurred, within 24 hours after delivery
Comparison of Quantra Clot Time result to Standard Kaolin Clotting time result
Time Frame: When post partum haemorrhage occurred, within 24 hours after delivery
Coagulation function assessed by Quantra and standard coagulation tests
When post partum haemorrhage occurred, within 24 hours after delivery
Comparison of Platelet Clot Stiffness result to standard platelet count result
Time Frame: When post partum haemorrhage occurred, within 24 hours after delivery
Platelet function assessed by Quantra and standard platelet count.
When post partum haemorrhage occurred, within 24 hours after delivery
Rate of satisfaction of anesthetist in charge of patient assessed by Lickert scale
Time Frame: When post partum haemorrhage occurred, within 24 hours after delivery
Rate of satisfaction of anesthetist in charge of patient assessed by Lickert scale [1-Strongly disagree ; 2-Disagree ; 3-Neither agree nor disagree ; 4-Agree ; 5-Strongly agree
When post partum haemorrhage occurred, within 24 hours after delivery

Collaborators and Investigators

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

Sponsor

University Hospital, Montpellier

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 (Anticipated)

May 1, 2022

Primary Completion (Anticipated)

May 1, 2023

Study Completion (Anticipated)

May 1, 2023

Study Registration Dates

First Submitted

March 23, 2022

First Submitted That Met QC Criteria

April 13, 2022

First Posted (Actual)

April 20, 2022

Study Record Updates

Last Update Posted (Actual)

April 20, 2022

Last Update Submitted That Met QC Criteria

April 13, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RECHMPL21_0729

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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