NCT03449420

Brief Summary

The aim of the study is to determine if thromboelastography parameters can be predictive of severe post partum hemorrhage.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2012

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

March 30, 2017

Completed
11 months until next milestone

First Posted

Study publicly available on registry

February 28, 2018

Completed
Last Updated

February 28, 2018

Status Verified

February 1, 2018

Enrollment Period

3.5 years

First QC Date

March 30, 2017

Last Update Submit

February 27, 2018

Conditions

Post Partum Hemorrhage

Keywords

thromboelastography

Outcome Measures

Primary Outcomes (1)

  • Calculated blood loss

    Calculated blood loss at 24 hours after delivery (Sum of the volume of blood transfused and the volume of blood loss calculated by the decrease in hematocrit.)

    during the 24 hours after delivery

Study Arms (1)

Post Partum Hemorrhage

Patients presenting with a post partum hemorrhage. A thromboelastography analysis is realized at discretion of the anesthesiologist in charge

Diagnostic Test: thromboelastography

Interventions

thromboelastographyDIAGNOSTIC_TEST

TEG5000® : Kaolin and Functional Fibrinogen tests on native blood sample

Post Partum Hemorrhage

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailspregnant women
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Women presenting with a post partum hemorrhage

You may qualify if:

  • Women presenting with a post partum hemorrhage
  • needing sulprostone infusion
  • during third trimester of pregnancy

You may not qualify if:

  • known coagulation disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Rigouzzo A, Louvet N, Favier R, Ore MV, Piana F, Girault L, Farrugia M, Sabourdin N, Constant I. Assessment of Coagulation by Thromboelastography During Ongoing Postpartum Hemorrhage: A Retrospective Cohort Analysis. Anesth Analg. 2020 Feb;130(2):416-425. doi: 10.1213/ANE.0000000000004422.

    PMID: 31567472DERIVED

MeSH Terms

Conditions

Postpartum Hemorrhage

Interventions

Thrombelastography

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPuerperal DisordersUterine HemorrhageHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Blood Coagulation TestsHematologic TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Officials

  • Agnes Rigouzzo, MD

    Hôpital Armand Trousseau

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Anesthesiology Department

Study Record Dates

First Submitted

March 30, 2017

First Posted

February 28, 2018

Study Start

January 1, 2012

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

February 28, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share