NCT01506102

Brief Summary

The purpose of this study is to establish reference values for thromboelastography (TEM-A) in healthy pregnant women during labor and 2 hours and 24 hours after delivery.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2011

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

November 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 5, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 9, 2012

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

January 9, 2012

Status Verified

January 1, 2012

Enrollment Period

6 months

First QC Date

January 5, 2012

Last Update Submit

January 6, 2012

Conditions

Delivery Uterine

Outcome Measures

Primary Outcomes (1)

  • TEM-A automated thromboelastometer, Framar Biomedica,Rome, Italy

    To determine the physiological reference individual values of maternal thromboelastography TEM-A during labor, immediately afeter delivery and in the postpartum period.

    24 hours postpartum

Interventions

ThromboelastographyDEVICE

Thromboelastography during labor and after delivery

Also known as: TEM-A automated thromboelastometer

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • healthy parturients in labor

You may not qualify if:

  • parturients with coagulation defects or anticoagulant therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Città di Roma Hospital

Roma, Roma, 00152, Italy

RECRUITING

MeSH Terms

Interventions

Thrombelastography

Intervention Hierarchy (Ancestors)

Blood Coagulation TestsHematologic TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Officials

  • Silvia Stirparo, MD

    Città di Roma Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Giorgio Capogna, MD

CONTACT

0039065847capogna.giorgio@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Staff Anesthesiologist

Study Record Dates

First Submitted

January 5, 2012

First Posted

January 9, 2012

Study Start

November 1, 2011

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

January 9, 2012

Record last verified: 2012-01

Locations

IT(1)