Thromboelastography During and After Delivery

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by Città di Roma Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Silvia Stirparo, Città di Roma Hospital
ClinicalTrials.gov Identifier:
NCT01506102
First received: January 5, 2012
Last updated: January 6, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention
Delivery Uterine
Device: Thromboelastography

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Diagnostic
Official Title: Determination of Thromboelastography Values in Pregnancy and After Delivery

Further study details as provided by Città di Roma Hospital:

Primary Outcome Measures:
  • TEM-A automated thromboelastometer, Framar Biomedica,Rome, Italy [ Time Frame: 24 hours postpartum ] [ Designated as safety issue: Yes ]
    To determine the physiological reference individual values of maternal thromboelastography TEM-A during labor, immediately afeter delivery and in the postpartum period.


Estimated Enrollment: 120
Study Start Date: November 2011
Estimated Study Completion Date: May 2012
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Thromboelastography
    Thromboelastography during labor and after delivery
    Other Name: TEM-A automated thromboelastometer
Detailed Description:

Previous, preliminary investigations by using thromboelastography, confirmed that pregnancy is a hypercoaguable state which remains in the first 24 hours postdelivery. Unfortunately results obtained by the existing studies that attempted to establish reference values for TEG suffer considerable bias.

The aim of this study will be to determine the range values for thomboelastography in pregnant women. Since there is no available information on the expected distribution of the outcome, a sequential design will be used. The main endpoint of the analysis will be a reliable estimate for the outcome expected in healthy women after labor. The investigators will state their target estimate as being reliable when the ratio between the estimate and its standard error is smaller than 2.

During labor, 2 hours after delivery and 24 hours postpartum, a venous blood sample will be taken from eligible women for thromboelastographic determination. Whole blood nonadditive TEM will be performed on the TEM-A automated thromboelastometer (Framar Biomedica,Rome, Italy) to obtain the four classical TEM parameters: reaction (R) time, k time, alpha angle and maximum amplitude (MA).

Inclusion criteria Healthy parturients in labor Exclusion criteria parturients who will eventually had: operative or instrumental vaginal delivery, estimated blood loss greater than 500 mL, the occurrence of II and III degree perineal lacerations, any coagulation disorder or anticoagulant therapy

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • healthy parturients in labor

Exclusion Criteria:

  • parturients with coagulation defects or anticoagulant therapy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01506102

Contacts
Contact: Giorgio Capogna, MD 0039065847 ext 204 capogna.giorgio@gmail.com

Locations
Italy
Città di Roma Hospital Recruiting
Roma, Italy, 00152
Contact: Silvia Stirparo, MD    0039065847 ext 204    silvia.s@tin.it   
Contact: Giorgio Capogna, MD    0039065847 ext 204    capogna.giorgio@gmail.com   
Principal Investigator: Silvia Stirparo, MD         
Principal Investigator: Giorgio Capogna, MD         
Principal Investigator: Gabriele Tola, MD         
Principal Investigator: Luca Ruggeri, MD         
Sponsors and Collaborators
Città di Roma Hospital
Investigators
Principal Investigator: Silvia Stirparo, MD Città di Roma Hospital
  More Information

No publications provided

Responsible Party: Silvia Stirparo, Staff Anesthesiologist, Città di Roma Hospital
ClinicalTrials.gov Identifier: NCT01506102     History of Changes
Other Study ID Numbers: TEM-A in pregnancy
Study First Received: January 5, 2012
Last Updated: January 6, 2012
Health Authority: Italy: Ministry of Health

ClinicalTrials.gov processed this record on October 20, 2014