Thromboelastography During and After Delivery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01506102
Recruitment Status : Unknown
Verified January 2012 by Silvia Stirparo, Città di Roma Hospital.
Recruitment status was:  Recruiting
First Posted : January 9, 2012
Last Update Posted : January 9, 2012
Information provided by (Responsible Party):
Silvia Stirparo, Città di Roma Hospital

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.

Condition or disease Intervention/treatment Phase
Delivery Uterine Device: Thromboelastography Not Applicable

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Official Title: Determination of Thromboelastography Values in Pregnancy and After Delivery
Study Start Date : November 2011
Estimated Primary Completion Date : May 2012
Estimated Study Completion Date : May 2012

Intervention Details:
    Device: Thromboelastography
    Thromboelastography during labor and after delivery
    Other Name: TEM-A automated thromboelastometer

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

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • healthy parturients in labor

Exclusion Criteria:

  • parturients with coagulation defects or anticoagulant therapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01506102

Contact: Giorgio Capogna, MD 0039065847 ext 204

Città di Roma Hospital Recruiting
Roma, Italy, 00152
Contact: Silvia Stirparo, MD    0039065847 ext 204   
Contact: Giorgio Capogna, MD    0039065847 ext 204   
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
Principal Investigator: Silvia Stirparo, MD Città di Roma Hospital

Responsible Party: Silvia Stirparo, Staff Anesthesiologist, Città di Roma Hospital Identifier: NCT01506102     History of Changes
Other Study ID Numbers: TEM-A in pregnancy
First Posted: January 9, 2012    Key Record Dates
Last Update Posted: January 9, 2012
Last Verified: January 2012