Thromboelastography During and After Delivery
|ClinicalTrials.gov 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
|Condition or disease||Intervention/treatment||Phase|
|Delivery Uterine||Device: Thromboelastography||Not Applicable|
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|
|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|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01506102
|Contact: Giorgio Capogna, MD||0039065847 ext firstname.lastname@example.org|
|Città di Roma Hospital||Recruiting|
|Roma, Italy, 00152|
|Contact: Silvia Stirparo, MD 0039065847 ext 204 email@example.com|
|Contact: Giorgio Capogna, MD 0039065847 ext 204 firstname.lastname@example.org|
|Principal Investigator: Silvia Stirparo, MD|
|Principal Investigator: Giorgio Capogna, MD|
|Principal Investigator: Gabriele Tola, MD|
|Principal Investigator: Luca Ruggeri, MD|
|Principal Investigator:||Silvia Stirparo, MD||Città di Roma Hospital|