Thromboelastography During and After Delivery
Recruitment status was Recruiting
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.
|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|
- 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.
|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)|
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
Please refer to this study by its ClinicalTrials.gov identifier: 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|