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

January 5, 2012
January 6, 2012
November 2011
May 2012   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01506102 on ClinicalTrials.gov Archive Site
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Thromboelastography During and After Delivery
Determination of Thromboelastography Values in Pregnancy and After Delivery

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.

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

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Diagnostic
Delivery Uterine
Device: Thromboelastography
Thromboelastography during labor and after delivery
Other Name: TEM-A automated thromboelastometer
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
May 2012
May 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • healthy parturients in labor

Exclusion Criteria:

  • parturients with coagulation defects or anticoagulant therapy
Female
18 Years to 40 Years
No
Contact: Giorgio Capogna, MD 0039065847 ext 204 capogna.giorgio@gmail.com
Italy
 
NCT01506102
TEM-A in pregnancy
No
Silvia Stirparo, Città di Roma Hospital
Città di Roma Hospital
Not Provided
Principal Investigator: Silvia Stirparo, MD Città di Roma Hospital
Città di Roma Hospital
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP