Thromboelastography During and After Delivery

Delivery Uterine Clinical Trial

Official title:

Determination of Thromboelastography Values in Pregnancy and After Delivery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01506102
• Other study ID #: TEM-A in pregnancy
• Status: Recruiting
• Phase: N/A
• First received: January 5, 2012
• Last updated: January 6, 2012
• Start date: November 2011
• Est. completion date: May 2012

Study information

• Verified date: January 2012
• Source: Città di Roma Hospital
• Contact: Giorgio Capogna, MD
• Phone: 0039065847
• Email: capogna.giorgio[@]gmail.com
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• healthy parturients in labor

Exclusion Criteria:

• parturients with coagulation defects or anticoagulant therapy

Study Design

Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Delivery Uterine

Intervention

Device:
• Thromboelastography
Thromboelastography during labor and after delivery

Locations

Country	Name	City	State
Italy	Città di Roma Hospital	Roma

Sponsors (1)

Lead Sponsor	Collaborator
Città di Roma Hospital

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	TEM-A automated thromboelastometer, Framar Biomedica,Rome, Italy	To determine the physiological reference individual values of maternal thromboelastography TEM-A during labor, immediately afeter delivery and in the postpartum period.	24 hours postpartum	Yes