Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
120 participants
INTERVENTIONAL
2011-11-30
2012-05-31
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
SINGLE
Interventions
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Thromboelastography
Thromboelastography during labor and after delivery
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
40 Years
FEMALE
No
Sponsors
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Città di Roma Hospital
OTHER
Responsible Party
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Silvia Stirparo
Staff Anesthesiologist
Principal Investigators
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Silvia Stirparo, MD
Role: PRINCIPAL_INVESTIGATOR
Città di Roma Hospital
Locations
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Città di Roma Hospital
Roma, Roma, Italy
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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TEM-A in pregnancy
Identifier Type: -
Identifier Source: org_study_id
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