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Thromboelastography During and After Delivery

Determination of Thromboelastography Values in Pregnancy and After Delivery

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01506102
Enrollment
120
Registered
2012-01-09
Start date
2011-11-30
Completion date
2012-05-31
Last updated
2012-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Delivery Uterine

Brief 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.

Detailed 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

Interventions

Thromboelastography during labor and after delivery

Sponsors

Città di Roma Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No

Inclusion criteria

* healthy parturients in labor

Exclusion criteria

* parturients with coagulation defects or anticoagulant therapy

Design outcomes

Primary

MeasureTime frameDescription
TEM-A automated thromboelastometer, Framar Biomedica,Rome, Italy24 hours postpartumTo determine the physiological reference individual values of maternal thromboelastography TEM-A during labor, immediately afeter delivery and in the postpartum period.

Countries

Italy

Contacts

Primary ContactGiorgio Capogna, MD
capogna.giorgio@gmail.com0039065847

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026