Cohort study of adverse pregnancy outcomes based on ROTEM profiles in early pregnancy.

Background: Hypercoagulability exceeding normal physiological changes in pregnancy may lead to adverse outcomes in select populations, but most prior studies have tested women outside of pregnancy. Rotational thromboelastometry (ROTEM), which performs a comprehensive clotting evaluation, may demonstrate abnormalities during early pregnancy that contribute to adverse outcomes. This study evaluated the relationship between ROTEM coagulation profiles during pregnancy with the outcome of miscarriage.

Methods: This was a prospective cohort study from a single center. Patients in early pregnancy (less than 20 weeks) were recruited from the obstetric clinic and the Emergency Department for ROTEM testing using extrinsic thromboelastometry (EXTEM), intrinsic thromboelastometry (INTEM), and natural thromboelastometry (NATEM) tracings. The cohort was followed to determine pregnancy outcomes for association with ROTEM clot formation kinetics. Results were analyzed using univariate analysis and multiple linear regression, controlling for patient age and estimated gestational age (EGA) in weeks.

Results: Over the study, 98 patients were recruited with 14 lost to follow-up and 7 having elective abortion. Miscarriage occurred in 26 patients, with live delivery without complications occurring in 51 patients. Both groups had similar mean patient age and racial and ethnic breakdown. ROTEM results were similar between groups on univariate analysis. After controlling the patient age and estimated gestational age, only EXTEM clotting time (CT) results differed between groups.

Conclusions: In patients tested during early pregnancy, ROTEM profiles were not associated with adverse pregnancy outcomes in this cohort except for EXTEM CT. This suggests that ROTEM clotting profiles may not be useful in identifying patients at higher risk for adverse pregnancy outcomes.