Obesity Clinical Trial
Official title:
Thromboelastometry (ROTEM) For Detecting Hypercoagulability in Morbidly Obese and Non Obese Parturients Following Cesarean Section Delivery: An Observational Study
Investigators hypothesized that the impact of surgery in terms of inducing a hypercoagulable state is more evident in morbidly obese pregnant women as opposed to their non-obese counterparts. The aim of this study is to investigate the change in coagulation status of morbidly obese and non-obese pregnant women following cesarean section delivery using thromboelastometry. This observational study would also make it possible to calculate the sample size for a future prospective controlled clinical trial to compare the incidence of Hypercoagulability in morbidly obese parturients as opposed to their non-obese counterparts. To the best of our knowledge, no other work has been done any in this area.
Following institutional ethical committee approval, 20 morbidly obese (BMI>40) and 20
non-obese (BMI < 30) parturients undergoing elective low segment cesarean section (LSCS)
delivery under spinal subarachnoid block will be recruited into the study. A written informed
consent will be obtained from all parturients prior to inclusion. All patients will receive
an information sheet at the preoperative assessment visit to inform them about this study.
Patients with a history of past or current thromboembolism will be excluded from the study as
well as those with liver disease and those already on anticoagulant/anti-platelet therapy for
repeated miscarriage or other indications. History of thromboembolism is defined as an
arterial or deep venous thrombosis, catheter thrombosis, or pulmonary embolism diagnosed by
ultrasound or spiral computed tomography (CT). Preoperative baseline full blood count and
clotting profile will be done. Parturients with abnormal platelet count or coagulation
results and those who will need conversion to general anesthesia will be excluded.
Data and sample collection Preoperative BMI, co-existing morbidities and laboratory test
results including INR, PTT and platelet count as well as operative time and postoperative
clinical or radiological evidence of thromboembolism will be recorded. A blood sample will be
collected for ROTEM analysis prior to establishing the block (baseline), immediately after
surgery and 8 hours later.
ROTEM analysis
Coagulability will be assessed using the ROTEM thromboelastometry analyzer (The ROTEM® delta,
Tem Systems Inc.®, Munich, Germany). Extrinsic rotational thromboelastometry (EXTEM),
intrinsic rotational thromboelastometry (INTEM) and FIBTEM will be measured for each blood
sample. Clotting time (CT), clot formation time (CFT) and maximum clot firmness (MCF) will be
recorded. Total clot strength will be assessed by "G" value as calculated according to the
formula: (5000xMCF)/100-MCF and expressed as dynes/cm2 . G has been shown to be valuable in
diagnosing hypo- and hypercoagulability . In non-obstetric cohorts, hypercoagulability was
defined as a G value of ≥ 11.7 dynes/cm2 and hypocoagulability as a G value of <5.0 dynes/cm2
(values provided by manufacturer).
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