Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Comparing Anti-XA Levels in Post-Cesarean Patients With BMI >35 Undergoing Enoxaparin Thromboprophylaxis With Weight Based Dosing Twice Daily Versus Fixed Dose 40 Milligrams Daily
Brief Summary: Pregnant and recently postpartum women are at significantly higher risk of developing a blood clot in their arms or legs known as a deep venous thrombosis (DVT) and/or a blood clot in their lungs known as a pulmonary embolism (PE) compared to their non pregnant counterparts. It is estimated that this risk increases anywhere from 4 to 50 times higher in pregnant versus non-pregnant women and further increases almost 11 fold in the post partum period. This risk is almost doubled when the patient undergoes cesarean delivery. In 2011, the American College of Obstetricians and Gynecologists (ACOG) issued updated guidelines stating that for patients undergoing cesarean delivery with additional risk factors for clot or thromboembolism, protective (prophylactic) treatment with low molecular weight heparin (LMWH) a type of blood thinner should be considered. However, no specific guidelines about which risk factors should be considered, or what medication doses should be used were provided. The American College of Chest Physicians (ACCP) Evidence-Based Clinical Practice Guidelines published in 2012 delineated who should be given prophylaxis based on various risk factors, however acknowledged that the recommendations were based on weak quality evidence.

ACOG endorses either once or twice a day dosing for high risk patients after delivery and states that adjustments for obese women should be made on a case by case basis. However, there are limited studies on the dosing of LMWH in specific subpopulations including post operative patients, pregnant patients and obese patients. All of these studies have urged further investigation of the correct dosing for these high risk subjects due to changes associated with pregnancy and the level of medication in the blood that may put these patients at higher risk of venous thromboembolism. Many previous studies have shown that women in these high risk categories do not achieve protective levels of the medication measured with a laboratory test; anti Xa level. The investigators hypothesize that due to their dual risk, obese post-operative recently pregnant women may not be adequately protected with the daily fixed dose and might need more frequent dosing to protect them.

The objective of this study is to assess what proportion of women achieve the desired anti Xa level with the fixed daily dose versus twice daily weight based dosing (0.5 mg/kg).


Options:
A: Arm Label: Enoxaparin Once Daily; Type: ACTIVE_COMPARATOR; Interventions: Drug: Enoxaparin | Arm Label: Enoxaparin Twice Daily; Type: ACTIVE_COMPARATOR; Interventions: Drug: Enoxaparin | Intervention Type: DRUG; Name: Enoxaparin; Assigned to Arm(s): Enoxaparin Once Daily, Enoxaparin Twice Daily
B: Arm Label: Control; Type: NO_INTERVENTION; Interventions: N/A | Arm Label: dalteparin sodium; Type: ACTIVE_COMPARATOR; Interventions: Drug: dalteparin sodium | Intervention Type: DRUG; Name: dalteparin sodium; Assigned to Arm(s): dalteparin sodium
C: Arm Label: low molecular weight heparin; Type: EXPERIMENTAL; Interventions: Drug: Dalteparin Sodium | Arm Label: Control Group; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: DRUG; Name: Dalteparin Sodium; Assigned to Arm(s): low molecular weight heparin
D: Arm Label: Group A(heparin group); Type: ACTIVE_COMPARATOR; Interventions: Drug: Heparin | Arm Label: Group B; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: DRUG; Name: Heparin; Assigned to Arm(s): Group A(heparin group)

Answer: A