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Bemiparin versus enoxaparin as thromboprophylaxis following vaginal and abdominal deliveries: a prospective clinical trial.

ABSTRACT: Venous thromboembolism (VTE) is a leading cause of maternal mortality and morbidity, with the highest incidence occurring during the postpartum period. This study compared the ability of two types of low-molecular-weight heparin, enoxaparin and bemiparin, to decrease the incidence of VTE following elective caesarean section, emergency caesarean section, and vaginal delivery in women who had risk factors for thromboembolism.In this prospective clinical trial using a sequential group allocation method, 7020 haemodynamically stable women delivered vaginally or abdominally at the Maternity Teaching Hospital, Kurdistan region, Erbil, Iraq, between May 1, 2012, and November 1, 2013. These women had risk factors for VTE and were allocated to the following groups: treatment with 3500 IU/day of bemiparin, 4000 IU/day of enoxaparin, or no intervention (control). The first dose was administered 6 hours after vaginal or abdominal delivery, or 8 hours after delivery in women receiving spinal anaesthesia. Subsequent doses were administered daily for up to 6 days. The incidence of VTE was assessed for up to 40 days postpartum. Data were analyzed using the Statistical Package for Social Sciences version 19. Proportions were compared using the chi square test of association or Fisher's exact test. Binary logistic regression analysis was used with VTE as the dependent variable.VTE occurred in 1 (0.042%) woman in the bemiparin group, two (0.085%) women in the enoxaparin group, and nine (0.384%) women in the control group (P?=?0.017). Regression analysis showed that women on bemiparin (OR?=?0.106; 95% CI?=?0.013-0.838) and enoxaparin (OR?=?0.226; 95% CI?=?0.049-1.049) were at lower risk of developing VTE than control women. Adverse events in the enoxaparin group included wound dehiscence, haematoma, and separation. None of these occurred in the bemiparin group.Postpartum bemiparin is significantly effective as a prophylaxis for VTE. Wound complications develop after use of enoxaparin, but not after bemiparin.ClinicalTrials.gov; Identifier: NCT01588171 ; date: April 26, 2012.

SUBMITTER: Alalaf SK

PROVIDER: S-EPMC4377203 | biostudies-literature | 2015 Mar

REPOSITORIES: biostudies-literature

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Bemiparin versus enoxaparin as thromboprophylaxis following vaginal and abdominal deliveries: a prospective clinical trial.

Alalaf Shahla K SK Jawad Rojan K RK Muhammad Parez R PR Ali Mahabad S MS Al Tawil Namir G NG

BMC pregnancy and childbirth 20150328

<h4>Background</h4>Venous thromboembolism (VTE) is a leading cause of maternal mortality and morbidity, with the highest incidence occurring during the postpartum period. This study compared the ability of two types of low-molecular-weight heparin, enoxaparin and bemiparin, to decrease the incidence of VTE following elective caesarean section, emergency caesarean section, and vaginal delivery in women who had risk factors for thromboembolism.<h4>Methods</h4>In this prospective clinical trial usi ...[more]

PMID: 25884460

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Project description:BACKGROUND:Venous thromboembolism (VTE) remained common complication following surgical resection of esophageal cancer. In this prospective randomized double-blind placebo-controlled trial (NCT01267305), we aim to compare the safety and efficacy between low molecular weight heparin (LMWH) once-daily (QD) and twice-daily (BID) for the prophylaxis of VTE following esophagectomy. METHODS:During August 2012 to July 2013, patients underwent esophagectomy were randomly assigned to nadroparin calcium QD (4,100 AxaIU qd + placebo qd, group QD), or nadroparin calcium BID (4,100 AxaIU q12h, group BID) in the prophylaxis of VTE. All patients received thrombelastography (TEG) before and 0/24/48/72 hours after operation. Daily vascular ultrasound of lower extremities was followed during the first 7 postoperative days to confirm the suspected deep venous thrombosis (DVT). Cumulatively postoperative chest drainage at 72 hours after the surgery was collected to identify the difference in volume and red blood cell (RBC) counts between the two groups. Any bleeding events and thromboembolic events were also documented. RESULTS:A total of 117 patients were enrolled in this study, and 111 eligible patients were randomly assigned (group QD: 55 patients; group BID: 56 patients). Patients' clinical features were close between the two groups. TEG analysis [R time, K time, alpha angel and maximum amplitude (MA)] before and instantly after operation showed nearly identical results. However, compared with group QD, all TEG measurements of 24/48/72 hours postoperatively showed significantly prolonged R time and K time, and decreased alpha angel in group BID. In ultrasound follow-ups, a total of four cases of DVT (four cases in group QD and no case in group BID) were found in this cohort (7.27% versus 0%, P=0.046), and one case of pulmonary embolism (PE) (in group QD) was observed. The incidence of VTE was lower in group BID (9.09% versus 0%, P=0.032). At 72 hours after surgery, the cumulative volume of chest drainage were close between these two groups (1,001.39±424.58 versus 1,133.61±513.93 mL, P=0.406). RBC counts in chest drainage were also identical between two groups [(2.56±1.98)×10(5) versus (2.71±4.67)×10(5), P=0.61]. No patient died due to VTE or bleeding events. CONCLUSIONS:For the prophylaxis of VTE, BID LMWH provided more potent efficacy and equal safety when compared to QD LMWH in patients undergoing selective esophagectomy. Further study based on larger population is required to confirm these findings.

Project description:Objective: To determine blood pressure (BP) patterns in the immediate postpartum period in preeclampsia with severe features (sPE) and normotensive pregnant women who had cesarean deliveries (CD).Study design: The BP levels of two groups comprising 50 sPE and 90 normotensive pregnant women who had CD were measured before delivery and on days 0-3 postpartum at four time points (05:00, 08:00, 14:00, and 22:00). Soluble fms-like tyrosine kinase-1 (sFlt-1) and placental growth factor (PIGF) were measured in the maternal serum ≤48 h before delivery.Results: Antihypertensive therapy was administered to 98, 96, 82, 78, and 56% of sPE antepartum and on postpartum days 0-3, respectively. De novo postpartum hypertension (BP ≥ 140/90 mmHg) occurred in 24.4% (22/90) of the normotensive group but only one required antihypertensive therapy. The occurrence of de novo postpartum hypertension was associated with maternal weight before delivery ≥ 84.5 kg (relative risks (RR) 2.6, CI 95% 1.2-5.8, p = .017), and body mass index before delivery ≥ 33.3 kg/m2 (RR 2.9, CI 95% 1.3-6.4, p = .008). In sPE, the BP decreased between predelivery period and postpartum day 0. From days 1 to 3 postpartum, there was a continuous increase in the daily mean BPs in both groups, with average daily increments (systolic/diastolic) being 5.6/4.6 mmHg and 0.6/1.3 mmHg in the sPE and normotensive women, respectively. Patient's group and time had a significant effect on BP, p < .001. Overall, daily mean BPs were higher in the sPE than the normotensive group (p < .001). Perceived stress (p = .022), low birth weight (p = .002), 5 min Apgar score ≤ 6 (p < .001) were significantly higher in the sPE group. sFlt-1/PIGF ratio was high in the hypertensive groups: sPE versus normotensive group, p < .001; de novo postpartum hypertension versus normotensives group that remained normotensive, p = .102.Conclusion: Postpartum BP and antihypertensive requirements are important considerations in managing sPE and normotensive pregnancies. sPE is associated with increased maternal stress and poor perinatal outcomes.

Dataset Information

Bemiparin versus enoxaparin as thromboprophylaxis following vaginal and abdominal deliveries: a prospective clinical trial.

Publications

Bemiparin versus enoxaparin as thromboprophylaxis following vaginal and abdominal deliveries: a prospective clinical trial.

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