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Published in: BMC Pregnancy and Childbirth 1/2015

Open Access 01-12-2015 | Research article

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

Authors: Shahla K Alalaf, Rojan K Jawad, Parez R Muhammad, Mahabad S Ali, Namir G Al Tawil

Published in: BMC Pregnancy and Childbirth | Issue 1/2015

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Abstract

Background

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.

Methods

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.

Results

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.

Conclusions

Postpartum bemiparin is significantly effective as a prophylaxis for VTE. Wound complications develop after use of enoxaparin, but not after bemiparin.

Trial registration

ClinicalTrials.gov; Identifier: NCT01588171; date: April 26, 2012.
Literature
1.
go back to reference Rosendaal FR. Risk factors for venous thrombotic disease. Thromb Haemost. 1999;82:610–9.PubMed Rosendaal FR. Risk factors for venous thrombotic disease. Thromb Haemost. 1999;82:610–9.PubMed
2.
go back to reference James AH, Tapson VF, Goldhaber SZ. Thrombosis during pregnancy and the postpartum period. Am J Obstet Gynecol. 2005;193:216–9.CrossRefPubMed James AH, Tapson VF, Goldhaber SZ. Thrombosis during pregnancy and the postpartum period. Am J Obstet Gynecol. 2005;193:216–9.CrossRefPubMed
3.
go back to reference Wu P, Poole TC, Pickett JA, Bhat A, Lees CC. Current obstetric guidelines on thromboprophylaxis in the United Kingdom: evidence based medicine? Eur J Obstet Gynecol Reprod Biol. 2013;168:7–11.CrossRefPubMed Wu P, Poole TC, Pickett JA, Bhat A, Lees CC. Current obstetric guidelines on thromboprophylaxis in the United Kingdom: evidence based medicine? Eur J Obstet Gynecol Reprod Biol. 2013;168:7–11.CrossRefPubMed
4.
go back to reference Bates SM, Greer IA, Pabinger I, Sofaer S, Hirsh J, American College of Chest Physicians. Venous thromboembolism, thrombophilia, antithrombotic therapy, and pregnancy: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition). Chest. 2008;133:844S–86.CrossRefPubMed Bates SM, Greer IA, Pabinger I, Sofaer S, Hirsh J, American College of Chest Physicians. Venous thromboembolism, thrombophilia, antithrombotic therapy, and pregnancy: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition). Chest. 2008;133:844S–86.CrossRefPubMed
5.
go back to reference Bain E, Wilson A, Tooher R, Gates S, Davis LJ, Middleton P. Prophylaxis for venous thromboembolic disease in pregnancy and the early postnatal period. Cochrane Database Syst Rev. 2014;2:CD001689.PubMed Bain E, Wilson A, Tooher R, Gates S, Davis LJ, Middleton P. Prophylaxis for venous thromboembolic disease in pregnancy and the early postnatal period. Cochrane Database Syst Rev. 2014;2:CD001689.PubMed
6.
go back to reference Royal College of Obstetricians and Gynaecologists. Reducing the risk of thrombosis and embolism during pregnancy and the puerperium 2009 (Green-top Guideline; No. 37). Royal College of Obstetricians and Gynaecologists. Reducing the risk of thrombosis and embolism during pregnancy and the puerperium 2009 (Green-top Guideline; No. 37).
7.
go back to reference Hill J, Treasure T. Reducing the risk of venous thromboembolism in patients admitted to hospital: summary of NICE guidance. BMJ. 2010;340:c95.CrossRefPubMed Hill J, Treasure T. Reducing the risk of venous thromboembolism in patients admitted to hospital: summary of NICE guidance. BMJ. 2010;340:c95.CrossRefPubMed
9.
go back to reference Lucas DN, Yentis SM, Kinsella SM, et al. Urgency of caesarean section: a new classification. J R Soc Med. 2000;93:346–50.PubMedPubMedCentral Lucas DN, Yentis SM, Kinsella SM, et al. Urgency of caesarean section: a new classification. J R Soc Med. 2000;93:346–50.PubMedPubMedCentral
10.
11.
go back to reference Dizon-Townson DS, Nelson LM, Jang H, Varner MW, Ward K. The incidence of the factor V Leiden mutation in an obstetric population and its relationship to deep vein thrombosis. Am J Obstet Gynecol. 1997;176:883–6.CrossRefPubMed Dizon-Townson DS, Nelson LM, Jang H, Varner MW, Ward K. The incidence of the factor V Leiden mutation in an obstetric population and its relationship to deep vein thrombosis. Am J Obstet Gynecol. 1997;176:883–6.CrossRefPubMed
12.
go back to reference Greer IA, Nelson-Piercy C. Low-molecular-weight heparins for thromboprophylaxis and treatment of venous thromboembolism in pregnancy: a systematic review of safety and efficacy. Blood. 2005;106:401–7.CrossRefPubMed Greer IA, Nelson-Piercy C. Low-molecular-weight heparins for thromboprophylaxis and treatment of venous thromboembolism in pregnancy: a systematic review of safety and efficacy. Blood. 2005;106:401–7.CrossRefPubMed
13.
go back to reference Piazza G, Goldhaber SZ. Acute pulmonary embolism: part II: treatment and prophylaxis. Circulation. 2006;114:e42–7.CrossRefPubMed Piazza G, Goldhaber SZ. Acute pulmonary embolism: part II: treatment and prophylaxis. Circulation. 2006;114:e42–7.CrossRefPubMed
14.
go back to reference Heit JA, Silverstein MD, Mohr DN, Petterson TM, O’Fallon WM, Melton 3rd LJ. Predictors of survival after deep vein thrombosis and pulmonary embolism: a population-based, cohort study. Arch Intern Med. 1999;159:445–53.CrossRefPubMed Heit JA, Silverstein MD, Mohr DN, Petterson TM, O’Fallon WM, Melton 3rd LJ. Predictors of survival after deep vein thrombosis and pulmonary embolism: a population-based, cohort study. Arch Intern Med. 1999;159:445–53.CrossRefPubMed
15.
go back to reference Ferres MA, Olivarez SA, Trinh V, Davidson C, Sangi-Haghpeykar H, Aagaard-Tillery KM. Rate of wound complications with enoxaparin use among women at high risk for postpartum thrombosis. Obstet Gynecol. 2011;117:119–24.CrossRefPubMed Ferres MA, Olivarez SA, Trinh V, Davidson C, Sangi-Haghpeykar H, Aagaard-Tillery KM. Rate of wound complications with enoxaparin use among women at high risk for postpartum thrombosis. Obstet Gynecol. 2011;117:119–24.CrossRefPubMed
16.
go back to reference Tooher R, Gates S, Dowswell T, Davis LJ. Prophylaxis for venous thromboembolic disease in pregnancy and the early postnatal period. Cochrane Database Syst Rev. 2010;5:CD001689.PubMed Tooher R, Gates S, Dowswell T, Davis LJ. Prophylaxis for venous thromboembolic disease in pregnancy and the early postnatal period. Cochrane Database Syst Rev. 2010;5:CD001689.PubMed
17.
go back to reference Connolly T. Thromboembolism prophylaxis and cesarean section: a survey of general obstetricians. South Med J. 2003;96:146–8.CrossRefPubMed Connolly T. Thromboembolism prophylaxis and cesarean section: a survey of general obstetricians. South Med J. 2003;96:146–8.CrossRefPubMed
18.
go back to reference Orme ML, Lewis PJ, de Swiet M, et al. NICE 2004 National Collaborating Centre for Women’s and Children’s Health, Commissioned by NICE. Caesarean section. London: RCOG Press; 2004. Orme ML, Lewis PJ, de Swiet M, et al. NICE 2004 National Collaborating Centre for Women’s and Children’s Health, Commissioned by NICE. Caesarean section. London: RCOG Press; 2004.
19.
go back to reference Cruz M, Fernández-Alonso AM, Rodríguez I, et al. Postcesarean thromboprophylaxis with two different regimens of bemiparin. Obstet Gynecol Int. 2011;2011:548327.PubMedPubMedCentral Cruz M, Fernández-Alonso AM, Rodríguez I, et al. Postcesarean thromboprophylaxis with two different regimens of bemiparin. Obstet Gynecol Int. 2011;2011:548327.PubMedPubMedCentral
20.
go back to reference Blondon M, Perrier A, Nendaz M, Righini M, et al. Thromboprophylaxis with low-molecular-weight heparin after cesarean delivery. Thromb Haemost. 2010;103:129–37.CrossRefPubMed Blondon M, Perrier A, Nendaz M, Righini M, et al. Thromboprophylaxis with low-molecular-weight heparin after cesarean delivery. Thromb Haemost. 2010;103:129–37.CrossRefPubMed
21.
go back to reference Segal S, Sadovsky E, Weinsten D, Polishk WZ. Prevention of postpartum venous thrombosis with low doses of heparin. Eur J Obstet Gynecol Reprod Biol. 1975;5:273–6.CrossRefPubMed Segal S, Sadovsky E, Weinsten D, Polishk WZ. Prevention of postpartum venous thrombosis with low doses of heparin. Eur J Obstet Gynecol Reprod Biol. 1975;5:273–6.CrossRefPubMed
22.
go back to reference O’Connor DJ, Scher LA, Gargiulo 3rd NJ, Jang J, Suggs WD, Lipsitz EC. Incidence and characteristics of venous thromboembolic disease during pregnancy and the postnatal period: acontemporary series. Ann Vasc Surg. 2011;25:9–14.CrossRefPubMed O’Connor DJ, Scher LA, Gargiulo 3rd NJ, Jang J, Suggs WD, Lipsitz EC. Incidence and characteristics of venous thromboembolic disease during pregnancy and the postnatal period: acontemporary series. Ann Vasc Surg. 2011;25:9–14.CrossRefPubMed
23.
go back to reference Heit JA, Kobbervig CE, James AH, Petterson TM, Bailey KR, Melton 3rd LJ. Trends in the incidence of venous thromboembolism during pregnancy or postpartum: a 30-year population-based study. Ann Intern Med. 2005;143:697–706.CrossRefPubMed Heit JA, Kobbervig CE, James AH, Petterson TM, Bailey KR, Melton 3rd LJ. Trends in the incidence of venous thromboembolism during pregnancy or postpartum: a 30-year population-based study. Ann Intern Med. 2005;143:697–706.CrossRefPubMed
24.
go back to reference Barbour LA, Pickard J. Controversies in thromboembolic disease during pregnancy: a critical review. Obstet Gynecol. 1995;86:621–33.PubMed Barbour LA, Pickard J. Controversies in thromboembolic disease during pregnancy: a critical review. Obstet Gynecol. 1995;86:621–33.PubMed
25.
go back to reference Rutherford S, Montoro M, McGehee W, Strong T. Thromboembolic disease associated with pregnancy: An 11-year review. Am J Obstet Gynecol. 1991;164:286 [abstract]. Rutherford S, Montoro M, McGehee W, Strong T. Thromboembolic disease associated with pregnancy: An 11-year review. Am J Obstet Gynecol. 1991;164:286 [abstract].
Metadata
Title
Bemiparin versus enoxaparin as thromboprophylaxis following vaginal and abdominal deliveries: a prospective clinical trial
Authors
Shahla K Alalaf
Rojan K Jawad
Parez R Muhammad
Mahabad S Ali
Namir G Al Tawil
Publication date
01-12-2015
Publisher
BioMed Central
Published in
BMC Pregnancy and Childbirth / Issue 1/2015
Electronic ISSN: 1471-2393
DOI
https://doi.org/10.1186/s12884-015-0515-2

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