Subscribe to RSS
DOI: 10.1055/s-0038-1635573
Risk Assessment and Management of Venous Thromboembolism in Women during Pregnancy and Puerperium (SAVE): An International, Cross-sectional Study
Funding Sanofi funded the study, and contributed to the elaboration of the study design and to the analysis. Sanofi author J.A. reviewed and approved the manuscript. J-C.G. and J.A. had full access to the data and the final responsibility for the decision to submit for publication.Publication History
14 September 2017
07 February 2018
Publication Date:
04 April 2018 (online)
Abstract
The clinical burden of obstetric venous thromboembolism (VTE) risk is inadequately established. This study assessed the prevalence and management of VTE risk during pregnancy and postpartum outside the Western world. This international, noninterventional study enrolled adult women with objectively confirmed pregnancy attending prenatal care/obstetric centers across 18 countries in Africa, Eurasia, Middle-East, and South Asia. Evaluations included proportions of at-risk women, prophylaxis as per international guidelines, prophylaxis type, factors determining prophylaxis, and physicians' awareness about VTE risk management guidelines and its impact on treatment decision. Data were analyzed globally and regionally. Physicians (N = 181) screened 4,978 women, and 4,010 were eligible. Of these, 51.4% were at risk (Eurasia, 90%; South Asia, 19.9%), mostly mild in intensity; >90% received prophylaxis as per the guidelines (except South Asia, 77%). Women in Eurasia and South Asia received both pharmacological and mechanical prophylaxes (>55%), while pharmacological prophylaxis (>50%) predominated in Africa and the Middle-East. Low-molecular-weight heparin was the pharmacological agent of choice. Prophylaxis decision was influenced by ethnicity, assisted reproductive techniques, caesarean section, and persistent moderate/high titer of anticardiolipin antibodies, though variable across regions. Prophylaxis decision in at-risk women was similar, irrespective of physicians' awareness of guidelines (except South Asia). A majority (>80%) of the physicians claimed to follow the guidelines. More than 50% of women during pregnancy and postpartum were at risk of VTE, and >90% received prophylaxis as per the guidelines. Physicians are generally aware of VTE risk and comply with guidelines while prescribing prophylaxis, although regional variations necessitate efforts to improve implementation of the guidelines.
Keywords
pregnancy - prophylaxis - puerperium - risk assessment and management - venous thromboembolismAuthors' Contributions
J-C.G. and J.A. designed the study and participated in writing the manuscript. All coauthors and study group members read and revised the draft, and approved the final submitted version.
* Members of the SAVE Study Group are listed in the Appendix.
-
References
- 1 Kuriya A, Piedimonte S, Spence AR, Czuzoj-Shulman N, Kezouh A, Abenhaim HA. Incidence and causes of maternal mortality in the USA. J Obstet Gynaecol Res 2016; 42 (06) 661-668
- 2 Knight M, Kenyon S, Brocklehurst P, Neilson J, Shakespeare J, Kurinczuk JJ. , eds.; on behalf of MBRRACE-UK. Saving Lives, Improving Mothers' Care: Lessons learned to inform future maternity care from the UK and Ireland. Confidential Enquiries into Maternal Deaths and Morbidity 2009–2012. Oxford, UK: University of Oxford; 2014
- 3 Pomp ER, Lenselink AM, Rosendaal FR, Doggen CJ. Pregnancy, the postpartum period and prothrombotic defects: risk of venous thrombosis in the MEGA study. J Thromb Haemost 2008; 6 (04) 632-637
- 4 Abbasi N, Balayla J, Laporta DP, Kezouh A, Abenhaim HA. Trends, risk factors and mortality among women with venous thromboembolism during labour and delivery: a population-based study of 8 million births. Arch Gynecol Obstet 2014; 289 (02) 275-284
- 5 Kourlaba G, Relakis J, Kontodimas S, Holm MV, Maniadakis N. A systematic review and meta-analysis of the epidemiology and burden of venous thromboembolism among pregnant women. Int J Gynaecol Obstet 2016; 132 (01) 4-10
- 6 Bates SM, Middeldorp S, Rodger M, James AH, Greer I. Guidance for the treatment and prevention of obstetric-associated venous thromboembolism. J Thromb Thrombolysis 2016; 41 (01) 92-128
- 7 Rath W, Tsikouras P, von Tempelhoff GF. Pharmacological Thromboprophylaxis during pregnancy and the puerperium: recommendations from current guidelines and their critical comparison [in German]. Z Geburtshilfe Neonatol 2016; 220 (03) 95-105
- 8 Bates SM, Greer IA, Middeldorp S, Veenstra DL, Prabulos AM, Vandvik PO. VTE, thrombophilia, antithrombotic therapy, and pregnancy: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest 2012; 141 (2, Suppl): e691S-e736S
- 9 Henriksson P, Westerlund E, Wallén H, Brandt L, Hovatta O, Ekbom A. Incidence of pulmonary and venous thromboembolism in pregnancies after in vitro fertilisation: cross sectional study. BMJ 2013; 346: e8632
- 10 Hansen AT, Kesmodel US, Juul S, Hvas AM. Increased venous thrombosis incidence in pregnancies after in vitro fertilization. Hum Reprod 2014; 29 (03) 611-617
- 11 Blondon M, Casini A, Hoppe KK, Boehlen F, Righini M, Smith NL. Risks of venous thromboembolism after cesarean sections: a meta-analysis. Chest 2016; 150 (03) 572-596
- 12 Tepper NK, Boulet SL, Whiteman MK. , et al. Postpartum venous thromboembolism: incidence and risk factors. Obstet Gynecol 2014; 123 (05) 987-996
- 13 Virkus RA, Løkkegaard E, Lidegaard Ø. , et al. Risk factors for venous thromboembolism in 1.3 million pregnancies: a nationwide prospective cohort. PLoS One 2014; 9 (05) e96495
- 14 Royal College of Obstetricians and Gynaecologists. Reducing the risk of venous thromboembolism during pregnancy and the puerperium. Green-top Guideline No. 37a. April 2015. Available at: https://www.rcog.org.uk/globalassets/documents/guidelines/gtg-37a.pdf . Accessed April 20, 2017
- 15 Eklöf B, Rutherford RB, Bergan JJ. , et al; American Venous Forum International Ad Hoc Committee for Revision of the CEAP Classification. Revision of the CEAP classification for chronic venous disorders: consensus statement. J Vasc Surg 2004; 40 (06) 1248-1252
- 16 Rodger M. Pregnancy and venous thromboembolism: ‘TIPPS’ for risk stratification. Hematology (Am Soc Hematol Educ Program) 2014; 2014 (01) 387-392
- 17 Alsayegh F, Al-Jassar W, Wani S. , et al. Venous thromboembolism risk and adequacy of prophylaxis in high risk pregnancy in the Arabian Gulf. Curr Vasc Pharmacol 2016; 14 (04) 368-373
- 18 Cregan A, Higgins JR, O'Shea S. Implementation of thromboprophylaxis guidelines. Ir Med J 2013; 106 (03) 80-82
- 19 Liew NC, Chang YH, Choi G. , et al; Asian Venous Thrombosis Forum. Asian venous thromboembolism guidelines: prevention of venous thromboembolism. Int Angiol 2012; 31 (06) 501-516
- 20 Stegenga H, Haines A, Jones K, Wilding J. ; Guideline Development Group. Identification, assessment, and management of overweight and obesity: summary of updated NICE guidance. BMJ 2014; 349: g6608
- 21 Randhawa NK, Tan EK, Sabnis MA. Effect of using population-specific body mass index cutoff points in the risk assessment of pregnant Asian women for venous thromboembolism. Singapore Med J 2013; 54 (08) 437-440
- 22 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 (02) 401-407
- 23 Bates SM, Greer IA, Pabinger I, Sofaer S, Hirsh J. Venous thromboembolism, thrombophilia, antithrombotic therapy, and pregnancy: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition). Chest 2008; 133 (6, Suppl): 844S-886S
- 24 Romualdi E, Dentali F, Rancan E. , et al. Anticoagulant therapy for venous thromboembolism during pregnancy: a systematic review and a meta-analysis of the literature. J Thromb Haemost 2013; 11 (02) 270-281
- 25 Caprini JA, Tapson VF, Hyers TM. , et al; NABOR Steering Committee. Treatment of venous thromboembolism: adherence to guidelines and impact of physician knowledge, attitudes, and beliefs. J Vasc Surg 2005; 42 (04) 726-733
- 26 Donnelly JC, Raglan GB, Bonanno C, Schulkin J, D'Alton ME. Practice patterns and preferences of obstetricians and gynecologists regarding thromboprophylaxis at the time of Cesarean section. J Matern Fetal Neonatal Med 2014; 27 (18) 1870-1873