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Combined oral contraceptives: venous thrombosis

  1. Marcos de Bastos1,
  2. Bernardine H. Stegeman2,
  3. Frits R. Rosendaal3,
  4. Astrid Van Hylckama Vlieg4,
  5. Frans M Helmerhorst5,
  6. Theo Stijnen6,
  7. Olaf M Dekkers4,*

Editorial Group: Cochrane Fertility Regulation Group

Published Online: 3 MAR 2014

Assessed as up-to-date: 30 DEC 2013

DOI: 10.1002/14651858.CD010813.pub2

How to Cite

de Bastos M, Stegeman BH, Rosendaal FR, Van Hylckama Vlieg A, Helmerhorst FM, Stijnen T, Dekkers OM. Combined oral contraceptives: venous thrombosis. Cochrane Database of Systematic Reviews 2014, Issue 3. Art. No.: CD010813. DOI: 10.1002/14651858.CD010813.pub2.

Author Information

  1. 1

    Instituto Previdencia dos Servidores do Estado de Minas Gerais, Minas Gerais, Brazil

  2. 2

    University College London, Department of Epidemiology and Public Health, London, UK

  3. 3

    Leiden University Medical Center, Epidemiology, Leiden, Netherlands

  4. 4

    Leiden University Medical Center, Department of Clinical Epidemiology, Leiden, Netherlands

  5. 5

    Leiden University Medical Center, Department of Gynaecology, Division of Reproductive Medicine and Dept. of Clinical Epidemiology, Leiden, Netherlands

  6. 6

    Leiden University Medical Center, Department of Medical Statistics, Leiden, Netherlands

*Olaf M Dekkers, Department of Clinical Epidemiology, Leiden University Medical Center, PO Box 9600, Leiden, 2300RC, Netherlands.

Publication History

  1. Publication Status: New
  2. Published Online: 3 MAR 2014



References to studies included in this review

  1. References to studies included in this review
  2. References to studies excluded from this review
  3. Additional references
  4. References to other published versions of this review
Andersen 1998 {published data only}
  • Andersen BS, Olsen J, Nielsen GL, Steffensen FH, Sorensen HT, Baech J, Gregersen H. Third generation oral contraceptives and heritable thrombophilia as risk factors of non-fatal venous thromboembolism. Thromb Haemost 1998;79:28-31.
Bird 2013 {published data only}
Bloemenkamp 1995 {published data only}
  • Bloemenkamp KW, Rosendaal FR, Helmerhorst FM, Buller HR, Vandenbroucke JP. Enhancement by factor V Leiden mutation of risk of deep-vein thrombosis associated with oral contraceptives containing a third-generation progestagen. Lancet 1995;346:1593-6.
Bloemenkamp 1999 {published data only}
  • Bloemenkamp KW, Rosendaal FR, Buller HR, Helmerhorst FM, Colly LP, Vandenbroucke JP. Risk of venous thrombosis with use of current low-dose oral contraceptives is not explained by diagnostic suspicion and referral bias. Arch Intern Med 1999;159:65-70.
Farmer 1996 {published data only}
Farmer 1998 {published data only}
Farmer 2000 {published data only}
Gronich 2011 {published data only}
  • Gronich 2011. Gronich N, Lavi I, Rennert G [Higher risk of venous thrombosis associated with drospirenone-containing oral contraceptives: a population-based cohort study]. CMAJ 2011;183:E1319-25.
Hedenmalm 2004 {published data only}
Heinemann 2002 {published data only}
Heinemann 2010 {published data only}
  • Heinemann LA, Dinger JC, Assmann A, Minh TD. Use of oral contraceptives containing gestodene and risk of venous thromboembolism: outlook 10 years after the third-generation 'pill scare'. Contraception 2010;81:401-7.
Herings 1999 {published data only}
Jick 2006 {published data only}
  • Jick SS, Kaye JA, Russmann S, Jick H. Risk of nonfatal venous thromboembolism with oral contraceptives containing norgestimate or desogestrel compared with oral contraceptives containing levonorgestrel. Contraception 2006;73:566-70.
Jick 2011 {published data only}
  • Jick SS, Hernandez RK. Risk of non-fatal venous thromboembolism in women using oral contraceptives containing drospirenone compared with women using oral contraceptives containing levonorgestrel: case-control study using United States claims data. BMJ 2011;342:d2151.
Lewis 1996 {published data only}
  • Lewis MA, Heinemann LA, MacRae KD, Bruppacher R, Spitzer WO. The increased risk of venous thromboembolism and the use of third generation progestagens: role of bias in observational research. The Transnational Research Group on Oral Contraceptives and the Health of Young Women. Contraception 1996;54:5-13.
Lidegaard 2002 {published data only}
Lidegaard 2011 {published data only}
  • Lidegaard O, Nielsen H, Skovlund CW, Skjeldestad FE, Løkkegaard E. Risk of venous thromboembolism from use of oral contraceptives containing different progestogens and oestrogen doses: Danish cohort study, 2001-9. BMJ 2011;343:d6423.
Martinelli 1999 {published data only}
  • Martinelli I, Taioli E, Bucciarelli P, Akhavan S, Mannucci PM. Interaction between the G20210A mutation of the prothrombin gene and oral contraceptive use in deep vein thrombosis. Arterioscler Thromb Vasc Biol 1999;19:700-3.
Parkin 2000 {published data only}
Parkin 2011 {published data only}
  • Parkin L, Sharples K, Hernandez RK, Jick SS. Risk of venous thromboembolism in users of oral contraceptives containing drospirenone or levonorgestrel: nested case-control study based on UK General Practice Research Database. BMJ 2011;342:d2139.
Samuelsson 2004 {published data only}
Todd 1999 {published data only}
van Hylckama Vlieg 2009 {published data only}
  • van Hylckama Vlieg A, Helmerhorst FM, Vandenbroucke JP, Doggen CJ, Rosendaal FR. The venous thrombotic risk of oral contraceptives, effects of oestrogen dose and progestogen type: results of the MEGA case-control study. BMJ 2009;339:b2921.
WHO 1995a {published data only}
  • World Health Organization Collaborative Study of Cardiovascular Disease and Steroid Hormone Contarception. Venous thromboembolic disease and combined oral contraceptives: results of international multicentre case-control study. The Lancet 1995;346:1575-82.
WHO 1995b {published data only}
  • Effect of different progestagens in low oestrogen oral contraceptives on venous thromboembolic disease. Study of Cardiovascular Disease and Steroid Hormone Contraception. Lancet 1995;346:1582-8.

References to studies excluded from this review

  1. References to studies included in this review
  2. References to studies excluded from this review
  3. Additional references
  4. References to other published versions of this review
Amundsen 2000 {published data only}
  • Amundsen T, Hoibraaten E, Skjeldestad FE. [Pulmonary embolism among young non-pregnant women]. Tidsskr. Nor Laegeforen 2000;120:326-9.
Austin 2009 {published data only}
  • Austin H, Lally C, Benson JM, et al. Hormonal contraception, sickle cell trait, and risk for venous thromboembolism among African American women. Am J Obstet Gynecol 2009;200:620. e1-620.e3.
Barsoum 2010 {published data only}
BCDSP 1973 {published data only}
  • Boston Collaborative Drug Surveillance Programme. Oral contraceptives and venous thromboembolic disease, surgically confirmed gallbladder disease, and breast tumours. Lancet 1973;7817:1399-1404.
Bergendal 2012 {published data only}
  • Bergendal A, Bremme K, Hedenmalm K, Larfars G, Odeberg J, Persson I, et al. Risk factors for venous thromboembolism in pre- and postmenopausal women. Thrombosis Research 2012;130:596-601.
Bernstein 1986 {published data only}
Bonifacj 1997 {published data only}
  • Bonifacj C, Quere I, Dupuy C, Janbon C, Daures JP. Case control studies of the risk factors for deep-vein thrombosis in an adult population hospitalized in internal medicine. Rev Epidemiol Sante Publique 1997;45:465-73.
Bottiger 1980 {published data only}
  • Bottiger LE. Oral contraceptives and Thromboembolic disease: effects of lowering oestrogen contente. The Lancet 1980;8178:1097-1101.
Burnhill 1999 {published data only}
  • Burnhill MS, The use of a large-scale surveillance system in Planned Parenthood Federation of America clinics to monitor cardiovascular events in users of combination oral contraceptives. Int J Fertil. Womens Med 1999;44:19-30.
Diddle 1978 {published data only}
  • Diddle AW, Gardner WMH, Williamson PH, Johnson JR, Hemphill JL, Godwin CW. Oral contraceptives steroids and thrombophlebitis. J Tenn Med Assoc 1978;71:22–26.
Dinger 2007 {published data only}
  • Dinger JC, Heinemann LA, Kuhl-Habich D. The safety of a drospirenone-containing oral contraceptive: final results from the European Active Surveillance Study on oral contraceptives based on oral contraceptives based on 142,475 women-years of observation. Contraception 2007;75:344-354.
Dinger 2010 {published data only}
  • Dinger J, Assmann A, Mohner S, Minh TD. Risk of venous thromboembolism and the use of dienogest- and drospirenone-containing oral contraceptives: results from a German case-control study. J Fam Plann Reprod Health Care 2010;36:123-9.
Eng 2008 {published data only}
  • Eng PM, Seeger JD, Loughlin J, Clifford CR, Mentor S, Walker AM. Supplementary data collection with case-cohort analysis to address potential confounding in a cohort study of thromboembolism in oral contraceptive initiators matched on claims-based propensity scores. Pharmacoepidemiol Drug Saf 2008;17:297–305.
Farmer 1997 {published data only}
Fuertes 1971 {published data only}
  • Fuertes A, Curet JO, Pelegrina I, Bangdiwala I. Thrombophlebitis among oral contraceptives for contraception. Obstet Gynecol 1971;38:259-263.
Gerstman 1991 {published data only}
  • Gerstman BB, Piper JM, Tomita DK, Ferguson WJ, Stadel BV, Lundin FE. Oral contraceptive estrogen dose and the risk of deep venous thromboembolic disease. Am J Epidemiol 1991;133:32-7.
Girolami 2004 {published data only}
Grodstein 1996 {published data only}
  • Grodstein F, Stampfer MJ, Goldhaber SZ, Manson JE, Colditz GA, Speizer FE, Willett WC, Hennekens CH. Prospective study of exogenous hormones and risk of pulmonary embolism in women. Lancet 1996;348:983-7.
Grounds 1974 {published data only}
Hall 2012 {published data only}
  • Hall K, Trussell J. Types of Combined Oral Contraceptives Used by Us Women, Including Women at Risk of Venous Thromboembolism. Contraception 2012;86:313-4.
Hedenmalm 2005 {published data only}
  • Hedenmalm K, Samuelsson E. Fatal venous thromboembolism associated with different combined oral contraceptives. A study of incidences and potential biases in spontaneous reporting. Drug Safety 2005;28:907-916.
Heinemann 2000 {published data only}
  • Heinemann LA, Garbe E, Farmer R, Lewis MA. Venous thromboembolism and oral contraceptive use: a methodological study of diagnostic suspicion and referral bias. Eur J Contracept Reprod Health Care 2000;5:183-191.
Helmrich 1987 {published data only}
Herings 1999a {published data only}
Heuser 2004 {published data only}
  • Heuser P, Tonga K, Hopkins R, Henderson M, Weatherall M, Metcalfe S, Beasley R.  Specific oral contraceptive use and venous thromboembolism resulting in hospital admission. N Z M J 2004;117:U1176.
Hirvonen 1990 {published data only}
  • Hirvonen E. Cardiovascular death among women under 40 years of age using low-estrogen oral contraceptives and intrauterine devices in Finland from 1975 to 1984. Am J Obstet Gynecol 1990;163:281-4.
Huerta 2007 {published data only}
  • Huerta C, Johansson S, Wallander M, Rodriíguez LAG. Risk factors and short-term mortality of venous thromboembolism diagnosed in the primary care setting in the United Kingdom. Arch Intern Med 2007;167:935-943.
Inman 1968 {published data only}
  • Inman WH, Chir B, Vessey MP. Investigation of deaths from pulmonary, coronary, and cerebral thrombosis and embolism in women of child-bearing age. BMJ 1968;2:193–9.
Inman 1970 {published data only}
  • Inman WH, Vessey MP, Westerholm B, Engelund A. Thromboembolic Disease and the Steroidal Content of Oral Contraceptives. A Report to the Committee on Safety of Drugs. British Medical Journal 1970;2:203-209.
IPPF 1976 {published data only}
  • Anonymous, Prospective long-term study of women on different contraceptives. IPPF. Med Bull 1976;10:2-3.
Kieler 2003 {published data only}
  • Kieler H, Persson I, Odlind V. Thromboembolism and combined oral contraceptives. Spontaneous reporting of adverse drug reactions indicate at least similar risk with themost recent contraceptives. Läkartidningen 2003;100:3050-2.
Lambrekht 1986 {published data only}
  • Lambrekht R, Vageman V, Vinkelman B, Geinrikh P. [Hormonal contraceptive agents as a risk factor in the development of acute thromboembolic diseases]. Khirurgiia (Mosk) 1986;12:90-3.
Lawrenson 2000 {published data only}
Legnani 2002 {published data only}
  • Legnani C, Palareti G, Guazzaloca G, Cosmi B, Lunghi B, Bernardi F, Coccheri S. Venous thromboembolism in young women; role of thrombophilic mutations and oral contraceptive use. Eur Heart J 2002;23:984-90.
Lewis 1997 {published data only}
Lewis 1999b {published data only}
  • Lewis MA, MacRae KD, Kuhl-Habichl D, Bruppacher R, Heinemann LA, Spitzer WO. The differential risk of oral contraceptives: the impact of full exposure history. Human Reproduction 1999;14:1493-9.
Lewis 1999c {published data only}
Lidegaard 1998a {published data only}
Lidegaard 1998b {published data only}
Lidegaard 2001 {published data only}
  • Lidegaard O, Schiodt AV, Poulsen EF. Oral contraceptives and thrombosis. Ugeskr Laeger 2001;163 (34):4549-4553.
Lidegaard 2009 {published data only}
Lindqvist 2009 {published data only}
Lis 1993 {published data only}
  • Lis Y, Spitzer WO, Mann RD, Cockburn I, Chukwujindu J, Thorogood M, et al. A concurrent cohort study of oral contraceptive use and cardiovascular risks. Pharmacoepidemiol Drug Saf 1993;2:51-63.
Ludwig 1970 {published data only}
  • Ludwig H. Ovulationshemmer und Venenerkrankungen. Ergebnisse der Angiologie und Phlebologie 1970;4:81–102.
Martinelli 2003 {published data only}
Meade 1980 {published data only}
  • Meade TW, Greenberg G, Thompson SG. Progestogens and cardiovascular reactions associated with oral contraceptives and a comparison of the safety of 50- and 30-mcg oestrogen preparations. BMJ 1980;280:1157-61.
Meinel 1988 {published data only}
  • Meinel H, Göretzlehner G, Heinemann L. Hormonal contraceptives and cardiovascular risk. Results of an East German multicenter case control study]. Zentralbl Gynakol 1988;110:1507-14.
Meurer 2001 {published data only}
  • Meurer LN, Slawson JG. What is the risk of venous thromboembolism (VT) among women taking third generation oral contraceptives ((COCs) in comparison with those taking contraceptives containing levonorgestrel?. The Journal of Family Practice 2001;50:108.
Nightingale 2000 {published data only}
  • Nightingale L, Lawrenson RA, Simpson EL, Williams TJ, MacRae KD, Farmer RD. The effects of age, body mass index, smoking and general health on the risk of venous thromboembolism in users of combined oral contraceptives. Eur J Contracept Reprod Health Care 2000;5:265-274.
Overgaard 1986 {published data only}
  • Overgaard K, Hauch O, Lidegaard O. [Venous thromboembolic disease and oral contraceptives]. Ugeskr Laeger 1986;148:2348-2350.
Pearce 2005 {published data only}
Petitti 1979 {published data only}
  • Petitti DB, Wingerd J, Pellegrin F, Ramcharan S. Risk of vascular disease in women. Smoking, oral contraceptives, noncontraceptive estrogens, and other factors. JAMA 1979;242:1150-4.
Pini 1996 {published data only}
  • Pini M, Scoditti U, Caliumi F, Manotti C, Quintaballa R, Pattacini A, Poli T, Tagliaferri A, di Lasio MG, Bernardi F. Risk of venous thromboembolism and stroke associated with oral contraceptives. Role of congenital thrombophilias. Recenti Prog Med 1996;87:331-7.
Porter 1982 {published data only}
  • Porter JB, Hunter JR, Danielson DA, Jick H, Stergachis A. Oral contraceptives and nonfatal vascular disease – recent experience. Obstet Gynecol 1982;59:299-302.
Porter 1985 {published data only}
Poulter 1996 {published data only}
  • Poulter NR, Farley TM, Chang CL, Marmot MG, Meirik O. Safety of combined oral contraceptive pills (letter). Lancet 1996;347:547.
Primignani 2005 {published data only}
Quinn 1992 {published data only}
  • Quinn DA, Thompson BT, Terrin ML, Thrall JH, Athanasoulis CA, McKusick KA, Stein PD, Hales CA. A Prospective investigation of pulmonary embolism in women and men. JAMA 1992;268:1689-1696.
RCPG 1978 {published data only}
  • Royal College of General Practitioners' oral contraception study. Oral contraceptives, venous thrombosis, and varicose veins. Journal ofthe Royal College of General Practitioners 1978;28:393-9.
Realini 1997 {published data only}
  • Realini JP, Encarnacion CE, Chintapalli KN, Rees CR. Oral contraceptives and venous thromboembolism: a case-control study designed to minimize detection bias. J Am Board Fam Pract 1997;10:315-321.
Reed 2012 {published data only}
  • Reed S, Bardenheuer K, Dinger J. . 2012, Conference:. VTE risk in users of combined oral contraceptives: Impact of a 24-day regimen containing drospirenone. Pharmacoepidemiology and Drug Safety 2012;Conference:169-170.
Roach 2013 {published data only}
Seaman 2004 {published data only}
Seeger 2007 {published data only}
  • Seeger JD, Loughlin J, Eng PM, Clifford CR, Cutone J, Walker AM. Risk of thromboembolism in women taking ethinylestradiol/drospirenone and other oral contraceptives. Obstet Gynecol 2007;110(3):587-93.
Seigel 1969 {published data only}
  • Seigel DG, Markush RE. Oral contraceptives and relative risk of death from venous and pulmonary thromboembolism in the United States. American Journal of Epidemiology 1969;90(1):11-16.
Sidney 2004 {published data only}
  • Sidney S, Petitti DB, Soff DG, Cundiff DL, Tolan KK, Quesenberry Jr. CP. Venous thromboembolic disease in users of low-estrogen combined estrogen-progestin oral contraceptives. Contraception 2004;70:3–10.
Spitzer 1993 {published data only}
Stolley 1975 {published data only}
Suissa 1997 {published data only}
Thorogood 1992 {published data only}
  • Thorogood M, Mann J, Murphy M, Vessey M. Risk factors for fatal venousthromboembolism in young women: A case-control study. International Journal of Epidemiology 1992;.21(1):48-52.
Tosetto 2003 {published data only}
Tsankova 2010a {published data only}
  • Tzankova V, Petrov V, Danchev N. Impact of oral contraceptives and smoking on arterial and deep venous thrombosis: A retrospective case-control study. Biotechnology & Biotechnological Equipment 2010;24:2026-30.
Tsankova 2010b {published data only}
  • Tsankova V, Petrov V, Astrug A. [Oral contraceptives increase deep venous thrombosis in smoking women], Akush. Ginekol. 2010 (Sofiia);49(5):8-13.
Ulmer 1997 {published data only}
  • Ulmer H, Pfeifer C, Pfeiffer KR, Bruppacher R. Hospitalization of young women after selected cardiovascular and thromboembolic incidents in Austria 1993 and 1994 [Hospitalisierung von jungen Frauen nach ausgew ihlten kardiovaskul iren und thromboembolischen Ereignissen in Osterreich 1993 und 1994]. Soz-Praventivmed 1997;42:342-350.
Vallee 2001 {published data only}
Van der Meer 1997 {published data only}
Vessey 1969 {published data only}
  • Vessey MP, Doll R. Investigation of relation between use of oral contraceptives andthromboembolic disease. A further report. BMJ 1969;2(5658):651-7.
Vessey 1986 {published data only}
  • Vessey M, Mant D, Smith A, Yeates D. Oral contraceptives and venous thromboembolism: findings in a large prospective study. BMJ 1986;292:526.
WHO 1989 {published data only}
  • WHO Collaborative Study. Cardiovascular disease and use of oral contraceptives. Bulletin of the World Health Organization 1989;67:417-423.
Worralurt 2005 {published data only}
  • Worralurt C, Taneepanichskul S. Risk factors of venous thromboembolism (VT) in Thai reproductive aged female: King Chulalongkorn Memorial Hospital experience. J Med Assoc Thai 2005;88:1502-5.
Yang 2007 {published data only}
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Additional references

  1. References to studies included in this review
  2. References to studies excluded from this review
  3. Additional references
  4. References to other published versions of this review
Bloemenkamp 2003
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References to other published versions of this review

  1. References to studies included in this review
  2. References to studies excluded from this review
  3. Additional references
  4. References to other published versions of this review
Stegeman 2013
  • Stegeman BH, de Bastos M, Rosendaal FR, van Hylckama Vlieg A, Helmerhorst FM, Stijnen T, et al. Different combined oral contraceptives and the risk of venous thrombosis: systematic review and network meta-analysis. BMJ 2013;347:f5298. [PUBMED: 24030561]