Risk stratification and heparin prophylaxis to prevent venous thromboembolism in pregnant women

Rupert M. Bauersachs; Joachim Dudenhausen; Andree Faridi; Thorsten Fischer; Samson Fung; Ulrich Geisen; Job Harenberg; Eberhard Herchenhan; Franz Keller; Bettina Kemkes-Matthes; Helmut Schinzel; Michael Spannagl; Christian J. Thaler; the EThIG Investigators

doi:10.1160/TH07-05-0329

Thrombosis and Haemostasis, Table of Contents

Thromb Haemost 2007; 98(06): 1237-1245
DOI: 10.1160/TH07-05-0329

Blood Coagulation, Fibrinolysis and Cellular Haemostasis

Schattauer GmbH

Risk stratification and heparin prophylaxis to prevent venous thromboembolism in pregnant women

Authors

Rupert M. Bauersachs

¹Department of Vascular Medicine, Klinikum Darmstadt, Darmstadt
Joachim Dudenhausen

²Department of Obstetrics, Charité – Campus Virchow-Kliniken, Berlin
Andree Faridi

³Obstetrics and Certified Breast Center, Asklepios Barmbek, Hamburg
Thorsten Fischer

⁴Department of Obstetrics and Gynaecology, Technische Universität München, München and Krankenhaus Landshut Achdorf, Landshut
Samson Fung

⁵Primelstraße 4, Eching
Ulrich Geisen

⁶Medical Department, Albert-Ludwigs-Universität, Freiburg
Job Harenberg

⁷IV. Medical Department, University Hospital Mannheim, Mannheim
Eberhard Herchenhan

⁸Medexcell-Institute, Erlangen
Franz Keller

⁹Trautenauer Straße 93, Würzburg
Bettina Kemkes-Matthes

¹⁰University Hospitals Giessen and Marburg GmbH, Haemostasis Center, Giessen
Helmut Schinzel

¹¹II. Medical Department, University Hospital Mainz, Mainz
Michael Spannagl

¹²Department of Haemostaseology, Klinikum Innenstadt, Ludwig-Maximilians-Universität München-Grosshadern, München
Christian J. Thaler

¹³Department of Obstetrics and Gynecology, Klinikum der Universität München, München; Germany

the EThIG Investigators

Abstract

Summary

Women with a history of venous thromboembolism (VTE), thrombophilia or both may be at increased risk of thrombosis during pregnancy, but the optimal management strategy is not well defined in clinical guidelines because of limited trial data. A strategy of risk assessment and heparin prophylaxis was evaluated in pregnant women at increased risk of VTE. In a prospective trial (Efficacy of Thromboprophylaxis as an Intervention during Gravidity [EThIG]), 810 pregnant women were assigned to one of three management strategies according to pre-defined risk factors related to history of VTE and thrombophilic profile. Low-risk women (group I), received 50–100 IU dalteparin/ kg body weight/ day for 14 days postpartum, or earlier when additional risk factors occurred. Women at high (group II) or very high risk (group III) received dalteparin from enrolment until six weeks postpartum (50–100 IU and 100–200 IU/ kg/ day, respectively). Objectively confirmed, symptomatic VTE occurred in 5/810 women (0.6%; 95% confidence interval [CI], 0.2 to 1.5%) (group I, 0 of 225; II, 3/469; III, 2/116). The rate of serious bleeding was 3.0% (95 % CI, 1.9 to 4.4%); 1.1% (95 % CI, 0.5 to 2.2%) was possibly dalteparin-related. There was no evidence of heparin- induced thrombocytopenia, one case of osteoporosis, and rates of miscarriage and stillbirth were similar to previous, retrospective studies. Risk-stratified heparin prophylaxis was associated with a low incidence of symptomatic VTE and few clinically important adverse events. Antepartum heparin prophylaxis is, therefore, warranted in pregnant women with idiopathic thrombosis or symptomatic thrombophilia.

Keywords

Venous thromboembolism - pregnancy - risk assessment - lowmolecular weight heparin - thromboprophylaxis

Full Text

References

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