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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

Rupert M. Bauersachs
1   Department of Vascular Medicine, Klinikum Darmstadt, Darmstadt
,
Joachim Dudenhausen
2   Department of Obstetrics, Charité – Campus Virchow-Kliniken, Berlin
,
Andree Faridi
3   Obstetrics and Certified Breast Center, Asklepios Barmbek, Hamburg
,
Thorsten Fischer
4   Department of Obstetrics and Gynaecology, Technische Universität München, München and Krankenhaus Landshut Achdorf, Landshut
,
Samson Fung
5   Primelstraße 4, Eching
,
Ulrich Geisen
6   Medical Department, Albert-Ludwigs-Universität, Freiburg
,
Job Harenberg
7   IV. Medical Department, University Hospital Mannheim, Mannheim
,
Eberhard Herchenhan
8   Medexcell-Institute, Erlangen
,
Franz Keller
9   Trautenauer Straße 93, Würzburg
,
Bettina Kemkes-Matthes
10   University Hospitals Giessen and Marburg GmbH, Haemostasis Center, Giessen
,
Helmut Schinzel
11   II. Medical Department, University Hospital Mainz, Mainz
,
Michael Spannagl
12   Department of Haemostaseology, Klinikum Innenstadt, Ludwig-Maximilians-Universität München-Grosshadern, München
,
Christian J. Thaler
13   Department of Obstetrics and Gynecology, Klinikum der Universität München, München; Germany
,
the EThIG Investigators › Author Affiliations Financial support: The EThIG study was an investigator-initiated and investigator-led study supported by an unrestricted grant from Pfizer GmbH. The Steering Committee was responsible for the design, conduct and analyses of the study. Interpretation, data and preparation of the manuscript were undertaken by the investigators, and fulfilled a requirement within the protocol. The database is held by the investigators, and data management, biostatistics and reporting was done by an independent biometric institute.
Further Information

Publication History

Received 05 May 2007

Accepted after revision 21 August 2007

Publication Date:
30 November 2017 (online)

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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

* The participants in the Efficacy of Thromboprophylaxis as an Intervention during Gravidity (EThIG) study are listed in the appendix.


 

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