Thromboprophylaxis for recurrent miscarriage in women with or without thrombophilia

Jantien Visser; Veli-Matti Ulander; Frans M. Helmerhorst; Katja Lampinen; Laure Morin-Papunen; Kitty W. M. Bloemenkamp; Risto J. Kaaja

doi:10.1160/TH10-05-0334

Thrombosis and Haemostasis, Inhaltsverzeichnis

Thromb Haemost 2011; 105(02): 295-301
DOI: 10.1160/TH10-05-0334

Blood Coagulation, Fibrinolysis and Cellular Haemostasis

Schattauer GmbH

Thromboprophylaxis for recurrent miscarriage in women with or without thrombophilia

HABENOX^[*]: A randomised multicentre trial

Jantien Visser

¹Department of Obstetrics, Gynaecology and Reproductive Medicine, Leiden University Medical Center, Leiden, the Netherlands

,

Veli-Matti Ulander

²Department of Obstetrics and Gynaecology, Helsinki University Hospital, Helsinki, Finland

,

Frans M. Helmerhorst

¹Department of Obstetrics, Gynaecology and Reproductive Medicine, Leiden University Medical Center, Leiden, the Netherlands

,

Katja Lampinen

³Department of Obstetrics and Gynaecology, Karolinska University Hospital, Stockholm, Sweden

,

Laure Morin-Papunen

⁴Department of Obstetrics and Gynaecology, Oulu University Hospital, Oulu, Finland

,

Kitty W. M. Bloemenkamp

¹Department of Obstetrics, Gynaecology and Reproductive Medicine, Leiden University Medical Center, Leiden, the Netherlands

,

Risto J. Kaaja

²Department of Obstetrics and Gynaecology, Helsinki University Hospital, Helsinki, Finland

› Institutsangaben

Abstract

Summary

Recurrent miscarriage affects 1–2% of women. In more than half of all recurrent miscarriage the cause still remains uncertain. Thrombophilia has been identified in about 50% of women with recurrent miscarriage and thromboprophylaxis has been suggested as an option of treatment. A randomised double-blind (for aspirin) multicentre trial was performed among 207 women with three or more consecutive first trimester (<13 weeks) miscarriages, two or more second trimester (13–24 weeks) miscarriages or one third trimester fetal loss combined with one first trimester miscarriage. Women were analysed for thrombophilia. After complete work-up, women were randomly allocated before seven weeks’ gestation to either enoxaparin 40 mg and placebo (n=68), enoxaparin 40 mg and aspirin 100 mg (n=63) or aspirin 100 mg (n=76). The primary outcome was live-birth rate. Secondary outcomes were pregnancy complications, neonatal outcome and adverse effects. The 0.92–1.48] was found for enoxaparin and placebo and 65% [RR 1.08, 95% CI 0.83–1.39] for enoxaparin and aspirin when compared to aspirin alone (61%, reference group). In the whole study group the live birth rate was 65% (95% CI 58.66–71.74) for women with three or more miscarriages (n=204). No difference in pregnancy complications, neonatal outcome or adverse effects was observed. No significant difference in live birth rate was found with enoxaparin treatment versus aspirin or a combination of both versus aspirin in women with recurrent miscarriage.

Keywords

Pregnancy - clinical trials - heparins/LMWH - thrombophilia

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Referenzen

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