SAFETY AND EFFICACY OF TINZAPARIN ADMINISTRATION DURING PREGNANCY
Abstract number: P-T-594
Kotsi1 P., Tsoucala1 C., Anastasopoulou1 I., Sarantopoulos1 A., Kanellopoulou1 G., Adraktas1 T., Karafoulidou1 A.
12nd regional Blood Transfusion Center - Hemophilia Center, Laikon General Hospital, Athens, Greece
How-to-cite Kotsi P, Tsoucala C, Anastasopoulou I, Sarantopoulos A, Kanellopoulou G, Adraktas T, Karafoulidou A. SAFETY AND EFFICACY OF TINZAPARIN ADMINISTRATION DURING PREGNANCY. J Thromb Haemost 2007; 5 Supplement 2: P-T-594
Introduction: Women with history of recurrent pregnancy loss (RPL) and thrombophilia have poor pregnancy outcomes. The use of LMWHs during pregnancy results in improved outcomes.
Methods: 41 women with RPL history and/or thrombophilia received tinzaparin once daily with dose adjustment (peak anti-Xa 0.3-0.5) for 43 pregnancies.
The primary efficacy endpoint was delivery of a healthy infant. Other efficacy endpoints were duration of gestation, birth weight, incidence of thrombosis and gestational vascular complications. Safety endpoints were infant and maternal drug related adverse events.
Results: From the treated women (previous VTE n=3, combined thrombophilia n=11, pregnancy complications n= 27) we had 40 alive neonates (pregnancy loss at 13-14 w n=3/1=chromosomal abnormality, 2=unknown). Gestational period was 30-33w 6.9%, 34-36w 4.6% and >36w 81.4%. Birth weight was <1500gr (1/40), 1500-2500gr (5/40), > 2500gr (34/40) (mean body weight=3050gr). Other complications were preeclampsia 3.3%, placental abruption 3.3%, IUGR 3/40 (7.5% -1 pregnancy related diabetes) and oligamnio 1/40 (3,3% sickle cell-beta-thalassemia). We had 1 thrombotic episode in a woman with ATIII deficiency and 20210 GA, 2 days after delivery.
No heparin induced thrombocytopenia or neonatal bleeding developed. 2 women developed skin rash and changed to another LMWH. Minor bleeding developed in 3/40 postpartum.
The optimal prophylactic regimen for specific defects has not yet been explored. The mean dose necessary to obtain 0.3-0.5 anti-Xa activity was 9500 IU/day, with a mean body weight 61 kg (range 49-82) in the beginning of pregnancy and reaching 76 kg (range 55- 90). The median age was 34y (24-40).
Conclusions: Prophylaxis with tinzaparin in our patients resulted in favourable gestational and neonatal outcome. Although the majority of deliveries were at term, the rate of preterm deliveries was also higher than normal. Future studies should be directed towards optimizing prophylactic strategies to minimize these complications.