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SAFETY ASSESSMENT OF AUTOLOGOUS BLOOD DONATION BY PREGNANT WOMEN-PRELIMINARY STUDY FOR A MULTICENTER TRIAL-

: We assessed the safety of autologous blood donation during pregnancy in a Japanese population using a prospec-tive study design. A total of 190 donations were performed by 66 patients between March 1, 2005 and May 31, 2006. Indications for autologous blood donation were blood type Rh negative (n＝11), atypical antibody positive test results (n＝5), placenta previa (n＝17), lower lying placenta (n＝14), leiomyoma of uterus (n＝17), and a history of massive blood loss at previous delivery (n＝2). Among 190 donations by 66 patients, 11 donations (5.8％) were complicated with Vasovagal Reaction (VVR). All donations were conducted with fetal heart rate (FHR) monitoring. No abnormal FHR pattern was observed during any donation. Sixty-eight neonates (2 twins) were delivered. Gestational age at delivery, birth weight, Apgar score at 1 minute, and Apgar score at 5 minutes was 37.6±3.5 (mean±SD) (gestational weeks). 2,892±431 (mean±SD) (g), 8 (median), and 9 (median), respectively. The neonatal period was uneventful in all babies. Average blood loss at delivery was 980±861 m l (mean±SD). Among 66 patients, 11 patients (16.7％) were transfused with autologous blood. Blood loss in patients who received transfusions was significantly greater than that in patients without transfusion (1,992± 1,279 m l (mean±SD) vs 752±531 m l (mean±SD)). All transfusions were achieved without side effects. In conclusion, autologous blood donation may present a slightly higher risk of VVR in pregnant women than in non-pregnant women. However, because no adverse events were observed in perinatal course, this procedure ap-pears to be applicable for patients at high risk of bleeding at delivery.