title: Experience with recombinant activated factor VII for severe post-partum hemorrhage in Japan, investigated by Perinatology Committee, Japan Society of Obstetrics and Gynecology.
abstract: OBJECTIVE
  To investigate the utility of recombinant activated Factor VII (rFVIIa) for severe post-partum hemorrhage (PPH) in Japan.
  
  
  METHODS
  We studied 69 patients treated with rFVIIa for severe PPH; 44 patients were from the registry of Japan Society of Obstetrical, Gynecological and Neonatal Hematology, and 25 were identified by a survey of the Japan Society of Obstetrics and Gynecology.
  
  
  RESULTS
  Overall, the mean and median blood loss were 11 835 mL and 8639 mL, respectively. Treatment before rFVIIa included transarterial embolization in 23 patients and hysterectomy in 38. Forty-two patients had a single dose, 17 had two doses, and four had three doses. The mean (± SD) single dose was 81.60 ± 16.25 µg/kg. Sixty-five patients survived, and four died. The cause of PPH in patients who died was uterine rupture plus amniotic fluid embolism in two patients, uterine cervical laceration in one, and placental abruption in one. The amount of blood loss in cases of death was 6428-43 810 mL. This suggested that whether a patient survives or not was more dependent on her general condition before and after rFVIIa treatment than on the amount of blood loss. Four patients had thromboembolic events after rFVIIa treatment (deep vein thrombosis; deep vein thrombosis plus pulmonary embolism; acute myocardial infarction; and pulmonary embolism); all of these patients recovered.
  
  
  CONCLUSIONS
  The present promising results may support the utility of rFVIIa for severe PPH in Japan.
authors.affiliation: Department of Obstetrics and Gynecology, Aiwa Hospital, Kawagoe, Saitama.|Perinatology Committee, Japan Society of Obstetrics and Gynecology, Tokyo.
authors.forename: Maki
authors.initials: M
authors.lastname: Murakami
authors.affiliation: Department of Obstetrics and Gynecology, Hamamatsu Medical Center, Hamamatsu.|Perinatology Committee, Japan Society of Obstetrics and Gynecology, Tokyo.|Japan Society of Obstetrical, Gynecological and Neonatal Hematology, Fukuoka, Japan.
authors.forename: Takao
authors.initials: T
authors.lastname: Kobayashi
authors.affiliation: Division of Obstetrics, Center of Maternal-Fetal, Neonatal and Reproductive Medicine, National Center for Child Health and Development.|Perinatology Committee, Japan Society of Obstetrics and Gynecology, Tokyo.
authors.forename: Takahiko
authors.initials: T
authors.lastname: Kubo
authors.affiliation: Perinatology Committee, Japan Society of Obstetrics and Gynecology, Tokyo.|Department of Perinatology and Gynecology, Kagawa University Graduate School of Medicine, Miki.
authors.forename: Toshiyuki
authors.initials: T
authors.lastname: Hata
authors.affiliation: Department of Obstetrics and Gynecology, Juntendo University Faculty of Medicine.|Perinatology Committee, Japan Society of Obstetrics and Gynecology, Tokyo.
authors.forename: Satoru
authors.initials: S
authors.lastname: Takeda
authors.affiliation: Perinatology Committee, Japan Society of Obstetrics and Gynecology, Tokyo.|Department of Obstetrics and Gynecology, Nagasaki University Faculty of Medicine, Nagasaki.
authors.forename: Hideaki
authors.initials: H
authors.lastname: Masuzaki
mesh_terms: D000328:Adult; D001803:Blood Transfusion; D015942:Factor VIIa / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D006473:Postpartum Hemorrhage / Q000188:drug therapy*; D011247:Pregnancy; D011994:Recombinant Proteins / Q000009:adverse effects / Q000627:therapeutic use; D013923:Thromboembolism / Q000139:chemically induced
chemical_list: D011994:Recombinant Proteins; C103587:recombinant FVIIa; D015942:Factor VIIa
keywords: critical bleeding in obstetrics; patient registry; post-partum hemorrhage; recombinant activated Factor VII; thromboembolism