Use of recombinant activated factor VII in primary postpartum hemorrhage: the Northern European registry 2000-2004.
OBJECTIVE
To collect data from nine European countries for cases of obstetric hemorrhage between 2000 and 2004 in which recombinant activated factor VII (rFVIIa) was used.


METHODS
The cases were identified through national surveys. Standardized case report forms included sociodemographic details, past medical and obstetric history, and details of the progress and management of labor in which the postpartum hemorrhage occurred. Clinicians were asked to describe subjectively the effect of rFVIIa administration using two mutually exclusive categories: 1) bleeding reduced or 2) bleeding unchanged or worse.


RESULTS
A total of 113 forms were returned (88%) with 97 (86%) classified as treatment, and 16 (14%) as "secondary prophylaxis." Clinicians noted improvements after a single dose for 80% of women in the treatment group, and for 75% in the secondary "prophylaxis" group. However, rFVIIa failed in 15 cases (13.8%). Few serious adverse events were noted related to rFVIIa administration; there were four cases of thromboembolism, one myocardial infarction, and one skin rash.


CONCLUSIONS
Clinical reports and hematologic data suggest improvement for more than 80% of women after rFVIIa administration and few adverse effects.


METHODS
II.
Alfirevic
Zarko
Z
Division of Perinatal and Reproductive Medicine, University of Liverpool, Liverpool Women's Hospital, Liverpool, United Kingdom. zarko@liv.ac.uk
Elbourne
Diana
D
Pavord
Sue
S
Bolte
Antoinette
A
Van Geijn
Herman
H
Mercier
Frederic
F
Ahonen
Jouni
J
Bremme
Katarina
K
Bødker
Birgit
B
Magnúsdóttir
Ebba Margrét
EM
Salvesen
Kjell
K
Prendiville
Walter
W
Truesdale
Ann
A
Clemens
Felicity
F
Piercy
Deborah
D
Gyte
Gill
G
D005060:Europe / Q000453:epidemiology; D015942:Factor VIIa / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D006473:Postpartum Hemorrhage / Q000188:drug therapy* / Q000453:epidemiology; D011247:Pregnancy; D011994:Recombinant Proteins / Q000009:adverse effects / Q000627:therapeutic use; D012042:Registries / Q000706:statistics & numerical data; D012189:Retrospective Studies; D016896:Treatment Outcome
D011994:Recombinant Proteins; C103587:recombinant FVIIa; D015942:Factor VIIa