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Obstetrics & Gynecology 2007;110:1270-1278
© 2007 by The American College of Obstetricians and Gynecologists
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ORIGINAL RESEARCH

Use of Recombinant Activated Factor VII in Primary Postpartum Hemorrhage

The Northern European Registry 2000–2004

Zarko Alfirevic, MD, FRCOG, Diana Elbourne, PhD, Sue Pavord, MBChB, FRCP, Antoinette Bolte, MD, Herman Van Geijn, MD, Frederic Mercier, MD, Jouni Ahonen, MD, Katarina Bremme, MD, Birgit Bødker, MD, Ebba Margrét Magnúsdóttir, MD, Kjell Salvesen, MD, Walter Prendiville, MAO, FRCOG, Ann Truesdale, BSc, Felicity Clemens, MPhil, Deborah Piercy, BSc and Gill Gyte, BSc

From the 1Division of Perinatal and Reproductive Medicine, University of Liverpool, Liverpool Women's Hospital, Liverpool, United Kingdom.

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.

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

LEVEL OF EVIDENCE: II




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Recombinant Factor VII for Postpartum Hemorrhage?
Journal Watch (General), January 2, 2008; 2008(102): 9 - 9.
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