title: Use of granulocyte colony-stimulating factor during pregnancy in women with chronic neutropenia.
abstract: OBJECTIVE
  To report outcomes associated with the administration of granulocyte colony-stimulating factor (G-CSF) to women with chronic neutropenia during pregnancy.
  
  
  METHODS
  We conducted an observational study of women of childbearing potential with congenital, cyclic, idiopathic, or autoimmune neutropenia enrolled in the Severe Chronic Neutropenia International Registry to determine outcomes of pregnancies, without and with chronic G-CSF therapy, 1999-2014. Treatment decisions were made by the patients' personal physicians. A research nurse conducted telephone interviews of all enrolled U.S. women of childbearing potential using a standard questionnaire. Comparisons used Fisher's exact test analysis and Student's t test.
  
  
  RESULTS
  One hundred seven women reported 224 pregnancies, 124 without G-CSF therapy and 100 on chronic G-CSF therapy (median dose 1.0 micrograms/kg per day, range 0.02-8.6 micrograms/kg per day). There were no significant differences in adverse events between the groups considering all pregnancies or individual mothers, for example, spontaneous terminations (all pregnancies: no G-CSF in 27/124, G-CSF in 13/100; P=.11, Fisher's exact test), preterm labors (all pregnancies, no G-CSF in 9/124, G-CSF in 2/100, P=.12). A study with at least 300 per group would be needed to detect a difference in these events with 80% statistical power (α=0.05). Four newborns of mothers with idiopathic or autoimmune neutropenia not on G-CSF (4/101) had life-threatening infections, whereas there were no similar events (0/90) in the treated group, but this difference was also not statistically significant (P=.124). Adverse events in the neonates were similar for the two groups.
  
  
  CONCLUSIONS
  This observational study showed no significant adverse effects of administration of G-CSF to women with severe chronic neutropenia during pregnancy.
  
  
  METHODS
  III.
authors.affiliation: Division of Pediatric Hematology/Oncology, University of Michigan, Ann Arbor, Michigan; the Department of Medicine, Severe Chronic Neutropenia International Registry, and the Department of Medicine, University of Washington, Seattle, Washington; the University of Louisville School of Medicine, Louisville, Kentucky; and the Department of Pediatrics, University of Massachusetts Medical School, Worcester, Massachusetts.
authors.forename: Laurence A
authors.initials: LA
authors.lastname: Boxer
authors.forename: Audrey Anna
authors.initials: AA
authors.lastname: Bolyard
authors.forename: Merideth L
authors.initials: ML
authors.lastname: Kelley
authors.forename: Tracy M
authors.initials: TM
authors.lastname: Marrero
authors.forename: Lan
authors.initials: L
authors.lastname: Phan
authors.forename: Jordan M
authors.initials: JM
authors.lastname: Bond
authors.forename: Peter E
authors.initials: PE
authors.lastname: Newburger
authors.forename: David C
authors.initials: DC
authors.lastname: Dale
mesh_terms: D000022:Abortion, Spontaneous / Q000453:epidemiology; D000293:Adolescent; D000328:Adult; D005260:Female; D005865:Gestational Age; D016179:Granulocyte Colony-Stimulating Factor / Q000627:therapeutic use*; D006801:Humans; D007231:Infant, Newborn; D007239:Infections / Q000453:epidemiology; D007958:Leukocyte Count; D050498:Live Birth; D009503:Neutropenia / Q000097:blood / Q000188:drug therapy*; D009504:Neutrophils; D007752:Obstetric Labor, Premature / Q000453:epidemiology; D011247:Pregnancy; D011250:Pregnancy Complications, Hematologic / Q000097:blood / Q000188:drug therapy*; D055815:Young Adult
chemical_list: D016179:Granulocyte Colony-Stimulating Factor