A randomized pilot trial of administration of granulocyte colony-stimulating factor to women before preterm delivery

OBJECTIVE: The object was to determine whether administering recombinant human granulocyte colony-stimulating factor to women before a preterm delivery (less than or equal to 30 weeks' gestation) would improve fetal neutrophil production and neonatal outcome without adverse maternal effects. STUDY DESIGN: A single dose (25 mu g/kg) of recombinant human granulocyte colony-stimulating factor or placebo was given to 26 women in preterm labor in a randomized, double-blind study. Neutrophil production was assessed by marrow aspirations of neonates 24 hours after delivery, blood neutrophil counts were measured in neonates for 1 week, and Scores for Neonatal Acute Physiologic State were calculated on days 1 and 7 of life. RESULTS: Of the 26 women enrolled, 16 were delivered of 20 infants within 3 weeks of receiving recombinant human granulocyte colony-stimulating factor. We found no apparent adverse effect on pregnancy duration or maternal comfort. The neonates born to mothers treated with recombinant human granulocyte colony-stimulating factor had a significantly greater marrow proliferative pool (P<.05 vs placebo) and a significant improvement in Scores for Neonatal Acute Physiologic State between days 1 and 7 (P<.02). CONCLUSIONS: Recombinant human granulocyte colony-stimulating factor administration to women before preterm delivery appears to have no significant immediate adverse effects on either the mother or the infant. and it could increase fetal neutrophil production and improve neonatal outcome.