Title: 471: Does induction of labor in women with a positive GBS vaginal culture decreases the risk for neonatal sepsis in women with PPROM between 34 and 37 weeks?
Abstract: ObjectivePreterm prelabor rupture of membranes (PPROM) is an important clinical problem which is associated with an increased risk of neonatal sepsis. In a large multicenter randomised controlled trial in theNetherlands (the PPROMEXIL-trial [ISRCTN29313500]) we showed that induction of labor was not advantageous compared to expectant management in women with PPROM between 34 and 37 weeks of gestation. In this present unplanned post hoc secondary analysis, we evaluate whether induction of labor might reduce the risk for neonatal sepsis in women with a positive vaginal culture for Group B streptococcus (GBS).Study DesignFrom January 2007 till September 2009 we randomly allocated women with PPROM between 34 and 37 weeks to induction of labor or expectant management. The primary outcome was neonatal sepsis defined as a positive blood culture or a CRP rise above 20mg/l with clinical signs of infection and/or positive surface cultures. Al women had a vaginal swab to test for GBS carrier status at the moment of entry in the trial. Here we test for interaction between GBS carrier status and treatment effect, and report the treatment effect in both subgroups.ResultsWe included 529 patients, of whom in 507 (96%) the GBS status was assessed, and 83 (16%) were GBS positive. Twenty six (4.9%) neonates developed a neonatal sepsis. The p-value for interaction between GBS carrier status and the effect of induction of labour on development of neonatal sepsis was .12. Relative risks for the effect of induction of labour on neonatal sepis were .44 (95%-CI .13 to 1.31) in GBS positive women and 1.38 (95%-CI .49 to 3.09) in GBS negative women.ConclusionsIn women with PPROM between 34 and 37 weeks as a group induction of labour does not reduce the risk of neonatal sepsis. These data show that there might be an indication that induction does reduce the risk of neonatal sepsis in the subgroup of women that are GBS positive. ObjectivePreterm prelabor rupture of membranes (PPROM) is an important clinical problem which is associated with an increased risk of neonatal sepsis. In a large multicenter randomised controlled trial in theNetherlands (the PPROMEXIL-trial [ISRCTN29313500]) we showed that induction of labor was not advantageous compared to expectant management in women with PPROM between 34 and 37 weeks of gestation. In this present unplanned post hoc secondary analysis, we evaluate whether induction of labor might reduce the risk for neonatal sepsis in women with a positive vaginal culture for Group B streptococcus (GBS). Preterm prelabor rupture of membranes (PPROM) is an important clinical problem which is associated with an increased risk of neonatal sepsis. In a large multicenter randomised controlled trial in theNetherlands (the PPROMEXIL-trial [ISRCTN29313500]) we showed that induction of labor was not advantageous compared to expectant management in women with PPROM between 34 and 37 weeks of gestation. In this present unplanned post hoc secondary analysis, we evaluate whether induction of labor might reduce the risk for neonatal sepsis in women with a positive vaginal culture for Group B streptococcus (GBS). Study DesignFrom January 2007 till September 2009 we randomly allocated women with PPROM between 34 and 37 weeks to induction of labor or expectant management. The primary outcome was neonatal sepsis defined as a positive blood culture or a CRP rise above 20mg/l with clinical signs of infection and/or positive surface cultures. Al women had a vaginal swab to test for GBS carrier status at the moment of entry in the trial. Here we test for interaction between GBS carrier status and treatment effect, and report the treatment effect in both subgroups. From January 2007 till September 2009 we randomly allocated women with PPROM between 34 and 37 weeks to induction of labor or expectant management. The primary outcome was neonatal sepsis defined as a positive blood culture or a CRP rise above 20mg/l with clinical signs of infection and/or positive surface cultures. Al women had a vaginal swab to test for GBS carrier status at the moment of entry in the trial. Here we test for interaction between GBS carrier status and treatment effect, and report the treatment effect in both subgroups. ResultsWe included 529 patients, of whom in 507 (96%) the GBS status was assessed, and 83 (16%) were GBS positive. Twenty six (4.9%) neonates developed a neonatal sepsis. The p-value for interaction between GBS carrier status and the effect of induction of labour on development of neonatal sepsis was .12. Relative risks for the effect of induction of labour on neonatal sepis were .44 (95%-CI .13 to 1.31) in GBS positive women and 1.38 (95%-CI .49 to 3.09) in GBS negative women. We included 529 patients, of whom in 507 (96%) the GBS status was assessed, and 83 (16%) were GBS positive. Twenty six (4.9%) neonates developed a neonatal sepsis. The p-value for interaction between GBS carrier status and the effect of induction of labour on development of neonatal sepsis was .12. Relative risks for the effect of induction of labour on neonatal sepis were .44 (95%-CI .13 to 1.31) in GBS positive women and 1.38 (95%-CI .49 to 3.09) in GBS negative women. ConclusionsIn women with PPROM between 34 and 37 weeks as a group induction of labour does not reduce the risk of neonatal sepsis. These data show that there might be an indication that induction does reduce the risk of neonatal sepsis in the subgroup of women that are GBS positive. In women with PPROM between 34 and 37 weeks as a group induction of labour does not reduce the risk of neonatal sepsis. These data show that there might be an indication that induction does reduce the risk of neonatal sepsis in the subgroup of women that are GBS positive.
Publication Year: 2011
Publication Date: 2011-01-01
Language: en
Type: article
Indexed In: ['crossref']
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