BJOG : an international journal of obstetrics and gynaecology · 2014
Using vaginal Group B Streptococcus colonisation in women with preterm premature rupture of membranes to guide the decision for immediate delivery: a secondary analysis of the PPROMEXIL trials.
Клиническое исследование I фазыКлиническое исследование II фазыСтатьяМногоцентровое исследованиеРандомизированное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Tajik P, van der Ham D P, Zafarmand M H, Hof M H P, Morris J, Franssen M T M, de Groot C J M, Duvekot J J, Oudijk M A, Willekes C, Bloemenkamp K W M, Porath M, Woiski M, Akerboom B M, Sikkema J M, Nij Bijvank B, Mulder A L M, Bossuyt P M, Mol B W J
Аннотация
OBJECTIVE: To investigate whether vaginal Group B Streptococcus (GBS) colonisation or other baseline characteristics of women with preterm premature rupture of membranes (PPROM) can help in identifying subgroups of women who would benefit from immediate delivery.
DESIGN: Secondary analysis of the PPROMEXIL trials.
SETTING: Sixty hospitals in the Netherlands.
POPULATION: Women with PPROM between 34 and 37 weeks of gestation.
METHODS: Random assignment of 723 women to immediate delivery or expectant management.
MAIN OUTCOME MEASURES: Early onset neonatal sepsis.
RESULTS: Vaginal GBS colonisation status was the only marker which was significantly associated with the benefit of immediate delivery (P for interaction: 0.04). GBS colonisation was observed in 14% of women. The risk of early onset neonatal sepsis in GBS-positive women was high (15.2%) when they were managed expectantly but this risk was reduced to 1.8% with immediate delivery. The early onset neonatal sepsis risk was much lower in neonates of GBS-negative women: 2.6% after expectant management and 2.9% with immediate delivery. We estimated that by inducing labour only in GBS-positive women, there would be a 10.4% increase in term delivery rate, while keeping neonatal sepsis and caesarean delivery rates comparable to a strategy of labour induction for all.
CONCLUSIONS: Our post hoc findings suggest that women with PROM between 34 and 37 weeks might benefit from immediate delivery if they have GBS vaginal colonisation, while in GBS-negative women labour induction could be delayed until 37 weeks.
DESIGN: Secondary analysis of the PPROMEXIL trials.
SETTING: Sixty hospitals in the Netherlands.
POPULATION: Women with PPROM between 34 and 37 weeks of gestation.
METHODS: Random assignment of 723 women to immediate delivery or expectant management.
MAIN OUTCOME MEASURES: Early onset neonatal sepsis.
RESULTS: Vaginal GBS colonisation status was the only marker which was significantly associated with the benefit of immediate delivery (P for interaction: 0.04). GBS colonisation was observed in 14% of women. The risk of early onset neonatal sepsis in GBS-positive women was high (15.2%) when they were managed expectantly but this risk was reduced to 1.8% with immediate delivery. The early onset neonatal sepsis risk was much lower in neonates of GBS-negative women: 2.6% after expectant management and 2.9% with immediate delivery. We estimated that by inducing labour only in GBS-positive women, there would be a 10.4% increase in term delivery rate, while keeping neonatal sepsis and caesarean delivery rates comparable to a strategy of labour induction for all.
CONCLUSIONS: Our post hoc findings suggest that women with PROM between 34 and 37 weeks might benefit from immediate delivery if they have GBS vaginal colonisation, while in GBS-negative women labour induction could be delayed until 37 weeks.