Section of Maternal Fetal Medicine, Department of Obstetrics and Gynecology, Women's Service Line, Ochsner Health, New Orleans, Louisiana.
Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, University of Alabama at Birmingham, Birmingham, Alabama.
J Matern Fetal Neonatal Med. 2024 Dec;37(1):2367082. doi: 10.1080/14767058.2024.2367082. Epub 2024 Jun 14.
It is currently unknown whether adjunctive azithromycin prophylaxis at the time of non-elective cesarean has differential effects on neonatal outcomes in the context of prematurity. The objective of this study was to compare whether neonatal outcomes differ in term and preterm infants exposed to adjunctive azithromycin prophylaxis before non-elective cesarean delivery.
A planned secondary analysis of a multi-center randomized controlled trial that enrolled women with singleton pregnancies ≥24 weeks gestation undergoing non-elective cesarean delivery (during labor or ≥4 h after membrane rupture). Women received standard antibiotic prophylaxis and were randomized to either adjunctive azithromycin (500 mg) or placebo. The primary composite outcome was neonatal death, suspected or confirmed neonatal sepsis, and serious neonatal morbidities (NEC, PVL, IVH, BPD). Secondary outcomes included NICU admission, neonatal readmission, culture positive infections and prevalence of resistant organisms. Odds ratios (OR) for the effect of azithromycin versus placebo were compared between gestational age strata (preterm [less than 37 weeks] versus term [37 weeks or greater]). Tests of interaction examined homogeneity of treatment effect with gestational age.
The analysis includes 2,013 infants, 226 preterm (11.2%) and 1,787 term. Mean gestational ages were 34 and 39.5 weeks, respectively. Within term and preterm strata, maternal and delivery characteristics were similar between the azithromycin and placebo groups. There was no difference in the odds of composite neonatal outcome between those exposed to azithromycin versus placebo in preterm neonates (OR 0.82, 95% CI 0.48-1.41) and in term neonates (OR 1.06, 95% CI 0.77-1.46), with no difference between gestational age strata ( = 0.42). Analysis of secondary outcomes also revealed no differences in treatment effects within or between gestational age strata.
Exposure to adjunctive azithromycin antibiotic prophylaxis for non-elective cesarean delivery does not increase neonatal morbidity or mortality in term or preterm infants.
https://clinicaltrials.gov, NCT01235546.
目前尚不清楚在早产儿的情况下，非择期剖宫产时辅助使用阿奇霉素预防是否会对新生儿结局产生不同影响。本研究的目的是比较在非择期剖宫产前接受辅助阿奇霉素预防的足月和早产婴儿的新生儿结局是否存在差异。
这是一项多中心随机对照试验的计划二次分析，纳入了妊娠 24 周以上的单胎妊娠妇女，这些妇女进行了非择期剖宫产（在分娩期间或胎膜破裂后 4 小时以上）。所有女性均接受标准抗生素预防，并随机分为阿奇霉素（500 毫克）组或安慰剂组。主要复合结局是新生儿死亡、疑似或确诊新生儿败血症和严重新生儿并发症（NEC、PVL、IVH、BPD）。次要结局包括新生儿重症监护病房（NICU）入院、新生儿再次入院、培养阳性感染和耐药菌的发生率。阿奇霉素与安慰剂的效果的比值比（OR）在妊娠年龄分层（早产[<37 周]与足月[37 周或以上]）之间进行了比较。检验治疗效果与妊娠年龄的交互作用，以检查同质性。
分析包括 2013 名婴儿，226 名早产儿（11.2%）和 1787 名足月儿。平均孕龄分别为 34 周和 39.5 周。在足月和早产分层中，阿奇霉素组和安慰剂组的产妇和分娩特征相似。在早产儿中，暴露于阿奇霉素的新生儿与暴露于安慰剂的新生儿的复合新生儿结局的几率没有差异（OR 0.82，95%CI 0.48-1.41），在足月儿中也没有差异（OR 1.06，95%CI 0.77-1.46），妊娠年龄分层之间没有差异（ = 0.42）。对次要结局的分析也表明，在妊娠年龄分层内或之间，治疗效果没有差异。
非择期剖宫产时辅助使用阿奇霉素抗生素预防不会增加足月或早产婴儿的新生儿发病率或死亡率。
