解脲脲原体和/或支原体羊膜腔感染抗生素预防早产的随机试验。
Antibiotics for amniotic-fluid colonization by Ureaplasma and/or Mycoplasma spp. to prevent preterm birth: A randomized trial.
机构信息
Inserm UMR 1153, Obstetrical, Perinatal and Pediatric Epidemiology Research Team (Epopé), Center for Epidemiology and Statistics Sorbonne Paris Cité, DHU Risks in pregnancy, Paris Descartes University, Paris, France.
Sorbonne University, Université Pierre et Marie Curie, Paris, France.
出版信息
PLoS One. 2018 Nov 7;13(11):e0206290. doi: 10.1371/journal.pone.0206290. eCollection 2018.
OBJECTIVE
To assess whether antibiotics used for treatment in asymptomatic second-trimester women positive for Mycoplasma or Ureaplasma spp. detected by amniotic-fluid PCR prevents preterm delivery.
DESIGN
A randomized, double-blind, placebo-controlled trial.
SETTING
10 maternal fetal medicine centers in France.
POPULATION
Women with a singleton pregnancy who underwent amniocentesis between 16 and 20 weeks' gestation (weeks) for Down syndrome screening. A sample of 238 women with PCR-positive findings per treatment group was needed to show a 50% reduction in the preterm delivery rate.
METHODS
Amniotic fluid was tested. Women with positive findings on real-time PCR of amniotic fluid for Mycoplasma hominis, Mycoplasma genitalium, Ureaplasma urealyticum and Ureaplasma parvum were randomized to receive josamycin or placebo. Amniotic fluid was also tested for 16S PCR.
MAIN OUTCOME MEASURES
The primary outcome was delivery before 37 weeks.
RESULTS
In total, 1043 women underwent amniotic-fluid screening with specific PCR detection between July 2008 and July 2011: PCR detection failed in 27 (2.6%), and 20 (1.9%) underwent termination of pregnancy. Among the 1016 women with PCR results, 980 had available data for the primary outcome (delivery before 37 weeks) and 29 (3.0%) were positive for Ureaplasma and/or Mycoplasma spp. Because of the low rate of women with PCR-positive findings, the trial was stopped prematurely. In total, 19 women were randomized to receive placebo (n = 8) or josamycin (n = 11) and their characteristics were comparable, as was the rate of preterm delivery and secondary outcomes. In comparing all PCR-positive and -negative women regardless of treatment, PCR positivity for Ureaplasma and/or Mycoplasma spp. was not associated with any adverse pregnancy or neonatal outcome. Amniotic-fluid screening by 16S PCR showed no other bacterial colonization associated with preterm birth.
CONCLUSIONS
Because of a low amniotic fluid colonization rate, the trial was interrupted. Maternal amniotic-fluid colonization by Mycoplasma and/or Ureaplasma spp. at 16-20 weeks in asymptomatic women is rare and not associated with adverse pregnancy outcomes.
TRIAL REGISTRATION
ClinicalTrials.gov NCT00718705.
目的
评估对经羊水 PCR 检测出的无症状妊娠中期支原体或脲原体呈阳性的女性使用抗生素治疗是否能预防早产。
设计
随机、双盲、安慰剂对照试验。
地点
法国 10 个母胎医学中心。
人群
接受羊膜穿刺术进行唐氏综合征筛查的单胎妊娠女性，妊娠 16 至 20 周。每个治疗组需要 238 名 PCR 阳性发现的女性，以显示早产率降低 50%。
方法
检测羊水。对羊水实时 PCR 检测出解脲脲原体、人型支原体、生殖支原体、解脲脲原体和微小脲原体阳性的女性进行随机分组，接受交沙霉素或安慰剂治疗。羊水还进行了 16S PCR 检测。
主要观察指标
主要结局是 37 周前分娩。
结果
2008 年 7 月至 2011 年 7 月期间，共 1043 名女性进行了羊水筛查，其中 27 例（2.6%）PCR 检测失败，20 例（1.9%）终止妊娠。在有 PCR 结果的 1016 名女性中，980 名有主要结局（37 周前分娩）的可用数据，29 名（3.0%）对脲原体和/或支原体呈阳性。由于 PCR 阳性发现的女性数量较低，试验提前终止。共有 19 名女性被随机分配至安慰剂组（n=8）或交沙霉素组（n=11），两组的特征相似，早产率和次要结局也相似。比较所有 PCR 阳性和阴性女性，无论治疗与否，脲原体和/或支原体 PCR 阳性与任何不良妊娠或新生儿结局无关。16S PCR 显示羊水筛查未发现与早产相关的其他细菌定植。
结论
由于羊水定植率较低，试验中断。无症状女性在妊娠 16-20 周时，羊水被支原体和/或脲原体定植的情况罕见，且与不良妊娠结局无关。
试验注册
ClinicalTrials.gov NCT00718705。
Zotero 插件