A randomised controlled double-blind clinical trial of 17-hydroxyprogesterone caproate for the prevention of preterm birth in twin gestation (PROGESTWIN): evidence for reduced neonatal morbidity
A randomised controlled double-blind clinical trial of 17-hydroxyprogesterone caproate for the prevention of preterm birth in twin gestation (PROGESTWIN): evidence for reduced neonatal morbidity
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DOI：
10.1111/1471-0528.13031
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发表时间：
2015-01-01
影响因子：
5.8
通讯作者：
Nassar, A. H.
中科院分区：
文献类型：
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作者：
Awwad, J.;Usta, I. M.;Nassar, A. H.
目的 确定 17α-羟基孕酮己酸酯 (17OHPC) 是否会延长妊娠 37 周以上（主要结果）并降低双胎妊娠中的新生儿发病率（次要结果）。设计随机对照双盲临床试验。设置三级护理大学医疗中心。人群未选择的双胎妊娠妇女。方法参与者每周注射 250 mg 17OHPC（n = 194) 或安慰剂 (n = 94)，妊娠 16-20 至 36 周。使用置换块随机化方法进行随机化。数据以意向治疗为基础进行分析。主要结局指标是妊娠37周前的早产（PTB）率。结果两组之间的平均分娩胎龄或妊娠37周、32周和28周前的早产率没有显着差异。极低出生体重新生儿的比例（
Objective To determine whether 17 alpha-hydroxyprogesterone caproate (17OHPC) prolongs gestation beyond 37 weeks of gestation (primary outcome) and reduces neonatal morbidity (secondary outcome) in twin pregnancy.Design Randomised controlled double-blind clinical trial.Setting Tertiary-care university medical centre.Population Unselected women with twin pregnancies.Methods Participants received weekly injections of 250 mg 17OHPC (n = 194) or placebo (n = 94), from 16-20 to 36 weeks of gestation. Randomisation was performed using the permuted-block randomisation method. Data were analysed on an intention-to-treat basis.Main outcome measure Preterm birth (PTB) rate before 37 weeks of gestation.Results There were no significant differences in the average gestational age at delivery, or in the rates of PTB before 37, 32, and 28 weeks of gestation, between the two groups. The proportion of very-low-birthweight neonates (