TCTR20210724001尚未招募2 期
Cefuroxime plus Azithromycin to reduce neonatal sepsis in preterm premature rupture of membranes between 24-33+6 weeks of gestation: a randomized controlled trial
Ratchasapisek Sompoch grant0 个研究点目标入组 110 人开始时间: 2021年7月24日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 110
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 15 Years 至 45 Years(—)
- 性别
- Female
入选标准
- •1.Women with singleton pregnancy between 24 - 33+6 weeks of gestational age.
- •2.Women with first episode of premature rupture of membrane
- •3.No evidence of intra-amniotic infection (chorioamnionitis)*
- •4.Reassuring fetus evaluated by nonstress test (NST) or biophysical profile (BPP)*
- •* Subsequent discovery of an evidence of intraamniotic infection (chorioamnionitis) or non-reassuring fetus is not an exclusion.
排除标准
- •1.Women with preterm labor with spontaneous rupture of membrane
- •2.Immunocompromised status such as human immunodeficiency virus infection, over diabetes mellitus etc.
- •3.Women with an autoimmune disease such as systemic lupus erythematosus,
- •rheumatoid arthritis and anti-phospholipid syndromes etc.
- •4. Women with known infection such as septicemia, pneumonia and pyelonephritis etc.
- •5.Women with already prescribed antibiotics within 7 days before the onset of preterm premature rupture of membrane.
- •6.History of Penicillin, Cephalosporin or Macrolide allergy.
- •7.Women with a contraindication for expectant management in case of preterm premature rupture of membrane such as intraamniotic infection, fetal non-reassuring.
- •8.Women with a fetal lethal anomaly *
- •9.History of obstetric operation or procedure in the current pregnancy such as cervical cerclage, fetal surgery) and Amniocentesis etc.
- •10.Women with abdominal trauma before the onset of preterm premature rupture of membrane.
- •11.Women with an active genital lesion such as genital herpes, herpes zoster, and Condyloma accuminata etc.
研究者
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