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临床试验/TCTR20210724001
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

发起方
Ratchasapisek Sompoch grant

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