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临床试验/2024-519263-18-00
2024-519263-18-00招募中4 期

Prevention of Group G/C Streptococcus Infections during Labour and postpartum - a randomized controlled multicenter trial (POGSI)

University Of Oulu3 个研究点 分布在 1 个国家目标入组 696 人开始时间: 2024年11月26日最近更新:

试验速览

阶段
4 期
状态
招募中
入组人数
696
试验地点
3
主要终点
A postpartum infection of the mother requiring antibiotic treatment up to 3 months after delivery

研究概览

简要总结

To evaluate the efficacy of intrapartum antibiotic profylaxis for the prevention of Group G/C infections of the mother and the newborn

入排标准

年龄范围
18 years 至 64 years(18-64 Years)
性别
Female
接受健康志愿者

入选标准

  • All pregnant women who are shown by late pregnancy culture (taken at 35+0-38+0 gestational weeks) to carry group G or C Streptococcus in their vaginal-rectal flora are asked to participate

排除标准

  • Exclusion criteria are as follows: The expectant mother carries both Group B Streptococcus (GBS) and group G/C Strptococcus; the expectant mother has had a urinary infection caused by Group B streptococcus at any time during her pregnancy or a previous child with GBS infection, as these women will routinely recieve antibiotic profylaxis;

结局指标

主要结局

A postpartum infection of the mother requiring antibiotic treatment up to 3 months after delivery

A postpartum infection of the mother requiring antibiotic treatment up to 3 months after delivery

次要结局

  • Positive blood culture of the mother, mode of delivery, need for blood culture from the newborn, antibiotic treatment of the newborn, transfer to NICU, days in the hospital for the mother and the newborn (lenght of stay after birth/delivery)

研究者

申办方类型
Educational Institution
责任方
Principal Investigator
主要研究者

Liisa Laatio

Scientific

University Of Oulu

研究点 (3)

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