患有自发早产风险的患者的共生菌:多中心,双盲,随机化,安慰剂对照试验 (PRIORI) 的协议
Katrien Nulens1,2, Els Papy3, Katrien Tartaglia4
1Department of Obstetrics and Gynaecology, Ziekenhuis Oost-Limburg, Genk, Belgium. katrien_nulens@hotmail.com.
Trials
|September 17, 2024
概括
口服共生菌可以通过改善阴道微生物组来帮助预防自发早产 (sPTB). 这项试验调查了共生菌.
科学领域:
- 产科和妇科 产科和妇科
- 微生物组研究 微生物组研究
- 临床试验 临床试验
背景情况:
- 自发早产 (sPTB) 是新生儿死亡的主要原因.
- 阴道失调和细菌性阴道炎与sPTB有关.
- 一个以乳酸菌为主导的微生物组与按期分娩有关.
研究的目的:
- 评估口服共生菌在高风险怀孕中预防sPTB的疗效.
- 分析共生菌在怀孕期间对阴道微生物组合的影响.
- 为了将阴道微生物组的变化与分娩时的妊娠年龄相关联.
主要方法:
- 多中心,双盲,随机,安慰剂对照试验.
- 包括单独怀孕的妇女和sPTB的风险因素.
- 口服共生菌 (乳酸菌种和益生菌) 或安慰剂,直到分娩为止.
- 通过16SrRNA测序和微生物培养进行阴道微生物组分析.
- 主要结局:分娩时的妊娠年龄;次要结局:PPROM,抗生素使用,新生儿结局.
主要成果:
- 该部分是在研究完成后填写的.
结论:
- 这项研究将评估口服共生菌对高危人群妊娠性阴道微生物群的影响.
- 它将微生物变化与分娩时间和妊娠结果相关联.
相关概念视频
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