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临床试验/NCT00855543
NCT00855543已完成不适用

Phospholipase A2 Producing Bacteria, Age at Gestation, Cervical Length Measurement and the Incidence of Pre-Term Labor

CAMC Health System2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2009年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
50
试验地点
2
主要终点
Incidence of spontaneous preterm birth

研究概览

简要总结

The purpose of this study is to better understand (1) if phospholipase A2 producing microorganisms and cytokines (IL-1, IL-4, IL-6, IL-10, and IL-13) are associated with premature labor (2) if pregnant teens are more likely to have phospholipase A2 producing bacteria than a pregnant adults and (3) if there is a difference in the cytokines between pregnant teens and adults.We hypothesize that phospholipase producing microorganisms may trigger the onset of premature labor. The following are hypothesized: (a) The microorganism cultured should show high activities of phospholipase A2 (b) The cervical length measurement predictive value should correspond to the gestation age at term (c) Vaginal flora of teen will be more susceptible to colonization with higher phospholipase A2 producing bacteria than that of an adult (d) The maternal genotype contribution to the concentration of IL-1, IL-4, IL-6, IL-10, IL-13, and TNF-alpha during the first trimester of pregnancy in teens is different in the production of inflammatory cytokines and modulators(e) The maternal genotype of teens therefore influences the production of phospholipase A2 and causes an increase in preterm delivery.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
14 Years 至 45 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • Gestational age <34 weeks
  • Singleton gestation
  • Urinalysis and urine culture collected via clean catch
  • Age range 14 - 45
  • Patient receiving prenatal care at CAMC Women's Medicine Center

排除标准

  • In labor or with uterine contractions
  • Known fetal anomalies
  • Dark amniotic fluid suggestive of previous bleeding
  • Multiple gestation
  • Known unbalance chromosomal complement
  • Pregnant patient with prior history of excisional cervical biopsy (either cold knife, loop electrosurgical excision procedure, or laser conization)
  • Patient with mullerian anomaly
  • Patient with 2 or more D&E secondary to spontaneous or induced abortion

结局指标

主要结局

Incidence of spontaneous preterm birth

时间窗: From enrollment during pregnancy until birth

次要结局

未报告次要终点

研究者

发起方
CAMC Health System
申办方类型
Other
责任方
Sponsor

研究点 (2)

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