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临床试验/NCT05207800
NCT05207800Unknown不适用

Predictive Value of Maternal Serum Pentraxin 3 (PTX 3) and Heparin-binding Protein (HBP) for Chorioamnionitis in Preterm Premature Rupture of Membranes

Second Affiliated Hospital of Wenzhou Medical University0 个研究点目标入组 180 人开始时间: 2022年2月10日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
180
主要终点
PTX3 and HBP concentrations in maternal blood

研究概览

简要总结

Objective: The aim of this study was to investigate the predictive value of maternal serum pentraxin 3 (PTX3) and heparin-binding protein (HBP) for chorioamnionitis in preterm premature rupture of membranes (PPROM).

Method: This observational prospective cohort study included a total of 180 pregnant women at 24-40 gestational weeks. There were 60 cases of term premature rupture of membranes (TPROM), 60 cases of preterm premature rupture of membranes(PPROM)and 60 cases of healthy women. The concentrations of PTX3 and HBP were measured in maternal blood and amniotic fluid using an enzyme-linked immunosorbent assay (ELISA). Western immunoblotting was used to analyze the expression of PTX3 and HBP in placental tissue. The localization and immunoreaction of PTX3 and HBP in placenta were determined via immunohistochemistry (IHC).

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
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • The pregnant woman is born at a gestational age of 24-40 weeks;
  • The pregnant woman has a single child;
  • Regular obstetric examination during pregnancy with complete obstetric examination data was diagnosed as premature rupture of membranes (PROM).

排除标准

  • Pregnancy complicated with medical and surgical diseases, such as thyroid dysfunction and chronic hypertension;
  • Insufficiency of vital organ function or complicated tumor;
  • Pregnant women with other pregnancy complications besides PROM, such as preeclampsia, etc.;
  • Neonates had major congenital malformations (congenital anal atresia, congenital biliary atresia, congenital heart disease and so on, whether prenatal suspicion or diagnosis postpartum)
  • Neonatal septicemia, hemolytic disease or other diseases affecting bilirubin metabolism.

结局指标

主要结局

PTX3 and HBP concentrations in maternal blood

时间窗: 24 weeks to 40 weeks gestation

PTX3 and HBP concentrations in maternal blood

次要结局

  • PTX3 and HBP concentrations in placental tissue(24 weeks to 40 weeks gestation)

研究者

发起方
Second Affiliated Hospital of Wenzhou Medical University
申办方类型
Other
责任方
Sponsor

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