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临床试验/NCT02691559
NCT02691559已完成不适用

The Possible Effect Of Amniotic Fluid pH On Neonatal Morbidities In Maternal Inflammation/Infection Associated Pregnancies

Kanuni Sultan Suleyman Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 184 人开始时间: 2015年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
184
试验地点
1
主要终点
A total of 200 amniotic fluid (1ml per one) would be collected and analyzed for the study.

研究概览

简要总结

Amniotic fluid (AF) pH can be affected by the maternal and/or fetal conditions such as PPROM, prematurity or fetal distress. It is known that fetal urine is the major content of AF since 20th gestational week. Besides fetal alveolar fluid (FAF), gastrointestinal tract, umbilical cord and fetal side of placenta are important sources for AF. Bombesin-like peptides, 8-hydroxydeoxyguanosine in fetal urine and leukotriene E(4), lecithin, sphingomyelin, lamellar body in FAF are molecules acting on fetal lung maturation. Varying levels of these molecules relevant to the stage of lung maturation may constitute an association to AF pHTo detect the possible effect of AF pH on neonatal respiratory morbidities 1 milliliters of AF is aspirated during C-section before incision of membranes. pH value of AFs were analyzed by the blood gas machine (Siemens RAPIDLab®1200 Systems) of NICU. Maternal and neonatal demographic features and clinical outcomes, incidences of morbidities such as respiratory distress syndrome (RDS), transient tachypnea of the newborn (TTN) are all recorded.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
— 至 5 Minutes(Child)
性别
All
接受健康志愿者
是

入选标准

  • •Inflammation/infection associated pregnancies Normal healthy pregnancies

排除标准

  • •Congenital abnormalities Chromosomal abnormalities Blood contaminated amniotic fluid

研究组 & 干预措施

maternal inflammation group

Active Comparator

Amniotic fluid analysis by blood gas device: evaluate the possible association between maternal inflammation and amniotic fluid pH two groups will be designed. One group will consist of infants born to mothers with infection/inflammation whereas the control group will consist of infants born to mothers without infection/inflammation. In all deliveries amniotic fluid will be taken and will be analyzed by blood gas device.

干预措施: Amniotic fluid analysis by blood gas device (Device)

normal pregnancy group

Active Comparator

Amniotic fluid analysis by blood gas device: The control group will consist of infants born to mothers without infection/inflammation. In all deliveries amniotic fluid will be taken and will be analyzed by blood gas device.

干预措施: Amniotic fluid analysis by blood gas device (Device)

结局指标

主要结局

A total of 200 amniotic fluid (1ml per one) would be collected and analyzed for the study.

时间窗: through study completion, an average of 8 months

Amniotic fluid will be analysed for the value of its pH

次要结局

  • A total of 200 amniotic fluid (1ml per one) would be collected and analyzed for the study.(through study completion, an average of 8 months)

研究者

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

Seda Yilmaz Semerci

Fellowship of Neonatology

Kanuni Sultan Suleyman Training and Research Hospital

研究点 (1)

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