跳至主要内容
临床试验/NCT05771415
NCT05771415已完成不适用

Near-infrared Spectroscopy: Differences in Placental Oxygenation in Relation to Ultrasound Maturation Grade in physiologIcal Term Pregnancies

University of Palermo1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2019年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
34
试验地点
1
主要终点
Placental oxygenation levels

研究概览

简要总结

The aim was to compare placental oxygenation in low risk, uncompli-cated, term pregnancies measured by near-infrared spectroscopy (NIRS) in relation to the placental maturity grade determined by ultrasound assessment according to Grannum scale.

The study included 34 singleton subjects divided into two groups accord-ing to placental maturation: low grade (Grannum 0-1; n=10) and high grade (Gran-num 2-3; n=24). In each study subjects, measurement was performed at two sites: (a) test site above the central part of the placenta, and (b) control site out of placenta on lower abdomen, in medial line, 3 cm from the symphysis. Student's t-test was used to compare tissue oxygenation index (TOI) values among the study groups. The normality of distribution was demonstrated by the Kolmogorov-Smirnov test.

研究设计

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

入排标准

性别
Female
接受健康志愿者

入选标准

  • singleton pregnancies low-risk pregnancies uncomplicated pregnancies term pregnancies (37th to 41+6 weeks of gestation) anterior placental localization abdominal wall of less than 3cm thickness.

排除标准

  • complicated pregnancies pre-term pregnancies Abdominal wall tick > 3cm

结局指标

主要结局

Placental oxygenation levels

时间窗: During the procedure

to compare placental oxygenation in low risk, uncomplicated, term pregnancies measured by near-infrared spectroscopy (NIRS) in relation to the placental maturity grade determined by ultrasound assessment according to Grannum scale.

次要结局

未报告次要终点

研究者

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

Andrea Etrusco

Principal investigator

University of Palermo

研究点 (1)

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