跳至主要内容
临床试验/NCT04364308
NCT04364308暂停不适用

The Relationship Between Umbilical Cord ph and Feto-maternal Doppler Studies in Scheduled Nonlaboring Term Singleton Caesarean Deliveries

University of Campania "Luigi Vanvitelli"1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2019年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
暂停
入组人数
100
试验地点
1
主要终点
The venous umbilical cord pH at birth was correlated with ultrasound doppler parameters

研究概览

简要总结

Perinatal asphyxia is a crucial reason for neonatal and childhood morbidity and death. Fetal and neonatal acidemia can be utilised as predictors for establishing such risk. Several researches have reported a marked relation between low values of fetal pH with short- and long-term adverse neonatal outcomes. Umbilical cord blood gas studies (UCGS) are considered critical data that gives an objective and certified evaluation of the oxygenation and metabolic status of the fetus. Before birth, the physician can evaluate fetal wellness through cardiotocography and prenatal ultrasound. Other studies had examined the role of fetal Doppler indices before birth and proposed that fetuses with lower impedance in the middle cerebral artery (MCA) or low cerebroplacental ratio (CPR) are at increased risk of adverse pregnancy outcome. However, no research has ever evaluated the possibility of a correlation between ultrasonographic fetal evaluation and fetal umbilical cord pH as a predictor of pre-delivery fetal pH.

The goal of our study was to discovered a potential association between the venous umbilical ph cord blood at delivery and the ultrasonographic feto-maternal doppler indices in patients with a scheduled nonlaboring term singleton caesarean deliveries (SCD), this research is a novel finding.

详细描述

the investigators included in our study only singleton term (37 0/7 - 41 6/7 weeks of gestation) pregnancies delivered by a scheduled nonlaboring term singleton caesarean deliveries.

This was an observational study carried out at a single university tertiary care center

For every patient, an ultrasound examination was performed within one day of delivery and the fetal doppler indices were recorded. The umbilical venous pH were obtained immediately after delivery and before placental detachment with heparinized syringes

The primary endpoints were CPR, umbilical (UA) and fetal MCA arteries indices. The second endpoints analysed when measurable were ductus venosus (DV) and uterine artery (Ut) pulsatility indices, all indices were examined using colour Doppler ultrasound according to a standard procedure and CPR was evaluated as the ratio between the MCA and UA pulsatility indices.

The venous umbilical cord pH at birth was correlated with ultrasound doppler parameters, calculating the correlation coefficient r2 and P-value. Statistical significance was fixed at P<0.05. the investigators performed a linear regression analysis to find the association between the different ultrasound indices and the venous pH.

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 44 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • singleton term (37 0/7 - 41 6/7 weeks of gestation) pregnancies delivered by a scheduled nonlaboring term singleton caesarean deliveries

排除标准

  • Pregnancies complicated by fetal malformations, stillbirth, preterm deliveries.

结局指标

主要结局

The venous umbilical cord pH at birth was correlated with ultrasound doppler parameters

时间窗: pre-intervention

the investigators recordered venous umbilical cord pH and all fetal doppler parameters

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

Marco La Verde

MD, research , gynecology and obstetrics, Principal Investigator

University of Campania "Luigi Vanvitelli"

研究点 (1)

Loading locations...

相似试验