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临床试验/NCT05599178
NCT05599178招募中不适用

Doppler Findings in the Fetal Cerebral Blood Vessels (VA/MCA) Within 24 Hours Before Delivery and Relation With Perinatal Outcome.

Universitaire Ziekenhuizen KU Leuven1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2022年12月23日最近更新:
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适应症

试验速览

阶段
不适用
状态
招募中
入组人数
120
试验地点
1
主要终点
Differences in VPR (Vertebro-Placental Ratio) between fetuses/neonates with a composite perinatal outcome score < 3 / => 3
研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

  1. Assess differences in flow patterns in the fetal cerebral blood vessels within 24 hours before delivery between fetuses with a normal vs. adverse perinatal outcome.
  2. Explore maternal and/or fetal characteristics that might influence technical feasibility of doppler sonography of the fetal cerebral blood vessels in early labor at term.
  3. Assess reliability of the technique by measuring intra- and inter-observer variation in a subset of participants.

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 —（Adult, Older Adult）
性别
Female
接受健康志愿者
否

入选标准

  • •Singleton pregnancy.
  • •Term gestation (37-42 weeks).
  • •Fetus in cephalic presentation.
  • •No known fetal chromosomal or (severe) congenital anomaly.
  • •Normally grown fetus (ultrasound scan demonstrating normal fetal growth between 30-37 weeks of gestation, defined as an estimated fetal weight/abdominal circumference > 10th centile or crossing <2 quartiles compared to earlier growth ultrasound).
  • •Absence of pre-existing doppler or amniotic fluid abnormalities.
  • •Normal fetal heart rate tracing / CTG (excluding pre-existing hypoxia).
  • •Admission in early spontaneous labor or induction of labor with expected delivery < 24 hours.
  • •Maternal age >= 18 years
  • •Willing to give written informed consent.

排除标准

  • •Advanced labor (> 4cm of cervical dilatation) at the time of admission on the labor ward.
  • •Severe pre-existing chronic maternal medical condition or poor obstetric history/antenatal complications associated with increased risk of adverse perinatal outcome (non-exhaustive e.g.: uncontrolled chronic hypertension, severe pre-eclampsia, uncontrolled (gestational) diabetes, maternal sepsis, major antepartum haemorrhage, intra-uterine infection, prolonged rupture of membranes > 18 hours, etc.).
  • •Intra-uterine fetal demise / death.
  • •Prelabour rupture of membranes with meconium-stained amniotic fluid.
  • •Patients not fulfilling all the inclusion criteria or refusing to give written informed consent.

结局指标

主要结局

Differences in VPR (Vertebro-Placental Ratio) between fetuses/neonates with a composite perinatal outcome score < 3 / => 3

时间窗: VPR measured in early labor (=< 4cm of cervical dilatation) - perinatal outcome score assessed at delivery - timespan between both observations variable, expected <12 hours.

次要结局

  • Differences in other doppler parameters (PI VA, PI MCA, CPR) between fetuses/neonates with a composite perinatal outcome score < 3 / => 3.(VPR measured in early labor (=< 4cm of cervical dilatation) - perinatal outcome score assessed at delivery - timespan between both observations variable, expected <12 hours.)
  • Differences in maternal and fetal characteristics between successful and unsuccessful doppler examinations (observations) of the fetal VA and MCA respectively.(Assessed in early labor (=< 4cm of cervical dilatation))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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