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临床试验/NCT04640467
NCT04640467Unknown不适用

Prediction of Late Fetal Growth Restriction in Uncomplicated Pregnancies Using Cerebroplacental Ratio: a Prospective Cohort Study

Assiut University1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2021年2月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
200
试验地点
1
主要终点
A composite of adverse neonatal outcomes

研究概览

简要总结

To investigate the screening performance of CPR and biophysical profile score for the prediction of composite of adverse neonatal morbidity and mortality and operative delivery (CS or instrumental) for intrapartum fetal distress in low-risk pregnancies

详细描述

Fetal growth is a dynamic process and its assessment requires multiple observations over time. In most women, placental function is sufficient to allow appropriate fetal growth throughout pregnancy, however in some, it may be not near term or during labor leading to intrapartum compromise Small for gestational age (SGA) is estimated fetal weight (EFW) or abdominal circumference (AC) below the 10th percentile of given reference ranges Fetal growth restriction (FGR) is fetus that has not achieved its growth potential. There are early-onset (< 32 weeks) and late-onset (≥ 32 weeks) types. Late FGR is defined as

  • AC/EFW < 3rd centile Or at least two out of three of:
  1. AC/EFW < 10th centile
  2. AC/EFW crossing centiles >2 quartiles
  3. Cerebroplacental ratio (CPR) <5th centile or Umbilical artery Pusitility Index(UAPI )>95th centile FGR fetuses will not necessarily be SGA at delivery and vice versa. In fact, most SGA are likely to be 'constitutionally' small CPR is the ratio of the Middle cerebral artery Pulsatility Index (MCAPI) to (UAPI). The CPR gradually rises until around the 34th week and subsequently slowly declines until term. Its use has been echoed recently because of association of an abnormal ratio with fetal distress in labor requiring emergency cesarean section , a lower cord pH, admission to the intensive care unit and poor neurological outcomes The biophysical profile (BPP) abnormalities that characterize late FGR include alteration of fetal breathing, oligohydramnios and loss of fetal heart rate reactivity on conventional cardiotocography ( CTG). It seems that BPP becomes abnormal only shortly before stillbirth .

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

  • •Women with uncomplicated singleton pregnancy who are planning a vaginal delivery
  • Gestational age from 36 ± 0/7 weeks until onset of active labor (cervical dilatation ≤ 4cm)
  • Cephalic presentation

排除标准

  • •Multiple pregnancy
  • known SGA fetus.
  • Medical disorders with pregnancy: diabetes mellitus, hypertension, pre-eclampsia
  • Known fetal anomaly or aneuploidy or stillbirth.
  • Any contraindication of vaginal delivery eg. placenta previa.

结局指标

主要结局

A composite of adverse neonatal outcomes

时间窗: Up to 48 hours After delivery

Apgar score ≤7 at 5 min or resuscitation with intubation, chest compressions or medication, admission to NICU ≥ 48 hours or hypoxic ischemic encephalopathy or cerebral palsy or stillbirth or neonatal death within 28 days

次要结局

  • Birth weight(Immediatly after delivery)
  • Estimated fetal weight(At Ultrasound examination at Gestational age from 36 ± 0/7 weeks until onset of active labor (cervical dilatation ≤ 4cm))
  • Demographic characteristics of the cohort(Gestational age from 36 ± 0/7 weeks until onset of active labor (cervical dilatation ≤ 4cm))
  • Operative delivery (instrumental and caesarean section) for intrapartum fetal compromise (IFC)(At time of delivery)

研究者

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

Mariam Sobhy Shawky

Resident of Obstetrics & Gynecology

Assiut University

研究点 (1)

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