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临床试验/NCT03866863
NCT03866863Unknown不适用

Intra Uterine Growth Restriction. Minimum Required Evidence-based Care and Neonatal Prognosis: Impact of Healthcare Pathways

Hospices Civils de Lyon1 个研究点 分布在 1 个国家目标入组 31,052 人开始时间: 2018年9月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
31,052
试验地点
1
主要终点
Number of patients diagnosed with Intrauterine growth restriction

研究概览

简要总结

Intrauterine growth restriction (IUGR) is associated with an increase in perinatal mortality and morbidity, as well as longer-term neurological, cognitive, cardiovascular and endocrine complications. In Europe, about 400,000 pregnancies per year are complicated by IUGR. However, antenatal diagnosis seems insufficient in clinical practice, making it impossible to recognize up to 75% of foetuses with IUGR. At a time when the use of good clinical practice has demonstrated a significant improvement in neonatal survival without severe morbidity, foetuses with IUGR are less likely to receive optimal care. Our hypothesis is that the rate of IUGR diagnosed underestimates the rate of actual IUGR.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • All birth more than 24 + 0 weeks of amenorrhea at the maternity ward of the hospital Femme-Mère-Enfant
  • from 1st of january 2011 to 31 december 2017.

排除标准

  • Infants born out of the hospital and secondarily hospitalized in the hospital Femme-Mère-Enfant .
  • Multiple pregnancies,
  • children with congenital fetal anomalies
  • pregnancies without first trimester ultrasound (to date the pregnancy)

结局指标

主要结局

Number of patients diagnosed with Intrauterine growth restriction

时间窗: Between 2011 and 2017

IUGR was defined in accordance with the consensus-based definition for early and late IUGR : birthweight \< 3rd centile using French AUDIPOG curves adjusted for term and sex or estimated fetal weight \< 10th centile combined with umbilical artery pulsatility index \> 95th centile or breakage of growth.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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