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临床试验/NCT05142644
NCT05142644已完成不适用

Intra Uterine Growth Retardation;Causes and Relationship

Karolinska Institutet1 个研究点 分布在 1 个国家目标入组 80,000 人开始时间: 2020年1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
80,000
试验地点
1
主要终点
The frequency of newborns with an affected perinatal outcome (low Apgar score and or affected acid-base status at labor)

研究概览

简要总结

Intrauterine growth restriction (IUGR) is a pregnancy complication in about 3-5% of all pregnancies in Sweden. IUGR fetuses are at high risk of morbidity and death. The method used in Sweden to detect IUGR is repeated measurements of pregnant women's symphysis-fundus measure (SF measure).

Weight estimation with ultrasound is performed only on indication; stagnant or deplaning SF dimensions or in the event of complications. Only high-risk pregnancies have repeated growth checks during pregnancy from the beginning.

There are potential benefits to detecting IUGR fetuses during pregnancy. Still, the effect is questioned. A meta-analysis of randomized studies could not benefit from a routine ultrasound in the third trimester.

The scientific purpose of this work is to evaluate the benefits of early detection and care of SGA (small for gestational age)/IUGR (growth-inhibited) fetuses and, if possible, to increase knowledge about this patient group. The hope is that this will lead to a better opportunity to personalize both preventive care and treatment of these women and children.

详细描述

Design: Register-based cohort study. Population: All pregnancies in Stockholm from 2014 to 2017 A Composite outcome for the study is constructed and consists of at least one of the following outcomes

  1. HIE (hypoxic-ischemic encephalopathy)2-3 (neonatal convulsions in the fetus after childbirth),
  2. Intracranial hemorrhage,
  3. Apgar score < 4 at 5 minutes,
  4. Arterial umbilical cord pH (potential of hydrogen) < 7.10,
  5. Intrauterine fetal death, 6)intrapartal death.

Inclusion: All pregnancies in Stockholm with a fetus, born between 2014 and 2017 and without chromosomal abnormalities or other structural abnormalities, will be included in the project.

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
Female
接受健康志愿者

入选标准

  • All pregnancies in Stockholm with a fetus, born between 2014 and 2017 and without chromosomal abnormalities or other serious structural abnormalities, will be included in the project.

排除标准

  • Pregnancies with known chromosomal abnormalities or other serious structural abnormalities

结局指标

主要结局

The frequency of newborns with an affected perinatal outcome (low Apgar score and or affected acid-base status at labor)

时间窗: 2014-2017

Will the perinatal outcome at delivery( be measured as a low Apgar score at 5 minutes or an affected acid-base status in cord blood) be improved if IUGR(intrauterine growth restriction) is identified before labor

次要结局

  • The frequency of newborns with an affected perinatal outcome (low Apgar score and or affected acid-base status at labor)(2)(January 1th 2014- december 31th 2017)

研究者

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

Eva Wiberg-Itzel

Associate professor

Karolinska Institutet

研究点 (1)

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