跳至主要内容
临床试验/NCT05774912
NCT05774912招募中不适用

Fetal Growth Curves and Doppler Velocimetry in the Italian Population, Multicenter Study

IRCCS Burlo Garofolo3 个研究点 分布在 1 个国家目标入组 2,500 人开始时间: 2021年4月26日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
2,500
试验地点
3
主要终点
Fetal growth evaluation

研究概览

简要总结

There is an ongoing international discussion regarding which fetal growth charts should be used. As a matter of fact, an extensive and clinically significant variability among different growth charts has been proved, even between studies of the highest methodological quality. Indeed, methodological aspects such as the study population, data collection, curve modeling and others are of crucial importance for the final outcome of the process. Beside the discussion on methodological issues, there is also an ongoing discussion regarding whether one international standard might be adequate to assess fetal growth all around the globe, or are there some differences related to ethnicity supporting the adoption of growth charts constructed based on national data, or even the customization. Recently, the International Society of Ultrasound in Obstetrics and Gynecology (ISUOG) Practice Guidelines on Ultrasound Assessment of Fetal Biometry and Growth recommended the application of "prescriptive biometry charts, obtained prospectively, truly population-based and derived from studies with the lowest possible methodological bias", and called for the practitioners' awareness regarding national or even local reference charts. Such awareness requires an exploratory and preliminary analysis of the impact of different charts by applying reference values to local findings.

On these grounds, there is an urgent need for a nationwide study for the prospective collection of data and the construction of methodologically robust national growth and Doppler standards.

详细描述

There is an ongoing international discussion regarding which fetal growth charts should be used. As a matter of fact, an extensive and clinically significant variability among different growth charts has been proved, even between studies of the highest methodological quality. Indeed, methodological aspects such as the study population, data collection, curve modeling and others are of crucial importance for the final outcome of the process. Beside the discussion on methodological issues, there is also an ongoing discussion regarding whether one international standard might be adequate to assess fetal growth all around the globe, or are there some differences related to ethnicity supporting the adoption of growth charts constructed based on national data, or even the customization.

Recently, the International Society of Ultrasound in Obstetrics and Gynecology (ISUOG) Practice Guidelines on Ultrasound Assessment of Fetal Biometry and Growth recommended the application of "prescriptive biometry charts, obtained prospectively, truly population-based and derived from studies with the lowest possible methodological bias", and called for the practitioners' awareness regarding national or even local reference charts. Such awareness requires an exploratory and preliminary analysis of the impact of different charts by applying reference values to local findings.

A recent multicentric Italian study promoted by the Italian Society of Ultrasound in Obstetrics and Gynecology (SIEOG), assessed the application of WHO growth charts published in 2006 and the Intergrowth 21 (IG-21st) growth charts in a large Italian cohort (n=7347) of low risk women with uneventful pregnancy. According to the results of the study the IG-21st standards identified the smallest proportion of fetuses below the 10th centile and the largest proportion of fetuses above the 90th centile, respectively. The proportion of fetuses with head circumference (HC), abdominal circumference (AC) and femur length (LF) above 90th centile was 29.9%, 32.5 and 46%, respectively. While the WHO references seem to be the closest to observed 10th centile, the proportion of fetuses above 90th centile was also higher than expected for an appropriate distribution of centiles, but smaller compared with IG-21st standards: 22.8%, 21.3% and 31.9% for HC, AC and LF, respectively. Overall, these data suggest that there might be differences linked to ethnic origin and not fully explained by maternal, socio-economic or other methodological factors as already suggested by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) and World Health Organization (WHO) groups.

These data suggest that, despite indisputable advantages that IG-21st growth standards might offer, immediate application into clinical practice might result into an under-diagnosis of small for gestational age fetuses and, especially, in an over-diagnosis of large for gestational age fetuses with major consequences for clinical practice. The WHO growth references seem to be more suitable for our population, although they might also over-estimate the proportion of large for gestational age fetuses. On the other hand, existing national growth charts lack crucial biometric parameters and centiles. This is of major importance, if we consider that recent consensus criteria suggested AC and estimated fetal weight (EFW) below the 3rd centile as independent criteria for the diagnosis fetal growth restriction.

On these grounds, there is an urgent need for a nationwide study for the prospective collection of data and the construction of methodologically robust national growth and Doppler standards.

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 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Age >18 years and ≤40 years
  • body mass index (BMI) 18-30 kg/m2
  • singleton pregnancy
  • the first day of the last menstrual period (LMP) known and the cycle reported to be regular, lasting 28 days ±4 days and a crown rump length (CRL) measured in early pregnancy
  • no history of chronic health problems
  • no long-term medication (including fertility treatment)
  • no environmental or economic constraints likely to impede fetal growth
  • not smoking currently or in the previous 6 months
  • no alcohol consumption
  • no history of recurrent miscarriages
  • no previous preterm delivery (<37 week) or birthweight < 2,500 grams
  • no evidence in the present pregnancy of congenital disease or fetal anomaly at study entry

排除标准

  • multiple pregnancy
  • fetuses with congenital structural or chromosomal anomalies including increased nuchal translucency (>99°centile)
  • fetal death
  • women with disorders that may affect fetal growth (pre-existing hypertension, diabetes mellitus, renal disease)
  • drug assumption (low dose aspirin, etc)
  • delivery <37 weeks
  • pregnancy complications (hypertensive disorders of pregnancy, infections, gestational diabetes, other diseases)
  • pregnancies conceived by assisted reproductive technology
  • Abnormal uterine arteries Doppler (if performed)
  • First trimester PAPP-A<0.3 MoM

结局指标

主要结局

Fetal growth evaluation

时间窗: From the weeks 14 of gestational age to delivery

Construction of national normal fetal growth reference charts

次要结局

未报告次要终点

研究者

发起方
IRCCS Burlo Garofolo
申办方类型
Other
责任方
Sponsor

研究点 (3)

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