跳至主要内容
临床试验/NCT04838431
NCT04838431终止不适用

Development of a Prediction Model for Large for Gestational Age Infants at First Trimester: a Preliminary Study

University of Modena and Reggio Emilia1 个研究点 分布在 1 个国家目标入组 503 人开始时间: 2018年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
503
试验地点
1
主要终点
LGA

研究概览

简要总结

Large for gestational age infants (LGA) have increased risks of adverse short-term perinatal outcomes. This study aims to develop a multivariable prediction model for the risk of giving birth to a LGA baby, by using biochemical, biophysical, anamnestic, and clinical maternal characteristics available at first trimester.

This prospective study includes all singleton pregnancies attending the first trimester aneuploidy screening at the Obstetric Unit of the University Hospital of Modena, in Northern Italy.

详细描述

For each subject, blood sample is collected in fasting conditions, then centrifuged, and the serum stored at minus 80° C, for subsequent biochemical analyses. PAPP-A, PlGF and Inibin A is measured with the automated DELFIA EXPRESS system (Thermo Fisher Scientific, Perkin Elmer ®). Insulin, high density lipoproteins (HDL) and triglycerides are measured through routine laboratory methods.

The mean arterial pressure (MAP) is measured with validated automated devices (Dinamap, BLTV6XX). After the women are seated and allowed to rest for 3-5 min, normal (22 to 32 cm) adult cuffs are fitted to their both arms. This is repeated two times with 1 min break in between. The MAP is calculated with the formula MAP DBP + 1/3(SBP - DBP) 21, where DBP represents diastolic blood pressure and SBP, systolic blood pressure. We calculate the final MAP as the average of all four measurements. Uterine artery Doppler studies including pulsatility index are measured through trans-abdominal ultrasound (Voluson E8 or Voluson E10) examinations. As indicated in Fetal Medicine Foundation (FMF), when carrying out Doppler studies, color flow mapping is used to identify each uterine artery along the side of the cervix and uterus at the level of the cervical internal os. Pulsed wave Doppler imaging is used with the sampling gate set at 2 mm to cover the whole vessel, and care is taken to ensure that the angle of insonation is less than 30°. When three to five similar consecutive waveforms are obtained, PI is measured. The uterine artery mPI is calculated by adding the right and left pulsatility index together, divided by two. All ultrasound and Doppler studies are carried out by a physician who had received the appropriate certificate of competence in the 11-13+6 week scans and Doppler study from the FMF.

Data on pregnancy outcome are collected from the hospital maternity records or directly from women if delivered elsewhere.

Medical records are reviewed by research associates to obtain anonymized data on mothers (i.e maternal demographics, BMI, age...) and their newborns (birthweight, gender, Apgar score, admission to the neonatal intensive care unit (NICU) and length of stay, neonatal morbidities, and mortality), and are organized in a password protected database.

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 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Singleton pregnancies attending the first trimester Down syndrome screening at the University Hospital of Modena, in the North of Italy (tertiary Hospital).

排除标准

  • Twin pregnancies
  • Pregnancies with major fetal abnormalities

结局指标

主要结局

LGA

时间窗: From 37-42 weeks

Risk for delivering a LGA infant, by combining the birtweight, the infant gender and the gestational age at birth

次要结局

未报告次要终点

研究者

发起方
University of Modena and Reggio Emilia
申办方类型
Other
责任方
Principal Investigator
主要研究者

Prof. Fabio Facchinetti

Director of the Obstetrics and Gynecolocy department

University of Modena and Reggio Emilia

研究点 (1)

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