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临床试验/NCT06407388
NCT06407388招募中不适用

Ultrasound Findings Predictive of Neonatal Outcomes in Diabetic Pregnancies

Eastern Virginia Medical School1 个研究点 分布在 1 个国家目标入组 156 人开始时间: 2023年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
156
试验地点
1
主要终点
Elevated TcB

研究概览

简要总结

The goal of our study is to identify ultrasonographic markers that can predict adverse neonatal outcomes. Specifically, we hypothesize that an increase in fetal liver volumes will increase transcutaneous bilirubin (TcB) in the newborn and thus jaundice requiring phototherapy. This information can be used in patient counseling and to guide future screening protocols for ultrasound in individuals with diabetes.

详细描述

This is a single center, prospective case control study. Cases will be collected prospectively and control subjects will be data collected retrospectively from the reference population of the human placenta project (IRB #15-09-FB-0179). If patients agree to participate, one ultrasound will be performed at 30-34 weeks' gestation to look at the fetal parameters as described below. It is standard of care for all patients with pregestational diabetes to receive growth ultrasounds throughout their pregnancy. Patients who are diagnosed with pregestational diabetes at EVMS routinely undergo an ultrasound at 30-34 weeks' gestation. Therefore, ultrasound data will be collected during their scheduled 30-34 week ultrasound visit and no additional ultrasounds will need to be performed. At the time of enrollment, the PI or other study collaborator will ensure that the patient has previously had a detailed ultrasound evaluation (Code 76811). These patients will then be followed prospectively until delivery. The neonates of the study patients will be followed via chart review after delivery.

研究设计

研究类型
Observational
观察模型
Case Control
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

  • Patients who enter pregnancy with a diagnosis of type I or type II diabetes mellitus.
  • Pregnant women between the ages of 18-45
  • Live, singleton gestation
  • Understanding and ability to give informed consent

排除标准

  • Patient unwilling or unable to provide consent
  • Intrauterine fetal demise (no fetal heart beat identified and documented by two physicians)
  • Age less than 18 years of age
  • Multifetal gestation
  • Chromosomal abnormality
  • Congenital infection (Toxoplasmosis, Cytomegalovirus, Rubella, Varicella Zoster, Parvovirus B19
  • Major fetal congenital malformations (such as: major congenital heart defect, omphalocele, open neural tube defect, etc)

结局指标

主要结局

Elevated TcB

时间窗: June 2023 to June 2025

The primary objective of this study is to identify if increased fetal liver volumes correlate with elevated transcutaneous bilirubin (TcB) in neonates of mothers with diabetes.

次要结局

  • Jaundice(June 2023 to June 2025)
  • Respiratory Distress(June 2023 to June 2025)
  • Hypoglycemia(June 2023 to June 2025)
  • Polycythemia(June 2023 to June 2025)

研究者

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

Alyssa Savelli-Binsted

Physician

Eastern Virginia Medical School

研究点 (1)

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