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临床试验/NCT02968316
NCT02968316Unknown不适用

Bioelectric Impedance Analysis and Pregnancy Outcomes

Maternal Fetal Medicine Associates1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2017年1月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
1,000
试验地点
1
主要终点
gestational age at delivery

研究概览

简要总结

This is a prospective observational study correlating Body Impedance Analysis (BIA) with pregnancy outcomes.

详细描述

BIA is a new method of measuring total body water, fat, and lean mass. It is measured noninvasively, and the investigators plan on using the InBody analyzer (www.InBody.com) in this study. The analysis takes a few seconds and only requires the participant to stand on a small platform and grasp a small device in each hand. The machine then uses low electrical current to analyze the body composition and produce a read-out.

The investigators plan on doing this analysis longitudinally across gestation in multiple trimesters to analyze the ability to predict maternal morbid conditions prior to the current clinically-based criteria as a novel marker to aid in routine prenatal care, as compared to the traditional weight measurement currently being done.

Both increased maternal prepregnancy weight (body mass index) and increased maternal gestational weight gain have been associated with increased risks of multiple obstetrical complications (both maternal and fetal). The investigators seek to compare the current standard with BIA in its ability to predict maternal/fetal adverse outcomes such as gestational diabetes, preeclampsia, and cesarean delivery.

PRIOR RESEARCH

There are a few studies in pregnant patients correlating BIA and pregnancy outcomes:

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 60 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • pregnant women

排除标准

  • refusal to participate

结局指标

主要结局

gestational age at delivery

时间窗: from date of enrollment up to delivery (within 1 year)

Preeclampsia

时间窗: from date of enrollment up to 6 weeks after delivery (within 1 year)

cesarean delivery

时间窗: from date of enrollment up to delivery (within 1 year)

neonatal birth weight

时间窗: from date of enrollment up to delivery (within 1 year)

gestational diabetes

时间窗: from date of enrollment up to 6 weeks after delivery (within 1 year)

次要结局

未报告次要终点

研究者

发起方
Maternal Fetal Medicine Associates
申办方类型
Other
责任方
Principal Investigator
主要研究者

Nathan Fox

Physician

Maternal Fetal Medicine Associates

研究点 (1)

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Bioelectric Impedance Analysis and Pregnancy Outcomes | 临床试验