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临床试验/NCT01669525
NCT01669525已完成不适用

Placental Growth and Maternal Serum Biomarkers in the Prediction of Adverse Pregnancy Outcome

University of Pennsylvania1 个研究点 分布在 1 个国家目标入组 1,043 人开始时间: 2009年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,043
试验地点
1
主要终点
Small for gestational birth weight (SGA-dichotomous)

研究概览

简要总结

The purpose of this study to determine if measurement of maternal serum biomarkers and evaluation of the placenta by ultrasound can improve prediction of adverse pregnancy outcomes.

详细描述

The placenta is known to play a vital role in maintaining a healthy pregnancy. Placental dysfunction is believed to be a driving factor in a variety of adverse obstetric outcomes, including fetal growth restriction and preeclampsia. Advances in 3D ultrasound have allowed for measurement of placental volumes during pregnancy. It may be that quantitative assessment of early placental growth can help identify pregnancies at risk for adverse outcome. Furthermore, various novel serum analytes have been proposed as predictors of adverse outcome. The investigators seek to prospectively measure placental volume and diameter at 11-14 weeks and 18-24 weeks to determine if placental growth can predict adverse outcome. In addition, the investigators seek to investigate the relationship between placental growth and serum levels of various biomarkers to see if improved detection of adverse outcome can be achieved.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
Female
接受健康志愿者

入选标准

  • All singleton gestations presenting for Sequential Screen testing at HUP
  • patients competent to provide verbal informed consent

排除标准

  • Multiple gestations
  • patients not competent to provide informed consent
  • patients found to be too late for the Sequential Screen
  • pregnancy losses 20 weeks gestation
  • major fetal anomalies
  • patient delivering outside of the UPHS

结局指标

主要结局

Small for gestational birth weight (SGA-dichotomous)

时间窗: from 11-14 weeks in pregnancy until delivery (approximately 40 weeks)

Neonatal weight and length are recorded at birth. This information will be retrieved from the medical record post partum.

次要结局

  • Includes a composite adverse outcome defined by any of the following: SGA, pre-eclampsia, or perinatal death.(post partum)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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