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临床试验/NCT03552055
NCT03552055已完成不适用

Urine and Serum Concentrations of Pregnancy-Associated Compounds During Gestation

Gynuity Health Projects2 个研究点 分布在 1 个国家目标入组 245 人开始时间: 2017年5月24日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
245
试验地点
2
主要终点
protein concentration

研究概览

简要总结

Investigators will collect serum and urine specimens from pregnant patients along the full pregnancy continuum, assay each specimen for selected placental proteins, and examine the relationships between concentrations of the proteins and gestational age as determined by ultrasound.

详细描述

Investigators will collect serum and urine specimens from pregnant patients along with ultrasound results and information about factors that may affect the concentrations of proteins or the estimation of gestational age. Investigators will obtain data across the full pregnancy continuum but we will over sample patients within five gestational weeks before and after the 10 week mark.

Investigators will assay each specimen for selected placental proteins (Human placental lactogen (HPL), Schwangerschaftsprotein 1 (SP1), Pregnancy-associated plasma protein A (PAPP-A), A Disintegrin and Metalloproteinase 12 (ADAM12), and Human chorionic gonadotropin (HGC)) and any other proteins of interest identified prior to running assays and will examine the relationships between concentrations of the proteins and gestational age as determined by ultrasound.

The goal is to identify at least one compound and a concentration threshold for that compound that can be used for differentiating pregnancies of less than 10 weeks in duration from later pregnancies.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Other

入排标准

性别
Female
接受健康志愿者

入选标准

  • Has an intrauterine pregnancy confirmed by ultrasound
  • Not known to have pregnancy-induced hypertension (preeclampsia) or diabetes
  • Not known to have a nonviable pregnancy, a multiple pregnancy, a pregnancy with a chromosomal or fetal abnormality, or a pregnancy with growth restriction
  • Not currently taking anticoagulants
  • Not currently having clinically significant vaginal bleeding, unusual pelvic pain, or other symptom suggestive of a pregnancy complication
  • No use of assisted reproductive technology to conceive the current pregnancy
  • Not previously enrolled in this study

排除标准

  • Does not meet inclusion criteria

结局指标

主要结局

protein concentration

时间窗: 1 day

Concentration of placental proteins in blood and urine

次要结局

未报告次要终点

研究者

发起方
Gynuity Health Projects
申办方类型
Other
责任方
Sponsor

研究点 (2)

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