跳至主要内容
临床试验/NCT02391519
NCT02391519招募中不适用

Effects of High Altitude on 5' Adenosine Monophosphate-activated Protein Kinase (AMPK) Activation and Peroxisome Proliferator-activated Receptor Gamma (PPARγ) Regulation

University of Colorado, Denver1 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2016年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
84
试验地点
1
主要终点
Changes in Myometrial artery dimensions

研究概览

简要总结

Pregnancy elicits adaptive changes in uteroplacental blood flow, which are altered at high altitude and may contribute to the observed 3-fold increase in intrauterine growth restriction (IUGR) and preeclampsia (PreE). The investigators propose to collect myometrial, cord blood, and placental tissue samples from women at high altitude (Summit County) and low altitude (Denver) in Colorado in order to determine if residence at altitude during pregnancy changes the vasoreactivity of myometrial arteries (MA). If altered MA vasoreactivity is found, further studies may be able to link these changes to the increased rates of PreE and IUGR at altitude and contribute to the understanding of these two disorders.

详细描述

The Investigators will determine if residence at altitude during pregnancy changes the vasoreactivity of myometrial arteries. This will be novel information regarding pregnancy at altitude and of significance not just for women and families in Colorado, but also at high-altitude locations throughout the world. If altered MA vasoreactivity is found, further studies may be able to link these changes to the increased rates of PreE and IUGR at altitude and contribute to the understanding of these two disorders.

The Investigators will also determine whether the chronic hypoxia of high altitude alters DNA methylation patterns and expression of key genes involved in metabolic homeostasis in maternal, placental and fetal cells and, in turn, the relationship of these changes to fetal growth and maternal well-being.

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

  • Women scheduled for cesarean delivery at University of Colorado Hospital (Denver, 1600 m) and St. Anthony's Summit Medical Center (Summit County, 3000 m)
  • Cesarean delivery at a prescheduled time without any labor, typically at 39 weeks gestation

排除标准

  • Women will be excluded if there are co-existing medical diagnoses that are known to affect vascular parameters (i.e., diabetes mellitus, gestational diabetes, any hypertensive disorder of pregnancy, or a current smoker).
  • Women with multiple gestations and preterm deliveries will also be excluded.

研究组 & 干预措施

High Altitude (3000 m)

Collection of myometrial, cord blood, and placental tissue samples from women at high altitude (Summit County) and low altitude (Denver) in Colorado in order to determine if residence at altitude during pregnancy changes the vasoreactivity of myometrial arteries (MA).

干预措施: Collection of myometrial, cord blood, and placental tissue samples (Procedure)

Low Altitude (1600 m)

Collection of myometrial, cord blood, and placental tissue samples from women at high altitude (Summit County) and low altitude (Denver) in Colorado in order to determine if residence at altitude during pregnancy changes the vasoreactivity of myometrial arteries (MA).

干预措施: Collection of myometrial, cord blood, and placental tissue samples (Procedure)

结局指标

主要结局

Changes in Myometrial artery dimensions

时间窗: Up to 1 year

Myometrial artery dimensions as quantified by immunohistochemistry or other staining techniques, and results of studies of isolated myometrial artery studies in which vasoconstrictor and vasodilator responses to pharmacological agonists are measured using absolute values and the percent maximal contraction to potassium chloride.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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