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临床试验/NCT03489564
NCT03489564已完成不适用

The Effect of Physical Activity on in Vivo and in Vitro Mitochondrial Capacity in Pregnant Women

Pennington Biomedical Research Center1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2018年3月19日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
1
主要终点
Infant in vitro mitochondrial capacity (by oxygen consumption rate)

研究概览

简要总结

This Pilot & Feasibility study will test the hypothesis that pregnant women who are more active will have better functioning mitochondria in vivo (higher ATPmax, via 31P-MRS), which will be positively related to maternal and infant mitochondrial function in vitro (higher oxygen consumption rates in primary myotubes and umbilical cord derived mesenchymal stem cells, respectively). Twenty pregnant women (10 active and 10 sedentary) will be recruited in the first trimester of pregnancy determined from self-reported physical activity and assessment by activity monitors. Placental biospecimens will be collected during delivery for other molecular mitochondrial analyses.

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 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Pregnant female
  • BMI between 18.5 kg/m2 and 30.0 kg/m2 prior to the current pregnancy (determined by self report and confirmation of pregravid BMI of the index pregnancy from the prenatal record)
  • Medically cleared for participation in the study by primary care obstetrician or midwife
  • Medically cleared for participation by the Medical Investigator
  • Medical record release (prenatal record, hospital delivery record) for study staff to access information in the medical record related to the current and if applicable, the prior pregnancy.

排除标准

  • Risk of early delivery (eg. history of preterm birth, spontaneous abortion, evidence of gestational hypertension (SBP >160 mmHg & DBP >110 mmHg) or pre-eclampsia in the current pregnancy)
  • History of intrauterine growth-restriction
  • Persistent second- or third-trimester bleeding
  • Placenta previa after 26 weeks gestation
  • Incompetent cervix or cerclage
  • Severe anemia
  • High-order pregnancy (e.g. triplets)
  • Family history of diabetes
  • Heart or lung disease
  • HIV or AIDS (self-reported)
  • Individuals with contraindication to magnetic resonance spectroscopy such as having magnetic metallic objects in their body
  • Unwillingness for placental biospecimens to be collected at delivery

结局指标

主要结局

Infant in vitro mitochondrial capacity (by oxygen consumption rate)

时间窗: 1 day

Infant in vitro mitochondrial capacity measured by oxygen consumption rates in umbilical cord derived mesenchymal stem cells at delivery

次要结局

  • Relationship between in vivo mitochondrial capacity and maternal in vitro mitochondrial capacity (by oxygen consumption rate)(About 15 weeks)
  • Relationship between in vivo mitochondrial capacity and infant in vitro mitochondrial capacity (by oxygen consumption rates)(About 20 weeks)

研究者

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

Leanne Redman

Associate Professor

Pennington Biomedical Research Center

研究点 (1)

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