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临床试验/NCT02420288
NCT02420288Unknown不适用

Effect of Physical Exercise Program on Fetoplacental Growth: a Randomized Controlled Trial

Universidad Politecnica de Madrid2 个研究点 分布在 1 个国家目标入组 124 人开始时间: 2014年11月最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
124
试验地点
2
主要终点
Placental weight

研究概览

简要总结

The aim of this study is to examine the effect of a supervised physical exercise program during pregnancy on fetoplacental growth.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Investigator, Outcomes Assessor)

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

  • Being healthy and able to exercise following American College of Obstetricians and Gynecologists (ACOG) guidelines
  • Being able to communicate in spanish
  • Giving birth at Hospital Universitario de Torrejón, Hospital Universitario de Puerta de Hierro or Hospital Universitario Severo Ochoa (Madrid)

排除标准

  • Multiparity
  • Obstetrician complications
  • Being interested in the study after 18 weeks
  • Not having availability to attend to the physical exercise program
  • Younger than 18 years old
  • Older than 45 years old

研究组 & 干预措施

Control Group

No Intervention

Pregnant women not participating in supervised physical exercise program. The subjects in this group will be monitored during pregnancy to know if they make any kind of exercise on your own, to know which are really sedentary pregnant women.

Exercise Group

Experimental

Pregnant women participating in supervised physical exercise program.

干预措施: Exercise Group (Behavioral)

结局指标

主要结局

Placental weight

时间窗: At delivery

Fetal birth weight

时间窗: At delivery

Change from baseline in maternal gestational weight

时间窗: 38-42 weeks of gestation

Maternal weight gain during pregnancy. Weight will be measured at the beginning and at the end of the pregnancy

次要结局

  • Fetal size outcomes(At delivery)
  • Maternal delivery outcomes (composite)(At delivery)
  • Changes from baseline in prenatal depression(Up to 36 weeks)
  • Pregestational weight and Body Mass Index (BMI)(Before pregnancy)
  • pH umbilical cord(At delivery)
  • Apgar score(At delivery)
  • Changes from baseline in maternal quality of life(Up to 36 weeks)
  • Gestational diabetes(24-28 weeks)
  • Fetal glycemia level(At delivery)
  • Postpartum depression(0-12 postpartum months)
  • Changes from baseline in urinary incontinence(Up to 36 weeks)

研究者

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

Marina Vargas Terrones

PhD student

Universidad Politecnica de Madrid

研究点 (2)

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