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临床试验/NCT00641550
NCT00641550Unknown不适用

Effects of Physical Exercise During Pregnancy on the Maternal and Perinatal Outcomes: A Randomized Clinical Trial

Universidade Estadual da Paraiba4 个研究点 分布在 1 个国家目标入组 188 人开始时间: 2008年4月最近更新:
适应症

试验速览

阶段
不适用
入组人数
188
试验地点
4
主要终点
Maternal outcome: preterm labor, weight gain, preeclampsia, gestational diabetes Perinatal outcome: birthweight, Apgar scores, body composition, admission at neonatal intensive care unit

研究概览

简要总结

The effects of physical exercise on pregnancy remain to be elucidated. A randomized controlled trial will be conducted to study the impact of exercise on maternal and perinatal outcomes. Our hypothesis is that physical exercise reduces preeclampsia incidence and improves birthweight when started early in pregnancy, with no impact on pregnancy duration, Apgar scores and neonatal complications.

详细描述

The study will include low risk pregnant women randomized to practice physical exercise beginning at 13 weeks, 20 weeks or no exercise group.

The objectives are:

  1. To describe and compare biological and obstetrical variables.
  2. To study doppler flow velocimetry indexes.
  3. To determine the association between physical exercise and maternal complications: preeclampsia, preterm labor, gestational diabetes and weight gain in pregnancy.
  4. To determine the association between physical exercise and perinatal outcomes: Apgar scores, birthweight, admission at intensive neonatal care unit, body composition and neonatal complications.

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
None

入排标准

年龄范围
10 Years 至 50 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • Gestational age < 13 weeks
  • Single pregnancy
  • Alive fetus
  • No previous practice of physical activity

排除标准

  • Chronic maternal diseases
  • Placenta praevia
  • History of preterm labor

结局指标

主要结局

Maternal outcome: preterm labor, weight gain, preeclampsia, gestational diabetes Perinatal outcome: birthweight, Apgar scores, body composition, admission at neonatal intensive care unit

时间窗: nine months

次要结局

  • Doppler flow velocimetry indexes: pulsatility, resistance and A/B relation (uterine arteries, fetal middle cerebral artery and umbilical arteries)(9 months)

研究者

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

Adriana Suely de Oliveira Melo

MD, MSc

Universidade Estadual da Paraiba

研究点 (4)

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