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临床试验/NCT01395342
NCT01395342已完成1 期

Assessment of Physical Exercise Using Stationary Bicycle for Pregnant Women With Risk for Preeclampsia Development

University of Campinas, Brazil2 个研究点 分布在 1 个国家目标入组 116 人开始时间: 2008年1月1日最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
发起方
入组人数
116
试验地点
2
主要终点
Risk to development pre-eclampsia

研究概览

简要总结

Introduction:

Hypertensive disorders during pregnancy are an important issue in global public health. It is current the leading cause of maternal mortality in Brazil.

Objective:

To assess the effect of physical exercise using stationary bicycle through blood pressure and heart rate measurements, incidence of pre-eclampsia and quality of life survey in pregnant women with chronic high blood pressure, previous preeclampsia pregnancies or both factors associated comparing to a group with no intervention. Verify the type of births, maternal and perinatal outcomes in both groups. Methodology: This randomized clinical trial enrolled pregnant women presenting chronic hih blood pressure, previous pre-eclampsia experience or both. Women from 12 to 20 gestational weeks were selected from the prenatal outpatient clinic and randomly allocated to the study or non-interventional group. Women at the study group performed physical exercise using stationary bicycle (horizontal bench model) during 20 minutes, once a week. The heart rate was maintained at 20% above resting heart rate and up to 140 bpm. Blood pressure and heart rate measurements were evaluated before and after exercise. The non-intervention group followed regular prenatal routine with weekly returns for heart rate and blood pressure measurements. Both groups fulfilled the quality of life survey (SF-36 questionnaire) at three times: between 12 and 20 weeks; 28 and 32 weeks and 36 and 41 weeks of gestation. After that data of parturition will be analyzed to compare the incidence of pre-eclampsia, types of birth, maternal and perinatal outcomes.

详细描述

Significance was assumed as p<.5%.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

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

  • pregnant with 12 to 20 weeks gestational
  • have chronic blood pressure, previous pre-eclampsia or both
  • able to perform a exercise

排除标准

  • multiple pregnancy
  • Systemic lupus erythematosus
  • heart disease
  • neurological disease
  • renal failure
  • persistent vaginal bleeding
  • isthmic-cervical insufficiency

结局指标

主要结局

Risk to development pre-eclampsia

时间窗: up to 28 weeks

The comparison between groups will be by the diagnosis of pre-eclampsia. Pre-eclampsia is diagnosed after 20 week of gestation with systolic blood pressure equal to or greater than 140 mmHg, diastolic blood pressure equal to or greater than 90 mmHg and proteinuria greater than or equal 0.3 g/d by 24 hour urine collection.

次要结局

  • Perinatal outcomes(up to 28 weeks)
  • Types of birth(up to 28 weeks)

研究者

发起方
University of Campinas, Brazil
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jose Luiz Pinto e Silva

PhD

University of Campinas, Brazil

研究点 (2)

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