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临床试验/NCT01477372
NCT01477372已完成不适用

Effect of Physical Exercise Program During Pregnancy on Excessive Weight Gain and Its Consequences

Universidad Politecnica de Madrid2 个研究点 分布在 1 个国家目标入组 320 人开始时间: 2007年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
320
试验地点
2
主要终点
Maternal weight gain

研究概览

简要总结

The purpose of this study was to assess the effectiveness of a moderated physical exercise program called Blooming Exercise Program (BEP) developed during pregnancy in order to control excessive maternal weight gain and its consequences. Additionally, other objectives of the study were to analyse the influence of BEP on urinary incontinence, on the other pregnancy outcomes and on the perception of the pregnant's health

详细描述

BACKROUND: Pregnancy and delivery can condition significantly women's health. In particular, an excessive gain of weight during pregnancy constitutes a risk factor which may lead to (i) different alterations during pregnancy such as gestational diabetes or hypertension, (ii) foetus health problems (macrosomia), (iii) delivery complications (dystocia, prolonged labour and increased number of caesareans) and (iv) future health disorders for the woman (overweight, obesity and cardiovascular alterations). Furthermore, during pregnancy pelvic floor health problems, such as urinary incontinence (IU) may arise or worsen.

OBJECTIVES: The main aim of this study was to assess the effectiveness of a moderate physical exercise program called Blooming Exercise Program (BEP) developed during pregnancy in order to control excessive maternal weight gain and its consequences. Additionally, other objectives of the study were to analyse the influence of BEP on urinary incontinence, on the other pregnancy outcomes (maternal and foetal) and on the perception of the pregnant's health.

DESIGN: A randomized, controlled trial called has been conducted. 300 healthy pregnant women were recruited and divided into an intervention group (IG, n=100) and a control group (CG, n=200). The IG participated in BEP as from week 10-12 of gestation (at least 56 sessions through 22 weeks. 3 sessions per week). The CG did not participate in any supervised program addressed to pregnant women but received regular health care. Pregnancy outcomes regarding the mother and the new born, urinary incontinence and women's habits data were obtained and registered through initial interviews, medical records and two specific questionnaires on health and urinary incontinency (ICIQ-SF and King's).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • Healthy pregnant women
  • Delivering in "Hospital Universitario de Fuenlabrada"
  • At week 10-14 of gestation
  • Able to attend 3 sessions per week until the end of the pregnancy

排除标准

  • Contraindications appointed by ACOG
  • Less than 56 sessions

结局指标

主要结局

Maternal weight gain

时间窗: week 36-38 of gestation

Maternal weight gain and proportion of participants exceeding weight gain above IOM (2009) recommendations

次要结局

  • Excessive weight gain related risks (gestational diabetes, macrosomia, type of delivery)(week 36-38 of gestation)
  • Urinary incontinence(week 36-38 of gestation)
  • Other pregnancy outcomes (maternal and foetal)(week 36-38 of gestation)

研究者

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

Ruben Barakat Carballo

Director

Universidad Politecnica de Madrid

研究点 (2)

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