Exercise Training in Pregnancy. Good for the Mother - Good for the Child?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 91
- 试验地点
- 2
- 主要终点
- Weight gain during pregnancy
研究概览
简要总结
Observational studies demonstrate that overweight in pregnancy is a risk factor for adverse pregnancy outcomes as fetal macrosomia, prolonged labor, low Apgar score, shoulder dystocia, nerve plexus injuries, increased proportion of instrumental deliveries and perineal ruptures. There is a 2.6 fold risk for gestational diabetes mellitus (fourfold in morbidly obese women) and a recent study has shown that fetuses of obese mothers develop insulin resistance in uterus.
Main aims of this study are to assess if regular exercise in pregnancy among obese women can prevent or influence weight gain; impaired cardiac function in mother and fetus/newborn; impaired vascular function in mother; insulin resistance/sensitivity; body composition in mother and offspring; lumbopelvic pain; urinary and/or fecal incontinence; prolonged labor
详细描述
Women with a self-reported pre-pregnancy BMI of 28 or more will be eligible for our study. Woman are eligible if they are 18 years or older, with a singleton live fetus at an early (week 12-14) ultrasound scan. Exclusion criteria are pregnancy complications with high risk for preterm labour or diseases that could interfere with participation.
Primary outcome measure is weight increase based on weight measured at 14 weeks and immediately before labour. Assessments are done at baseline at 14 (12-18) weeks of pregnancy, and again in week 38, as well as 3 months postpartum. Some measurements are also done at other points in time. The maternal secondary outcome measurements include fasting glucose, glucose tolerance assessed by 2-h, 75 mg per-oral glucose tolerance test, insulin resistance assessed by HOMA-IR, weight, height, body composition estimated by skinfold measurements in pregnancy and by dual energy x-ray absorptiometry postpartum, blood markers, lumbopelvic pain, urin- and fecal incontinence, quality of life, psychological wellbeing, depression, and diet.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pre-pregnancy body mass index of 28 or more
- •18 years or more
- •singleton live fetus at the routine ultrasound scan
排除标准
- •high risk for preterm labor or diseases that could interfere with participation
结局指标
主要结局
Weight gain during pregnancy
时间窗: From 14 weeks pregnancy to delivery
Measured in kg
次要结局
- Blood markers for cardiovascular disease(From 14 weeks pregnancy to 38 weeks pregnancy and also at 3 months postpartum)
- Markers of inflammation and metabolism in cord blood(At delivery)
- Fasting glucose(From 14 weeks pregnancy to 38 weeks pregnancy and also at 3 months postpartum)
- Glucose tolerance(From 14 weeks pregnancy to 38 weeks pregnancy and also at 3 months postpartum)
- Quality of life(From 14 weeks pregnancy to 38 weeks pregnancy and also at 3 months postpartum)
- Lumbopelvic pain(From 14 weeks pregnancy to 38 weeks pregnancy and also at 3 months postpartum)
- Insulin resistance(From 14 weeks pregnancy to 38 weeks pregnancy and also at 3 months postpartum)
- Diet(From 14 weeks pregnancy to 38 weeks pregnancy and also at 3 months postpartum)
- Body composition(From 14 weeks pregnancy to 38 weeks pregnancy and also at 3 months postpartum)
- Sleep(From 14 weeks pregnancy to 38 weeks pregnancy and also at 3 months postpartum)
- Offspring birth weight, length and head circumference(At delivery)
- Delivery complications(At delivery)
- Urin- and fecal incontinence(From 14 weeks pregnancy to 38 weeks pregnancy and also at 3 months postpartum)
- Physical activity(From 14 weeks pregnancy to 38 weeks pregnancy and also at 3 months postpartum)