Acute Fetal Response to Prenatal Yoga: A Single Blinded, Randomized Controlled Trial (TRY Yoga Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- umbilical artery S/D ratio (Dopplers)
研究概览
简要总结
Prenatal yoga has become a popular means of exercise during pregnancy.
详细描述
In 2012, yoga was reported to be practiced by approximately 20 million Americans, out of which 82% are women practitioners. The effects of yoga on the fetus have not been demonstrated. The purpose of this study is to evaluate the acute fetal response to yoga exercises by assessing fetal well-being via ultrasound and non-stress testing among healthy women. The investigators hypothesize that yoga during pregnancy does not have any acute negative effects on fetal behavior as assessed by umbilical artery Dopplers and fetal heart rate or maternal vital signs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (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
- 否
入选标准
- •Uncomplicated singletons pregnancies
- •Gestational age between 28 0/7 and 36 6/7 weeks
- •No known fetal anomalies
- •Women with no prior experience with yoga
- •Currently receiving routine prenatal care
- •No contraindications to exercise
- •Able to read and understand English
- •Well dated pregnancy
排除标准
- •Pregnant minors less than 18 years of age
- •Multiple gestations
- •Those patients that have been advised by their doctor not to exercise during this pregnancy (i.e. Vaginal bleeding, history of preterm delivery less than 34 weeks, cervical insufficiency, cerclage in place, placenta previa, any chronic medical conditions)
- •Congenital fetal anomalies or intrauterine growth restriction
- •Cigarette smokers
- •Chronic narcotic dependence
研究组 & 干预措施
Yoga Intervention
A 1-hour yoga session will take place with guided instruction provided by a registered yoga instructor. The class includes a warm up period of 5 minutes, which includes sitting with the eyes closed and slowly breathing through the nose. After which the participant will perform a series of yoga postures in coordination with her breathing for approximately 45 minutes. The last 10 minutes of class will encompass a semi-recumbent relaxation period. This is a one time intervention.
干预措施: Yoga intervention (Behavioral)
Control group
In order to control for 1 hour worth of time, the participants in the control group will be given a 1 hour Power Point presentation on the benefits of exercise and yoga during pregnancy.
结局指标
主要结局
umbilical artery S/D ratio (Dopplers)
时间窗: An umbilical artery ratio will be obtained on the day of intervention via an ultrasound machine. The first assessment will be before the intervention. The second assessment will be after a 1 hour intervention.
The primary outcome of our study will be assessing umbilical artery S/D ratio (Dopplers). Doppler examination will be performed on the day of intervention. Approximately 20-30 minutes prior to the intervention and 20-30 minutes after a 1 hour intervention.
次要结局
- Fetal Heart Rate(Fetal heart rate will be obtained on the day of intervention via a non stress test. The first assessment will be before the intervention. The second assessment will be after a 1 hour intervention.)
研究者
Dev Maulik
MD, PhD
University of Missouri, Kansas City