Massage to Reduce Intrauterine Artery Resistance, Prematurity and Low Birthweight
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Change Doppler Ultrasound
研究概览
简要总结
This project will investigate the effects of massage therapy on depressed pregnant women. The investigators expect that massage therapy will improve blood flow from the mother to the fetus and reduce prematurity and depression.
详细描述
Prenatal depression has been associated with adverse neonatal outcomes including preterm birth and low birthweight. Potential underlying mechanisms for prenatal depression effects on prematurity and low birthweight involve the elevated sympathetic nervous system SNS and Hypothalamic Pituitary Adrenal HPA Axis function noted in depressed pregnant women. These may lead to increased uterine artery resistance and the resulting limited blood flow, oxygen and nutrients to the fetus. Moderate pressure massage therapy may reduce this problem in depressed pregnant women by decreasing SNS and HPA axis function, resulting in decreased uterine artery resistance, increased oxygen and nutrients to the fetus and lower prematurity and low birthweight. An alternative model being explored here is that moderate pressure massage may increase progesterone/estriol ratios, which counteract the negative cortisol effects on gestational age. Eighty pregnant women with depression symptoms will be recruited at approximately 20 weeks gestation and randomly assigned to a moderate pressure massage therapy or to a SHAM light pressure massage touch/attention control group. The women will receive 20-minute weekly massage therapy sessions from 20 to 30 weeks gestation. At 20 and 30 weeks gestation, depressed symptoms will be assessed using the CES-D, and saliva samples will be collected to assay alpha amylase as an SNS marker, cortisol as an HPA axis marker and progesterone and estriol levels. Maternal Doppler ultrasound will be conducted to assess the uterine artery resistance index as an estimate of uterine artery blood flow. Upon delivery, the mothers' medical charts will be reviewed to record gestational age and birthweight. The investigators are hypothesizing that the moderate pressure massage group will elicit an increase in progesterone/estriol ratios and decreases in alpha amylase and cortisol levels, which in turn will lead to reduced uterine artery resistance and a lower incidence of prematurity and low birthweight.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Uncomplicated singleton pregnancy
- •Depression
- •< 20 weeks GA at recruitment
排除标准
- •Pregnancy complications
- •Smoking, drug use
结局指标
主要结局
Change Doppler Ultrasound
时间窗: First Day of Study and 10 Weeks After
Change in Doppler Ultrasound to assess Uterine Artery Resistance Index values
次要结局
- Change in CES-D(First Day of Study and 10 Weeks After)
- Change Saliva Samples(First Day of Study and 10 Weeks After)
- Birth Outcome Data(Birth)
研究者
Miguel Diego
Research Associate Professor
University of Miami
