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临床试验/NCT02203734
NCT02203734已完成不适用

Massage to Reduce Intrauterine Artery Resistance, Prematurity and Low Birthweight

Miguel Diego2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2012年2月最近更新:
适应症

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

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

发起方
Miguel Diego
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Miguel Diego

Research Associate Professor

University of Miami

研究点 (2)

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