Massage To Improve Uterine Artery Blood Flow

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Massage to Reduce Intrauterine Artery Resistance, Prematurity and Low Birthweight

Conditions
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Pregnancy, Depression

Intervention / Treatment
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* Procedure: Moderate Pressure Massage
* Procedure: Light Pressure Massage


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Uncomplicated singleton pregnancy Depression < 20 weeks GA at recruitment Exclusion Criteria: Pregnancy complications HIV Smoking, drug use

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Moderate Pressure Massage<br>Moderate Pressure Massage Therapy | Procedure: Moderate Pressure Massage<br>* The massage therapy will begin with the mother in a side-lying position, with pillows positioned behind her back and between her legs for support. The massage is given in the following sequence and repeated twice (10 minutes on each side for 20 minutes total) on the following areas: 1) Head and neck: 2) Back: 3) Arms: and 4) Legs. The effective moderate pressure (measured by a pressure meter) is 8 db or a slight indentation in the skin.<br>|
| Sham Comparator: Light Pressure Massage<br>Light Pressure Massage Therapy | Procedure: Light Pressure Massage<br>* The light pressure massage group will receive light pressure massage in contrast to the treatment group who will receive moderate pressure massage. As with moderate pressure massage, each session will begin with the mother in a side-lying position, with pillows positioned behind her back and between her legs for support. The massage is given in the following sequence and repeated twice (10 minutes on each side for 20 minutes total) on the following areas: 1) Head and neck: 2) Back: 3) Arms: and 4) Legs.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change Doppler Ultrasound | Change in Doppler Ultrasound to assess Uterine Artery Resistance Index values | First Day of Study and 10 Weeks After | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in CES-D | Change in Depression Questionaire Scores | First Day of Study and 10 Weeks After | 
| Change Saliva Samples | Saliva samples to assess changes in cortisol and alpha amylase | First Day of Study and 10 Weeks After | 
| Birth Outcome Data | Obtain birth outcome data (Birthweight and Gestational age) from medical records after birth of baby | Birth | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Massage, Pregnancy, Depression