Massage To Improve Uterine Artery Blood Flow

Not Applicable

Completed

• Conditions: Pregnancy; Depression
• Interventions: Procedure: Light Pressure Massage; Procedure: Moderate Pressure Massage

• Registration Number: NCT02203734
• Lead Sponsor: Miguel Diego

Brief Summary

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

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.

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2013-11-28
• Study First Submitted QC: 2014-07-28
• Study First Posted: 2014-07-30
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-08
• Last Update Posted: 2015-10-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 24

Inclusion Criteria

• Uncomplicated singleton pregnancy
• Depression
• < 20 weeks GA at recruitment

Exclusion Criteria

• Pregnancy complications
• HIV
• Smoking, drug use

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Light Pressure Massage	Light Pressure Massage	Light Pressure Massage Therapy
Moderate Pressure Massage	Moderate Pressure Massage	Moderate Pressure Massage Therapy

Primary Outcome Measures

Name	Time	Method
Change Doppler Ultrasound	First Day of Study and 10 Weeks After	Change in Doppler Ultrasound to assess Uterine Artery Resistance Index values

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Miami; 🇺🇸 Miami, Florida, United States