Massage To Improve Uterine Artery Blood Flow

• ClinicalTrials.gov Identifier: NCT02203734
• Recruitment Status: Completed
• First Posted: July 30, 2014
• Last Update Posted: October 9, 2015
• Sponsor: Miguel Diego
• Collaborator: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Information provided by (Responsible Party): Miguel Diego, University of Miami

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Pregnancy; Depression	Procedure: Moderate Pressure Massage; Procedure: Light Pressure Massage	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Massage to Reduce Intrauterine Artery Resistance, Prematurity and Low Birthweight
• Study Start Date: February 2012
• Actual Primary Completion Date: September 2015
• Actual Study Completion Date: September 2015

Arms and Interventions

Arm	Intervention/treatment
Experimental: Moderate Pressure Massage; Moderate Pressure Massage Therapy	Procedure: Moderate Pressure Massage; 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.
Sham Comparator: Light Pressure Massage; Light Pressure Massage Therapy	Procedure: Light Pressure Massage; 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.

Outcome Measures

Primary Outcome Measures :

1. Change Doppler Ultrasound [ Time Frame: First Day of Study and 10 Weeks After ]
   Change in Doppler Ultrasound to assess Uterine Artery Resistance Index values

Secondary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 40 Years (Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

• Pregnancy complications
• HIV
• Smoking, drug use

Contacts and Locations

Locations

United States, Florida

University of Miami

Miami, Florida, United States, 33136

Sponsors and Collaborators

Miguel Diego

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

More Information

Additional Information:

Touch Research Institute 

• Responsible Party: Miguel Diego, Research Associate Professor, University of Miami
• ClinicalTrials.gov Identifier: NCT02203734
• Other Study ID Numbers: 20080617; R21HD069872-01A1 ( U.S. NIH Grant/Contract )
• First Posted: July 30, 2014
• Last Update Posted: October 9, 2015
• Last Verified: October 2015

Keywords provided by Miguel Diego, University of Miami:

Pregnancy; Depression; Massage

Additional relevant MeSH terms:

Depression; Behavioral Symptoms