COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Massage To Improve Uterine Artery Blood Flow

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02203734
Recruitment Status : Completed
First Posted : July 30, 2014
Last Update Posted : October 9, 2015
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Miguel Diego, University of Miami

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.

Layout table for study information
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

Resource links provided by the National Library of Medicine


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.




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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02203734


Locations
Layout table for location information
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)
Additional Information:
Layout table for additonal information
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    Key Record Dates
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:
Layout table for MeSH terms
Depression
Behavioral Symptoms