Massage To Improve Uterine Artery Blood Flow
Massage to Reduce Intrauterine Artery Resistance, Prematurity and Low Birthweight
2 other identifiers
interventional
24
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable pregnancy
Started Feb 2012
Longer than P75 for not_applicable pregnancy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2012
CompletedFirst Submitted
Initial submission to the registry
November 28, 2013
CompletedFirst Posted
Study publicly available on registry
July 30, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2015
CompletedOctober 9, 2015
October 1, 2015
3.6 years
November 28, 2013
October 8, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change Doppler Ultrasound
Change in Doppler Ultrasound to assess Uterine Artery Resistance Index values
First Day of Study and 10 Weeks After
Secondary Outcomes (3)
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
Study Arms (2)
Moderate Pressure Massage
EXPERIMENTALModerate Pressure Massage Therapy
Light Pressure Massage
SHAM COMPARATORLight Pressure Massage Therapy
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Uncomplicated singleton pregnancy
- Depression
- \< 20 weeks GA at recruitment
You may not qualify if:
- Pregnancy complications
- HIV
- Smoking, drug use
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Miami
Miami, Florida, 33136, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Research Associate Professor
Study Record Dates
First Submitted
November 28, 2013
First Posted
July 30, 2014
Study Start
February 1, 2012
Primary Completion
September 1, 2015
Study Completion
September 1, 2015
Last Updated
October 9, 2015
Record last verified: 2015-10