<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02203734</url>
  </required_header>
  <id_info>
    <org_study_id>20080617</org_study_id>
    <secondary_id>R21HD069872-01A1</secondary_id>
    <nct_id>NCT02203734</nct_id>
  </id_info>
  <brief_title>Massage To Improve Uterine Artery Blood Flow</brief_title>
  <official_title>Massage to Reduce Intrauterine Artery Resistance, Prematurity and Low Birthweight</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Miguel Diego</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Miami</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This project will investigate the effects of massage therapy on depressed pregnant women. The&#xD;
      investigators expect that massage therapy will improve blood flow from the mother to the&#xD;
      fetus and reduce prematurity and depression.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Prenatal depression has been associated with adverse neonatal outcomes including preterm&#xD;
      birth and low birthweight. Potential underlying mechanisms for prenatal depression effects on&#xD;
      prematurity and low birthweight involve the elevated sympathetic nervous system SNS and&#xD;
      Hypothalamic Pituitary Adrenal HPA Axis function noted in depressed pregnant women. These may&#xD;
      lead to increased uterine artery resistance and the resulting limited blood flow, oxygen and&#xD;
      nutrients to the fetus. Moderate pressure massage therapy may reduce this problem in&#xD;
      depressed pregnant women by decreasing SNS and HPA axis function, resulting in decreased&#xD;
      uterine artery resistance, increased oxygen and nutrients to the fetus and lower prematurity&#xD;
      and low birthweight. An alternative model being explored here is that moderate pressure&#xD;
      massage may increase progesterone/estriol ratios, which counteract the negative cortisol&#xD;
      effects on gestational age. Eighty pregnant women with depression symptoms will be recruited&#xD;
      at approximately 20 weeks gestation and randomly assigned to a moderate pressure massage&#xD;
      therapy or to a SHAM light pressure massage touch/attention control group. The women will&#xD;
      receive 20-minute weekly massage therapy sessions from 20 to 30 weeks gestation. At 20 and 30&#xD;
      weeks gestation, depressed symptoms will be assessed using the CES-D, and saliva samples will&#xD;
      be collected to assay alpha amylase as an SNS marker, cortisol as an HPA axis marker and&#xD;
      progesterone and estriol levels. Maternal Doppler ultrasound will be conducted to assess the&#xD;
      uterine artery resistance index as an estimate of uterine artery blood flow. Upon delivery,&#xD;
      the mothers' medical charts will be reviewed to record gestational age and birthweight. The&#xD;
      investigators are hypothesizing that the moderate pressure massage group will elicit an&#xD;
      increase in progesterone/estriol ratios and decreases in alpha amylase and cortisol levels,&#xD;
      which in turn will lead to reduced uterine artery resistance and a lower incidence of&#xD;
      prematurity and low birthweight.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>February 2012</start_date>
  <completion_date type="Actual">September 2015</completion_date>
  <primary_completion_date type="Actual">September 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change Doppler Ultrasound</measure>
    <time_frame>First Day of Study and 10 Weeks After</time_frame>
    <description>Change in Doppler Ultrasound to assess Uterine Artery Resistance Index values</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in CES-D</measure>
    <time_frame>First Day of Study and 10 Weeks After</time_frame>
    <description>Change in Depression Questionaire Scores</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change Saliva Samples</measure>
    <time_frame>First Day of Study and 10 Weeks After</time_frame>
    <description>Saliva samples to assess changes in cortisol and alpha amylase</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Birth Outcome Data</measure>
    <time_frame>Birth</time_frame>
    <description>Obtain birth outcome data (Birthweight and Gestational age) from medical records after birth of baby</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Pregnancy</condition>
  <condition>Depression</condition>
  <arm_group>
    <arm_group_label>Moderate Pressure Massage</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Moderate Pressure Massage Therapy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Light Pressure Massage</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Light Pressure Massage Therapy</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Moderate Pressure Massage</intervention_name>
    <description>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.</description>
    <arm_group_label>Moderate Pressure Massage</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Light Pressure Massage</intervention_name>
    <description>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.</description>
    <arm_group_label>Light Pressure Massage</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Uncomplicated singleton pregnancy&#xD;
&#xD;
          -  Depression&#xD;
&#xD;
          -  &lt; 20 weeks GA at recruitment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy complications&#xD;
&#xD;
          -  HIV&#xD;
&#xD;
          -  Smoking, drug use&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Miami</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33136</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www6.miami.edu/touch-research/</url>
    <description>Touch Research Institute</description>
  </link>
  <verification_date>October 2015</verification_date>
  <study_first_submitted>November 28, 2013</study_first_submitted>
  <study_first_submitted_qc>July 28, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 30, 2014</study_first_posted>
  <last_update_submitted>October 8, 2015</last_update_submitted>
  <last_update_submitted_qc>October 8, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 9, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Miami</investigator_affiliation>
    <investigator_full_name>Miguel Diego</investigator_full_name>
    <investigator_title>Research Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Pregnancy</keyword>
  <keyword>Depression</keyword>
  <keyword>Massage</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depression</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02203734
org study id: 20080617
secondary id: R21HD069872-01A1
nct id: NCT02203734
lead sponsor: 
collaborator: 
has dmc: Yes
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Change Doppler Ultrasound
time frame: First Day of Study and 10 Weeks After
description: Change in Doppler Ultrasound to assess Uterine Artery Resistance Index values
measure: Change in CES-D
time frame: First Day of Study and 10 Weeks After
description: Change in Depression Questionaire Scores
measure: Change Saliva Samples
time frame: First Day of Study and 10 Weeks After
description: Saliva samples to assess changes in cortisol and alpha amylase
measure: Birth Outcome Data
time frame: Birth
description: Obtain birth outcome data (Birthweight and Gestational age) from medical records after birth of baby
arm group label: Moderate Pressure Massage
arm group type: Experimental
description: Moderate Pressure Massage Therapy
arm group label: Light Pressure Massage
arm group type: Sham Comparator
description: Light Pressure Massage Therapy
intervention type: Procedure
intervention name: Moderate Pressure Massage
description: 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.
arm group label: Moderate Pressure Massage
intervention type: Procedure
intervention name: Light Pressure Massage
description: 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.
arm group label: Light Pressure Massage
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
url: http://www6.miami.edu/touch-research/
description: Touch Research Institute
responsible party type: Sponsor-Investigator
investigator affiliation: University of Miami
investigator full name: Miguel Diego
investigator title: Research Associate Professor
mesh term: Depression