<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/NCT03839004</url>
  </required_header>
  <id_info>
    <org_study_id>MYND&amp;CO</org_study_id>
    <nct_id>NCT03839004</nct_id>
  </id_info>
  <brief_title>MYND&amp;CO: Studio Pilota Dell'Evoluzione Della Salute Psico-fisica Della Donna in Gravidanza</brief_title>
  <acronym>MYND&amp;CO</acronym>
  <official_title>&quot;MYND&amp;CO: Studio Pilota Sull'Evoluzione Della Salute Psico-fisica Della Donna in Gravidanza Secondo Una modalità Multidisciplinare e Personalizzata&quot;</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To evaluate an integral approach to the maternal-fetal diad.&#xD;
&#xD;
      A randomized non farmacological monocentric trial.&#xD;
&#xD;
      400 women with single spontaneous pregnancies are randomized.&#xD;
&#xD;
      200 recieve standardized traditional obstetrical care&#xD;
&#xD;
      200 recieve nutritional advice, osteopathic treatment, yoga classes, mindfulness classes and&#xD;
      coaching as well as regular obstetrical care.&#xD;
&#xD;
      We evaluate the psychological status at recruitment, at the end of pregnancy and 40 days&#xD;
      after birth.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The first international scientific research project focusing on a holistic approach to&#xD;
      pregnancy is starting now at the Clinica Mangiagalli in Milan.&#xD;
&#xD;
      This innovative model aims to the gold standard of a &quot;positive pregnancy&quot;, which supports&#xD;
      both the somatic and psychological component of the mother-newborn unit, and thus organically&#xD;
      and proactively prevents the main issues arising during pregnancy and delivery due to&#xD;
      unhealthy lifestyles.&#xD;
&#xD;
      A team of experts will take comprehensive care of the mother, first by means of an accurate&#xD;
      evaluation of her nutritional profile, and then of her biomechanic (osteo-skeletal) state.&#xD;
&#xD;
      Then, the experts will lead an &quot;academic&quot; path, which will initiate a development of her&#xD;
      biochemistry (through nutrition), respiration (through yoga), physical wellbeing (through&#xD;
      osteopathy and yoga); and strengthen her sense of self, removing her self-doubt (through&#xD;
      mindfulness and yoga).&#xD;
&#xD;
      The women will be supported up until childbirth, so as to attempt to prevent the main&#xD;
      complications of pregnancy and of delivery.&#xD;
&#xD;
      This model does not aim to substitute the allopathic one which is currently in place&#xD;
      (ultrasounds, ob-gyn appointments, tests, etc.), but to enhance its nature in a more&#xD;
      effectively THERAPEUTIC manner, increasing the mother-newborn unit's potential of health.&#xD;
&#xD;
      In summary:&#xD;
&#xD;
        -  Weekly mindfulness meet-ups&#xD;
&#xD;
        -  Weekly yoga meet-ups&#xD;
&#xD;
        -  Nutritional screening and further check-ups, if needed&#xD;
&#xD;
        -  Osteopathic screening&#xD;
&#xD;
        -  Five motivational meetings with a coach&#xD;
&#xD;
        -  Four obstetrical appointments&#xD;
&#xD;
        -  Obstetrical screening and check-ups up until childbirth&#xD;
&#xD;
      The team in charge of the project is made up of gynaecologists, midwives, psychologists,&#xD;
      osteopaths, nutritionists and yoga teachers, who all collaborate on a regular basis with the&#xD;
      Clinica Mangiagalli.&#xD;
&#xD;
      The project is offered to women free of charge.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 8, 2019</start_date>
  <completion_date type="Anticipated">January 2021</completion_date>
  <primary_completion_date type="Anticipated">August 2020</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>Single Group Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Evolution in women's mental health from t0( first trimester) to after birth (40 days after delivery)</measure>
    <time_frame>from third month of pregnancy to 1 month after delivery</time_frame>
    <description>evaluated by the means of psychological questionaire SF12</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Woman's physical health during pregnancy</measure>
    <time_frame>from first trimester of pregnancy to day of delivery</time_frame>
    <description>weight gain in pregnancy</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Diagnosis of pregnancy-related diabetes</measure>
    <time_frame>from 24 weeks of pregnancy to the day of delivery</time_frame>
    <description>positive blood glucose curve or fasting glucose &gt;92 on 2 different measurements</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Diagnosis of pregnancy-related hypertension</measure>
    <time_frame>from the 20th week of gestation to 40 days after delivery</time_frame>
    <description>diagnosis of hypertension from the 20th week of gestation to 40 days after delivery</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Woman's osteo-muscular health during pregnancy</measure>
    <time_frame>from the 20th week of gestation to 40 days after delivery</time_frame>
    <description>diagnosis of low back pain and sciatic nerve pain during pregnancy</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Quality of delivery</measure>
    <time_frame>birth</time_frame>
    <description>number of operative deliveries/ cesarean sections</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Newborn's health</measure>
    <time_frame>birth</time_frame>
    <description>apgar</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Newborn's pH</measure>
    <time_frame>birth</time_frame>
    <description>pH at birth</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Newborn's weight</measure>
    <time_frame>birth</time_frame>
    <description>weight at birth</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Newborn's blood gas</measure>
    <time_frame>birth</time_frame>
    <description>blood gas at birth</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">400</enrollment>
  <condition>Pregnancy</condition>
  <condition>Mental Health Wellness 1</condition>
  <arm_group>
    <arm_group_label>Intervention group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>200 woman with single spontaneous pregnancies who recieve, as well as traditional obstetrical care, yoga classes, myndfulness classes, coaching, nutrition counselling and osteopathic treatment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Controls</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>200 woman with single spontaneous pregnancies recieving traditional obstetrical care</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Integrated approach to pregnancy</intervention_name>
    <description>Yoga classes, mindfulness classes, coaching, nutrition counselling and osteopathy</description>
    <arm_group_label>Intervention group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  singleton pregnancies&#xD;
&#xD;
          -  spontaneous pregnancies&#xD;
&#xD;
          -  no maternal medical conditions&#xD;
&#xD;
          -  no language barrier&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  maternal or fetal medical conditions&#xD;
&#xD;
          -  age &lt;18 or &lt;45&#xD;
&#xD;
          -  ivf&#xD;
&#xD;
          -  language barrier&#xD;
&#xD;
          -  multiple pregnancies&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>female</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Niccolò Giovannini, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>IRCCS Clinica Mangiagalli</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Niccolo' Giovannini, Dr.</last_name>
    <phone>00393387026884</phone>
    <email>niccolo.giovannini@policlinico.mi.it</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Giulia Emily Cetera, Dr.</last_name>
    <phone>00393356583395</phone>
    <email>giuliaemily.cetera@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Fondazione IRCCS Ca' Granda</name>
      <address>
        <city>Milano</city>
        <zip>20122</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Clinica Mangiagalli</last_name>
      <phone>02.5503</phone>
      <email>comunicazione@policlinico.mi.it</email>
    </contact>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>January 10, 2019</study_first_submitted>
  <study_first_submitted_qc>February 11, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 12, 2019</study_first_posted>
  <last_update_submitted>February 11, 2019</last_update_submitted>
  <last_update_submitted_qc>February 11, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 12, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>individual participant data will not be shared</ipd_description>
  </patient_data>
  <!-- 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/NCT03839004
org study id: MYND&CO
nct id: NCT03839004
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
To evaluate an integral approach to the maternal-fetal diad.

      A randomized non farmacological monocentric trial.

      400 women with single spontaneous pregnancies are randomized.

      200 recieve standardized traditional obstetrical care

      200 recieve nutritional advice, osteopathic treatment, yoga classes, mindfulness classes and
      coaching as well as regular obstetrical care.

      We evaluate the psychological status at recruitment, at the end of pregnancy and 40 days
      after birth.
The first international scientific research project focusing on a holistic approach to
      pregnancy is starting now at the Clinica Mangiagalli in Milan.

      This innovative model aims to the gold standard of a "positive pregnancy", which supports
      both the somatic and psychological component of the mother-newborn unit, and thus organically
      and proactively prevents the main issues arising during pregnancy and delivery due to
      unhealthy lifestyles.

      A team of experts will take comprehensive care of the mother, first by means of an accurate
      evaluation of her nutritional profile, and then of her biomechanic (osteo-skeletal) state.

      Then, the experts will lead an "academic" path, which will initiate a development of her
      biochemistry (through nutrition), respiration (through yoga), physical wellbeing (through
      osteopathy and yoga); and strengthen her sense of self, removing her self-doubt (through
      mindfulness and yoga).

      The women will be supported up until childbirth, so as to attempt to prevent the main
      complications of pregnancy and of delivery.

      This model does not aim to substitute the allopathic one which is currently in place
      (ultrasounds, ob-gyn appointments, tests, etc.), but to enhance its nature in a more
      effectively THERAPEUTIC manner, increasing the mother-newborn unit's potential of health.

      In summary:

        -  Weekly mindfulness meet-ups

        -  Weekly yoga meet-ups

        -  Nutritional screening and further check-ups, if needed

        -  Osteopathic screening

        -  Five motivational meetings with a coach

        -  Four obstetrical appointments

        -  Obstetrical screening and check-ups up until childbirth

      The team in charge of the project is made up of gynaecologists, midwives, psychologists,
      osteopaths, nutritionists and yoga teachers, who all collaborate on a regular basis with the
      Clinica Mangiagalli.

      The project is offered to women free of charge.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Evolution in women's mental health from t0( first trimester) to after birth (40 days after delivery)
time frame: from third month of pregnancy to 1 month after delivery
description: evaluated by the means of psychological questionaire SF12
measure: Woman's physical health during pregnancy
time frame: from first trimester of pregnancy to day of delivery
description: weight gain in pregnancy
measure: Diagnosis of pregnancy-related diabetes
time frame: from 24 weeks of pregnancy to the day of delivery
description: positive blood glucose curve or fasting glucose >92 on 2 different measurements
measure: Diagnosis of pregnancy-related hypertension
time frame: from the 20th week of gestation to 40 days after delivery
description: diagnosis of hypertension from the 20th week of gestation to 40 days after delivery
measure: Woman's osteo-muscular health during pregnancy
time frame: from the 20th week of gestation to 40 days after delivery
description: diagnosis of low back pain and sciatic nerve pain during pregnancy
measure: Quality of delivery
time frame: birth
description: number of operative deliveries/ cesarean sections
measure: Newborn's health
time frame: birth
description: apgar
measure: Newborn's pH
time frame: birth
description: pH at birth
measure: Newborn's weight
time frame: birth
description: weight at birth
measure: Newborn's blood gas
time frame: birth
description: blood gas at birth
arm group label: Intervention group
arm group type: Experimental
description: 200 woman with single spontaneous pregnancies who recieve, as well as traditional obstetrical care, yoga classes, myndfulness classes, coaching, nutrition counselling and osteopathic treatment
arm group label: Controls
arm group type: No Intervention
description: 200 woman with single spontaneous pregnancies recieving traditional obstetrical care
intervention type: Behavioral
intervention name: Integrated approach to pregnancy
description: Yoga classes, mindfulness classes, coaching, nutrition counselling and osteopathy
arm group label: Intervention group
criteria: 
gender: Female
gender based: Yes
gender description: female
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Niccolò Giovannini, MD
role: Principal Investigator
affiliation: IRCCS Clinica Mangiagalli
last name: Niccolo' Giovannini, Dr.
phone: 00393387026884
email: niccolo.giovannini@policlinico.mi.it
last name: Giulia Emily Cetera, Dr.
phone: 00393356583395
email: giuliaemily.cetera@gmail.com
facility: 
status: Recruiting
contact: 
country: Italy
responsible party type: Sponsor
sharing ipd: No
ipd description: individual participant data will not be shared