<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/NCT04438928</url>
  </required_header>
  <id_info>
    <org_study_id>18366</org_study_id>
    <nct_id>NCT04438928</nct_id>
  </id_info>
  <brief_title>Clinical Study on the Effect of Elevit Pregnancy 2nd &amp; 3rd Trimester (Multi-micronutrients &amp; DHA Supplement) on the Nutritional Status of Pregnant Women During Second and Third Trimester</brief_title>
  <official_title>Effects of Multiple Micronutrients and Docosahexaenoic Acid (DHA) Supplementation During Pregnancy on Maternal Biomarkers and Infant Anthropometric Outcomes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bayer</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bayer</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to collect information how adding a soft gel preparation of&#xD;
      micronutrients such as vitamins, dietary minerals plus omega-3 fatty acid (docosahexaenoic&#xD;
      acid, DHA) to the diet of pregnant women during the 2nd and 3rd trimesters of pregnancy&#xD;
      effects the nutritional state of the mother and infants at delivery.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 27, 2016</start_date>
  <completion_date type="Actual">December 5, 2019</completion_date>
  <primary_completion_date type="Actual">December 5, 2019</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>Supportive Care</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline: Blood RBC DHA/wt% TFA</measure>
    <time_frame>Baseline: Screening at gestational age (GA) week 11 to 13 and at GA week 24 to 26 and week 34 to 36</time_frame>
    <description>In order to assess the beneficial effects of supplementation with micronutrients and DHA (docosahexaenoic acid) during 2nd and 3rd trimesters of pregnancy, the red blood cell (RBC) DHA weight percent of total fatty acids (DHA wt% TFA) will be measured compared to baseline as primary maternal variable.&#xD;
Gestational age is a measure of the age of a pregnancy which is taken from the beginning of the woman's last menstrual period (LMP), or the corresponding age of the gestation as estimated by a more accurate method if available. Such methods include adding 14 days to a known duration since fertilization (as is possible in in vitro fertilization), or by obstetric ultrasonography. The popularity of using such a definition of gestational age is that menstrual periods are essentially always noticed, while there is usually a lack of a convenient way to discern when fertilization occurred.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline: Blood RBC EPA/wt% TFA</measure>
    <time_frame>Baseline: Screening at gestational age (GA) week 11 to 13 and at GA week 24 to 26 and week 34 to 36</time_frame>
    <description>Red blood cell (RBC) EPA (eicosapentaenoic acid) weight percent of total fatty acids (DHA wt% TFA).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline: Blood RBC DHA/TFA ratio %</measure>
    <time_frame>Baseline: Screening at gestational age (GA) week 11 to 13 and at GA week 24 to 26 and week 34 to 36</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline: Blood RBC Omega 3 index in RBC</measure>
    <time_frame>Baseline: Screening at gestational age (GA) week 11 to 13 and at GA week 24 to 26 and week 34 to 36</time_frame>
    <description>The &quot;omega-3 index&quot; reflects the content of EPA plus DHA in erythrocyte membranes expressed as a percentage of total erythrocyte fatty acids.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline: Blood 25-hydroxyvitamin D concentration %</measure>
    <time_frame>Baseline: Screening at gestational age (GA) week 11 to 13 and at GA week 24 to 26 and week 34 to 36</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline: Blood Glutathione (GSH)/oxidized Glutathione (GSSG) ratio %</measure>
    <time_frame>Baseline: Screening at gestational age (GA) week 11 to 13 and at GA week 24 to 26 and week 34 to 36</time_frame>
    <description>Glutathione exists in reduced (GSH) and oxidized (GSSG) states. Reduced glutathione is the most abundant antioxidant in aerobic cells and participates in the detoxification of lipid hydroperoxides and hydrogen peroxide exerted by glutathione peroxidases. When cells are exposes to increased oxidative stress levels, GSSG accumulates and the GSH/GSSG ratio decreases.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline: Blood Reactive oxygen metabolites (ROMs) concentrations %</measure>
    <time_frame>Baseline: Screening at gestational age (GA) week 11 to 13 and at GA week 24 to 26 and week 34 to 36</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline: Blood 8-Isoprostane concentration %</measure>
    <time_frame>Baseline: Screening at gestational age (GA) week 11 to 13 and at GA week 24 to 26 and week 34 to 36</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infant sex</measure>
    <time_frame>At delivery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infant gestational age</measure>
    <time_frame>At delivery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infant head circumference</measure>
    <time_frame>At delivery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infant weight measurements</measure>
    <time_frame>At delivery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infant length measurements</measure>
    <time_frame>At delivery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infant ponderal index</measure>
    <time_frame>At delivery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infant skinfold thickness</measure>
    <time_frame>At delivery</time_frame>
    <description>Triplicate measurements: triceps, biceps, suprailiac, and subscapular on left side with standard skinfold caliper operated with constant pressure of 10 g/mm2)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infant Apgar score</measure>
    <time_frame>At delivery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Infant bone density</measure>
    <time_frame>Up to 10 days after delivery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Umbilical cord blood gas analysis</measure>
    <time_frame>At delivery</time_frame>
    <description>Cord blood sample evaluations in a subset of women undergoing Caesarean section.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Umbilical cord blood pH analysis</measure>
    <time_frame>At delivery</time_frame>
    <description>Cord blood sample evaluations in a subset of women undergoing Caesarean section.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cord blood metabolomic analysis</measure>
    <time_frame>At delivery</time_frame>
    <description>Cord blood sample evaluations in a subset of women undergoing Caesarean section.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Placental weight</measure>
    <time_frame>At delivery</time_frame>
    <description>Placenta tissue sample evaluation in a subset of women undergoing caesarean section.&#xD;
Placental efficiency will be estimated through the feto/placental weight (F/P) ratio, calculated as birth weight divided by the placental weight.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Placental biometric parameters</measure>
    <time_frame>At delivery</time_frame>
    <description>Placenta tissue sample evaluation in a subset of women undergoing caesarean section.&#xD;
i.e. larger (D) and smaller (d) diameters of the chorionic elliptical disc, feto/placental weight (F/P ratio)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood, cord blood and placental RBC DHA/wt% TFA</measure>
    <time_frame>At delivery</time_frame>
    <description>Sample evaluations in a subset of women undergoing Caesarean section.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood, cord blood and placental RBC EPA wt% TFA</measure>
    <time_frame>At delivery</time_frame>
    <description>Sample evaluations in a subset of women undergoing Caesarean section.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood, cord blood and placental DHA/TFA ratio %</measure>
    <time_frame>At delivery</time_frame>
    <description>Sample evaluations in a subset of women undergoing Caesarean section.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood, cord blood and placental RBC Omega 3 index</measure>
    <time_frame>At delivery</time_frame>
    <description>Sample evaluations in a subset of women undergoing Caesarean section.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mitochondrial DNA content evaluation in placental tissue and isolated trophoblast cells</measure>
    <time_frame>At delivery</time_frame>
    <description>mtDNA is a well-accepted molecular marker to assess mitochondria content.&#xD;
Sample evaluations in a subset of women undergoing Caesarean section.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>IL-6 (Interleukin 6), IL-10 (Interleukin 10) and TNF-α (Tumor Necrosis Factor Alpha) in placental tissue and isolated trophoblast cells</measure>
    <time_frame>At delivery</time_frame>
    <description>These genes are constitutively expressed in human placenta and are a reliable marker of inflammation.&#xD;
Sample evaluations in a subset of women undergoing Caesarean section.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Placental tissue metabolomic analysis</measure>
    <time_frame>At delivery</time_frame>
    <description>Sample evaluations in a subset of women undergoing Caesarean section.&#xD;
The rationale for conducting metabolomic analysis is to understand if multi-micronutrient supplement (MMS) supplementation during the second and third trimester of pregnancy influences maternal and infant gestational outcomes (e.g. oxidative stress, placental function).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood, cord blood and placental 8-isoprostane</measure>
    <time_frame>At delivery</time_frame>
    <description>Sample evaluations in a subset of women undergoing Caesarean section.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blood, cord blood and placental reactive oxygen metabolites (ROMs) concentrations %</measure>
    <time_frame>At delivery</time_frame>
    <description>Sample evaluations in a subset of women undergoing Caesarean section.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Adverse Events (AEs)</measure>
    <time_frame>Within 7 days after Delivery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Severity of AEs</measure>
    <time_frame>Within 7 days after Delivery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AE relationship to the investigational product</measure>
    <time_frame>Within 7 days after Delivery</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Maternal Food Frequency Questionnaire FFQ</measure>
    <time_frame>Up to GA week 34-36</time_frame>
    <description>Focus on foods providing DHA</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">164</enrollment>
  <condition>Healthy Pregnant Women</condition>
  <arm_group>
    <arm_group_label>Healthy pregnant women - Supplement</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Supplementation with micronutrients plus docosahexaenoic acid (DHA) preparation (Multimicronutrients and docosahexaenoic acid (MMS) soft gel capsules) during 2nd and 3rd trimesters of pregnancy.&#xD;
Subgroup: Healthy pregnant women with Caesarean section [A subset of subjects (approximately 10 subjects per study arm) undergoing elective Caesarean section (for reasons independent from the study)]</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy pregnant women - Non-Supplement</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Control study group&#xD;
Subgroup: Healthy pregnant women with Caesarean section [A subset of subjects (approximately 10 subjects per study arm) undergoing elective Caesarean section (for reasons independent from the study)]</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Elevit Pregnancy 2nd &amp; 3rd Trimester</intervention_name>
    <description>Once daily micronutrient plus DHA supplementation (Multi-micronutrients and docosahexaenoic acid (MMS) soft gel capsules)</description>
    <arm_group_label>Healthy pregnant women - Supplement</arm_group_label>
    <other_name>BAY 987765 Multi-micronutrient &amp; DHA</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Non-Supplement</intervention_name>
    <description>Control study group of pregnant women non-supplemented with multi-micronutrients and docosahexaenoic acid (MMS) soft gel capsules</description>
    <arm_group_label>Healthy pregnant women - Non-Supplement</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy pregnant Caucasian women aged 18 to 42 years (inclusive) in their 1st - 2nd&#xD;
             trimester (gestational age (GA) week 11-14 at screening);&#xD;
&#xD;
          -  Hemoglobin (Hg) &gt; 105g/L;&#xD;
&#xD;
          -  Inconspicuous fetal anomaly screening;&#xD;
&#xD;
          -  Normal ultrasound examination (Ultra Sonography (USG));&#xD;
&#xD;
          -  Singleton pregnancy;&#xD;
&#xD;
          -  Taking at least 400 mcg folate per day;&#xD;
&#xD;
          -  Seronegative for Human Immunodeficiency Virus (HIV), Hepatitis B and Hepatitis C at&#xD;
             screening;&#xD;
&#xD;
          -  Pregnant women who, in the opinion of the Investigator, are willing and able to&#xD;
             participate in all scheduled visits, to adhere to the supplementation plan, to&#xD;
             laboratory tests and to all other study related procedures according to the clinical&#xD;
             protocol;&#xD;
&#xD;
          -  Pregnant women providing a personally signed and dated given informed consent to&#xD;
             participate in the study and to adhere to all study procedures indicating that they&#xD;
             have been informed of all pertinent aspects of the trial and that they understood and&#xD;
             accepted these, prior to admission to the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Physical (including vital signs e.g. blood pressure and pulse rate), hematological and&#xD;
             clinical-chemical parameters deviating from normal and with clinical relevance;&#xD;
&#xD;
          -  Any infection (acute or chronic) at screening and baseline;&#xD;
&#xD;
          -  Any current metabolic diseases (e.g. diabetes, hypothyroidism);&#xD;
&#xD;
          -  Less than 12 months from previous delivery;&#xD;
&#xD;
          -  Any history or current diseases, which are associated with malabsorption, or other&#xD;
             severe diseases of the gastrointestinal tract (e.g. chronic inflammatory bowel&#xD;
             disease, iron accumulation, iron utilization disorders); Any history or current&#xD;
             neurological, cardiac, endocrine or bleeding disorders;&#xD;
&#xD;
          -  Specific diets (e.g. vegan vegetarian, celiac, lactose free);&#xD;
&#xD;
          -  Body mass index (BMI) &lt; 18 or &gt;30 kg/m2;&#xD;
&#xD;
          -  Pregnant women already taking DHA/multivitamin supplements (except folate or iron);&#xD;
&#xD;
          -  Diagnosed or suspected malignant or premalignant disease;&#xD;
&#xD;
          -  Current clinically significant depression;&#xD;
&#xD;
          -  Current intake of pharmaceuticals or dietary supplements which may interact with any&#xD;
             of the ingredients of the trial treatment (i.e. fluoroquinolones, bisphosphonates,&#xD;
             levodopa, levothyroxine, penicillamine, antibiotics containing tetracycline or&#xD;
             trietine);&#xD;
&#xD;
          -  History of or current diseases where vitamin, mineral, trace element or DHA&#xD;
             supplementation might be not recommended /contraindicated [such as sickle cell anemia,&#xD;
             copper metabolism disorders (Wilson's disease), renal disease, nephrolithiasis,&#xD;
             urolithiasis, hypercalcemia, hypercalciuria, hepatobiliary diseases, existing&#xD;
             hypervitaminosis, iron metabolism disorders, hypermagnesemia];&#xD;
&#xD;
          -  Severe Hyperemesis gravidarum;&#xD;
&#xD;
          -  Previous adverse birth outcomes (e.g. small for gestational age, low birth weight,&#xD;
             premature birth, stillbirth, more than two consecutive spontaneous abortions);&#xD;
&#xD;
          -  Previous adverse pregnancy outcomes (e.g. gestational diabetes);&#xD;
&#xD;
          -  Diagnosed congenital abnormalities in current or previous pregnancy;&#xD;
&#xD;
          -  Known carrier or affected with a genetic disease or condition (e.g. mutation carrier&#xD;
             for autosomal recessive diseases);&#xD;
&#xD;
          -  History of or current abuse of drugs, alcohol or other substances;&#xD;
&#xD;
          -  Current smokers and women who smoked during current pregnancy;&#xD;
&#xD;
          -  Any history of hypersensitivity or known allergy to any of the ingredients of the&#xD;
             study supplement.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>42 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bayer Study Director</last_name>
    <role>Study Director</role>
    <affiliation>Bayer</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>ASST Fatebenefratelli Sacco</name>
      <address>
        <city>Milano</city>
        <state>Lombardia</state>
        <zip>20154</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>ASST Fatebenefratelli Sacco</name>
      <address>
        <city>Milano</city>
        <state>Lombardia</state>
        <zip>20157</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>May 29, 2020</study_first_submitted>
  <study_first_submitted_qc>June 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 19, 2020</study_first_posted>
  <last_update_submitted>November 12, 2020</last_update_submitted>
  <last_update_submitted_qc>November 12, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 16, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Micronutrients</mesh_term>
  </intervention_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/NCT04438928
org study id: 18366
nct id: NCT04438928
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to collect information how adding a soft gel preparation of
      micronutrients such as vitamins, dietary minerals plus omega-3 fatty acid (docosahexaenoic
      acid, DHA) to the diet of pregnant women during the 2nd and 3rd trimesters of pregnancy
      effects the nutritional state of the mother and infants at delivery.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Triple (Participant, Care Provider, Investigator)
measure: Change from baseline: Blood RBC DHA/wt% TFA
time frame: Baseline: Screening at gestational age (GA) week 11 to 13 and at GA week 24 to 26 and week 34 to 36
description: In order to assess the beneficial effects of supplementation with micronutrients and DHA (docosahexaenoic acid) during 2nd and 3rd trimesters of pregnancy, the red blood cell (RBC) DHA weight percent of total fatty acids (DHA wt% TFA) will be measured compared to baseline as primary maternal variable.
Gestational age is a measure of the age of a pregnancy which is taken from the beginning of the woman's last menstrual period (LMP), or the corresponding age of the gestation as estimated by a more accurate method if available. Such methods include adding 14 days to a known duration since fertilization (as is possible in in vitro fertilization), or by obstetric ultrasonography. The popularity of using such a definition of gestational age is that menstrual periods are essentially always noticed, while there is usually a lack of a convenient way to discern when fertilization occurred.
measure: Change from baseline: Blood RBC EPA/wt% TFA
time frame: Baseline: Screening at gestational age (GA) week 11 to 13 and at GA week 24 to 26 and week 34 to 36
description: Red blood cell (RBC) EPA (eicosapentaenoic acid) weight percent of total fatty acids (DHA wt% TFA).
measure: Change from baseline: Blood RBC DHA/TFA ratio %
time frame: Baseline: Screening at gestational age (GA) week 11 to 13 and at GA week 24 to 26 and week 34 to 36
measure: Change from baseline: Blood RBC Omega 3 index in RBC
time frame: Baseline: Screening at gestational age (GA) week 11 to 13 and at GA week 24 to 26 and week 34 to 36
description: The "omega-3 index" reflects the content of EPA plus DHA in erythrocyte membranes expressed as a percentage of total erythrocyte fatty acids.
measure: Change from baseline: Blood 25-hydroxyvitamin D concentration %
time frame: Baseline: Screening at gestational age (GA) week 11 to 13 and at GA week 24 to 26 and week 34 to 36
measure: Change from baseline: Blood Glutathione (GSH)/oxidized Glutathione (GSSG) ratio %
time frame: Baseline: Screening at gestational age (GA) week 11 to 13 and at GA week 24 to 26 and week 34 to 36
description: Glutathione exists in reduced (GSH) and oxidized (GSSG) states. Reduced glutathione is the most abundant antioxidant in aerobic cells and participates in the detoxification of lipid hydroperoxides and hydrogen peroxide exerted by glutathione peroxidases. When cells are exposes to increased oxidative stress levels, GSSG accumulates and the GSH/GSSG ratio decreases.
measure: Change from baseline: Blood Reactive oxygen metabolites (ROMs) concentrations %
time frame: Baseline: Screening at gestational age (GA) week 11 to 13 and at GA week 24 to 26 and week 34 to 36
measure: Change from baseline: Blood 8-Isoprostane concentration %
time frame: Baseline: Screening at gestational age (GA) week 11 to 13 and at GA week 24 to 26 and week 34 to 36
measure: Infant sex
time frame: At delivery
measure: Infant gestational age
time frame: At delivery
measure: Infant head circumference
time frame: At delivery
measure: Infant weight measurements
time frame: At delivery
measure: Infant length measurements
time frame: At delivery
measure: Infant ponderal index
time frame: At delivery
measure: Infant skinfold thickness
time frame: At delivery
description: Triplicate measurements: triceps, biceps, suprailiac, and subscapular on left side with standard skinfold caliper operated with constant pressure of 10 g/mm2)
measure: Infant Apgar score
time frame: At delivery
measure: Infant bone density
time frame: Up to 10 days after delivery
measure: Umbilical cord blood gas analysis
time frame: At delivery
description: Cord blood sample evaluations in a subset of women undergoing Caesarean section.
measure: Umbilical cord blood pH analysis
time frame: At delivery
description: Cord blood sample evaluations in a subset of women undergoing Caesarean section.
measure: Cord blood metabolomic analysis
time frame: At delivery
description: Cord blood sample evaluations in a subset of women undergoing Caesarean section.
measure: Placental weight
time frame: At delivery
description: Placenta tissue sample evaluation in a subset of women undergoing caesarean section.
Placental efficiency will be estimated through the feto/placental weight (F/P) ratio, calculated as birth weight divided by the placental weight.
measure: Placental biometric parameters
time frame: At delivery
description: Placenta tissue sample evaluation in a subset of women undergoing caesarean section.
i.e. larger (D) and smaller (d) diameters of the chorionic elliptical disc, feto/placental weight (F/P ratio)
measure: Blood, cord blood and placental RBC DHA/wt% TFA
time frame: At delivery
description: Sample evaluations in a subset of women undergoing Caesarean section.
measure: Blood, cord blood and placental RBC EPA wt% TFA
time frame: At delivery
description: Sample evaluations in a subset of women undergoing Caesarean section.
measure: Blood, cord blood and placental DHA/TFA ratio %
time frame: At delivery
description: Sample evaluations in a subset of women undergoing Caesarean section.
measure: Blood, cord blood and placental RBC Omega 3 index
time frame: At delivery
description: Sample evaluations in a subset of women undergoing Caesarean section.
measure: Mitochondrial DNA content evaluation in placental tissue and isolated trophoblast cells
time frame: At delivery
description: mtDNA is a well-accepted molecular marker to assess mitochondria content.
Sample evaluations in a subset of women undergoing Caesarean section.
measure: IL-6 (Interleukin 6), IL-10 (Interleukin 10) and TNF-α (Tumor Necrosis Factor Alpha) in placental tissue and isolated trophoblast cells
time frame: At delivery
description: These genes are constitutively expressed in human placenta and are a reliable marker of inflammation.
Sample evaluations in a subset of women undergoing Caesarean section.
measure: Placental tissue metabolomic analysis
time frame: At delivery
description: Sample evaluations in a subset of women undergoing Caesarean section.
The rationale for conducting metabolomic analysis is to understand if multi-micronutrient supplement (MMS) supplementation during the second and third trimester of pregnancy influences maternal and infant gestational outcomes (e.g. oxidative stress, placental function).
measure: Blood, cord blood and placental 8-isoprostane
time frame: At delivery
description: Sample evaluations in a subset of women undergoing Caesarean section.
measure: Blood, cord blood and placental reactive oxygen metabolites (ROMs) concentrations %
time frame: At delivery
description: Sample evaluations in a subset of women undergoing Caesarean section.
measure: Number of Adverse Events (AEs)
time frame: Within 7 days after Delivery
measure: Severity of AEs
time frame: Within 7 days after Delivery
measure: AE relationship to the investigational product
time frame: Within 7 days after Delivery
measure: Maternal Food Frequency Questionnaire FFQ
time frame: Up to GA week 34-36
description: Focus on foods providing DHA
arm group label: Healthy pregnant women - Supplement
arm group type: Experimental
description: Supplementation with micronutrients plus docosahexaenoic acid (DHA) preparation (Multimicronutrients and docosahexaenoic acid (MMS) soft gel capsules) during 2nd and 3rd trimesters of pregnancy.
Subgroup: Healthy pregnant women with Caesarean section [A subset of subjects (approximately 10 subjects per study arm) undergoing elective Caesarean section (for reasons independent from the study)]
arm group label: Healthy pregnant women - Non-Supplement
arm group type: Other
description: Control study group
Subgroup: Healthy pregnant women with Caesarean section [A subset of subjects (approximately 10 subjects per study arm) undergoing elective Caesarean section (for reasons independent from the study)]
intervention type: Dietary Supplement
intervention name: Elevit Pregnancy 2nd & 3rd Trimester
description: Once daily micronutrient plus DHA supplementation (Multi-micronutrients and docosahexaenoic acid (MMS) soft gel capsules)
arm group label: Healthy pregnant women - Supplement
other name: BAY 987765 Multi-micronutrient & DHA
intervention type: Other
intervention name: Non-Supplement
description: Control study group of pregnant women non-supplemented with multi-micronutrients and docosahexaenoic acid (MMS) soft gel capsules
arm group label: Healthy pregnant women - Non-Supplement
criteria: 
gender: Female
gender based: Yes
minimum age: 18 Years
maximum age: 42 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Bayer Study Director
role: Study Director
affiliation: Bayer
facility: 
facility: 
country: Italy
responsible party type: Sponsor
mesh term: Micronutrients