<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/NCT03792464</url>
  </required_header>
  <id_info>
    <org_study_id>2017-02322</org_study_id>
    <nct_id>NCT03792464</nct_id>
  </id_info>
  <brief_title>Serum Hepcidin in Pregnant Women and the Association With Pregnancy Outcome</brief_title>
  <official_title>Serum Hepcidin and Iron Status Parameters in Pregnant Women and the Association With Adverse Maternal and Fetal Outcome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Basel, Switzerland</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Basel, Switzerland</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>
      Hepcidin production is normally upregulated by iron stores, and in obesity has been shown to&#xD;
      be overexpressed and correlated with low iron status. The increased hepcidin may restrain the&#xD;
      iron release from the cells by affecting the expression of ferroportin, which probably&#xD;
      associates with the development of diabetes complication. Firstly, investigator examines the&#xD;
      difference of serum hepcidin and iron parameters between obese and non-obese pregnant women;&#xD;
      secondly, the correlation between serum hepcidin and adverse maternal and neonatal outcomes&#xD;
      in pregnant women will be tested.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a mono-center, observational, controlled study with 2 parallel groups (obese versus&#xD;
      non-obese pregnant women). The study will be conducted at the University Hospital of Basel,&#xD;
      Department of Obstetrics and Antenatal Care. A total of N=188 healthy pregnant women&#xD;
      (expected 40% with BMI ≥ 30 kg/m2) will be recruited in the first trimester in our&#xD;
      outpatients' department in order to have a total of 169 evaluable women, considering a&#xD;
      drop-out rate of 10%. Serum hepcidin, iron and hematological parameters will be measured at&#xD;
      11-14, 24-28, 32-36 weeks of gestation and at labor. The blood pressure, weight, weight gain,&#xD;
      BMI and smoking status will be examined at all visits. Blood samples will be measured in the&#xD;
      University Hospital of Basel, Department of Laboratory Medicine. Recruitment will begin in&#xD;
      January 2019.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 30, 2019</start_date>
  <completion_date type="Actual">October 31, 2021</completion_date>
  <primary_completion_date type="Actual">October 31, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Serum hepcidin at 11-14 weeks of gestation</measure>
    <time_frame>11-14 weeks of gestation</time_frame>
    <description>serum hepcidin (ng/ml)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Serum hepcidin at 24-28, 32-36 weeks of gestation and at labor;</measure>
    <time_frame>at 24-28, 32-36 weeks of gestation</time_frame>
    <description>serum hepcidin (ng/ml)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>serum ferritin (µg/l),</measure>
    <time_frame>at 24-28, 32-36 weeks of gestation</time_frame>
    <description>iron status Parameter</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HRC (%),</measure>
    <time_frame>at 11-14, 24-28, 32-36 weeks of gestation</time_frame>
    <description>blood parameter</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>hemoglobin (g/l),</measure>
    <time_frame>at 11-14, 24-28, 32-36 weeks of gestation</time_frame>
    <description>blood parameter</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>red blood cells (x1012/l),</measure>
    <time_frame>at 11-14, 24-28, 32-36 weeks of gestation</time_frame>
    <description>blood parameter</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>hematocrit (l/l),</measure>
    <time_frame>at 11-14, 24-28, 32-36 weeks of gestation</time_frame>
    <description>blood parameter</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MCV (fl),</measure>
    <time_frame>at 11-14, 24-28, 32-36 weeks of gestation</time_frame>
    <description>blood parameter</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MCH (pg),</measure>
    <time_frame>at 11-14, 24-28, 32-36 weeks of gestation</time_frame>
    <description>blood parameter</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MCHC (g/l),</measure>
    <time_frame>at 11-14, 24-28, 32-36 weeks of gestation</time_frame>
    <description>blood parameter</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>red blood cell distribution width (%)</measure>
    <time_frame>at 11-14, 24-28, 32-36 weeks of gestation</time_frame>
    <description>blood parameter</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>soluble transferrin receptors (mg/l)</measure>
    <time_frame>at 24-28, 32-36 weeks of gestation</time_frame>
    <description>iron status Parameter</description>
  </secondary_outcome>
  <other_outcome>
    <measure>preeclampsia (presence: yes/no)</measure>
    <time_frame>from 11 week of gestation to the 3 days after the birth</time_frame>
    <description>maternal outcome</description>
  </other_outcome>
  <other_outcome>
    <measure>pregnancy induced hypertension (presence: yes/no),</measure>
    <time_frame>from 11 week of gestation to the birth</time_frame>
    <description>maternal outcome</description>
  </other_outcome>
  <other_outcome>
    <measure>infection in pregnancy (presence: yes/no),</measure>
    <time_frame>from 11 week of gestation to the 5 days after the birth</time_frame>
    <description>maternal outcome</description>
  </other_outcome>
  <other_outcome>
    <measure>anemia (presence: yes/no)</measure>
    <time_frame>from 11 week of gestation to 3 days after the birth</time_frame>
    <description>maternal outcome</description>
  </other_outcome>
  <other_outcome>
    <measure>iron deficiency (presence: yes/no),</measure>
    <time_frame>from 11 week of gestation to the birth</time_frame>
    <description>maternal outcome</description>
  </other_outcome>
  <other_outcome>
    <measure>cholestasis in pregnancy (presence:yes/no),</measure>
    <time_frame>from 11 week of gestation to the birth</time_frame>
    <description>maternal outcome</description>
  </other_outcome>
  <other_outcome>
    <measure>gestational diabetes mellitus (presence: yes/no),</measure>
    <time_frame>from 11 week of gestation to the birth</time_frame>
    <description>maternal outcome</description>
  </other_outcome>
  <other_outcome>
    <measure>abnormal placentation (presence: yes/no),</measure>
    <time_frame>from 11 week of gestation to the birth</time_frame>
    <description>maternal outcome</description>
  </other_outcome>
  <other_outcome>
    <measure>blood loss during birth (ml)</measure>
    <time_frame>at the birth</time_frame>
    <description>maternal outcome</description>
  </other_outcome>
  <other_outcome>
    <measure>transfusion requirement (presence: yes/no)</measure>
    <time_frame>at the birth</time_frame>
    <description>maternal outcome</description>
  </other_outcome>
  <other_outcome>
    <measure>gestational age at birth (gestational week and day)</measure>
    <time_frame>at the birth</time_frame>
    <description>neonatal outcome</description>
  </other_outcome>
  <other_outcome>
    <measure>birth weight (g)</measure>
    <time_frame>at the birth</time_frame>
    <description>neonatal outcome</description>
  </other_outcome>
  <other_outcome>
    <measure>preterm delivery (presence: yes/no)</measure>
    <time_frame>at the birth</time_frame>
    <description>neonatal outcome</description>
  </other_outcome>
  <other_outcome>
    <measure>preterm premature rupture of fetal membrane (presence: yes/no)</measure>
    <time_frame>at the birth</time_frame>
    <description>neonatal outcome</description>
  </other_outcome>
  <other_outcome>
    <measure>intrauterine growth restriction (yes/no)</measure>
    <time_frame>from 11 week of gestation to the birth</time_frame>
    <description>neonatal outcome</description>
  </other_outcome>
  <other_outcome>
    <measure>intrauterine fetal death</measure>
    <time_frame>from 11 week of gestation to the birth</time_frame>
    <description>neonatal outcome</description>
  </other_outcome>
  <enrollment type="Actual">188</enrollment>
  <condition>Anemia</condition>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Hematological and serum iron parameters will be determined using routine laboratory&#xD;
      methodology. Blood samples are collected by venipuncture. All blood measurements will be&#xD;
      conducted at the University Hospital of Basel, Department of Laboratory Medicine.&#xD;
&#xD;
      Hb, RBC, HCT, MCV, MCHC, MRC, HRC and CHr are measured using a hematology analyzer. Mean&#xD;
      corpuscular hemoglobin is automatically calculated from Hb and RBC. Ferritin is assessed by&#xD;
      chemiluminescence immunoassay and CRP is assessed by immunoturbidimetry. Soluble transferrin&#xD;
      receptors and serum hepcidin are measured with an ELISA.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        188 singleton pregnancies will be recruited in the first trimester at the University&#xD;
        Hospital of Basel, Department of Obstetrics and Antenatal Care.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  women with a BMI ≥ 18.5 kg/m2,&#xD;
&#xD;
          -  maternal age ≥ 18 years,&#xD;
&#xD;
          -  singleton pregnancy,&#xD;
&#xD;
          -  gestational age at recruitment: 11-14 of gestational weeks,&#xD;
&#xD;
          -  written informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnant women with a BMI&lt; 18.5 kg/m2,&#xD;
&#xD;
          -  congenital anomaly of fetus,&#xD;
&#xD;
          -  severe maternal diseases of heart, liver, kidney, cardiovascular system,&#xD;
             gastrointestinal tract, neurologic disorders and psychiatric disorders.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>pregnant women</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gabriela Amstad Bencaiova</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Obsterics, University Hospital of Basel</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital Basel</name>
      <address>
        <city>Basel</city>
        <state>Basel Stadt</state>
        <zip>4031</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>November 2021</verification_date>
  <study_first_submitted>December 3, 2018</study_first_submitted>
  <study_first_submitted_qc>December 30, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">January 3, 2019</study_first_posted>
  <last_update_submitted>November 10, 2021</last_update_submitted>
  <last_update_submitted_qc>November 10, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 11, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT03792464
org study id: 2017-02322
nct id: NCT03792464
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Hepcidin production is normally upregulated by iron stores, and in obesity has been shown to
      be overexpressed and correlated with low iron status. The increased hepcidin may restrain the
      iron release from the cells by affecting the expression of ferroportin, which probably
      associates with the development of diabetes complication. Firstly, investigator examines the
      difference of serum hepcidin and iron parameters between obese and non-obese pregnant women;
      secondly, the correlation between serum hepcidin and adverse maternal and neonatal outcomes
      in pregnant women will be tested.
This is a mono-center, observational, controlled study with 2 parallel groups (obese versus
      non-obese pregnant women). The study will be conducted at the University Hospital of Basel,
      Department of Obstetrics and Antenatal Care. A total of N=188 healthy pregnant women
      (expected 40% with BMI ≥ 30 kg/m2) will be recruited in the first trimester in our
      outpatients' department in order to have a total of 169 evaluable women, considering a
      drop-out rate of 10%. Serum hepcidin, iron and hematological parameters will be measured at
      11-14, 24-28, 32-36 weeks of gestation and at labor. The blood pressure, weight, weight gain,
      BMI and smoking status will be examined at all visits. Blood samples will be measured in the
      University Hospital of Basel, Department of Laboratory Medicine. Recruitment will begin in
      January 2019.
observational model: Cohort
time perspective: Prospective
measure: Serum hepcidin at 11-14 weeks of gestation
time frame: 11-14 weeks of gestation
description: serum hepcidin (ng/ml)
measure: Serum hepcidin at 24-28, 32-36 weeks of gestation and at labor;
time frame: at 24-28, 32-36 weeks of gestation
description: serum hepcidin (ng/ml)
measure: serum ferritin (µg/l),
time frame: at 24-28, 32-36 weeks of gestation
description: iron status Parameter
measure: HRC (%),
time frame: at 11-14, 24-28, 32-36 weeks of gestation
description: blood parameter
measure: hemoglobin (g/l),
time frame: at 11-14, 24-28, 32-36 weeks of gestation
description: blood parameter
measure: red blood cells (x1012/l),
time frame: at 11-14, 24-28, 32-36 weeks of gestation
description: blood parameter
measure: hematocrit (l/l),
time frame: at 11-14, 24-28, 32-36 weeks of gestation
description: blood parameter
measure: MCV (fl),
time frame: at 11-14, 24-28, 32-36 weeks of gestation
description: blood parameter
measure: MCH (pg),
time frame: at 11-14, 24-28, 32-36 weeks of gestation
description: blood parameter
measure: MCHC (g/l),
time frame: at 11-14, 24-28, 32-36 weeks of gestation
description: blood parameter
measure: red blood cell distribution width (%)
time frame: at 11-14, 24-28, 32-36 weeks of gestation
description: blood parameter
measure: soluble transferrin receptors (mg/l)
time frame: at 24-28, 32-36 weeks of gestation
description: iron status Parameter
measure: preeclampsia (presence: yes/no)
time frame: from 11 week of gestation to the 3 days after the birth
description: maternal outcome
measure: pregnancy induced hypertension (presence: yes/no),
time frame: from 11 week of gestation to the birth
description: maternal outcome
measure: infection in pregnancy (presence: yes/no),
time frame: from 11 week of gestation to the 5 days after the birth
description: maternal outcome
measure: anemia (presence: yes/no)
time frame: from 11 week of gestation to 3 days after the birth
description: maternal outcome
measure: iron deficiency (presence: yes/no),
time frame: from 11 week of gestation to the birth
description: maternal outcome
measure: cholestasis in pregnancy (presence:yes/no),
time frame: from 11 week of gestation to the birth
description: maternal outcome
measure: gestational diabetes mellitus (presence: yes/no),
time frame: from 11 week of gestation to the birth
description: maternal outcome
measure: abnormal placentation (presence: yes/no),
time frame: from 11 week of gestation to the birth
description: maternal outcome
measure: blood loss during birth (ml)
time frame: at the birth
description: maternal outcome
measure: transfusion requirement (presence: yes/no)
time frame: at the birth
description: maternal outcome
measure: gestational age at birth (gestational week and day)
time frame: at the birth
description: neonatal outcome
measure: birth weight (g)
time frame: at the birth
description: neonatal outcome
measure: preterm delivery (presence: yes/no)
time frame: at the birth
description: neonatal outcome
measure: preterm premature rupture of fetal membrane (presence: yes/no)
time frame: at the birth
description: neonatal outcome
measure: intrauterine growth restriction (yes/no)
time frame: from 11 week of gestation to the birth
description: neonatal outcome
measure: intrauterine fetal death
time frame: from 11 week of gestation to the birth
description: neonatal outcome
Hematological and serum iron parameters will be determined using routine laboratory
      methodology. Blood samples are collected by venipuncture. All blood measurements will be
      conducted at the University Hospital of Basel, Department of Laboratory Medicine.

      Hb, RBC, HCT, MCV, MCHC, MRC, HRC and CHr are measured using a hematology analyzer. Mean
      corpuscular hemoglobin is automatically calculated from Hb and RBC. Ferritin is assessed by
      chemiluminescence immunoassay and CRP is assessed by immunoturbidimetry. Soluble transferrin
      receptors and serum hepcidin are measured with an ELISA.
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
gender based: Yes
gender description: pregnant women
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: No
last name: Gabriela Amstad Bencaiova
role: Principal Investigator
affiliation: Department of Obsterics, University Hospital of Basel
facility: 
country: Switzerland
responsible party type: Sponsor