<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/NCT03837119</url>
  </required_header>
  <id_info>
    <org_study_id>2018-00101; sp19Hoesli</org_study_id>
    <nct_id>NCT03837119</nct_id>
  </id_info>
  <brief_title>Maternal and Perinatal Pregnancy Outcome in Women With Heterozygous Hemoglobinopathies</brief_title>
  <official_title>Maternal and Perinatal Pregnancy Outcome in Women With Heterozygous Hemoglobinopathies</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>No</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>
      This retrospective study aims to investigate pregnancy outcome in women with heterozygous&#xD;
      hemoglobinopathies (regarding gestational diabetes, cholestasis and urinary tract infections)&#xD;
      and to analyze if there are aggravated maternal and/or perinatal risks.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 4, 2018</start_date>
  <completion_date type="Actual">April 11, 2021</completion_date>
  <primary_completion_date type="Actual">April 11, 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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>gestational diabetes</measure>
    <time_frame>in the course of pregnancy until delivery</time_frame>
    <description>number of women developing gestational diabetes in pregnancy</description>
  </primary_outcome>
  <primary_outcome>
    <measure>cholestasis in pregnancy</measure>
    <time_frame>in the course of pregnancy until delivery</time_frame>
    <description>number of women developing cholestasis in pregnancy</description>
  </primary_outcome>
  <primary_outcome>
    <measure>urinary tract infection</measure>
    <time_frame>in the course of pregnancy until delivery</time_frame>
    <description>number of women developing urinary tract infection</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">540</enrollment>
  <condition>Heterozygous Haemoglobinopathy</condition>
  <arm_group>
    <arm_group_label>Heterozygous Hemoglobinopathy</arm_group_label>
    <description>pregnancy outcome in women with heterozygous hemoglobinopathy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No Heterozygous Hemoglobinopathy</arm_group_label>
    <description>pregnancy outcome in women without heterozygous hemoglobinopathy</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>pregnancy outcome</intervention_name>
    <description>descriptive statistics of variables</description>
    <arm_group_label>Heterozygous Hemoglobinopathy</arm_group_label>
    <arm_group_label>No Heterozygous Hemoglobinopathy</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        pregnant women being treated at Universitätsspital Basel/ Frauenklinik (from 2015 until&#xD;
        2017) and at Universitätsspital Zürich (from 2004-2006)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  pregnant women with or without heterozygous hemoglobinopathy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  refusal of study participation&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Irene Hoesli, Prof. Dr. MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Frauenklinik Universitätsspital Basel</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Frauenklinik University Hospital Basel</name>
      <address>
        <city>Basel</city>
        <zip>4031</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Frauenklinik University Hospital Zürich</name>
      <address>
        <city>Zürich</city>
        <zip>8091</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <results_reference>
    <citation>Kasparek J, Burkhardt T, Hoesli I, Amstad Bencaiova G. Pregnancy outcomes in women with a hemoglobinopathy trait: a multicenter, retrospective study. Arch Gynecol Obstet. 2021 Nov;304(5):1197-1203. doi: 10.1007/s00404-021-06058-y. Epub 2021 Apr 11.</citation>
    <PMID>33842991</PMID>
  </results_reference>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>February 8, 2019</study_first_submitted>
  <study_first_submitted_qc>February 8, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 11, 2019</study_first_posted>
  <last_update_submitted>June 30, 2021</last_update_submitted>
  <last_update_submitted_qc>June 30, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 6, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>pregnancy</keyword>
  <keyword>gestational diabetes</keyword>
  <keyword>cholestasis in pregnancy</keyword>
  <keyword>urinary tract infection in pregnancy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hemoglobinopathies</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/NCT03837119
org study id: 2018-00101; sp19Hoesli
nct id: NCT03837119
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This retrospective study aims to investigate pregnancy outcome in women with heterozygous
      hemoglobinopathies (regarding gestational diabetes, cholestasis and urinary tract infections)
      and to analyze if there are aggravated maternal and/or perinatal risks.
observational model: Cohort
time perspective: Retrospective
measure: gestational diabetes
time frame: in the course of pregnancy until delivery
description: number of women developing gestational diabetes in pregnancy
measure: cholestasis in pregnancy
time frame: in the course of pregnancy until delivery
description: number of women developing cholestasis in pregnancy
measure: urinary tract infection
time frame: in the course of pregnancy until delivery
description: number of women developing urinary tract infection
arm group label: Heterozygous Hemoglobinopathy
description: pregnancy outcome in women with heterozygous hemoglobinopathy
arm group label: No Heterozygous Hemoglobinopathy
description: pregnancy outcome in women without heterozygous hemoglobinopathy
intervention type: Other
intervention name: pregnancy outcome
description: descriptive statistics of variables
arm group label: Heterozygous Hemoglobinopathy
arm group label: No Heterozygous Hemoglobinopathy
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Irene Hoesli, Prof. Dr. MD
role: Principal Investigator
affiliation: Frauenklinik Universitätsspital Basel
facility: 
facility: 
country: Switzerland
citation: Kasparek J, Burkhardt T, Hoesli I, Amstad Bencaiova G. Pregnancy outcomes in women with a hemoglobinopathy trait: a multicenter, retrospective study. Arch Gynecol Obstet. 2021 Nov;304(5):1197-1203. doi: 10.1007/s00404-021-06058-y. Epub 2021 Apr 11.
PMID: 33842991
responsible party type: Sponsor
mesh term: Hemoglobinopathies