<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/NCT03796949</url>
  </required_header>
  <id_info>
    <org_study_id>960624abc</org_study_id>
    <nct_id>NCT03796949</nct_id>
  </id_info>
  <brief_title>Threatened Preterm Birth and Time of Subsequent Delivery -a Prediction Model</brief_title>
  <official_title>Threatened Preterm Birth and Time of Subsequent Delivery; Prediction Model Based on Biomarkers and Maternal/Obstetrical Characteristics</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Linkoeping University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Linkoeping University</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 study investigates immunological and clinical markers in threatened preterm birth aiming&#xD;
      to create a prediction model for preterm birth.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Preterm birth is the main cause of neonatal mortality and morbidity and despite a lot of&#xD;
      effort the mechanisms leading to preterm birth are poorly understood. In threatened preterm&#xD;
      birth it is difficult to identify the true high risk cases ultimately leading to preterm&#xD;
      birth. These women are often overtreated.&#xD;
&#xD;
      In this study blood samples are taken from women with threatened preterm birth and from women&#xD;
      with normal pregnancies before and during labor.&#xD;
&#xD;
      Differences in clinical characteristics and immunological markers between the groups are&#xD;
      studied in order to design a prediction model for preterm birth.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 2014</start_date>
  <completion_date type="Actual">September 2018</completion_date>
  <primary_completion_date type="Actual">August 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Time of delivery</measure>
    <time_frame>Outcome noted at delivery</time_frame>
    <description>Delivery before 34 weeks of gestation or after 34 weeks of gestation</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">204</enrollment>
  <condition>Preterm Birth</condition>
  <condition>Immunologic Activity Alteration</condition>
  <arm_group>
    <arm_group_label>threatened preterm birth</arm_group_label>
    <description>Women with either preterm labor or preterm prelabor rupture of the membranes. Blood samples taken at time of inclusion in the study.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Controls</arm_group_label>
    <description>Women with normal pregnancies. Blood samples taken at time of inclusion in the study, either prelabor (during pregnancy) or during active phase of labor.</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Plasma samples Serum samples RNA samples Placental biopsies&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        80 women with threatened preterm labor before 34 weeks of gestation, 40 women with preterm&#xD;
        prelabor rupture of the membranes before 34 weeks of gestation, 40 women with normal&#xD;
        pregnancies in labor at term, 44 women with normal pregnancies during pregnancy (before&#xD;
        labor)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Threatened preterm birth before 34 weeks of gestation; either threatened preterm labor&#xD;
             and/or preterm prelabor rupture of the membranes&#xD;
&#xD;
          -  Age &gt; 18 years&#xD;
&#xD;
          -  Swedish-speaking (understanding study information)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Multiple gestation&#xD;
&#xD;
          -  Blood borne infections&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marie Blomberg, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Obstetrics and Gynecology, Linköping University, Linköping, Sweden</affiliation>
  </overall_official>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 7, 2019</study_first_submitted>
  <study_first_submitted_qc>January 7, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 8, 2019</study_first_posted>
  <last_update_submitted>January 7, 2019</last_update_submitted>
  <last_update_submitted_qc>January 7, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 8, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Linkoeping University</investigator_affiliation>
    <investigator_full_name>Marie Blomberg</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Premature Birth</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03796949
org study id: 960624abc
nct id: NCT03796949
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study investigates immunological and clinical markers in threatened preterm birth aiming
      to create a prediction model for preterm birth.
Preterm birth is the main cause of neonatal mortality and morbidity and despite a lot of
      effort the mechanisms leading to preterm birth are poorly understood. In threatened preterm
      birth it is difficult to identify the true high risk cases ultimately leading to preterm
      birth. These women are often overtreated.

      In this study blood samples are taken from women with threatened preterm birth and from women
      with normal pregnancies before and during labor.

      Differences in clinical characteristics and immunological markers between the groups are
      studied in order to design a prediction model for preterm birth.
observational model: Case-Control
time perspective: Prospective
measure: Time of delivery
time frame: Outcome noted at delivery
description: Delivery before 34 weeks of gestation or after 34 weeks of gestation
arm group label: threatened preterm birth
description: Women with either preterm labor or preterm prelabor rupture of the membranes. Blood samples taken at time of inclusion in the study.
arm group label: Controls
description: Women with normal pregnancies. Blood samples taken at time of inclusion in the study, either prelabor (during pregnancy) or during active phase of labor.
Plasma samples Serum samples RNA samples Placental biopsies
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Marie Blomberg, MD PhD
role: Principal Investigator
affiliation: Department of Obstetrics and Gynecology, Linköping University, Linköping, Sweden
responsible party type: Principal Investigator
investigator affiliation: Linkoeping University
investigator full name: Marie Blomberg
investigator title: Professor
mesh term: Premature Birth
sharing ipd: No