<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/NCT02982265</url>
  </required_header>
  <id_info>
    <org_study_id>Reg. 2016/0161</org_study_id>
    <nct_id>NCT02982265</nct_id>
  </id_info>
  <brief_title>Pre-eclampsia/Eclampsia in Italy Over the Years 2010-2016</brief_title>
  <official_title>&quot;Pre-eclampsia/Eclampsia in Italy Over the Years 2010-2016&quot; Retrospective Observational Multicenter Study Carried Out Through an On-line Self-administered Questionnaire</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Papa Giovanni XXIII Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Papa Giovanni XXIII Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Pre-eclampsia is a heterogeneous multisystem disorder that complicates 2-8% of pregnancies&#xD;
      and remains a leading cause of maternal and perinatal mortality and morbidity.&#xD;
&#xD;
      Pre-eclampsia is defined as new onset of hypertension (defined as a diastolic blood pressure&#xD;
      ≥ 90 mm Hg and a systolic blood pressure ≥ 140 mmHg on at least two different recordings&#xD;
      taken at least 4-6 h apart and less than 7 days apart, using an appropriate cuff) and&#xD;
      substantial proteinuria (defined as excretion of protein ≥300 mg in 24 h or a protein&#xD;
      concentration ≥ 300 mg/L or ≥ &quot;1 +&quot; on dipstick in at least two random urine samples taken at&#xD;
      least 4-6 h apart but no more than 7 days apart) at or after 20 weeks of gestation.&#xD;
&#xD;
      Pre-eclampsia only occurs in the presence of placenta and is resolved by delivery of the&#xD;
      same. However, the underlying causes of the disease remain largely unknown.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Poor placentation is considered a powerful predisposing factor for pre-eclampsia. Recently,&#xD;
      it has been suggested that the occurrence of pre-eclampsia requires a combination of an&#xD;
      excessive or atypical maternal immune response to the trophoblast and/or exaggerated&#xD;
      endothelial activation as well as a generalised hyper-inflammatory state resulting in&#xD;
      endothelial dysfunction and associated increased vascular reactivity. Any factors (maternal&#xD;
      and paternal constitutional, genetic and environmental risk factors) that enhance these&#xD;
      responses would predispose to pre-eclampsia.&#xD;
&#xD;
      The list of predisposing factors includes: extremes of maternal age, black race, previous&#xD;
      history of pre-eclampsia, family history of pre-eclampsia, multifetal gestation, ≥ 10 years&#xD;
      from previous pregnancy, limited sperm exposure, first paternity, pregnancies after donor&#xD;
      insemination (assisted reproductive technology), oocyte donation or embryo donation, chronic&#xD;
      hypertension or renal disease, rheumatic disease, maternal low birth weight, obesity and&#xD;
      insulin resistance, pre-gestational diabetes mellitus, increased testosterone, increased&#xD;
      homocysteine concentration, atherosclerosis (increased triglycerides and LDL, decreased HDL),&#xD;
      maternal infections, pre-existing thrombophilia, maternal susceptibility genes and hydropic&#xD;
      degeneration of placenta. Finally, smoking seems to be inversely correlated with&#xD;
      pre-eclampsia.&#xD;
&#xD;
      Pre-eclampsia can result in a fetal syndrome characterized by fetal growth restriction,&#xD;
      reduced amniotic fluid, abnormal oxygenation, fetal demise and preterm birth. Moreover, women&#xD;
      with pre-eclampsia are at increased risk for abruptio placentae, disseminated&#xD;
      coagulopathy/HELLP syndrome, pulmonary oedema, acute renal failure, eclampsia, cerebral&#xD;
      haemorrhage, death and cardiovascular or renal disease.&#xD;
&#xD;
      Early prediction of pre-eclampsia would allow for close surveillance and preventive&#xD;
      strategies&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2016</start_date>
  <completion_date type="Actual">January 2020</completion_date>
  <primary_completion_date type="Actual">January 2020</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <target_duration>3 Months</target_duration>
  <primary_outcome>
    <measure>Incidence of preeclampsia/eclampsia in Italy</measure>
    <time_frame>Three months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Aggregation of predisposing factors to pre-eclampsia / eclampsia in Italy measured by a novel multiple choice on-line questionnaire</measure>
    <time_frame>Three months</time_frame>
    <description>Either, or maternal and paternal: extremes of age (years), extremes of weight (BMI in kg/m2), blood group, ethnic group, level of education (primary, secondary or academic), cardiovascular predisposing factors (hypertension defined as over 140/90 mmHg BP, diabetes mellitus defined as fasting glycemia over 126 mg/dl or over 200mg/dl in a glucose tolerance test, hypercholesterolemia defined as LDL over 240mg/dl, hyperhomocysteinemia defined as homocysteinemia over 15 mol/l, cigarette smoking), family history of pre-eclampsia/eclampsia and/or of cardiovascular predisposing factors (as above), presence of rheumatological and/or immunological disorders, pre-existing thrombophilia.&#xD;
Maternal only: history of pre-eclampsia, over 10 years from last pregnancy, multiple partners, assisted reproductive technology (ART), oocyte or embryo donation, weight at term (Kg).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Maternal outcomes measured by a novel multiple choice on-line questionnaire</measure>
    <time_frame>Three months</time_frame>
    <description>gestational week at term; gestational diabetes (defined as fasting plasma glucose level over 126 mg/dl or a fasting glycemia over 92 mg/dl and a 1-hour glycemia over 180 mg/dl and a 2-hour glycemia over 153 mg/dL in the 75 g oral glucose tolerance test), hypertension (defined as a diastolic blood pressure ≥ 90 mm Hg and a systolic blood pressure ≥ 140 mmHg on at least two different recordings taken at least 4-6 h apart and less than 7 days apart, using an appropriate cuff) and/or kidney failure (defined by the abrupt loss of kidney function; a serum creatinine concentration above 0.8 mg/dL during pregnancy may indicate an underlying renal dysfunction) resolved after childbirth or within 3 months from delivery or over 3 months from delivery or current.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fetal outcomes measured by a novel multiple choice on-line questionnaire</measure>
    <time_frame>Three months</time_frame>
    <description>weight at birth (grams), blood group when tested, abortion</description>
  </secondary_outcome>
  <enrollment type="Actual">1527</enrollment>
  <condition>Preeclampsia/Eclampsia</condition>
  <eligibility>
    <study_pop>
      <textblock>
        -  Women discharged from the enrolling Centres with a diagnosis of preeclampsia and/or&#xD;
             eclampsia over the years 2010-2016, identified by the ICD-9-CM codes 642.4 to 642.44,&#xD;
             642.5 to 642.54, 642.6 to 642.64 and 642.7 to 642.74.&#xD;
&#xD;
          -  Fathers&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Ability to read and understand the Italian language and fill in the questionnaire,&#xD;
             including access to the Internet.&#xD;
&#xD;
          -  Ability of both parents to give informed consent to the processing of personal data,&#xD;
             with the understanding that the consent could be withdrawn at any time&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to reach the patients by telephone and inform them about the study&#xD;
&#xD;
          -  Death or incapacitating illness of one or both parents following discharge from&#xD;
             hospital&#xD;
&#xD;
          -  Refusal of one or both parents to disclose their email address&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Chiara Viviani, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>ASST Papa Giovanni XXIII, Bergamo, Italy</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Asst Papa Giovanni Xxiii</name>
      <address>
        <city>Bergamo</city>
        <zip>24127</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>November 14, 2016</study_first_submitted>
  <study_first_submitted_qc>November 30, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 5, 2016</study_first_posted>
  <last_update_submitted>March 3, 2020</last_update_submitted>
  <last_update_submitted_qc>March 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Papa Giovanni XXIII Hospital</investigator_affiliation>
    <investigator_full_name>Chiara Viviani</investigator_full_name>
    <investigator_title>Dr</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pre-Eclampsia</mesh_term>
    <mesh_term>Eclampsia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT02982265
org study id: Reg. 2016/0161
nct id: NCT02982265
lead sponsor: 
has dmc: No
Pre-eclampsia is a heterogeneous multisystem disorder that complicates 2-8% of pregnancies
      and remains a leading cause of maternal and perinatal mortality and morbidity.

      Pre-eclampsia is defined as new onset of hypertension (defined as a diastolic blood pressure
      ≥ 90 mm Hg and a systolic blood pressure ≥ 140 mmHg on at least two different recordings
      taken at least 4-6 h apart and less than 7 days apart, using an appropriate cuff) and
      substantial proteinuria (defined as excretion of protein ≥300 mg in 24 h or a protein
      concentration ≥ 300 mg/L or ≥ "1 +" on dipstick in at least two random urine samples taken at
      least 4-6 h apart but no more than 7 days apart) at or after 20 weeks of gestation.

      Pre-eclampsia only occurs in the presence of placenta and is resolved by delivery of the
      same. However, the underlying causes of the disease remain largely unknown.
Poor placentation is considered a powerful predisposing factor for pre-eclampsia. Recently,
      it has been suggested that the occurrence of pre-eclampsia requires a combination of an
      excessive or atypical maternal immune response to the trophoblast and/or exaggerated
      endothelial activation as well as a generalised hyper-inflammatory state resulting in
      endothelial dysfunction and associated increased vascular reactivity. Any factors (maternal
      and paternal constitutional, genetic and environmental risk factors) that enhance these
      responses would predispose to pre-eclampsia.

      The list of predisposing factors includes: extremes of maternal age, black race, previous
      history of pre-eclampsia, family history of pre-eclampsia, multifetal gestation, ≥ 10 years
      from previous pregnancy, limited sperm exposure, first paternity, pregnancies after donor
      insemination (assisted reproductive technology), oocyte donation or embryo donation, chronic
      hypertension or renal disease, rheumatic disease, maternal low birth weight, obesity and
      insulin resistance, pre-gestational diabetes mellitus, increased testosterone, increased
      homocysteine concentration, atherosclerosis (increased triglycerides and LDL, decreased HDL),
      maternal infections, pre-existing thrombophilia, maternal susceptibility genes and hydropic
      degeneration of placenta. Finally, smoking seems to be inversely correlated with
      pre-eclampsia.

      Pre-eclampsia can result in a fetal syndrome characterized by fetal growth restriction,
      reduced amniotic fluid, abnormal oxygenation, fetal demise and preterm birth. Moreover, women
      with pre-eclampsia are at increased risk for abruptio placentae, disseminated
      coagulopathy/HELLP syndrome, pulmonary oedema, acute renal failure, eclampsia, cerebral
      haemorrhage, death and cardiovascular or renal disease.

      Early prediction of pre-eclampsia would allow for close surveillance and preventive
      strategies
observational model: Cohort
time perspective: Other
measure: Incidence of preeclampsia/eclampsia in Italy
time frame: Three months
measure: Aggregation of predisposing factors to pre-eclampsia / eclampsia in Italy measured by a novel multiple choice on-line questionnaire
time frame: Three months
description: Either, or maternal and paternal: extremes of age (years), extremes of weight (BMI in kg/m2), blood group, ethnic group, level of education (primary, secondary or academic), cardiovascular predisposing factors (hypertension defined as over 140/90 mmHg BP, diabetes mellitus defined as fasting glycemia over 126 mg/dl or over 200mg/dl in a glucose tolerance test, hypercholesterolemia defined as LDL over 240mg/dl, hyperhomocysteinemia defined as homocysteinemia over 15 mol/l, cigarette smoking), family history of pre-eclampsia/eclampsia and/or of cardiovascular predisposing factors (as above), presence of rheumatological and/or immunological disorders, pre-existing thrombophilia.
Maternal only: history of pre-eclampsia, over 10 years from last pregnancy, multiple partners, assisted reproductive technology (ART), oocyte or embryo donation, weight at term (Kg).
measure: Maternal outcomes measured by a novel multiple choice on-line questionnaire
time frame: Three months
description: gestational week at term; gestational diabetes (defined as fasting plasma glucose level over 126 mg/dl or a fasting glycemia over 92 mg/dl and a 1-hour glycemia over 180 mg/dl and a 2-hour glycemia over 153 mg/dL in the 75 g oral glucose tolerance test), hypertension (defined as a diastolic blood pressure ≥ 90 mm Hg and a systolic blood pressure ≥ 140 mmHg on at least two different recordings taken at least 4-6 h apart and less than 7 days apart, using an appropriate cuff) and/or kidney failure (defined by the abrupt loss of kidney function; a serum creatinine concentration above 0.8 mg/dL during pregnancy may indicate an underlying renal dysfunction) resolved after childbirth or within 3 months from delivery or over 3 months from delivery or current.
measure: Fetal outcomes measured by a novel multiple choice on-line questionnaire
time frame: Three months
description: weight at birth (grams), blood group when tested, abortion
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Chiara Viviani, M.D.
role: Principal Investigator
affiliation: ASST Papa Giovanni XXIII, Bergamo, Italy
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: Papa Giovanni XXIII Hospital
investigator full name: Chiara Viviani
investigator title: Dr
mesh term: Pre-Eclampsia
mesh term: Eclampsia
sharing ipd: Undecided