xml: <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/NCT06020378</url>
    </required_header>
    <id_info>
      <org_study_id>IIT-2022-0186</org_study_id>
      <nct_id>NCT06020378</nct_id>
    </id_info>
    <brief_title>Hydroxychloroquine May be Beneficial for Preeclampsia</brief_title>
    <official_title>Hydroxychloroquine Treatment During Pregnancy is Associated With Lower Risk of Preeclampsia in Patients With Recurrent Spontaneous Abortion of Unknown Aetiology</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>RenJi Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>RenJi Hospital</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 purpose of this research is to investigate the impact of hydroxychloroquine on the&#xD;
        incidence of hypertensive pregnancy disorders in women with a history of recurrent&#xD;
        spontaneous abortion (RSA).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Preeclampsia affects about 3-5% of all pregnancies and is estimated to cause at least 42 000&#xD;
        maternal deaths annually, remaining an important cause of death and complications for the&#xD;
        mother and baby. However, no treatment yet has been found that affects disease progression&#xD;
        except for termination of pregnancy which may cause iatrogenic preterm labor. Therefore,&#xD;
        keenly sought for approaches to improving clinical outcomes in pre-eclampsia would be needed.&#xD;
  &#xD;
        Hydroxychloroquine (HCQ), an antimalarial drug, is commonly used in the treatment of pregnant&#xD;
        women with RSA and has proven to be safe for both the mother and the fetus. Because of the&#xD;
        antioxidant effect, anti-inflammatory effect, and vasculoprotective effect of HCQ, it has&#xD;
        been thought to be beneficial in the prevention of preeclampsia.&#xD;
  &#xD;
        Therefore, we conducted a retrospective cohort study to evaluate the impact of HCQ treatment&#xD;
        on the prevention of preeclampsia in RSA pregnancies.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">December 1, 2023</start_date>
    <completion_date type="Anticipated">December 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">July 1, 2024</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>Composite morbidity</measure>
      <time_frame>Gestational period</time_frame>
      <description>Preeclampsia, gestational hypertension, preeclampsia superimposed upon chronic hypertension</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>fetal growth restriction</measure>
      <time_frame>37 weeks of gestational age</time_frame>
      <description>&lt;10th percentile for gestational age</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Preterm delivery</measure>
      <time_frame>37 weeks of gestational age</time_frame>
      <description>Delivery before 37 weeks</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Abruptio placenta</measure>
      <time_frame>37 weeks of gestational age</time_frame>
      <description>The number of cases of abruptio placenta that appear in both groups at any given time during pregnancy</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">359</enrollment>
    <condition>Pre-Eclampsia</condition>
    <arm_group>
      <arm_group_label>Hydroxychloroquine treatment group</arm_group_label>
      <description>The Hydroxychloroquine treatment group was defined as having exposure to Hydroxychloroquine during pregnancy.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Hydroxychloroquine nontreatment group</arm_group_label>
      <description>The Hydroxychloroquine nontreatment group was defined as having no exposure to Hydroxychloroquine during pregnancy.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Hydroxychloroquine</intervention_name>
      <description>Hydroxychloroquine was administered during pregnancy</description>
      <arm_group_label>Hydroxychloroquine treatment group</arm_group_label>
      <other_name>Plaquenil</other_name>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          pregnant women with RSA who delivered after 28 weeks from November 2016 to August 2022 at&#xD;
          Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. singleton pregnant women&#xD;
  &#xD;
            2. with a history of two or more miscarriages&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. indication to a treatment according to the severe cardiovascular, immune, respiratory,&#xD;
               gastrointestinal/liver and biliary system, kidney and urinary system, nervous system,&#xD;
               musculoskeletal system, psychiatric, infectious disease, malignancy,&#xD;
  &#xD;
            2. major malformation of the fetus diagnosed at 11-13 weeks of gestation.&#xD;
  &#xD;
            3. Known paternal, maternal, or embryo chromosome abnormality;&#xD;
  &#xD;
            4. Abnormal uterine anatomy at hysterosalpingography/hysteroscopy or hydrosonography that&#xD;
               might explain RM in the first trimester of pregnancy;&#xD;
  &#xD;
            5. Maternal endocrine dysfunction: premature ovarian failure, hyperprolactinemia, corpus&#xD;
               luteal insufficiency, untreated diabetes mellitus or untreated thyroid dysfunction.&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 7, 2023</study_first_submitted>
    <study_first_submitted_qc>August 27, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 31, 2023</study_first_posted>
    <last_update_submitted>August 27, 2023</last_update_submitted>
    <last_update_submitted_qc>August 27, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 31, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </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>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Hydroxychloroquine</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06020378
  org study id: IIT-2022-0186
  nct id: NCT06020378
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of this research is to investigate the impact of hydroxychloroquine on the
        incidence of hypertensive pregnancy disorders in women with a history of recurrent
        spontaneous abortion (RSA).
  Preeclampsia affects about 3-5% of all pregnancies and is estimated to cause at least 42 000
        maternal deaths annually, remaining an important cause of death and complications for the
        mother and baby. However, no treatment yet has been found that affects disease progression
        except for termination of pregnancy which may cause iatrogenic preterm labor. Therefore,
        keenly sought for approaches to improving clinical outcomes in pre-eclampsia would be needed.
  
        Hydroxychloroquine (HCQ), an antimalarial drug, is commonly used in the treatment of pregnant
        women with RSA and has proven to be safe for both the mother and the fetus. Because of the
        antioxidant effect, anti-inflammatory effect, and vasculoprotective effect of HCQ, it has
        been thought to be beneficial in the prevention of preeclampsia.
  
        Therefore, we conducted a retrospective cohort study to evaluate the impact of HCQ treatment
        on the prevention of preeclampsia in RSA pregnancies.
  observational model: Cohort
  time perspective: Retrospective
  measure: Composite morbidity
  time frame: Gestational period
  description: Preeclampsia, gestational hypertension, preeclampsia superimposed upon chronic hypertension
  measure: fetal growth restriction
  time frame: 37 weeks of gestational age
  description: <10th percentile for gestational age
  measure: Preterm delivery
  time frame: 37 weeks of gestational age
  description: Delivery before 37 weeks
  measure: Abruptio placenta
  time frame: 37 weeks of gestational age
  description: The number of cases of abruptio placenta that appear in both groups at any given time during pregnancy
  arm group label: Hydroxychloroquine treatment group
  description: The Hydroxychloroquine treatment group was defined as having exposure to Hydroxychloroquine during pregnancy.
  arm group label: Hydroxychloroquine nontreatment group
  description: The Hydroxychloroquine nontreatment group was defined as having no exposure to Hydroxychloroquine during pregnancy.
  intervention type: Drug
  intervention name: Hydroxychloroquine
  description: Hydroxychloroquine was administered during pregnancy
  arm group label: Hydroxychloroquine treatment group
  other name: Plaquenil
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: Female
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: No
  responsible party type: Sponsor
  mesh term: Pre-Eclampsia
  mesh term: Eclampsia
  mesh term: Hydroxychloroquine
  sharing ipd: Undecided