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/NCT05986357</url>
    </required_header>
    <id_info>
      <org_study_id>C reactive protein abortion</org_study_id>
      <nct_id>NCT05986357</nct_id>
    </id_info>
    <brief_title>The Relation of High Sensitivity C Reactive Protein and Total Leucocytic Count Levels in Threatened Abortion</brief_title>
    <official_title>The Relation Between Maternal Serum High Sensitivity C Reactive Protein and Total and Differential Leucocytic Count Levels in Healthy Pregnant Women With Threatened Abortion and the Outcome of Pregnancy</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Beni-Suef University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Beni-Suef University</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>
        to identify the relation between maternal serum high sensitivity C reactive protein and total&#xD;
        and differential leucocytic count values in healthy pregnant women with threatened abortion&#xD;
        and the outcome of pregnancy&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        observational prospective cohort research will be pregnant women attending to obstetrics and&#xD;
        gynecology department of University Hospital. After enrollment, participants will be divided&#xD;
        into two groups:&#xD;
  &#xD;
          -  Study group: had 120 healthy women presenting with threatened miscarriage.&#xD;
  &#xD;
          -  Control group: had 120 healthy women with an uncomplicated single pregnancy. informed&#xD;
             permission will be obtained. All cases subjected to the following: taking complete&#xD;
             history, General examination, Special investigations including Obstetric ultrasonography&#xD;
             for assessment of gestational age, and exclusion of congenital anomalies or multi-fetal&#xD;
             gestation. Laboratory investigations including Estimation of the complete blood picture&#xD;
             (CBC), Highly sensitive CRP (HS-CRP) single measurement, Women over 1st trimester&#xD;
             abdominal ultrasonographic examination (6-13weeks) using Toshiba with transabdominal&#xD;
             transducer probe frequency of 7 MHz to evaluate the following data: Measuring of the&#xD;
             fetal crown-rump length (CRL) done to confirm the fetal gestational age and the&#xD;
             viability of the fetus. Gestational age will be calculated from the beginning of the&#xD;
             last regular menstrual cycle. Women who had hormone therapy or progesterone supplements,&#xD;
             as well as pregnancies with a discrepancy between LMP and crown rump length of more than&#xD;
             three days, were excluded from the research.&#xD;
  &#xD;
        Pregnant women will be under close follow up every 2 weeks by: Obstetric U/S, Measure blood&#xD;
        pressure and inform us if severe bleeding occurs.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">July 30, 2023</start_date>
    <completion_date type="Anticipated">October 30, 2023</completion_date>
    <primary_completion_date type="Anticipated">October 30, 2023</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>Highly sensitive CRP (HS-CRP)</measure>
      <time_frame>9 months</time_frame>
      <description>A high level of hs-CRP, i.e., greater than 3 mg/L,</description>
    </primary_outcome>
    <primary_outcome>
      <measure>total leucocytic count</measure>
      <time_frame>9 months</time_frame>
      <description>measures the number of white blood cells (WBCs) in blood</description>
    </primary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">240</enrollment>
    <condition>Abortion Early</condition>
    <arm_group>
      <arm_group_label>Study group</arm_group_label>
      <description>120 healthy women presenting with threatened miscarriage.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control group</arm_group_label>
      <description>120 healthy women with an uncomplicated single pregnancy.</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>maternal serum C reactive protein</intervention_name>
      <description>maternal serum high sensitivity C reactive protein</description>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_label>Study group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>total leucocytic count levels</intervention_name>
      <description>total leucocytic count levels</description>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_label>Study group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>differential leucocytic count levels</intervention_name>
      <description>differential leucocytic count levels</description>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_label>Study group</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Single intrauterine pregnancy with vaginal hemorrhage and/or abdominal pain in the study&#xD;
          group, an ultrasound showing an intrauterine gestational sac with a live fetus and a&#xD;
          regular fetal heartbeat, with/without a sub-chorionic hematoma, and healthy women who come&#xD;
          for routine antenatal care with spontaneous pregnancy.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Single intrauterine pregnancy with vaginal hemorrhage and/or abdominal pain in the&#xD;
               study group,&#xD;
  &#xD;
            -  an ultrasound showing an intrauterine gestational sac with a live fetus and a regular&#xD;
               fetal heartbeat, with/without a sub-chorionic hematoma,&#xD;
  &#xD;
            -  healthy women who come for routine antenatal care with spontaneous pregnancy.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Age over 40&#xD;
  &#xD;
            -  smoking&#xD;
  &#xD;
            -  multiple pregnancies&#xD;
  &#xD;
            -  endocrinological diseases&#xD;
  &#xD;
            -  history of repeated spontaneous abortions.&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>40 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Beni-suef University</last_name>
      <phone>082 2318605</phone>
      <phone_ext>02</phone_ext>
      <email>fom@med.bsu.edu.eg</email>
    </overall_contact>
    <location>
      <facility>
        <name>Beni-suef university Hospital</name>
        <address>
          <city>Banī Suwayf</city>
          <state>Beni Suef</state>
          <zip>62521</zip>
          <country>Egypt</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 25, 2023</study_first_submitted>
    <study_first_submitted_qc>August 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 1, 2023</last_update_submitted>
    <last_update_submitted_qc>August 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Beni-Suef University</investigator_affiliation>
      <investigator_full_name>Sara Abdallah Mohamed Salem</investigator_full_name>
      <investigator_title>principle investigator/Lecturer of Gynecology and obstetrics Faculty of medicine Beni-Suef University</investigator_title>
    </responsible_party>
    <keyword>C reactive protein</keyword>
    <keyword>total and differential leucocytic count</keyword>
    <keyword>abortion</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Abortion, Threatened</mesh_term>
    </condition_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/NCT05986357
  org study id: C reactive protein abortion
  nct id: NCT05986357
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  to identify the relation between maternal serum high sensitivity C reactive protein and total
        and differential leucocytic count values in healthy pregnant women with threatened abortion
        and the outcome of pregnancy
  observational prospective cohort research will be pregnant women attending to obstetrics and
        gynecology department of University Hospital. After enrollment, participants will be divided
        into two groups:
  
          -  Study group: had 120 healthy women presenting with threatened miscarriage.
  
          -  Control group: had 120 healthy women with an uncomplicated single pregnancy. informed
             permission will be obtained. All cases subjected to the following: taking complete
             history, General examination, Special investigations including Obstetric ultrasonography
             for assessment of gestational age, and exclusion of congenital anomalies or multi-fetal
             gestation. Laboratory investigations including Estimation of the complete blood picture
             (CBC), Highly sensitive CRP (HS-CRP) single measurement, Women over 1st trimester
             abdominal ultrasonographic examination (6-13weeks) using Toshiba with transabdominal
             transducer probe frequency of 7 MHz to evaluate the following data: Measuring of the
             fetal crown-rump length (CRL) done to confirm the fetal gestational age and the
             viability of the fetus. Gestational age will be calculated from the beginning of the
             last regular menstrual cycle. Women who had hormone therapy or progesterone supplements,
             as well as pregnancies with a discrepancy between LMP and crown rump length of more than
             three days, were excluded from the research.
  
        Pregnant women will be under close follow up every 2 weeks by: Obstetric U/S, Measure blood
        pressure and inform us if severe bleeding occurs.
  observational model: Case-Control
  time perspective: Prospective
  measure: Highly sensitive CRP (HS-CRP)
  time frame: 9 months
  description: A high level of hs-CRP, i.e., greater than 3 mg/L,
  measure: total leucocytic count
  time frame: 9 months
  description: measures the number of white blood cells (WBCs) in blood
  arm group label: Study group
  description: 120 healthy women presenting with threatened miscarriage.
  arm group label: Control group
  description: 120 healthy women with an uncomplicated single pregnancy.
  intervention type: Diagnostic Test
  intervention name: maternal serum C reactive protein
  description: maternal serum high sensitivity C reactive protein
  arm group label: Control group
  arm group label: Study group
  intervention type: Diagnostic Test
  intervention name: total leucocytic count levels
  description: total leucocytic count levels
  arm group label: Control group
  arm group label: Study group
  intervention type: Diagnostic Test
  intervention name: differential leucocytic count levels
  description: differential leucocytic count levels
  arm group label: Control group
  arm group label: Study group
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: 40 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Beni-suef University
  phone: 082 2318605
  phone ext: 02
  email: fom@med.bsu.edu.eg
  facility: 
  country: Egypt
  responsible party type: Principal Investigator
  investigator affiliation: Beni-Suef University
  investigator full name: Sara Abdallah Mohamed Salem
  investigator title: principle investigator/Lecturer of Gynecology and obstetrics Faculty of medicine Beni-Suef University
  mesh term: Abortion, Threatened
  sharing ipd: Undecided