<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/NCT02992145</url>
  </required_header>
  <id_info>
    <org_study_id>AinShams MH 01</org_study_id>
    <nct_id>NCT02992145</nct_id>
  </id_info>
  <brief_title>Androgens Level in the Third Trimester of Pregnancy in Patients With Preeclampsia</brief_title>
  <official_title>Androgens Level in the Third Trimester of Pregnancy in Patients With Preeclampsia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ain Shams Maternity Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ain Shams Maternity Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to compare between androgens level (serum total and free testosterone) in&#xD;
      women with preeclampsia and normal ones in the third trimester of pregnancy (28-40 weeks).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Methodology:&#xD;
&#xD;
      All women in this study will be subjected to:&#xD;
&#xD;
        -  All women are candidates for this study according to inclusion and exclusion criteria.&#xD;
&#xD;
        -  History taking with special emphases on last menstrual period to determine the exact&#xD;
           Gestational age.&#xD;
&#xD;
        -  A reliable date is defined as the occurrence of regular menstrual cycles (28±7 days) in&#xD;
           patients who have not taken oral contraceptives during the three months before&#xD;
           conception and have no irregular bleeding.&#xD;
&#xD;
        -  General and abdominal examination for each patient to determine those patients matching&#xD;
           with the inclusion criteria.&#xD;
&#xD;
        -  Preeclampsia refers to the new onset of hypertension (systolic blood pressure ≥140 mmHg&#xD;
           ,or diastolic blood pressure≥ 90 mmHg ,or both, measured on two occasions &gt; 6 hours&#xD;
           apart) and either proteinuria or end organ dysfunction after 20 weeks of gestation in a&#xD;
           previously normotensive woman.&#xD;
&#xD;
        -  At Ain Shams University Hospitals, the investigator will use ELISA based test system&#xD;
           intended for the quantitative measurement of total and free testosterone for patients of&#xD;
           both groups.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 2016</start_date>
  <completion_date type="Actual">December 2016</completion_date>
  <primary_completion_date type="Actual">December 2016</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Total and free testosterone level</measure>
    <time_frame>9 months</time_frame>
    <description>Higher in preeclamptic patients than normal pregnant ladies</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">80</enrollment>
  <condition>Pre-Eclampsia</condition>
  <arm_group>
    <arm_group_label>Case group: This group will include forty (40) preeclampt</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group: This group will include forty (40) normoten</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Study Site:&#xD;
&#xD;
        Ain Shams University Maternity Hospital&#xD;
&#xD;
        Study Design:&#xD;
&#xD;
        This study is a case control study.&#xD;
&#xD;
        Study Population:&#xD;
&#xD;
        Patients will be divided into two groups:&#xD;
&#xD;
        Case group:&#xD;
&#xD;
        This group will include forty (40) preeclamptic patients at the third trimester (28-40&#xD;
        weeks) admitted at Ain Shams University Maternity Hospital.&#xD;
&#xD;
        Control group:&#xD;
&#xD;
        This group will include forty (40) normotensive pregnant women at term admitted at Ain&#xD;
        Shams University Maternity Hospital.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Pregnant women (primigravidas) at third trimester i.e. 28-40 weeks.&#xD;
&#xD;
          2. Age between 20 and 35 years old.&#xD;
&#xD;
          3. Live fetus.&#xD;
&#xD;
          4. Having no history of pregestational hypertension.&#xD;
&#xD;
          5. Having no history of diseases associated with hormone disorders (thyroid gland&#xD;
             disorders, DM, hyperprolactinemia or polycystic ovary syndrome).&#xD;
&#xD;
          6. During their pregnancy they did not receive antihypertensive medications.&#xD;
&#xD;
          7. Nonsmoker.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  1- First and second trimester pregnant women. 2- Women younger than 20 years old and&#xD;
             older than 35 years old 3- Intrauterine fetal death. 4- History of pregestational&#xD;
             hypertension. 5- History of hormonal disorders (thyroid gland disorders and&#xD;
             hyperprolactinemia).&#xD;
&#xD;
             6- Smoker. 7- Polycystic ovary syndrome. 8- Signs or symptoms of hyper-androgenism&#xD;
             (hirsutism, acne, oily skin, etc.). 9- Diabetes mellitus. 10- Drug use except ordinary&#xD;
             supplementation (iron, folic acid).&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Noha H Rabei, Professor of Obs&amp;Gyn</last_name>
    <role>Study Chair</role>
    <affiliation>Ain Shams Maternity Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Malames M Faisal, Lecturer of Obs&amp;Gyna</last_name>
    <role>Study Director</role>
    <affiliation>Ain Shams Maternity Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Hoda E Abd elwahab, Fellow of medical tests</last_name>
    <role>Study Director</role>
    <affiliation>Ain Shams Hospitals</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ain Shams Maternity Hospital-Faculty of Medicine- Ain Shams University</name>
      <address>
        <city>Cairo Governorate</city>
        <state>Cairo</state>
        <zip>00202</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <results_reference>
    <citation>https://www.ncbi.nlm.nih.gov/pubmed/12746983</citation>
  </results_reference>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 12, 2016</study_first_submitted>
  <study_first_submitted_qc>December 12, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 14, 2016</study_first_posted>
  <last_update_submitted>December 15, 2016</last_update_submitted>
  <last_update_submitted_qc>December 15, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 16, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ain Shams Maternity Hospital</investigator_affiliation>
    <investigator_full_name>Ahmed Ismail Ahmed Mohamed</investigator_full_name>
    <investigator_title>Obstetrics and gynaecology resident</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/NCT02992145
org study id: AinShams MH 01
nct id: NCT02992145
lead sponsor: 
has dmc: Yes
This study aims to compare between androgens level (serum total and free testosterone) in
      women with preeclampsia and normal ones in the third trimester of pregnancy (28-40 weeks).
Methodology:

      All women in this study will be subjected to:

        -  All women are candidates for this study according to inclusion and exclusion criteria.

        -  History taking with special emphases on last menstrual period to determine the exact
           Gestational age.

        -  A reliable date is defined as the occurrence of regular menstrual cycles (28±7 days) in
           patients who have not taken oral contraceptives during the three months before
           conception and have no irregular bleeding.

        -  General and abdominal examination for each patient to determine those patients matching
           with the inclusion criteria.

        -  Preeclampsia refers to the new onset of hypertension (systolic blood pressure ≥140 mmHg
           ,or diastolic blood pressure≥ 90 mmHg ,or both, measured on two occasions > 6 hours
           apart) and either proteinuria or end organ dysfunction after 20 weeks of gestation in a
           previously normotensive woman.

        -  At Ain Shams University Hospitals, the investigator will use ELISA based test system
           intended for the quantitative measurement of total and free testosterone for patients of
           both groups.
observational model: Case-Control
time perspective: Retrospective
measure: Total and free testosterone level
time frame: 9 months
description: Higher in preeclamptic patients than normal pregnant ladies
arm group label: Case group: This group will include forty (40) preeclampt
arm group label: Control group: This group will include forty (40) normoten
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 20 Years
maximum age: 35 Years
healthy volunteers: No
last name: Noha H Rabei, Professor of Obs&Gyn
role: Study Chair
affiliation: Ain Shams Maternity Hospital
last name: Malames M Faisal, Lecturer of Obs&Gyna
role: Study Director
affiliation: Ain Shams Maternity Hospital
last name: Hoda E Abd elwahab, Fellow of medical tests
role: Study Director
affiliation: Ain Shams Hospitals
facility: 
country: Egypt
citation: https://www.ncbi.nlm.nih.gov/pubmed/12746983
responsible party type: Principal Investigator
investigator affiliation: Ain Shams Maternity Hospital
investigator full name: Ahmed Ismail Ahmed Mohamed
investigator title: Obstetrics and gynaecology resident
mesh term: Pre-Eclampsia
mesh term: Eclampsia
sharing ipd: Undecided