<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/NCT02255903</url>
  </required_header>
  <id_info>
    <org_study_id>khalid-mohamed</org_study_id>
    <nct_id>NCT02255903</nct_id>
  </id_info>
  <brief_title>Middle Cerebral To Umbilical Artery Doppler Ratio And Amniotic Fluid Volume Measurement In Post-date Pregnancies in King Khalid Military Central City</brief_title>
  <official_title>Middle Cerebral To Umbilical Artery Doppler Ratio And Amniotic Fluid Volume Measurement In Post-date Pregnancies in King Faisal Military Central City</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Benha University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Benha University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to assess the values of MCA PI / UA PI and MCA RI / UA RI ratios and&#xD;
      amniotic fluid volume in predicting the adverse perinatal fetal outcome in uncomplicated&#xD;
      postdate pregnancy&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Study Will be a case-control study that will be conducted at Banha University Hospital&#xD;
      and AFHSR in Saudi Arabia after the approval of Institutional ethical committee. One hundred&#xD;
      pregnant women will be recruited from antenatal clinic. Starting from November 2022. An&#xD;
      informed consent will be obtained from the patients . The patients will be subdivided into&#xD;
      two groups:&#xD;
&#xD;
      Group 1(Control Group):consist of 100 pregnant females with gestational age 37-40 weeks.&#xD;
&#xD;
      Group 2 (post date Group):consist of 100 pregnant females with gestational age 41 weeks or&#xD;
      more.&#xD;
&#xD;
      Inclusion criteria:&#xD;
&#xD;
        1. Singleton, viable fetus in the vertex presentation.&#xD;
&#xD;
        2. History of regular menstrual cycles.&#xD;
&#xD;
        3. Gestational age calculated from the first day of last menstryal period or by&#xD;
           first-trimester or second-trimester (before 20 weeks) ultrasound examination.&#xD;
&#xD;
        4. No obstetric or medical complications of pregnancy apart from post-date pregnancy&#xD;
&#xD;
      All patients will be subjected to:&#xD;
&#xD;
        1. Detailed history: including, personal history, menstural history, obstetric history,&#xD;
           present history and past history.&#xD;
&#xD;
        2. Physical examination: general, abdominal and pelvic examination.&#xD;
&#xD;
        3. Investigations: including, A- Ultrasound examintion for amniotic fluid index (AFI)&#xD;
           measurement.&#xD;
&#xD;
      B- Doppler studies:&#xD;
&#xD;
      i - Middle cerebral artery pulsatility index (MCA -PI) and resistace index(MCA-RI).&#xD;
&#xD;
      ii - Umbilical artery pulsatility index (UA-PI) and resistance index (UA-RI). iii -&#xD;
      Cerebro-Placental ratio (CPR).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Anticipated">February 2022</start_date>
  <completion_date type="Anticipated">August 2023</completion_date>
  <primary_completion_date type="Anticipated">May 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>Adverse pregnancy outcome</measure>
    <time_frame>at time of delivery</time_frame>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Pregnancy, Prolonged</condition>
  <arm_group>
    <arm_group_label>Group 1(Control Group):</arm_group_label>
    <description>ultrasound and Doppler examination: of 100 pregnant females with gestational age 37-40 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2 (post date Group)</arm_group_label>
    <description>ultrasound and Doppler examination:will be done for 100 pregnant females with gestational age 41 weeks or more</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>ultrasound and Doppler examination</intervention_name>
    <description>ultrasound and Doppler examination: Trans-abdominal ultrasound examination will be peformed to all patienst while women in a slightly tilted position with the head of the bed raised 30 degrees and with a small pillow under the right lion</description>
    <arm_group_label>Group 1(Control Group):</arm_group_label>
    <arm_group_label>Group 2 (post date Group)</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Two hundred pregnant women will be recruited from outpatient clinic. Starting from February&#xD;
        2022. An informed consent will be obtained from the patients . The patients will be&#xD;
        subdivided into two groups:&#xD;
&#xD;
        Group 1(Control Group):consist of 100 pregnant females with gestational age 37-40 weeks.&#xD;
&#xD;
        Group 2 (post date Group):consist of 100 pregnant females with gestational age 41 weeks or&#xD;
        more.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Singleton, viable fetus in the vertex presentation&#xD;
&#xD;
          2. History of regular menstrual cycles&#xD;
&#xD;
          3. Gestational age calculated from the first day of last menstryal period or by&#xD;
             first-trimester or second-trimester (before 20 weeks) ultrasound examination&#xD;
&#xD;
          4. No obstetric or medical complications of pregnancy apart from post-date pregnancy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients unsure of their dates&#xD;
&#xD;
          2. Medical disorders with pregnancy as (hypertension, diabetes mellitus or Rh&#xD;
             isoimmunization)&#xD;
&#xD;
          3. Prelabor rupture of membranes&#xD;
&#xD;
          4. Polyhydramnios&#xD;
&#xD;
          5. Women with multiple pregnancy&#xD;
&#xD;
          6. Congenital fetal anomalies&#xD;
&#xD;
          7. Antepartum hemorrhage&#xD;
&#xD;
          8. Previus cesarean section&#xD;
&#xD;
          9. Fetal malpresentation&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>48 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>khalid ibrahim, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Armed Forces Hospitals, Southern Region, Saudi Arabia</affiliation>
  </overall_official>
  <overall_official>
    <last_name>KHALID IBRAHIM, MD</last_name>
    <role>Study Director</role>
    <affiliation>Armed Forces Hospitals, Southern Region, Saudi Arabia</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>khalid Ibrahim, MD</last_name>
    <phone>201281469651</phone>
    <email>dr.khalidkhader77@yahoo.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>KHALID IBRAHIM, MD</last_name>
    <phone>966596984055</phone>
  </overall_contact_backup>
  <location>
    <facility>
      <name>AFHSR</name>
      <address>
        <city>Khamis Mushait</city>
        <state>Afhsa</state>
        <zip>10018</zip>
        <country>Saudi Arabia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>khalid ibrahum, MD</last_name>
      <phone>201281469651</phone>
      <email>dr.khalidkhader77@yahoo.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Saudi Arabia</country>
  </location_countries>
  <removed_countries>
    <country>Egypt</country>
  </removed_countries>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>September 26, 2014</study_first_submitted>
  <study_first_submitted_qc>September 30, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 3, 2014</study_first_posted>
  <last_update_submitted>January 30, 2022</last_update_submitted>
  <last_update_submitted_qc>January 30, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 14, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Benha University</investigator_affiliation>
    <investigator_full_name>khalid abd aziz mohamed</investigator_full_name>
    <investigator_title>lecturer and consultant of oblgyne</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pregnancy, Prolonged</mesh_term>
  </condition_browse>
  <!-- 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/NCT02255903
org study id: khalid-mohamed
nct id: NCT02255903
lead sponsor: 
has dmc: No
The aim of this study is to assess the values of MCA PI / UA PI and MCA RI / UA RI ratios and
      amniotic fluid volume in predicting the adverse perinatal fetal outcome in uncomplicated
      postdate pregnancy
The Study Will be a case-control study that will be conducted at Banha University Hospital
      and AFHSR in Saudi Arabia after the approval of Institutional ethical committee. One hundred
      pregnant women will be recruited from antenatal clinic. Starting from November 2022. An
      informed consent will be obtained from the patients . The patients will be subdivided into
      two groups:

      Group 1(Control Group):consist of 100 pregnant females with gestational age 37-40 weeks.

      Group 2 (post date Group):consist of 100 pregnant females with gestational age 41 weeks or
      more.

      Inclusion criteria:

        1. Singleton, viable fetus in the vertex presentation.

        2. History of regular menstrual cycles.

        3. Gestational age calculated from the first day of last menstryal period or by
           first-trimester or second-trimester (before 20 weeks) ultrasound examination.

        4. No obstetric or medical complications of pregnancy apart from post-date pregnancy

      All patients will be subjected to:

        1. Detailed history: including, personal history, menstural history, obstetric history,
           present history and past history.

        2. Physical examination: general, abdominal and pelvic examination.

        3. Investigations: including, A- Ultrasound examintion for amniotic fluid index (AFI)
           measurement.

      B- Doppler studies:

      i - Middle cerebral artery pulsatility index (MCA -PI) and resistace index(MCA-RI).

      ii - Umbilical artery pulsatility index (UA-PI) and resistance index (UA-RI). iii -
      Cerebro-Placental ratio (CPR).
observational model: Case-Control
time perspective: Prospective
measure: Adverse pregnancy outcome
time frame: at time of delivery
arm group label: Group 1(Control Group):
description: ultrasound and Doppler examination: of 100 pregnant females with gestational age 37-40 weeks.
arm group label: Group 2 (post date Group)
description: ultrasound and Doppler examination:will be done for 100 pregnant females with gestational age 41 weeks or more
intervention type: Other
intervention name: ultrasound and Doppler examination
description: ultrasound and Doppler examination: Trans-abdominal ultrasound examination will be peformed to all patienst while women in a slightly tilted position with the head of the bed raised 30 degrees and with a small pillow under the right lion
arm group label: Group 1(Control Group):
arm group label: Group 2 (post date Group)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 19 Years
maximum age: 48 Years
healthy volunteers: No
last name: khalid ibrahim, MD
role: Study Chair
affiliation: Armed Forces Hospitals, Southern Region, Saudi Arabia
last name: KHALID IBRAHIM, MD
role: Study Director
affiliation: Armed Forces Hospitals, Southern Region, Saudi Arabia
last name: khalid Ibrahim, MD
phone: 201281469651
email: dr.khalidkhader77@yahoo.com
last name: KHALID IBRAHIM, MD
phone: 966596984055
facility: 
status: Recruiting
contact: 
country: Saudi Arabia
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Benha University
investigator full name: khalid abd aziz mohamed
investigator title: lecturer and consultant of oblgyne
mesh term: Pregnancy, Prolonged