<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/NCT03264599</url>
  </required_header>
  <id_info>
    <org_study_id>12</org_study_id>
    <nct_id>NCT03264599</nct_id>
  </id_info>
  <brief_title>Measurement of the Fetal Occiput-spine Angle During the First Stage of Labor as Predictor of the Outcome of Labor</brief_title>
  <official_title>Measurement of the Fetal Occiput-spine Angle During the First Stage of Labor as Predictor of the Maternal and Fetal Outcome of Labor</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      2D trans abdominal ultrasound was done during the first stage of labor. If fetal position is&#xD;
      occiput anterior and fetal presentation is vertex, two dimensional sagittal picture of the&#xD;
      fetal head and upper spine was acquired and stored in the ultrasound machine. On this image,&#xD;
      the offline measurement of the angle formed by a line tangential to the occipital bone and a&#xD;
      line tangential to the first vertebral body of the cervical spine (occiput-spine angle) will&#xD;
      be performed to quantify the degree of fetal head flexion in respect to the trunk&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      2D trans abdominal ultrasound was done during the first stage of labor. If fetal position is&#xD;
      occiput anterior and fetal presentation is vertex, two dimensional sagittal picture of the&#xD;
      fetal head and upper spine was acquired and stored in the ultrasound machine. On this image,&#xD;
      the offline measurement of the angle formed by a line tangential to the occipital bone and a&#xD;
      line tangential to the first vertebral body of the cervical spine (occiput-spine angle) will&#xD;
      be performed to quantify the degree of fetal head flexion in respect to the trunk.&#xD;
&#xD;
      The sonographer was not involved in the patient's care and the managing obstetrician was&#xD;
      blinded to the ultrasound findings and the occiput-spine angle. For each patient of the study&#xD;
      group, the progress of labor using a partogram ( cervical dilation ,effacement ,consistency,&#xD;
      position and station ) and the mode of delivery were assessed retrospectively.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 11, 2016</start_date>
  <completion_date type="Actual">August 20, 2017</completion_date>
  <primary_completion_date type="Actual">July 21, 2017</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>vaginal delivery</measure>
    <time_frame>24 hours</time_frame>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">400</enrollment>
  <condition>Vaginal Delivery</condition>
  <arm_group>
    <arm_group_label>occiput-spine angle &gt; or = 126</arm_group_label>
    <description>2D trans abdominal ultrasound was done during the first stage of labor. If fetal position is occiput anterior and fetal presentation is vertex, two dimensional sagittal picture of the fetal head and upper spine was acquired and stored in the ultrasound machine. On this image, the offline measurement of the angle formed by a line tangential to the occipital bone and a line tangential to the first vertebral body of the cervical spine (occiput-spine angle &gt; or = 126) will be performed to quantify the degree of fetal head flexion in respect to the trunk</description>
  </arm_group>
  <arm_group>
    <arm_group_label>occiput-spine angle&lt;126</arm_group_label>
    <description>2D trans abdominal ultrasound was done during the first stage of labor. If fetal position is occiput anterior and fetal presentation is vertex, two dimensional sagittal picture of the fetal head and upper spine was acquired and stored in the ultrasound machine. On this image, the offline measurement of the angle formed by a line tangential to the occipital bone and a line tangential to the first vertebral body of the cervical spine (occiput-spine angle &lt; 126) will be performed to quantify the degree of fetal head flexion in respect to the trunk</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>transabdominal ultrasound</intervention_name>
    <description>2D trans abdominal ultrasound was done during the first stage of labor. If fetal position is occiput anterior and fetal presentation is vertex, two dimensional sagittal picture of the fetal head and upper spine was acquired and stored in the ultrasound machine. On this image, the offline measurement of the angle formed by a line tangential to the occipital bone and a line tangential to the first vertebral body of the cervical spine (occiput-spine angle) will be performed to quantify the degree of fetal head flexion in respect to the trunk</description>
    <arm_group_label>occiput-spine angle &gt; or = 126</arm_group_label>
    <arm_group_label>occiput-spine angle&lt;126</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        a total of 400 women with gestational age 37 weeks or more and history of one vaginal&#xD;
        delivery at least&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age between 18 &amp; 35 years old.&#xD;
&#xD;
          2. BMI is less than 30&#xD;
&#xD;
          3. The gestational age between 37- 42 weeks. (calculated by LMP or 1st trimesteric U/S)&#xD;
&#xD;
          4. Singleton pregnancy.&#xD;
&#xD;
          5. History of one vaginal delivery.&#xD;
&#xD;
          6. Occiputo anterior position.&#xD;
&#xD;
          7. Active phase of first stage of labor.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Age (below18 or above 35).&#xD;
&#xD;
          2. Primigravida.&#xD;
&#xD;
          3. Occiputo posterior position.&#xD;
&#xD;
          4. Indications of cesarean section like malpresentations , macrosomia , placenta previa,&#xD;
             previous cesarean section .&#xD;
&#xD;
          5. Multiple gestation.&#xD;
&#xD;
          6. Medical disorders like hypertension, DM, liver or renal diseases&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Ahmed Maged, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>kasr Alainy medical school</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kasr Alainy medical school</name>
      <address>
        <city>Cairo</city>
        <zip>12151</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 25, 2017</study_first_submitted>
  <study_first_submitted_qc>August 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 29, 2017</study_first_posted>
  <last_update_submitted>August 25, 2017</last_update_submitted>
  <last_update_submitted_qc>August 25, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 29, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Ahmed Maged</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <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/NCT03264599
org study id: 12
nct id: NCT03264599
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
2D trans abdominal ultrasound was done during the first stage of labor. If fetal position is
      occiput anterior and fetal presentation is vertex, two dimensional sagittal picture of the
      fetal head and upper spine was acquired and stored in the ultrasound machine. On this image,
      the offline measurement of the angle formed by a line tangential to the occipital bone and a
      line tangential to the first vertebral body of the cervical spine (occiput-spine angle) will
      be performed to quantify the degree of fetal head flexion in respect to the trunk
2D trans abdominal ultrasound was done during the first stage of labor. If fetal position is
      occiput anterior and fetal presentation is vertex, two dimensional sagittal picture of the
      fetal head and upper spine was acquired and stored in the ultrasound machine. On this image,
      the offline measurement of the angle formed by a line tangential to the occipital bone and a
      line tangential to the first vertebral body of the cervical spine (occiput-spine angle) will
      be performed to quantify the degree of fetal head flexion in respect to the trunk.

      The sonographer was not involved in the patient's care and the managing obstetrician was
      blinded to the ultrasound findings and the occiput-spine angle. For each patient of the study
      group, the progress of labor using a partogram ( cervical dilation ,effacement ,consistency,
      position and station ) and the mode of delivery were assessed retrospectively.
observational model: Cohort
time perspective: Prospective
measure: vaginal delivery
time frame: 24 hours
arm group label: occiput-spine angle > or = 126
description: 2D trans abdominal ultrasound was done during the first stage of labor. If fetal position is occiput anterior and fetal presentation is vertex, two dimensional sagittal picture of the fetal head and upper spine was acquired and stored in the ultrasound machine. On this image, the offline measurement of the angle formed by a line tangential to the occipital bone and a line tangential to the first vertebral body of the cervical spine (occiput-spine angle > or = 126) will be performed to quantify the degree of fetal head flexion in respect to the trunk
arm group label: occiput-spine angle<126
description: 2D trans abdominal ultrasound was done during the first stage of labor. If fetal position is occiput anterior and fetal presentation is vertex, two dimensional sagittal picture of the fetal head and upper spine was acquired and stored in the ultrasound machine. On this image, the offline measurement of the angle formed by a line tangential to the occipital bone and a line tangential to the first vertebral body of the cervical spine (occiput-spine angle < 126) will be performed to quantify the degree of fetal head flexion in respect to the trunk
intervention type: Device
intervention name: transabdominal ultrasound
description: 2D trans abdominal ultrasound was done during the first stage of labor. If fetal position is occiput anterior and fetal presentation is vertex, two dimensional sagittal picture of the fetal head and upper spine was acquired and stored in the ultrasound machine. On this image, the offline measurement of the angle formed by a line tangential to the occipital bone and a line tangential to the first vertebral body of the cervical spine (occiput-spine angle) will be performed to quantify the degree of fetal head flexion in respect to the trunk
arm group label: occiput-spine angle > or = 126
arm group label: occiput-spine angle<126
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
gender based: Yes
minimum age: 18 Years
maximum age: 35 Years
last name: Ahmed Maged, MD
role: Principal Investigator
affiliation: kasr Alainy medical school
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Ahmed Maged
investigator title: Professor
sharing ipd: Undecided