<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/NCT03789903</url>
  </required_header>
  <id_info>
    <org_study_id>ain shams maternity hos</org_study_id>
    <nct_id>NCT03789903</nct_id>
  </id_info>
  <brief_title>Amniotic Fluid Lactate in Perterm Premature Rupture of Membranes</brief_title>
  <official_title>Amniotic Fluid Lactate in Predicting Latency in Perterm Premature Rupture of Membranes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ain Shams University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ain Shams 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>
      AF lactate level could help in predicting the duration from ROM till delivery&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 1, 2018</start_date>
  <completion_date type="Anticipated">March 1, 2019</completion_date>
  <primary_completion_date type="Anticipated">January 1, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>latency period</measure>
    <time_frame>upto 48 hours</time_frame>
    <description>duration from ROM till the occurrence of active labor</description>
  </primary_outcome>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Rupture of Membranes; Premature</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>amniotic fluid lactate</intervention_name>
    <description>AF lactate</description>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. women with PPROM&#xD;
&#xD;
          2. GA between 24 to 34 weeks&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. chorioamnionitis&#xD;
&#xD;
          2. previous Preterm labor&#xD;
&#xD;
          3. abruptio placentae&#xD;
&#xD;
          4. UTI ,pyelonephritis&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Radwa R Ali, MD</last_name>
    <phone>01283492979</phone>
    <phone_ext>02002</phone_ext>
    <email>radwaebed@yahoo.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>AinShams university maternity hospital</name>
      <address>
        <city>Cairo</city>
        <state>Abbassya</state>
        <zip>11566</zip>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ahmed K Maklad, MD</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 26, 2018</study_first_submitted>
  <study_first_submitted_qc>December 27, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 31, 2018</study_first_posted>
  <last_update_submitted>December 27, 2018</last_update_submitted>
  <last_update_submitted_qc>December 27, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 31, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ain Shams University</investigator_affiliation>
    <investigator_full_name>Radwa Rasheedy Ali</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Premature Birth</mesh_term>
    <mesh_term>Fetal Membranes, Premature Rupture</mesh_term>
    <mesh_term>Rupture</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/NCT03789903
org study id: ain shams maternity hos
nct id: NCT03789903
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
AF lactate level could help in predicting the duration from ROM till delivery
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: latency period
time frame: upto 48 hours
description: duration from ROM till the occurrence of active labor
intervention type: Diagnostic Test
intervention name: amniotic fluid lactate
description: AF lactate
criteria: 
gender: Female
minimum age: 25 Years
maximum age: 35 Years
healthy volunteers: No
last name: Radwa R Ali, MD
phone: 01283492979
phone ext: 02002
email: radwaebed@yahoo.com
facility: 
status: Recruiting
contact: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Ain Shams University
investigator full name: Radwa Rasheedy Ali
investigator title: Principal Investigator
mesh term: Premature Birth
mesh term: Fetal Membranes, Premature Rupture
mesh term: Rupture