<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/NCT02985086</url>
  </required_header>
  <id_info>
    <org_study_id>SantaMariaGarciadeOrtaPortugal</org_study_id>
    <nct_id>NCT02985086</nct_id>
  </id_info>
  <brief_title>Immediate Versus Delayed Induction in Term-PROM Using or Not Antibiotic Prophylaxis</brief_title>
  <official_title>The Role of Antibiotic Prophylaxis in Immediate Versus Delayed Induction in Term-PROM - a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital de Santa Maria, Portugal</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital de Santa Maria, Portugal</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary aim of this study is to determine if antibiotics combined with immediate&#xD;
      induction can significantly reduce the rate of maternal and neonatal infection compared with&#xD;
      immediate induction alone in women presenting with PROM later than the 37+0 weeks of&#xD;
      gestation. The secondary aim is to compare the rates of infection between immediate and&#xD;
      delayed induction in women submitted to antibiotic prophylaxis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In a randomized controlled non-blind trial, low-risk women with singleton term pregnancies&#xD;
      and a negative Group B Streptococcus culture presenting with PROM are randomly assigned to&#xD;
      group A (immediate induction with antibiotic prophylaxis), group B (immediate induction&#xD;
      without antibiotic prophylaxis) or group C (delayed induction with antibiotic prophylaxis).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>July 2013</start_date>
  <completion_date type="Anticipated">July 2018</completion_date>
  <primary_completion_date type="Anticipated">July 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Maternal and neonatal infection rate</measure>
    <time_frame>intrapartum and immediate postpartum</time_frame>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">568</enrollment>
  <condition>Maternal Infection During Pregnancy (Diagnosis)</condition>
  <condition>Neonatal Infection</condition>
  <arm_group>
    <arm_group_label>Immediate induction with antibiotic prophylaxis</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Immediate induction with antibiotic prophylaxis</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Immediate induction without antibiotic prophylaxis</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Immediate induction without antibiotic prophylaxis</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Delayed induction with antibiotic prophylaxis</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Delayed induction (&gt;= 12 hours after PROM) with antibiotic prophylaxis</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cefoxitin</intervention_name>
    <arm_group_label>Delayed induction with antibiotic prophylaxis</arm_group_label>
    <arm_group_label>Immediate induction with antibiotic prophylaxis</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>oxytocin/misoprostol</intervention_name>
    <arm_group_label>Delayed induction with antibiotic prophylaxis</arm_group_label>
    <arm_group_label>Immediate induction with antibiotic prophylaxis</arm_group_label>
    <arm_group_label>Immediate induction without antibiotic prophylaxis</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  term (≥ 37+0 weeks) singleton pregnancy, a vertex presentation, ruptured membranes for&#xD;
             less than 12 hours and a negative Group B Streptococcus (GBS) culture performed&#xD;
             between 35 and 37 weeks.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  active labor, absence of GBS culture or indication for GBS antibiotic prophylaxis,&#xD;
             contraindication to expectant management or to vaginal delivery&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Filipa FV Passos, MD</last_name>
    <phone>00351966634530</phone>
    <email>filipafariavazpassos@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Rita Silva, MD</last_name>
    <phone>00351963915366</phone>
    <email>r.i.t.a.i.m.s.i.l.v.a@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Hospital Garcia de Orta, EPE</name>
      <address>
        <city>Almada</city>
        <country>Portugal</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hospital de Santa Maria, CHLN, EPE</name>
      <address>
        <city>Lisbon</city>
        <country>Portugal</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>Portugal</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 5, 2016</study_first_submitted>
  <study_first_submitted_qc>December 5, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 7, 2016</study_first_posted>
  <last_update_submitted>December 10, 2016</last_update_submitted>
  <last_update_submitted_qc>December 10, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 13, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital de Santa Maria, Portugal</investigator_affiliation>
    <investigator_full_name>Filipa Faria Vaz Passos</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>term premature rupture of membranes, antibiotic prophylaxis, chorioamnionitis, endometritis, neonatal infection</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cefoxitin</mesh_term>
    <mesh_term>Misoprostol</mesh_term>
    <mesh_term>Oxytocin</mesh_term>
  </intervention_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/NCT02985086
org study id: SantaMariaGarciadeOrtaPortugal
nct id: NCT02985086
lead sponsor: 
has dmc: No
The primary aim of this study is to determine if antibiotics combined with immediate
      induction can significantly reduce the rate of maternal and neonatal infection compared with
      immediate induction alone in women presenting with PROM later than the 37+0 weeks of
      gestation. The secondary aim is to compare the rates of infection between immediate and
      delayed induction in women submitted to antibiotic prophylaxis.
In a randomized controlled non-blind trial, low-risk women with singleton term pregnancies
      and a negative Group B Streptococcus culture presenting with PROM are randomly assigned to
      group A (immediate induction with antibiotic prophylaxis), group B (immediate induction
      without antibiotic prophylaxis) or group C (delayed induction with antibiotic prophylaxis).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Maternal and neonatal infection rate
time frame: intrapartum and immediate postpartum
arm group label: Immediate induction with antibiotic prophylaxis
arm group type: Active Comparator
description: Immediate induction with antibiotic prophylaxis
arm group label: Immediate induction without antibiotic prophylaxis
arm group type: Active Comparator
description: Immediate induction without antibiotic prophylaxis
arm group label: Delayed induction with antibiotic prophylaxis
arm group type: Active Comparator
description: Delayed induction (>= 12 hours after PROM) with antibiotic prophylaxis
intervention type: Drug
intervention name: Cefoxitin
arm group label: Delayed induction with antibiotic prophylaxis
arm group label: Immediate induction with antibiotic prophylaxis
intervention type: Drug
intervention name: oxytocin/misoprostol
arm group label: Delayed induction with antibiotic prophylaxis
arm group label: Immediate induction with antibiotic prophylaxis
arm group label: Immediate induction without antibiotic prophylaxis
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Filipa FV Passos, MD
phone: 00351966634530
email: filipafariavazpassos@gmail.com
last name: Rita Silva, MD
phone: 00351963915366
email: r.i.t.a.i.m.s.i.l.v.a@gmail.com
facility: 
status: Recruiting
facility: 
status: Recruiting
country: Portugal
responsible party type: Principal Investigator
investigator affiliation: Hospital de Santa Maria, Portugal
investigator full name: Filipa Faria Vaz Passos
investigator title: Principal Investigator
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Cefoxitin
mesh term: Misoprostol
mesh term: Oxytocin