<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/NCT03251898</url>
  </required_header>
  <id_info>
    <org_study_id>BayiChildrens-01</org_study_id>
    <nct_id>NCT03251898</nct_id>
  </id_info>
  <brief_title>Correlation Between Premature Rupture of Membranes and Early-onset Neonatal Infections</brief_title>
  <official_title>Multicenter Study on Correlation Between Premature Rupture of Membranes and Early-onset Neonatal Infections</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bayi Children's Hospital Affiliated to PLA Army General Hospital, China</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Northwest Women's and Children's Hospital, Xi'an, Shaanxi</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Chengdu Women's and Children's Central Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Shenzhen Maternity &amp; Child Healthcare Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Nanjing Maternity and Child Health Care Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Shenzhen Bao'an Maternal and Child Health Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Second Hospital of Jilin University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Seventh Medical Center of PLA General Hospital</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>
      This study hypothesizes that early-onset neonatal Infections are related to premature rupture&#xD;
      of membrane (PROM) and that early intervention can improve the prognosis of newborns. The&#xD;
      objective of this study is to analyze the correlation between PROM and early-onset neonatal&#xD;
      infections and to assess the prognosis of newborns. A cohort study is designed to implement&#xD;
      the study. The subjects of study group are pregnant women who are diagnosed as PROM or&#xD;
      chorioamnionitis and whose gestational age is ≥ 24 weeks. The subjects of control group are&#xD;
      pregnant women without PROM and chorioamnionitis. Control group and research group are paired&#xD;
      at 1: 1 ratio. The main contents of the study include three aspects. (1) The correlation&#xD;
      between PROM and chorioamnionitis. (2) The correlation between PROM and early-onset neonatal&#xD;
      infections. (3) The pathogenesis of intrauterine infection and neonatal infection.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 15, 2017</start_date>
  <completion_date type="Actual">April 30, 2018</completion_date>
  <primary_completion_date type="Actual">March 31, 2018</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>3 Weeks</target_duration>
  <primary_outcome>
    <measure>the incidence of early-onset neonatal infections</measure>
    <time_frame>7 days after birth</time_frame>
    <description>The incidence of early-onset neonatal infections will be compared between study group and control group.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">15926</enrollment>
  <condition>Premature Rupture of Membrane</condition>
  <condition>Neonatal Infection</condition>
  <arm_group>
    <arm_group_label>study group</arm_group_label>
    <description>pregnant women who are diagnosed as PROM or chorioamnionitis and whose gestational age is ≥ 24 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <description>pregnant women without PROM and chorioamnionitis</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        The pregnant women who are hospitalized to delivery in the collaborator hospitals.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  PROM or chorioamnionitis&#xD;
&#xD;
          -  gestational age is ≥ 24 weeks&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  gestational age &lt;24 weeks&#xD;
&#xD;
          -  artificial rupture of membrane for labor induction&#xD;
&#xD;
          -  natural rupture of membrane during induction before labor&#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_official>
    <last_name>Xing Li</last_name>
    <role>Principal Investigator</role>
    <affiliation>Bayi Children's Hospital Affiliated to PLA Army General Hospital, China</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Shaodong Hua</last_name>
    <role>Principal Investigator</role>
    <affiliation>Bayi Children's Hospital Affiliated to PLA Army General Hospital, China</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jie Cui</last_name>
    <role>Principal Investigator</role>
    <affiliation>Bayi Children's Hospital Affiliated to PLA Army General Hospital, China</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Lei Li</last_name>
    <role>Principal Investigator</role>
    <affiliation>Bayi Children's Hospital Affiliated to PLA Army General Hospital, China</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Chengdu Women's and Children's Central Hospital</name>
      <address>
        <city>Chengdu</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Second Hospital of Jilin University</name>
      <address>
        <city>Jilin</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nanjing Maternity and Child Health Care Hospital</name>
      <address>
        <city>Nanjing</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shenzhen Bao'an Maternal and Child Health Hospital</name>
      <address>
        <city>Shenzhen</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shenzhen Maternity &amp; Child Healthcare Hospital</name>
      <address>
        <city>Shenzhen</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwest Women's and Children's Hospital</name>
      <address>
        <city>Xi'an</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 15, 2017</study_first_submitted>
  <study_first_submitted_qc>August 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 16, 2017</study_first_posted>
  <last_update_submitted>April 23, 2020</last_update_submitted>
  <last_update_submitted_qc>April 23, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 27, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <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/NCT03251898
org study id: BayiChildrens-01
nct id: NCT03251898
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
This study hypothesizes that early-onset neonatal Infections are related to premature rupture
      of membrane (PROM) and that early intervention can improve the prognosis of newborns. The
      objective of this study is to analyze the correlation between PROM and early-onset neonatal
      infections and to assess the prognosis of newborns. A cohort study is designed to implement
      the study. The subjects of study group are pregnant women who are diagnosed as PROM or
      chorioamnionitis and whose gestational age is ≥ 24 weeks. The subjects of control group are
      pregnant women without PROM and chorioamnionitis. Control group and research group are paired
      at 1: 1 ratio. The main contents of the study include three aspects. (1) The correlation
      between PROM and chorioamnionitis. (2) The correlation between PROM and early-onset neonatal
      infections. (3) The pathogenesis of intrauterine infection and neonatal infection.
observational model: Cohort
time perspective: Prospective
measure: the incidence of early-onset neonatal infections
time frame: 7 days after birth
description: The incidence of early-onset neonatal infections will be compared between study group and control group.
arm group label: study group
description: pregnant women who are diagnosed as PROM or chorioamnionitis and whose gestational age is ≥ 24 weeks
arm group label: control group
description: pregnant women without PROM and chorioamnionitis
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Xing Li
role: Principal Investigator
affiliation: Bayi Children's Hospital Affiliated to PLA Army General Hospital, China
last name: Shaodong Hua
role: Principal Investigator
affiliation: Bayi Children's Hospital Affiliated to PLA Army General Hospital, China
last name: Jie Cui
role: Principal Investigator
affiliation: Bayi Children's Hospital Affiliated to PLA Army General Hospital, China
last name: Lei Li
role: Principal Investigator
affiliation: Bayi Children's Hospital Affiliated to PLA Army General Hospital, China
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: China
responsible party type: Sponsor
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Premature Birth
mesh term: Fetal Membranes, Premature Rupture
mesh term: Rupture