<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/NCT04434391</url>
  </required_header>
  <id_info>
    <org_study_id>QF-PCR in GBS screening</org_study_id>
    <nct_id>NCT04434391</nct_id>
  </id_info>
  <brief_title>QF-PCR In GBS Diagnosis During Pregnancy</brief_title>
  <acronym>QFPCRIGDDP</acronym>
  <official_title>Quantitative Fluorescence Polymerase Chain Reaction (QF-PCR) in Group B Strep (GBS) Rectovaginal Colonization Diagnosis During Pregnancy.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking Union Medical College Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Peking Union Medical College Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Estimate the sensitivity and specificity of Quantitative Fluorescence Polymerase Chain&#xD;
      Reaction (QF-PCR) in diagnosing Group B Strep (GBS) rectovaginal colonization during&#xD;
      pregnancy, and follow the outcome of the mothers and infants. According to the outcome of&#xD;
      this study,the investigator wish to determine that wether QF-PCR is an appropriate screening&#xD;
      method for GBS in primary hospitals in China.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a study which include 300 pregnant women who will deliver their babies in PUMCH.&#xD;
&#xD;
        1. Obtain vaginal and rectal swab for Group B Strep (GBS) culture and Quantitative&#xD;
           Fluorescence Polymerase Chain Reaction (QF-PCR) test between 35-37 weeks.&#xD;
&#xD;
        2. Obtain intrauterine swabs of the woman whose vaginal-rectal GBS test is positive,for&#xD;
           both GBS culture and GBS QF-PCR.&#xD;
&#xD;
        3. Obtain rectal and pharynx swabs of the newborns of the woman whose vaginal-rectal GBS&#xD;
           test is positive,for both GBS culture and GBS QF-PCR.&#xD;
&#xD;
        4. Blood test for GBS culture and GBS QF-PCR will be carried out to all the babies&#xD;
           transferred to neonatal intensive care unit(NICU).&#xD;
&#xD;
        5. For all the samples that GBS culture result was not consistent with QF-PCR, We will do&#xD;
           gene sequencing for verification.&#xD;
&#xD;
        6. Pregnant outcome will be followed such as Apgar score,neonatal pneumonia, urinary tract&#xD;
           infection, chorioamnionitis, endometritis,sepsis, and bacteremia,It also can cause focal&#xD;
           infections such as pneumonia, meningitis, and endocarditis.&#xD;
&#xD;
      Inclusion Criteria:&#xD;
&#xD;
      1.Singleton gestation.Pregnant women between 35-37 weeks gestation. 2.22 years of age or&#xD;
      older. 3.Plan to deliver baby in Peking Union Medical College Hospital (PUMCH).&#xD;
&#xD;
      Exclusion Criteria:&#xD;
&#xD;
        1. Preexisting morbidity: Immunocompromised status (HIV +; malignancy; history of organ&#xD;
           transplant; chronic steroid therapy; autoimmune disease requiring treatment during&#xD;
           pregnancy, and other immunocompromised states); Type 1 diabetes and type 2&#xD;
           diabetes;congenital cardiac disease and cardiac valvular disease requiring antibiotic&#xD;
           prophylaxis during procedure/labor; pulmonary disease; renal disease; chronic hepatic&#xD;
           disease; inflammatory bowel disease; stomach or duodenal ulcer; bowel resection, gastric&#xD;
           bypass, and chronic indwelling venous, bladder, or gastric catheter.&#xD;
&#xD;
        2. Multi-fetal gestation.&#xD;
&#xD;
        3. Chronic (daily) use of broad spectrum antibiotics. 4。Prolonged antibiotic use (&gt; 7 days)&#xD;
           in the 4 weeks prior to GBS culture screening.&#xD;
&#xD;
      5.History of infant with GBS sepsis. 6.intrauterine growth retardation(IUGR), Fetal&#xD;
      Anomalies-major diagnosed at time of second trimester anatomy ultrasound.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2013</start_date>
  <completion_date type="Actual">February 2014</completion_date>
  <primary_completion_date type="Actual">December 2013</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>Percentage of participants with positive results of GBS culture or/and QF-PCR</measure>
    <time_frame>3 months</time_frame>
    <description>The percentage will be calculated separately as follows:&#xD;
Number of positive GBS culture from vaginal/rectal swabs in all participants;&#xD;
Number of positive GBS QF-PCR from vaginal/rectal swabs in all participants;&#xD;
Number of positive GBS culture/QF-PCR from intrauterine swabs in women whose vaginal-rectal GBS test is positive;&#xD;
Number of positive GBS culture from pharynx/rectal swabs in newborns whose mother 's vaginal-rectal GBS test is positive;&#xD;
Number of positive GBS QF-PCR from pharynx/rectal swabs in newborns whose mother 's vaginal-rectal GBS test is positive;</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of participants with adverse outcomes of pregnancy</measure>
    <time_frame>3 months</time_frame>
    <description>Compare the maternal ante- intra- and postpartum outcomes (urinary tract infections, chorioamnionitis, endometritis, cellulitis, bacteremia, sepsis, and other infectious morbidity) and neonatal outcomes (gestational age at delivery, APGAR scores, bilirubin levels, C-reactive protein, rule out sepsis evaluation, sepsis, pneumonia, meningitis, neonatal ICU admission, and length of hospital stay).</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">300</enrollment>
  <condition>GBS</condition>
  <arm_group>
    <arm_group_label>QF-PCR for GBS screening</arm_group_label>
    <description>QF-PCR for vaginal-rectal samples in pregnant women</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>QF-PCR for GBS screening</intervention_name>
    <description>QF-PCR for GBS screening in pregnant women,compared with GBS culture test.</description>
    <arm_group_label>QF-PCR for GBS screening</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  1.Singleton gestation.Pregnant women between 35-37 weeks gestation. 2.22 years of age&#xD;
             or older. 3.Plan to deliver baby in PUMCH.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  1.Singleton gestation.Pregnant women between 35-37 weeks gestation. 2.22 years of age&#xD;
             or older. 3.Plan to deliver baby in PUMCH.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  1.Preexisting morbidity: Immunocompromised status (HIV +; malignancy; history of organ&#xD;
             transplant; chronic steroid therapy; autoimmune disease requiring treatment during&#xD;
             pregnancy, and other immunocompromised states); Type 1 diabetes and type 2&#xD;
             diabetes;congenital cardiac disease and cardiac valvular disease requiring antibiotic&#xD;
             prophylaxis during procedure/labor; pulmonary disease; renal disease; chronic hepatic&#xD;
             disease; inflammatory bowel disease; stomach or duodenal ulcer; bowel resection,&#xD;
             gastric bypass, and chronic indwelling venous, bladder, or gastric catheter.&#xD;
&#xD;
             2.Multi-fetal gestation. 3.Chronic (daily) use of broad spectrum antibiotics.&#xD;
             4.Prolonged antibiotic use (&gt; 7 days) in the 4 weeks prior to GBS culture screening.&#xD;
&#xD;
             5.History of infant with GBS sepsis. 6.IUGR, Fetal Anomalies-major diagnosed at time&#xD;
             of second trimester anatomy ultrasound。 7.Anticipated delivery &lt;35 wks for&#xD;
             maternal/fetal indication 8.Placenta previa or accreta (with anticipated delivery&#xD;
             prior to 35 weeks)&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>22 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Liangkun MA, MD</last_name>
    <role>Study Director</role>
    <affiliation>Peking Union Medical College</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of ob gyn, Peking Union Medical College Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100730</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>December 2013</verification_date>
  <study_first_submitted>July 18, 2013</study_first_submitted>
  <study_first_submitted_qc>June 13, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>June 13, 2020</last_update_submitted>
  <last_update_submitted_qc>June 13, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 16, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>GBS screening</keyword>
  <keyword>pregnancy outcome</keyword>
  <keyword>QF-PCR</keyword>
  <!-- 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/NCT04434391
org study id: QF-PCR in GBS screening
nct id: NCT04434391
lead sponsor: 
has dmc: Yes
Estimate the sensitivity and specificity of Quantitative Fluorescence Polymerase Chain
      Reaction (QF-PCR) in diagnosing Group B Strep (GBS) rectovaginal colonization during
      pregnancy, and follow the outcome of the mothers and infants. According to the outcome of
      this study,the investigator wish to determine that wether QF-PCR is an appropriate screening
      method for GBS in primary hospitals in China.
This is a study which include 300 pregnant women who will deliver their babies in PUMCH.

        1. Obtain vaginal and rectal swab for Group B Strep (GBS) culture and Quantitative
           Fluorescence Polymerase Chain Reaction (QF-PCR) test between 35-37 weeks.

        2. Obtain intrauterine swabs of the woman whose vaginal-rectal GBS test is positive,for
           both GBS culture and GBS QF-PCR.

        3. Obtain rectal and pharynx swabs of the newborns of the woman whose vaginal-rectal GBS
           test is positive,for both GBS culture and GBS QF-PCR.

        4. Blood test for GBS culture and GBS QF-PCR will be carried out to all the babies
           transferred to neonatal intensive care unit(NICU).

        5. For all the samples that GBS culture result was not consistent with QF-PCR, We will do
           gene sequencing for verification.

        6. Pregnant outcome will be followed such as Apgar score,neonatal pneumonia, urinary tract
           infection, chorioamnionitis, endometritis,sepsis, and bacteremia,It also can cause focal
           infections such as pneumonia, meningitis, and endocarditis.

      Inclusion Criteria:

      1.Singleton gestation.Pregnant women between 35-37 weeks gestation. 2.22 years of age or
      older. 3.Plan to deliver baby in Peking Union Medical College Hospital (PUMCH).

      Exclusion Criteria:

        1. Preexisting morbidity: Immunocompromised status (HIV +; malignancy; history of organ
           transplant; chronic steroid therapy; autoimmune disease requiring treatment during
           pregnancy, and other immunocompromised states); Type 1 diabetes and type 2
           diabetes;congenital cardiac disease and cardiac valvular disease requiring antibiotic
           prophylaxis during procedure/labor; pulmonary disease; renal disease; chronic hepatic
           disease; inflammatory bowel disease; stomach or duodenal ulcer; bowel resection, gastric
           bypass, and chronic indwelling venous, bladder, or gastric catheter.

        2. Multi-fetal gestation.

        3. Chronic (daily) use of broad spectrum antibiotics. 4。Prolonged antibiotic use (> 7 days)
           in the 4 weeks prior to GBS culture screening.

      5.History of infant with GBS sepsis. 6.intrauterine growth retardation(IUGR), Fetal
      Anomalies-major diagnosed at time of second trimester anatomy ultrasound.
observational model: Cohort
time perspective: Prospective
measure: Percentage of participants with positive results of GBS culture or/and QF-PCR
time frame: 3 months
description: The percentage will be calculated separately as follows:
Number of positive GBS culture from vaginal/rectal swabs in all participants;
Number of positive GBS QF-PCR from vaginal/rectal swabs in all participants;
Number of positive GBS culture/QF-PCR from intrauterine swabs in women whose vaginal-rectal GBS test is positive;
Number of positive GBS culture from pharynx/rectal swabs in newborns whose mother 's vaginal-rectal GBS test is positive;
Number of positive GBS QF-PCR from pharynx/rectal swabs in newborns whose mother 's vaginal-rectal GBS test is positive;
measure: Number of participants with adverse outcomes of pregnancy
time frame: 3 months
description: Compare the maternal ante- intra- and postpartum outcomes (urinary tract infections, chorioamnionitis, endometritis, cellulitis, bacteremia, sepsis, and other infectious morbidity) and neonatal outcomes (gestational age at delivery, APGAR scores, bilirubin levels, C-reactive protein, rule out sepsis evaluation, sepsis, pneumonia, meningitis, neonatal ICU admission, and length of hospital stay).
arm group label: QF-PCR for GBS screening
description: QF-PCR for vaginal-rectal samples in pregnant women
intervention type: Other
intervention name: QF-PCR for GBS screening
description: QF-PCR for GBS screening in pregnant women,compared with GBS culture test.
arm group label: QF-PCR for GBS screening
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: 22 Years
maximum age: 45 Years
healthy volunteers: No
last name: Liangkun MA, MD
role: Study Director
affiliation: Peking Union Medical College
facility: 
country: China
responsible party type: Sponsor