<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/NCT04411745</url>
  </required_header>
  <id_info>
    <org_study_id>2015.659</org_study_id>
    <nct_id>NCT04411745</nct_id>
  </id_info>
  <brief_title>Capturing Early Events in Human Parturition</brief_title>
  <official_title>Capturing Early Events in Human Parturition Based on Whole-transcriptome Analysis of Maternal Blood Before and After Spontaneous Onset of Labor at Term</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chinese University of Hong Kong</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chinese University of Hong Kong</source>
  <oversight_info>
    <has_dmc>No</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>
      This is a prospective observational study on normal singleton pregnant women who have no sign&#xD;
      of labor at 40 weeks of gestation or pregnant women who admitted to hospital for any sign of&#xD;
      labor at term, aiming to identify labor-associated markers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The mechanisms that instigate human parturition have not been completely understood, though&#xD;
      hypotheses such as 'functional progesterone withdrawal' and inflammatory signaling have been&#xD;
      proposed. Researchers including our group have previously identified panels of genes which&#xD;
      were differentially expressed between placentas obtained after spontaneous birth and those&#xD;
      after elective cesarean delivery. However, such findings obtained after birth could only&#xD;
      reflects the late changes in parturition. Similar findings in other gestational tissues, such&#xD;
      as fetal membranes, amniotic fluids, myometrial biopsies are available, but these sample&#xD;
      types cannot be readily collected until delivery.&#xD;
&#xD;
      Thus, we propose to explore biomarkers in maternal blood with a view to developing any useful&#xD;
      analytes for predicting labor.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">December 1, 2016</start_date>
  <completion_date type="Anticipated">December 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2024</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>RNA gene expression</measure>
    <time_frame>Between 36 and 41 weeks of gestation</time_frame>
    <description>Peripheral blood samples will be taken for RNA gene expression</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">500</enrollment>
  <condition>Parturition; Precipitate</condition>
  <arm_group>
    <arm_group_label>Parturition</arm_group_label>
    <description>Healthy women who are carrying a healthy singleton pregnancy, but have not yet gone to labor at 40 weeks of gestation or who are at term and admitted to hospital for any sign of labor.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No intervention, observational study</intervention_name>
    <arm_group_label>Parturition</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Peripheral blood samples&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Healthy women who are carrying a healthy singleton pregnancy, but have not yet gone to&#xD;
        labor at 40 weeks of gestation or who are at term and admitted to hospital for any sign of&#xD;
        labor.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Healthy women who are carrying a healthy singleton pregnancy, but have not yet gone to&#xD;
        labor at 40 weeks of gestation or who are at term and admitted to hospital for any sign of&#xD;
        labor are invited to join the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any obstetric contraindications for undergoing labor or vaginal delivery (e.g.&#xD;
             placenta previa, cephalo-pelvic disproportion, macrosomia, previous classical cesarean&#xD;
             section or uterine tear, etc).&#xD;
&#xD;
          -  Any maternal or fetal complications that require immediate or early delivery (e.g.&#xD;
             pre-eclampsia, abruption placenta, fetal distress, rupture of membranes, in utero&#xD;
             death, etc).&#xD;
&#xD;
          -  Any maternal or fetal complications that make vaginal birth an unfavorable choice&#xD;
             (e.g. fetal growth restriction, fetal compromise or distress, etc).&#xD;
&#xD;
          -  Any conditions that are known to affect the onset of labor (e.g. anencephaly).&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Pregnant women</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tak Yeung LEUNG, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chinese University of Hong Kong</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Tak Yeung LEUNG, MD</last_name>
    <phone>852-35052806</phone>
    <email>tyleung@cuhk.edu.hk</email>
  </overall_contact>
  <location>
    <facility>
      <name>The Chinese University of Hong Kong</name>
      <address>
        <city>Sha Tin</city>
        <country>Hong Kong</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Tak Yeung LEUNG</last_name>
      <phone>852-35052806</phone>
      <email>tyleung@cuhk.edu.hk</email>
    </contact>
  </location>
  <location_countries>
    <country>Hong Kong</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>May 28, 2020</study_first_submitted>
  <study_first_submitted_qc>May 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 2, 2020</study_first_posted>
  <last_update_submitted>March 5, 2023</last_update_submitted>
  <last_update_submitted_qc>March 5, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 7, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chinese University of Hong Kong</investigator_affiliation>
    <investigator_full_name>Tak Yeung LEUNG</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>transcriptome</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/NCT04411745
org study id: 2015.659
nct id: NCT04411745
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a prospective observational study on normal singleton pregnant women who have no sign
      of labor at 40 weeks of gestation or pregnant women who admitted to hospital for any sign of
      labor at term, aiming to identify labor-associated markers.
The mechanisms that instigate human parturition have not been completely understood, though
      hypotheses such as 'functional progesterone withdrawal' and inflammatory signaling have been
      proposed. Researchers including our group have previously identified panels of genes which
      were differentially expressed between placentas obtained after spontaneous birth and those
      after elective cesarean delivery. However, such findings obtained after birth could only
      reflects the late changes in parturition. Similar findings in other gestational tissues, such
      as fetal membranes, amniotic fluids, myometrial biopsies are available, but these sample
      types cannot be readily collected until delivery.

      Thus, we propose to explore biomarkers in maternal blood with a view to developing any useful
      analytes for predicting labor.
observational model: Cohort
time perspective: Prospective
measure: RNA gene expression
time frame: Between 36 and 41 weeks of gestation
description: Peripheral blood samples will be taken for RNA gene expression
arm group label: Parturition
description: Healthy women who are carrying a healthy singleton pregnancy, but have not yet gone to labor at 40 weeks of gestation or who are at term and admitted to hospital for any sign of labor.
intervention type: Other
intervention name: No intervention, observational study
arm group label: Parturition
Peripheral blood samples
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
gender based: Yes
gender description: Pregnant women
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Tak Yeung LEUNG, MD
role: Principal Investigator
affiliation: Chinese University of Hong Kong
last name: Tak Yeung LEUNG, MD
phone: 852-35052806
email: tyleung@cuhk.edu.hk
facility: 
status: Recruiting
contact: 
country: Hong Kong
responsible party type: Principal Investigator
investigator affiliation: Chinese University of Hong Kong
investigator full name: Tak Yeung LEUNG
investigator title: Professor