<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/NCT04417296</url>
  </required_header>
  <id_info>
    <org_study_id>004</org_study_id>
    <nct_id>NCT04417296</nct_id>
  </id_info>
  <brief_title>IMPACTS OF BRAXTON-HICKS CONTRACTIONS ON COMPUTERISED CARDIOTOCOGRAPHY PARAMETERS: A POTENTIAL LINK.</brief_title>
  <official_title>IMPACTS OF BRAXTON-HICKS CONTRACTIONS ON COMPUTERISED CARDIOTOCOGRAPHY PARAMETERS: A POTENTIAL LINK.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Campania &quot;Luigi Vanvitelli&quot;</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Campania &quot;Luigi Vanvitelli&quot;</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>
      Several types of research examined the relationship of Braxton-Hicks contractions and uterine&#xD;
      flow. Nevertheless, no one considered the relationship of the maternal perception of&#xD;
      Braxton-Hicks contractions with the fetal wellbeing quantifies through computerised&#xD;
      cardiotocography. Our study wants to estimate the correlation between the maternal perception&#xD;
      of Braxton-Hicks contractions and antepartum computerised cardiotocography parameters.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 1, 2019</start_date>
  <completion_date type="Actual">August 14, 2021</completion_date>
  <primary_completion_date type="Actual">April 1, 2020</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>the comparison of the antepartum computerised cardiotocography between the patients with Braxton-Hicks contractions and the patients without uterine activity</measure>
    <time_frame>pre-intervention</time_frame>
    <description>External cCTG was completed at least 20 minutes (maximum 60 minutes), two transducers were placed on the maternal abdomen: one over the fetal heart level and the other one at the uterine fundus. For each cCTG, the following data were evaluated: Basal FHR</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">49</enrollment>
  <condition>Braxton Hicks' Contractions</condition>
  <arm_group>
    <arm_group_label>nonlaboring term singleton pregnancies</arm_group_label>
    <description>All patients had an uncomplicated pregnancy and to define a pregnancy uncomplicated we adopted Chappell's definition: &quot;a normotensive pregnancy, delivered at &gt;37 weeks, ending in a live-born baby who was not small for gestational age and did not have any other notable pregnancy complications&quot;</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>antepartum computerised cardiotocography analysis</intervention_name>
    <description>A common obstetric methodical to evaluate the fetal well-being is the antepartum fetal heart rate (FHR) monitoring through cardiotocography (CTG)</description>
    <arm_group_label>nonlaboring term singleton pregnancies</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        We included pregnant who were referred for the fetal antepartum cardiotocography monitoring&#xD;
        to the outpatient clinic of the &quot;Luigi Vanvitelli&quot; University of Campania in Naples, Italy.&#xD;
        All patients had an uncomplicated pregnancy and to define a pregnancy uncomplicated we&#xD;
        adopted Chappell's definition: &quot;a normotensive pregnancy, delivered at &gt;37 weeks, ending in&#xD;
        a live-born baby who was not small for gestational age and did not have any other notable&#xD;
        pregnancy complications&quot;&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Nonlaboring women with a term uncomplicated singleton pregnancy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  complicated singleton pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>48 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Università degli studi della Campania &quot;Luigi Vanvitelli&quot;- OB &amp; Gyn -</name>
      <address>
        <city>Napoli</city>
        <state>Italia</state>
        <zip>80138</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>June 1, 2020</study_first_submitted>
  <study_first_submitted_qc>June 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>May 4, 2022</last_update_submitted>
  <last_update_submitted_qc>May 4, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 5, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Campania &quot;Luigi Vanvitelli&quot;</investigator_affiliation>
    <investigator_full_name>Marco La Verde</investigator_full_name>
    <investigator_title>MD, research , gynecology and obstetrics, Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Braxton Hicks' contractions</keyword>
  <keyword>uterine contractions</keyword>
  <keyword>fetal well-being</keyword>
  <keyword>Computerized cardiotocography (cCTG)</keyword>
  <keyword>Fetal heart rate (FHR)</keyword>
  <keyword>Pregnancy</keyword>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04417296
org study id: 004
nct id: NCT04417296
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Several types of research examined the relationship of Braxton-Hicks contractions and uterine
      flow. Nevertheless, no one considered the relationship of the maternal perception of
      Braxton-Hicks contractions with the fetal wellbeing quantifies through computerised
      cardiotocography. Our study wants to estimate the correlation between the maternal perception
      of Braxton-Hicks contractions and antepartum computerised cardiotocography parameters.
observational model: Cohort
time perspective: Prospective
measure: the comparison of the antepartum computerised cardiotocography between the patients with Braxton-Hicks contractions and the patients without uterine activity
time frame: pre-intervention
description: External cCTG was completed at least 20 minutes (maximum 60 minutes), two transducers were placed on the maternal abdomen: one over the fetal heart level and the other one at the uterine fundus. For each cCTG, the following data were evaluated: Basal FHR
arm group label: nonlaboring term singleton pregnancies
description: All patients had an uncomplicated pregnancy and to define a pregnancy uncomplicated we adopted Chappell's definition: "a normotensive pregnancy, delivered at >37 weeks, ending in a live-born baby who was not small for gestational age and did not have any other notable pregnancy complications"
intervention type: Diagnostic Test
intervention name: antepartum computerised cardiotocography analysis
description: A common obstetric methodical to evaluate the fetal well-being is the antepartum fetal heart rate (FHR) monitoring through cardiotocography (CTG)
arm group label: nonlaboring term singleton pregnancies
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 48 Years
healthy volunteers: No
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: University of Campania "Luigi Vanvitelli"
investigator full name: Marco La Verde
investigator title: MD, research , gynecology and obstetrics, Principal Investigator
sharing ipd: Undecided