<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/NCT03242356</url>
  </required_header>
  <id_info>
    <org_study_id>69HCL17_0454</org_study_id>
    <nct_id>NCT03242356</nct_id>
  </id_info>
  <brief_title>Oral Feeding During Established Labor at Our Institution</brief_title>
  <official_title>Oral Feeding During Established Labor. Current Practices in the Obstetric Department of the Femme Mère Enfant Hospital (Lyon, France)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospices Civils de Lyon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospices Civils de Lyon</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>
      Current French guidelines allow oral intake of clear fluid in women in established labor&#xD;
      under epidural analgesia. To date, no study assessed how these guidelines are followed in&#xD;
      clinical practice. This study aims to assess the current practices as to the fasting during&#xD;
      the labor at our institution, while assessing the experience and the expectations of the&#xD;
      parturients (level of comfort or discomfort related to fasting).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 25, 2017</start_date>
  <completion_date type="Actual">November 25, 2017</completion_date>
  <primary_completion_date type="Actual">November 25, 2017</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>Rate of parturients who declared to have ingested clear fluid during the labor.</measure>
    <time_frame>The survey will be completed within 2 hours following the delivery</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Determine the instructions given by health professionals, their spontaneous or non-spontaneous character and the information related to the given fast, according to the parturient</measure>
    <time_frame>The survey will be completed within 2 hours following the delivery</time_frame>
    <description>Determine the instructions given by health professionals, whether they are spontaneous or not</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Specify the type of liquid ingested (water or sweet liquid) and its volume</measure>
    <time_frame>The survey will be completed within 2 hours following the delivery</time_frame>
    <description>Nature and volume of liquids ingested</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Specify the frequency of ingestion of solid foods during labor</measure>
    <time_frame>The survey will be completed within 2 hours following the delivery</time_frame>
    <description>Nature and quantity of ingested solids</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assess the degree of discomfort associated with thirst that was felt during labor</measure>
    <time_frame>The survey will be completed within 2 hours following the delivery</time_frame>
    <description>Degree of discomfort related to thirst on a simple numeric scale (0: no discomfort at 10: very uncomfortable)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assess the degree of discomfort associated with hunger that was felt during labor</measure>
    <time_frame>The survey will be completed within 2 hours following the delivery</time_frame>
    <description>Degree of discomfort related to hunger on a simple numeric scale (0: no discomfort at 10: very uncomfortable)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate women's satisfaction with the fasting instructions received</measure>
    <time_frame>The survey will be completed within 2 hours following the delivery</time_frame>
    <description>Satisfaction with fasting instructions given on a simple numerical scale (0: very high dissatisfaction, 10: maximum satisfaction)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Determine if nausea and vomiting are more common in women who have ingested fluids during labor</measure>
    <time_frame>The survey will be completed within 2 hours following the delivery</time_frame>
    <description>Incidence of at least one episode of nausea and vomiting during labor</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Analyze the factors associated with fasting during work and their concordance with the French recommendations on fasting during labor</measure>
    <time_frame>The survey will be completed within 2 hours following the delivery</time_frame>
    <description>Analysis of independent risk factors for the patient's strict fasting during labor</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Indicate the total duration of fast and solid fasting before birth</measure>
    <time_frame>The survey will be completed within 2 hours following the delivery</time_frame>
    <description>Total duration of liquid fasting and solids preceding birth</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compare fasting instructions received by patients and practices reported by professionals</measure>
    <time_frame>The survey will be completed within 2 hours following the delivery</time_frame>
    <description>Fasting instructions received by patients and practices reported by professionals obtained during a practice survey</description>
  </secondary_outcome>
  <enrollment type="Actual">195</enrollment>
  <condition>Labor</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaire to assess of the application of the current French guidelines as to fasting during labor.</intervention_name>
    <description>Questionnaire focuses on :&#xD;
oral intake of clear fluid during the labor&#xD;
oral intake of solid meal during the labor&#xD;
fasting duration for solid and liquids&#xD;
instruction received as to fasting during labor, nature of these instructions, and who given the instruction (midwife, nurse anesthetist, …)&#xD;
discomfort related to thirst during labor&#xD;
discomfort related to hunger during labor&#xD;
We will also record several medical data as to the course of pregnancy and delivery, analgesia technique, history and characteristics of the parturient.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All adult women who were in labor in our hospital interviewed within 2 hours after vaginal&#xD;
        delivery or cesarean section decided during the labor&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All adult woman who has been in labor in our hospital&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient refusal&#xD;
&#xD;
          -  Elective cesarean section, or emergency cesarean section in a woman not in labor&#xD;
&#xD;
          -  Intrauterine fetal death&#xD;
&#xD;
          -  Therapeutic abortion&#xD;
&#xD;
          -  Patient consent not available (for example, in case of severe post-partum hemorrhage)&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>hopital Femme Mère Enfant</name>
      <address>
        <city>Bron</city>
        <zip>69677</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 4, 2017</study_first_submitted>
  <study_first_submitted_qc>August 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 8, 2017</study_first_posted>
  <last_update_submitted>April 12, 2018</last_update_submitted>
  <last_update_submitted_qc>April 12, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 13, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT03242356
org study id: 69HCL17_0454
nct id: NCT03242356
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Current French guidelines allow oral intake of clear fluid in women in established labor
      under epidural analgesia. To date, no study assessed how these guidelines are followed in
      clinical practice. This study aims to assess the current practices as to the fasting during
      the labor at our institution, while assessing the experience and the expectations of the
      parturients (level of comfort or discomfort related to fasting).
observational model: Cohort
time perspective: Prospective
measure: Rate of parturients who declared to have ingested clear fluid during the labor.
time frame: The survey will be completed within 2 hours following the delivery
measure: Determine the instructions given by health professionals, their spontaneous or non-spontaneous character and the information related to the given fast, according to the parturient
time frame: The survey will be completed within 2 hours following the delivery
description: Determine the instructions given by health professionals, whether they are spontaneous or not
measure: Specify the type of liquid ingested (water or sweet liquid) and its volume
time frame: The survey will be completed within 2 hours following the delivery
description: Nature and volume of liquids ingested
measure: Specify the frequency of ingestion of solid foods during labor
time frame: The survey will be completed within 2 hours following the delivery
description: Nature and quantity of ingested solids
measure: Assess the degree of discomfort associated with thirst that was felt during labor
time frame: The survey will be completed within 2 hours following the delivery
description: Degree of discomfort related to thirst on a simple numeric scale (0: no discomfort at 10: very uncomfortable)
measure: Assess the degree of discomfort associated with hunger that was felt during labor
time frame: The survey will be completed within 2 hours following the delivery
description: Degree of discomfort related to hunger on a simple numeric scale (0: no discomfort at 10: very uncomfortable)
measure: Evaluate women's satisfaction with the fasting instructions received
time frame: The survey will be completed within 2 hours following the delivery
description: Satisfaction with fasting instructions given on a simple numerical scale (0: very high dissatisfaction, 10: maximum satisfaction)
measure: Determine if nausea and vomiting are more common in women who have ingested fluids during labor
time frame: The survey will be completed within 2 hours following the delivery
description: Incidence of at least one episode of nausea and vomiting during labor
measure: Analyze the factors associated with fasting during work and their concordance with the French recommendations on fasting during labor
time frame: The survey will be completed within 2 hours following the delivery
description: Analysis of independent risk factors for the patient's strict fasting during labor
measure: Indicate the total duration of fast and solid fasting before birth
time frame: The survey will be completed within 2 hours following the delivery
description: Total duration of liquid fasting and solids preceding birth
measure: Compare fasting instructions received by patients and practices reported by professionals
time frame: The survey will be completed within 2 hours following the delivery
description: Fasting instructions received by patients and practices reported by professionals obtained during a practice survey
intervention type: Other
intervention name: Questionnaire to assess of the application of the current French guidelines as to fasting during labor.
description: Questionnaire focuses on :
oral intake of clear fluid during the labor
oral intake of solid meal during the labor
fasting duration for solid and liquids
instruction received as to fasting during labor, nature of these instructions, and who given the instruction (midwife, nurse anesthetist, …)
discomfort related to thirst during labor
discomfort related to hunger during labor
We will also record several medical data as to the course of pregnancy and delivery, analgesia technique, history and characteristics of the parturient.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor