<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/NCT03276741</url>
  </required_header>
  <id_info>
    <org_study_id>FDG20170006H</org_study_id>
    <nct_id>NCT03276741</nct_id>
  </id_info>
  <brief_title>Oral Intake During Labor</brief_title>
  <official_title>Unrestricted Low Fat, Low Residue Oral Intake During Labor: A Randomized Controlled Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>David Grant U.S. Air Force Medical Center</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>David Grant U.S. Air Force Medical Center</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>
      A randomized clinical trial (RCT) to evaluate the impact of unrestricted low fat, low residue&#xD;
      oral intake during labor on maternal and neonatal outcomes as well as maternal satisfaction.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is a quantitative, randomized experimental design study to determine the impact of&#xD;
      unrestricted low fat, low residue oral intake during labor on the indicated outcome variables&#xD;
      and patient satisfaction. The comparison group will continue standard care of being allowed a&#xD;
      clear liquid during active labor (≥6cm dilation), while the experimental group would be&#xD;
      allowed to self-regulate oral intake with a low fat, low residue diet during active labor.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Unable to recruit to enrollment target&#xD;
  </why_stopped>
  <start_date type="Actual">September 29, 2017</start_date>
  <completion_date type="Actual">January 11, 2020</completion_date>
  <primary_completion_date type="Actual">January 11, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>quantitative, randomized experimental design study</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>Personal identification removed (use of personal identification code)</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Nausea</measure>
    <time_frame>active labor (6cm or greater dilation) through delivery of the infant</time_frame>
    <description># episodes</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Vomiting</measure>
    <time_frame>active labor (6cm or greater dilation) through delivery of the infant</time_frame>
    <description># episodes</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Duration of labor</measure>
    <time_frame>active labor (6cm or greater dilation) through delivery of the infant</time_frame>
    <description>#hours/minutes</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mode of delivery</measure>
    <time_frame>at birth</time_frame>
    <description>cesarean section, operative vaginal delivery, spontaneous vaginal delivery</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Aspiration</measure>
    <time_frame>active labor (6cm or greater dilation) through delivery of the infant</time_frame>
    <description># episodes</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Newborn APGAR Score</measure>
    <time_frame>5 min of life</time_frame>
    <description>&lt; 7</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Maternal Satisfaction</measure>
    <time_frame>active labor (6cm or greater dilation) through delivery of the infant</time_frame>
    <description>open ended survey question</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">126</enrollment>
  <condition>Labor Complication</condition>
  <condition>Food Aspiration</condition>
  <condition>Complication of Anesthesia</condition>
  <condition>Satisfaction</condition>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Routine care during labor (authorized clear liquid diet).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Experimental Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients in the experimental group will have a gastric soft/bland diet available, which will include lean protein, fruits, vegetables, and low-fat dairy. This will be ordered in the electronic medical record (EMR) and is a standard &quot;non-select meal,&quot; referred to as a gastric/soft bland diet that is not based on patient's preferred menu selections.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>gastric soft/bland diet</intervention_name>
    <description>Patients in the experimental group will have a gastric soft/bland diet available.</description>
    <arm_group_label>Experimental Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Active Duty and Department of Defense (DoD) beneficiary Pregnant women 18 years of age&#xD;
             and older&#xD;
&#xD;
          -  37 weeks gestation or greater at time of admission&#xD;
&#xD;
          -  singleton fetus&#xD;
&#xD;
          -  cephalic presentation&#xD;
&#xD;
          -  who plan to labor/deliver at DGMC (military beneficiaries).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Morbid/severe obesity (pre-pregnancy BMI ≥40 kg/m2&#xD;
&#xD;
          -  diabetes&#xD;
&#xD;
          -  hypertension (to include pre-eclampsia or eclampsia)&#xD;
&#xD;
          -  previous cesarean section&#xD;
&#xD;
          -  uncontrolled gastroesophageal reflux disease (GERD) (symptomatic with medication)&#xD;
&#xD;
          -  past history or current diagnosis of hyperemesis gravidarum&#xD;
&#xD;
          -  food allergies to any items contained in the gastric/soft bland diet&#xD;
&#xD;
          -  patients utilizing nitrous oxide for labor analgesia (should this treatment be&#xD;
             available at DGMC)&#xD;
&#xD;
          -  Difficult airway as defined by the anesthesia staff.&#xD;
&#xD;
          -  Mallampati score 3 or 4&#xD;
&#xD;
          -  Thyroid mental distance less than 7 cm or 3 finger breaths&#xD;
&#xD;
          -  Mouth opening less than 3 finger breaths&#xD;
&#xD;
          -  Short thick neck, Micrognathia&#xD;
&#xD;
          -  Further indications as determined by the anesthesia provider doing the anesthesia&#xD;
             preoperative assessment (pregnancy in and of itself will not be considered a&#xD;
             disqualification due to airway changes during labor)&quot; in order to define difficult&#xD;
             airway per anesthesia.&#xD;
&#xD;
          -  Under age 18&#xD;
&#xD;
          -  Additional clinical risk factors as determined by the care provider&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Study includes 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>Jeanette M Anderson, MSN</last_name>
    <role>Principal Investigator</role>
    <affiliation>David Grant Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>USAF David Grant Medical Center</name>
      <address>
        <city>Travis Air Force Base</city>
        <state>California</state>
        <zip>94535</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>September 6, 2017</study_first_submitted>
  <study_first_submitted_qc>September 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 8, 2017</study_first_posted>
  <last_update_submitted>April 22, 2020</last_update_submitted>
  <last_update_submitted_qc>April 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 24, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>David Grant U.S. Air Force Medical Center</investigator_affiliation>
    <investigator_full_name>Jeanette Anderson</investigator_full_name>
    <investigator_title>Branch Chief, Provision of Inpatient Nursing Care</investigator_title>
  </responsible_party>
  <keyword>labor</keyword>
  <keyword>anesthesia</keyword>
  <keyword>oral intake</keyword>
  <keyword>maternal satisfaction</keyword>
  <keyword>newborn complications</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obstetric Labor Complications</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>December 18, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/41/NCT03276741/ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03276741
org study id: FDG20170006H
nct id: NCT03276741
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A randomized clinical trial (RCT) to evaluate the impact of unrestricted low fat, low residue
      oral intake during labor on maternal and neonatal outcomes as well as maternal satisfaction.
This study is a quantitative, randomized experimental design study to determine the impact of
      unrestricted low fat, low residue oral intake during labor on the indicated outcome variables
      and patient satisfaction. The comparison group will continue standard care of being allowed a
      clear liquid during active labor (≥6cm dilation), while the experimental group would be
      allowed to self-regulate oral intake with a low fat, low residue diet during active labor.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: quantitative, randomized experimental design study
primary purpose: Supportive Care
masking: Single (Outcomes Assessor)
masking description: Personal identification removed (use of personal identification code)
measure: Nausea
time frame: active labor (6cm or greater dilation) through delivery of the infant
description: # episodes
measure: Vomiting
time frame: active labor (6cm or greater dilation) through delivery of the infant
description: # episodes
measure: Duration of labor
time frame: active labor (6cm or greater dilation) through delivery of the infant
description: #hours/minutes
measure: Mode of delivery
time frame: at birth
description: cesarean section, operative vaginal delivery, spontaneous vaginal delivery
measure: Aspiration
time frame: active labor (6cm or greater dilation) through delivery of the infant
description: # episodes
measure: Newborn APGAR Score
time frame: 5 min of life
description: < 7
measure: Maternal Satisfaction
time frame: active labor (6cm or greater dilation) through delivery of the infant
description: open ended survey question
arm group label: Control Group
arm group type: No Intervention
description: Routine care during labor (authorized clear liquid diet).
arm group label: Experimental Group
arm group type: Active Comparator
description: Patients in the experimental group will have a gastric soft/bland diet available, which will include lean protein, fruits, vegetables, and low-fat dairy. This will be ordered in the electronic medical record (EMR) and is a standard "non-select meal," referred to as a gastric/soft bland diet that is not based on patient's preferred menu selections.
intervention type: Dietary Supplement
intervention name: gastric soft/bland diet
description: Patients in the experimental group will have a gastric soft/bland diet available.
arm group label: Experimental Group
criteria: 
gender: Female
gender based: Yes
gender description: Study includes pregnant women
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Jeanette M Anderson, MSN
role: Principal Investigator
affiliation: David Grant Medical Center
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: David Grant U.S. Air Force Medical Center
investigator full name: Jeanette Anderson
investigator title: Branch Chief, Provision of Inpatient Nursing Care
mesh term: Obstetric Labor Complications
provided document: 