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Oral Intake During Labor

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03276741
Recruitment Status : Terminated (Unable to recruit to enrollment target)
First Posted : September 8, 2017
Last Update Posted : April 24, 2020
Sponsor:
Information provided by (Responsible Party):
Jeanette Anderson, David Grant U.S. Air Force Medical Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Labor Complication Food Aspiration Complication of Anesthesia Satisfaction Dietary Supplement: gastric soft/bland diet Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 126 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: quantitative, randomized experimental design study
Masking: Single (Outcomes Assessor)
Masking Description: Personal identification removed (use of personal identification code)
Primary Purpose: Supportive Care
Official Title: Unrestricted Low Fat, Low Residue Oral Intake During Labor: A Randomized Controlled Study
Actual Study Start Date : September 29, 2017
Actual Primary Completion Date : January 11, 2020
Actual Study Completion Date : January 11, 2020

Arm Intervention/treatment
No Intervention: Control Group
Routine care during labor (authorized clear liquid diet).
Active Comparator: Experimental Group
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.
Dietary Supplement: gastric soft/bland diet
Patients in the experimental group will have a gastric soft/bland diet available.




Primary Outcome Measures :
  1. Nausea [ Time Frame: active labor (6cm or greater dilation) through delivery of the infant ]
    # episodes

  2. Vomiting [ Time Frame: active labor (6cm or greater dilation) through delivery of the infant ]
    # episodes

  3. Duration of labor [ Time Frame: active labor (6cm or greater dilation) through delivery of the infant ]
    #hours/minutes

  4. Mode of delivery [ Time Frame: at birth ]
    cesarean section, operative vaginal delivery, spontaneous vaginal delivery

  5. Aspiration [ Time Frame: active labor (6cm or greater dilation) through delivery of the infant ]
    # episodes

  6. Newborn APGAR Score [ Time Frame: 5 min of life ]
    < 7

  7. Maternal Satisfaction [ Time Frame: active labor (6cm or greater dilation) through delivery of the infant ]
    open ended survey question



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Study includes pregnant women
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Active Duty and Department of Defense (DoD) beneficiary Pregnant women 18 years of age and older
  • 37 weeks gestation or greater at time of admission
  • singleton fetus
  • cephalic presentation
  • who plan to labor/deliver at DGMC (military beneficiaries).

Exclusion Criteria:

  • Morbid/severe obesity (pre-pregnancy BMI ≥40 kg/m2
  • diabetes
  • hypertension (to include pre-eclampsia or eclampsia)
  • previous cesarean section
  • uncontrolled gastroesophageal reflux disease (GERD) (symptomatic with medication)
  • past history or current diagnosis of hyperemesis gravidarum
  • food allergies to any items contained in the gastric/soft bland diet
  • patients utilizing nitrous oxide for labor analgesia (should this treatment be available at DGMC)
  • Difficult airway as defined by the anesthesia staff.
  • Mallampati score 3 or 4
  • Thyroid mental distance less than 7 cm or 3 finger breaths
  • Mouth opening less than 3 finger breaths
  • Short thick neck, Micrognathia
  • Further indications as determined by the anesthesia provider doing the anesthesia preoperative assessment (pregnancy in and of itself will not be considered a disqualification due to airway changes during labor)" in order to define difficult airway per anesthesia.
  • Under age 18
  • Additional clinical risk factors as determined by the care provider

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03276741


Locations
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United States, California
USAF David Grant Medical Center
Travis Air Force Base, California, United States, 94535
Sponsors and Collaborators
David Grant U.S. Air Force Medical Center
Investigators
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Principal Investigator: Jeanette M Anderson, MSN David Grant Medical Center
  Study Documents (Full-Text)

Documents provided by Jeanette Anderson, David Grant U.S. Air Force Medical Center:
Informed Consent Form  [PDF] December 18, 2019

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Responsible Party: Jeanette Anderson, Branch Chief, Provision of Inpatient Nursing Care, David Grant U.S. Air Force Medical Center
ClinicalTrials.gov Identifier: NCT03276741    
Other Study ID Numbers: FDG20170006H
First Posted: September 8, 2017    Key Record Dates
Last Update Posted: April 24, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jeanette Anderson, David Grant U.S. Air Force Medical Center:
labor
anesthesia
oral intake
maternal satisfaction
newborn complications
Additional relevant MeSH terms:
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Obstetric Labor Complications
Pregnancy Complications