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Oral Intake During Labor

Primary Purpose

Labor Complication, Food Aspiration, Complication of Anesthesia

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
gastric soft/bland diet
Sponsored by
David Grant U.S. Air Force Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Labor Complication focused on measuring labor, anesthesia, oral intake, maternal satisfaction, newborn complications

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • USAF David Grant Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Control Group

Experimental Group

Arm Description

Routine care during labor (authorized clear liquid diet).

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.

Outcomes

Primary Outcome Measures

Nausea
# episodes
Vomiting
# episodes
Duration of labor
#hours/minutes
Mode of delivery
cesarean section, operative vaginal delivery, spontaneous vaginal delivery
Aspiration
# episodes
Newborn APGAR Score
< 7
Maternal Satisfaction
open ended survey question

Secondary Outcome Measures

Full Information

First Posted
September 6, 2017
Last Updated
April 22, 2020
Sponsor
David Grant U.S. Air Force Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03276741
Brief Title
Oral Intake During Labor
Official Title
Unrestricted Low Fat, Low Residue Oral Intake During Labor: A Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Terminated
Why Stopped
Unable to recruit to enrollment target
Study Start Date
September 29, 2017 (Actual)
Primary Completion Date
January 11, 2020 (Actual)
Study Completion Date
January 11, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
David Grant U.S. Air Force Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Labor Complication, Food Aspiration, Complication of Anesthesia, Satisfaction
Keywords
labor, anesthesia, oral intake, maternal satisfaction, newborn complications

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
quantitative, randomized experimental design study
Masking
Outcomes Assessor
Masking Description
Personal identification removed (use of personal identification code)
Allocation
Randomized
Enrollment
126 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Routine care during labor (authorized clear liquid diet).
Arm Title
Experimental Group
Arm Type
Active Comparator
Arm 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(s)
gastric soft/bland diet
Intervention Description
Patients in the experimental group will have a gastric soft/bland diet available.
Primary Outcome Measure Information:
Title
Nausea
Description
# episodes
Time Frame
active labor (6cm or greater dilation) through delivery of the infant
Title
Vomiting
Description
# episodes
Time Frame
active labor (6cm or greater dilation) through delivery of the infant
Title
Duration of labor
Description
#hours/minutes
Time Frame
active labor (6cm or greater dilation) through delivery of the infant
Title
Mode of delivery
Description
cesarean section, operative vaginal delivery, spontaneous vaginal delivery
Time Frame
at birth
Title
Aspiration
Description
# episodes
Time Frame
active labor (6cm or greater dilation) through delivery of the infant
Title
Newborn APGAR Score
Description
< 7
Time Frame
5 min of life
Title
Maternal Satisfaction
Description
open ended survey question
Time Frame
active labor (6cm or greater dilation) through delivery of the infant

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Study includes pregnant women
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeanette M Anderson, MSN
Organizational Affiliation
David Grant Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
USAF David Grant Medical Center
City
Travis Air Force Base
State/Province
California
ZIP/Postal Code
94535
Country
United States

12. IPD Sharing Statement

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Oral Intake During Labor

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