Oral Intake During Labor

Unrestricted Low Fat, Low Residue Oral Intake During Labor: A Randomized Controlled Study

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.

Study Overview

• Status: Terminated
• Conditions: Satisfaction; Labor Complication; Complication of Anesthesia; Food Aspiration
• Intervention / Treatment: Dietary supplement: gastric soft/bland diet

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.

• Study Type: Interventional
• Enrollment (Actual): 126
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Travis Air Force Base, California, United States, 94535
      • USAF David Grant Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nausea	# episodes	active labor (6cm or greater dilation) through delivery of the infant
Vomiting	# episodes	active labor (6cm or greater dilation) through delivery of the infant
Duration of labor	#hours/minutes	active labor (6cm or greater dilation) through delivery of the infant
Mode of delivery	cesarean section, operative vaginal delivery, spontaneous vaginal delivery	at birth
Aspiration	# episodes	active labor (6cm or greater dilation) through delivery of the infant
Newborn APGAR Score	< 7	5 min of life
Maternal Satisfaction	open ended survey question	active labor (6cm or greater dilation) through delivery of the infant

Collaborators and Investigators

• Sponsor: David Grant U.S. Air Force Medical Center
• Investigators: Principal Investigator: Jeanette M Anderson, MSN, David Grant Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): September 29, 2017
• Primary Completion (Actual): January 11, 2020
• Study Completion (Actual): January 11, 2020

Study Registration Dates

• First Submitted: September 6, 2017
• First Submitted That Met QC Criteria: September 7, 2017
• First Posted (Actual): September 8, 2017

Study Record Updates

• Last Update Posted (Actual): April 24, 2020
• Last Update Submitted That Met QC Criteria: April 22, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: anesthesia; labor; oral intake; maternal satisfaction; newborn complications
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications
• Other Study ID Numbers: FDG20170006H

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No