Oral Intake During Labor

David Grant U.S. Air Force Medical Center

Status: Terminated

Conditions: Satisfaction; Complication of Anesthesia; Labor Complication; Food Aspiration

Treatments: Dietary Supplement: gastric soft/bland diet

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT03276741

FDG20170006H

Details and patient eligibility

About

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.

Full 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.

Enrollment: 126 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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126 participants in 2 patient groups

Control Group

No Intervention group

Description:

Routine care during labor (authorized clear liquid diet).

Experimental Group

Active Comparator group

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.

Treatment:

Dietary Supplement: gastric soft/bland diet