Oral Intake During Labor

Stopped early · Not applicable

Conditions studied: Labor Complication, Food Aspiration, Complication of Anesthesia, Satisfaction

In brief

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.

Key facts

Study ID

NCT03276741

Run by

David Grant U.S. Air Force Medical Center

People needed

126

Starts

2017-09-29

Expected to finish

2020-01-11

Last updated by the study team

2020-04-24

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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