Status:
TERMINATED
Oral Intake During Labor
Lead Sponsor:
David Grant U.S. Air Force Medical Center
Conditions:
Labor Complication
Food Aspiration
Eligibility:
FEMALE
18+ years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 29 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 11 2020
Estimated Enrollment :
126 Patients enrolled
Trial Details
Trial ID
NCT03276741
Start Date
September 29 2017
End Date
January 11 2020
Last Update
April 24 2020
Active Locations (1)
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1
USAF David Grant Medical Center
Travis Air Force Base, California, United States, 94535