Complication of Anesthesia, Food Aspiration, Labor Complication, Satisfaction
Conditions
Keywords
labor, anesthesia, oral intake, maternal satisfaction, newborn complications
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.
Interventions
DIETARY_SUPPLEMENTgastric soft/bland diet
Patients in the experimental group will have a gastric soft/bland diet available.
Sponsors
David Grant U.S. Air Force Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Masking description
Personal identification removed (use of personal identification code)
Intervention model description
quantitative, randomized experimental design study
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Nausea | active labor (6cm or greater dilation) through delivery of the infant | \# episodes |
| Vomiting | active labor (6cm or greater dilation) through delivery of the infant | \# episodes |
| Duration of labor | active labor (6cm or greater dilation) through delivery of the infant | #hours/minutes |
| Mode of delivery | at birth | cesarean section, operative vaginal delivery, spontaneous vaginal delivery |
| Aspiration | active labor (6cm or greater dilation) through delivery of the infant | \# episodes |
| Newborn APGAR Score | 5 min of life | \< 7 |
| Maternal Satisfaction | active labor (6cm or greater dilation) through delivery of the infant | open ended survey question |
Countries
United States
Outcome results
None listed