Oral Intake During Labor

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Dietary Supplement: gastric soft/bland diet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: quantitative, randomized experimental design study
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Group<br>Routine care during labor (authorized clear liquid diet). | |
| Active Comparator: Experimental Group<br>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<br>* Patients in the experimental group will have a gastric soft/bland diet available.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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labor, anesthesia, oral intake, maternal satisfaction, newborn complications