Unrestricted Low Fat, Low Residue Oral Intake During Labor: A Randomized Controlled Study
| Registry | NCT03276741 |
|---|---|
| Status | Terminated - Unable to recruit to enrollment target |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: single, supportive care |
| Enrollment | 126 (Actual) |
| Sponsor | David Grant U.S. Air Force Medical Center (Fed) |
| Conditions | Labor Complication, Food Aspiration, Complication of Anesthesia, Satisfaction |
| Interventions | gastric soft/bland diet (Dietary supplement) |
| Dates | start 2017-09-29, primary completion 2020-01-11, completion 2020-01-11, first posted 2017-09-08, last updated 2020-04-24 |
| Locations | 1 site in United States |
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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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Control Group | No intervention | Routine care during labor (authorized clear liquid diet). | |
| Experimental Group | Active comparator | Dietary Supplement: gastric soft/bland diet | 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. |
Sex: Female, ages: 18 Years to any, 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
| Facility | City | Country | Status |
|---|---|---|---|
| USAF David Grant Medical Center | Travis Air Force Base, California | United States |