Satisfaction Clinical Trial
Official title:
Unrestricted Low Fat, Low Residue Oral Intake During Labor: A Randomized Controlled Study
Verified date | April 2020 |
Source | David Grant U.S. Air Force Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 126 |
Est. completion date | January 11, 2020 |
Est. primary completion date | January 11, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | USAF David Grant Medical Center | Travis Air Force Base | California |
Lead Sponsor | Collaborator |
---|---|
David Grant U.S. Air Force Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Nausea | # episodes | active labor (6cm or greater dilation) through delivery of the infant | |
Primary | Vomiting | # episodes | active labor (6cm or greater dilation) through delivery of the infant | |
Primary | Duration of labor | #hours/minutes | active labor (6cm or greater dilation) through delivery of the infant | |
Primary | Mode of delivery | cesarean section, operative vaginal delivery, spontaneous vaginal delivery | at birth | |
Primary | Aspiration | # episodes | active labor (6cm or greater dilation) through delivery of the infant | |
Primary | Newborn APGAR Score | < 7 | 5 min of life | |
Primary | Maternal Satisfaction | open ended survey question | active labor (6cm or greater dilation) through delivery of the infant |
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