Clinical trial NCT03276741: Oral Intake During Labor
Official title: Unrestricted Low Fat, Low Residue Oral Intake During Labor: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Labor Complication
Food Aspiration
Complication of Anesthesia
Satisfaction
Keywords: labor
anesthesia
oral intake
maternal satisfaction
newborn complications
Lead sponsor: David Grant U.S. Air Force Medical Center
Sponsor class: FED
First posted: 2017-09-08
Enrollment: 126
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: quantitative, randomized experimental design study
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Nausea
timeFrame: active labor (6cm or greater dilation) through delivery of the infant
measure: Vomiting
timeFrame: active labor (6cm or greater dilation) through delivery of the infant
measure: Duration of labor
timeFrame: active labor (6cm or greater dilation) through delivery of the infant
measure: Mode of delivery
timeFrame: at birth
measure: Aspiration
timeFrame: active labor (6cm or greater dilation) through delivery of the infant
measure: Newborn APGAR Score
timeFrame: 5 min of life
measure: Maternal Satisfaction
timeFrame: active labor (6cm or greater dilation) through delivery of the infant
Secondary outcomes:
Other outcomes:
Locations:
city: Travis Air Force Base
country: United States
facility: USAF David Grant Medical Center
state: California
Study officials:
affiliation: David Grant Medical Center
name: Jeanette M Anderson, MSN
role: PRINCIPAL_INVESTIGATOR
References: