Oral Intake During Labor

Not Applicable

Terminated

• Conditions: Labor Complication; Complication of Anesthesia; Satisfaction; Food Aspiration
• Interventions: Dietary Supplement: gastric soft/bland diet

• Registration Number: NCT03276741
• Lead Sponsor: David Grant U.S. Air Force Medical Center

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.

Study Timeline

• Study First Submitted: 2017-09-06
• Study First Submitted QC: 2017-09-07
• Study First Posted: 2017-09-08
• Study Start: 2017-09-29
• Primary Completion: 2020-01-11
• Study Completion: 2020-01-11
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-22
• Last Update Posted: 2020-04-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 126

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental Group	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.

Primary Outcome Measures

Name	Time	Method
Maternal Satisfaction	active labor (6cm or greater dilation) through delivery of the infant	open ended survey question
Aspiration	active labor (6cm or greater dilation) through delivery of the infant	# episodes
Mode of delivery	at birth	cesarean section, operative vaginal delivery, spontaneous vaginal delivery
Duration of labor	active labor (6cm or greater dilation) through delivery of the infant	#hours/minutes
Newborn APGAR Score	5 min of life	\< 7
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

Trial Locations

Locations (1)

USAF David Grant Medical Center; 🇺🇸 Travis Air Force Base, California, United States