An interventional study of gastric soft/bland diet in Labor Complication, Food Aspiration and Complication of Anesthesia, sponsored by David Grant U.S. Air Force Medical Center. Terminated at 1 site in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-04-24.
Sponsored by David Grant U.S. Air Force Medical Center · Not applicable, Interventional, and Supportive care
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.
88 studies on the registry are indexed under Obstetric Labor Complications; 24 are open to participants now.
This study's enrollment of 126 is below the median of 159 across 63 interventional studies indexed under Obstetric Labor Complications.
Browse Obstetric Labor Complications studies →David Grant U.S. Air Force Medical Center is the lead sponsor of 28 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Routine care during labor (authorized clear liquid 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.
Dietary Supplement: gastric soft/bland diet
Patients in the experimental group will have a gastric soft/bland diet available.
Nausea
# episodes
Time frame: active labor (6cm or greater dilation) through delivery of the infant
Vomiting
# episodes
Time frame: active labor (6cm or greater dilation) through delivery of the infant
Duration of labor
#hours/minutes
Time frame: active labor (6cm or greater dilation) through delivery of the infant
Mode of delivery
cesarean section, operative vaginal delivery, spontaneous vaginal delivery
Time frame: at birth
Aspiration
# episodes
Time frame: active labor (6cm or greater dilation) through delivery of the infant
Newborn APGAR Score
\< 7
Time frame: 5 min of life
Maternal Satisfaction
open ended survey question
Time frame: active labor (6cm or greater dilation) through delivery of the infant
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Sep 2017 to primary completion in Jan 2020, 27 months.
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This study is terminated, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.
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Obstetric Labor Complications →
David Grant U.S. Air Force Medical Center