NCT03276741

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
126

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 6, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 8, 2017

Completed
21 days until next milestone

Study Start

First participant enrolled

September 29, 2017

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 11, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 11, 2020

Completed
Last Updated

April 24, 2020

Status Verified

April 1, 2020

Enrollment Period

2.3 years

First QC Date

September 6, 2017

Last Update Submit

April 22, 2020

Conditions

Labor ComplicationFood AspirationComplication of AnesthesiaSatisfaction

Keywords

laboranesthesiaoral intakematernal satisfactionnewborn complications

Outcome Measures

Primary Outcomes (7)

  • Nausea

    \# episodes

    active labor (6cm or greater dilation) through delivery of the infant

  • Vomiting

    \# episodes

    active labor (6cm or greater dilation) through delivery of the infant

  • Duration of labor

    #hours/minutes

    active labor (6cm or greater dilation) through delivery of the infant

  • Mode of delivery

    cesarean section, operative vaginal delivery, spontaneous vaginal delivery

    at birth

  • Aspiration

    \# episodes

    active labor (6cm or greater dilation) through delivery of the infant

  • Newborn APGAR Score

    \< 7

    5 min of life

  • Maternal Satisfaction

    open ended survey question

    active labor (6cm or greater dilation) through delivery of the infant

Study Arms (2)

Control Group

NO INTERVENTION

Routine care during labor (authorized clear liquid diet).

Experimental Group

ACTIVE COMPARATOR

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

Interventions

gastric soft/bland dietDIETARY_SUPPLEMENT

Patients in the experimental group will have a gastric soft/bland diet available.

Experimental Group

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsStudy includes pregnant women
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Active Duty and Department of Defense (DoD) beneficiary Pregnant women 18 years of age and older
  • weeks gestation or greater at time of admission
  • singleton fetus
  • cephalic presentation
  • who plan to labor/deliver at DGMC (military beneficiaries).

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

USAF David Grant Medical Center

Travis Air Force Base, California, 94535, United States

Location

MeSH Terms

Conditions

Obstetric Labor ComplicationsPersonal Satisfaction

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesBehavior

Study Officials

  • Jeanette M Anderson, MSN

    David Grant Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Personal identification removed (use of personal identification code)
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: quantitative, randomized experimental design study
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Branch Chief, Provision of Inpatient Nursing Care

Study Record Dates

First Submitted

September 6, 2017

First Posted

September 8, 2017

Study Start

September 29, 2017

Primary Completion

January 11, 2020

Study Completion

January 11, 2020

Last Updated

April 24, 2020

Record last verified: 2020-04

Locations

US(1)