Labor ComplicationNCT03276741
Oral Intake During Labor
A study testing gastric soft/bland diet in people with Labor Complication and Food Aspiration, run by David Grant U.S. Air Force Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labor Complication, Food Aspiration, Complication of Anesthesia
- What is being tested?
- gastric soft/bland diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Sep 2017to 11 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
USAF David Grant Medical Center
Travis Air Force Base, California, 94535
About this study
Official title: Unrestricted Low Fat, Low Residue Oral Intake During Labor: A Randomized Controlled Study
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.
Read the 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.
- Being tested
- gastric soft/bland diet
- Keywords
- labor, anesthesia, oral intake, maternal satisfaction, newborn complications
- Medical subject headings
- Obstetric Labor Complications, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gastric soft/bland dietDietary supplement
Patients in the experimental group will have a gastric soft/bland diet available.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: gastric soft/bland diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nausea
# episodes
Measured: active labor (6cm or greater dilation) through delivery of the infant
Vomiting
# episodes
Measured: active labor (6cm or greater dilation) through delivery of the infant
Duration of labor
#hours/minutes
Measured: active labor (6cm or greater dilation) through delivery of the infant
Mode of delivery
cesarean section, operative vaginal delivery, spontaneous vaginal delivery
Measured: at birth
Aspiration
# episodes
Measured: active labor (6cm or greater dilation) through delivery of the infant
Newborn APGAR Score
< 7
Measured: 5 min of life
Maternal Satisfaction
open ended survey question
Measured: active labor (6cm or greater dilation) through delivery of the infant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2017
- Study start29 Sep 2017
- Primary completion11 Jan 2020
- Study completion11 Jan 2020
Why it stopped: Unable to recruit to enrollment target
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labor ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- quantitative, randomized experimental design study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- David Grant U.S. Air Force Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Jeanette Anderson, David Grant U.S. Air Force Medical Center
- Investigators
- Jeanette M Anderson, MSN, Principal investigator, David Grant Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03276741
- Sponsor's protocol ID
- FDG20170006H
- Status last verified
- Apr 2020
- First submitted
- 6 Sep 2017
- Last updated
- 24 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Unrestricted Low Fat, Low Residue Oral Intake During Labor: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT03276741
- Acronym / sponsor ID
- FDG20170006H
- Keywords
- labor, anesthesia, oral intake, maternal satisfaction, newborn complications
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to recruit to enrollment target
- Enrolment
- 126 participants (actual)
- Lead sponsor
- David Grant U.S. Air Force Medical CenterUS federal agency
- Study start
- 29 Sep 2017 (actual)
- Primary completion
- 11 Jan 2020 (actual)
- Study completion
- 11 Jan 2020 (actual)
- First posted
- 8 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- quantitative, randomized experimental design study
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Routine care during labor (authorized clear liquid diet). |
| Experimental Group | Active comparator | Dietary Supplement: gastric soft/bland dietPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (16 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| gastric soft/bland dietPatients in the experimental group will have a gastric soft/bland diet available. | Dietary supplement | Experimental Group |
Primary outcome
Nausea
Time frame: active labor (6cm or greater dilation) through delivery of the infant
# episodes
Vomiting
Time frame: active labor (6cm or greater dilation) through delivery of the infant
# episodes
Duration of labor
Time frame: active labor (6cm or greater dilation) through delivery of the infant
#hours/minutes
Mode of delivery
Time frame: at birth
cesarean section, operative vaginal delivery, spontaneous vaginal delivery
Aspiration
Time frame: active labor (6cm or greater dilation) through delivery of the infant
# episodes
Newborn APGAR Score
Time frame: 5 min of life
< 7
Maternal Satisfaction
Time frame: active labor (6cm or greater dilation) through delivery of the infant
open ended survey question
Results and safety
The study was stopped early (reason given: Unable to recruit to enrollment target). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2020.
Related trials for Labor Complication
Enrolling by invitationObservational study
Assessment of Worldwide Acute Kidney Injury Epidemiology in Neonates 2.0
Acute Kidney Injury, Fluid Overload
Recruiting
The Effect of Breast Milk, 10% and 20% Dextrose on Pain and Physiological Variables During Heel Puncture in Infants
Newborn Care, Pain Management
Active, not recruiting
Prone Positioning During Delayed Cord Clamping
Delayed Cord Clamping
Not yet recruiting
The Hemodynamic Impact of High-frequency Oscillatory Ventilation and Periodic Sighs in Preterm Infants
Preterm, Respiratory Distress Syndrome in Premature Infant
RecruitingPhase 3
Selective Antibiotics When Symptoms Develop Versus Universal Antibiotics for Preterm Neonates
Sepsis, PROM, Preterm (Pregnancy)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeanette M Anderson, MSN principal investigator
David Grant Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing gastric soft/bland diet in people with Labor Complication and Food Aspiration, run by David Grant U.S. Air Force Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Unable to recruit to enrollment target). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nausea (time frame: active labor (6cm or greater dilation) through delivery of the infant). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2020.