PregnancyNCT01672424
Ultrasound Assessment of Gastric Emptying
An observational study of Pregnancy, run by University of Pittsburgh at 1 site in United States.
Trial summary
Hypothesis: The volume of gastric contents will be the same for a high protein drink versus ice chips as measured by ultrasound at 20 minute intervals for two hours in the laboring parturient. Read more about this study
- Who is it for?
- Ages 14 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy
- What is being tested?
- Ice Chips and Protein Drink
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- May 2012to Aug 2012
- Phase
- Observational
- 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 14 to 50 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: All women of childbearing age (including children aged 14 years and above) who request epidural analgesia at Magee-Womens Hospital of UPMC will be eligible to participate in the study. The racial, gender and ethnic characteristics of the proposed subject population reflects the demographics of Pittsburgh and the surrounding area and/or the patient population of the University of Pittsburgh Medical Center Health System. Every attempt will be made to recruit subjects in respective proportion to these demographics.
Who may be able to join
- All women of childbearing age (including children aged 14 years and above) who request epidural analgesia at Magee-Womens Hospital of UPMC will be eligible to participate in the study
- All participants will be recruited at Magee-Womens Hospital
- All women must present ≤ 5cm cervical dilatation at the time of epidural insertion
- > 36 weeks gestation
- Singleton pregnancy
- Vertex presentation
- NPO ≥ 4 hours prior to epidural insertion
Who cannot join
- Women with diabetes (at increased risk for gastroparesis and fetal macrosomia)
- Multiple gestation
- Non-vertex fetal presentation
- Chronic opioid use (delayed gastric emptying)
- History of gastric bypass surgery (abnormal anatomical stomach)
- Severe morbid obesity (BMI > 40kg/m2 due to increased intragastric pressure)
Show all 9Show fewer
- History of known obstetric or medical complication (i.e. preeclampsia) that may increase the likelihood of a complicated or operative delivery (i.e. cesarean section)
- No exclusion criteria shall be based on race and ethnicity
- Men will not be included since they cannot become pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
UPMC Magee-Womens Hospital
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Ultrasound Assessment of Gastric Emptying Following the Addition of a High Protein Drink vs Ice Chips During Labor
Hypothesis: The volume of gastric contents will be the same for a high protein drink versus ice chips as measured by ultrasound at 20 minute intervals for two hours in the laboring parturient.
Specific Aim: To determine the volume of gastric contents at various time intervals (every 20 minutes for 2 hours) in patients with an epidural that are given a high protein drink versus those that are given ice chips, with ultrasound.
Read the detailed description
Since the 1940s women have had restrictions on oral intake during labor. This idea was first introduced by Mendelson, who raised awareness on the relationship between oral intake during labor and the risk of aspiration of acidic gastric contents if general anesthesia was needed. The aspiration of gastric contents could potentially result in severe maternal morbidity or mortality. As a result, women in labor who receive analgesia are typically restricted to just ice chips in order to prevent aspiration in the rare case that they may require general anesthesia for an emergent or stat cesarean section.
However, recent literature reports that the actual risk of aspiration during labor is extremely low. The risk of aspiration is minimized due to improved general anesthetic techniques involving the use of non-particulate antacids to neutralize gastric acidity and rapid sequence induction to quickly secure the patients airway. Many countries have lenient policies on NPO status during labor, including the Netherlands and United Kingdom, who allow solid food intake during this period.
The policy of "nothing by mouth" during labor and the relationship of aspiration of gastric contents were explored by Mendelson. He experimented on rabbits to explore the effects of gastric contents on their lungs. The rabbits only died when they aspirated material containing hydrochloric acid, and no deaths were due to aspiration of fluids with a neutral pH. Therefore, if oral intake in labor were to be permitted, the ideal characteristics would be for the substance to be in liquid form, isotonic, normothermic, pH of 7.4, and have a low residue.
Labor can be compared to continuous moderate aerobic exercise and these women can experience a state of accelerated starvation. This state of starvation results in the production of ketones for an alternative source of energy. There is much debate about whether this production is harmful to the mother or fetus. A study done by Kubli in 2002 evaluated the effects of isotonic sports drinks and the production of ketones. The drinks decreased ketosis but proved no benefit regarding labor outcome (i.e. length of labor, spontaneous delivery rate). It is important to note that isotonic sports drinks do not contain a significant amount of protein.
It is common for many women in labor to experience nausea and emesis. Protein intake during labor may have a beneficial effect in the prevention of nausea and emesis. The feeling of nausea is experienced when stomach muscles contract irregularly and protein has been shown to re-establish a normal, steadier, and slower rhythm. Protein has been believed to decrease incidence of nausea by decreasing these so-called gastric arrhythmias more so than a carbohydrate meal can (i.e. non-beneficial effect of isotonic sports drinks). It has also been shown that high protein intake decreases nausea and emesis in patients receiving cancer chemotherapy. Furthermore, it has been determined that administration of a protein-rich intake prevents nausea whether given 5 minutes or 45 minutes prior to the nauseating stimuli (i.e. cancer chemotherapy).
It is traditionally thought that gastric emptying in pregnancy is delayed related to changes in hormones such as progesterone as well as the increased abdominal pressure on the gastrum. Perlas et al. has determined that bedside ultrasonography can be a useful non invasive tool to determine gastric content and volume and that the gastric antrum view is the best view to determine gastric volume. In their study of 18 healthy volunteers, a complete cross sectional view of the antrum was obtained 100% of the time, and they found the correlation coefficient to be 0.86 in the right lateral decubitus position. However, their study was not performed on pregnant women.
Wong and colleagues have done several gastric emptying studies after ingestion of water using ultrasound on obese and non-obese non-laboring parturients. In their study of term non laboring women, they found gastric emptying half time was shorter (24 min vs. 33 min) after the ingestion of 300 ml of water than after 50 ml of water. In term obese pregnant women, they did not find any significant difference in gastric emptying after ingestion of 300 ml vs 50 ml. In effect, all water in both studies was back to baseline level at 60 mins post ingestion.
We are unaware of the gastric emptying time of protein solution in pregnant women. Barret et al. has determined that complete gastric emptying of a protein solution takes approximately 2 hours as compared to 1 hour for a glucose solution, and 3 hours for a solid meal in healthy non pregnant adults.
As a follow up to the protein study (PRO10070074), we plan on evaluating the gastric emptying of the protein drink and ice chips using ultrasound to determine gastric volume as described above.
- Conditions
- Pregnancy
- Being tested
- Ice Chips, Protein Drink
- Keywords
- NPO, Gastric Emptying, Ice Chips, Protein Drink, Ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ice ChipsOther
11 ounces of ice chips given to the laboring parturient
Protein DrinkOther
Also called Premier Nutrition Protein Shake (TM)
Patients will receive 11 ounces of a protein shake which contains 30 grams of protein
| Study group | Role | What they receive |
|---|---|---|
| Group P: High Protein Drink | Patients receiving the high protein drink with 30 grams of protein in 11 fluid ounces. Receives: Other: Protein Drink | |
| Group C: Ice Chips | The control group consisting patient receiving 11 ounces of ice chips Receives: Other: Ice Chips |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastric Emptying
Gastric emptying will be measured with ultrasounds every twenty minutes for two hours
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2012 (estimated)
- Study startMay 2012
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Manuel C Vallejo, MD, Principal investigator, Physician Services Division (UPP and CMI) | UPP | Anesthesiology and Pain Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01672424
- Sponsor's protocol ID
- PRO11090441
- Status last verified
- Feb 2013
- First submitted
- 21 Aug 2012
- Last updated
- 4 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Assessment of Gastric Emptying Following the Addition of a High Protein Drink vs Ice Chips During Labor
- ClinicalTrials.gov ID
- NCT01672424
- Acronym / sponsor ID
- PRO11090441
- Conditions
- Pregnancy
- Keywords
- NPO, Gastric Emptying, Ice Chips, Protein Drink, Ultrasound
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 24 Aug 2012 (estimated)
- 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.
Hypothesis: The volume of gastric contents will be the same for a high protein drink versus ice chips as measured by ultrasound at 20 minute intervals for two hours in the laboring parturient.
Specific Aim: To determine the volume of gastric contents at various time intervals (every 20 minutes for 2 hours) in patients with an epidural that are given a high protein drink versus those that are given ice chips, with ultrasound.
Detailed description
Since the 1940s women have had restrictions on oral intake during labor. This idea was first introduced by Mendelson, who raised awareness on the relationship between oral intake during labor and the risk of aspiration of acidic gastric contents if general anesthesia was needed. The aspiration of gastric contents could potentially result in severe maternal morbidity or mortality. As a result, women in labor who receive analgesia are typically restricted to just ice chips in order to prevent aspiration in the rare case that they may require general anesthesia for an emergent or stat cesarean section.
However, recent literature reports that the actual risk of aspiration during labor is extremely low. The risk of aspiration is minimized due to improved general anesthetic techniques involving the use of non-particulate antacids to neutralize gastric acidity and rapid sequence induction to quickly secure the patients airway. Many countries have lenient policies on NPO status during labor, including the Netherlands and United Kingdom, who allow solid food intake during this period.
The policy of "nothing by mouth" during labor and the relationship of aspiration of gastric contents were explored by Mendelson. He experimented on rabbits to explore the effects of gastric contents on their lungs. The rabbits only died when they aspirated material containing hydrochloric acid, and no deaths were due to aspiration of fluids with a neutral pH. Therefore, if oral intake in labor were to be permitted, the ideal characteristics would be for the substance to be in liquid form, isotonic, normothermic, pH of 7.4, and have a low residue.
Labor can be compared to continuous moderate aerobic exercise and these women can experience a state of accelerated starvation. This state of starvation results in the production of ketones for an alternative source of energy. There is much debate about whether this production is harmful to the mother or fetus. A study done by Kubli in 2002 evaluated the effects of isotonic sports drinks and the production of ketones. The drinks decreased ketosis but proved no benefit regarding labor outcome (i.e. length of labor, spontaneous delivery rate). It is important to note that isotonic sports drinks do not contain a significant amount of protein.
It is common for many women in labor to experience nausea and emesis. Protein intake during labor may have a beneficial effect in the prevention of nausea and emesis. The feeling of nausea is experienced when stomach muscles contract irregularly and protein has been shown to re-establish a normal, steadier, and slower rhythm. Protein has been believed to decrease incidence of nausea by decreasing these so-called gastric arrhythmias more so than a carbohydrate meal can (i.e. non-beneficial effect of isotonic sports drinks). It has also been shown that high protein intake decreases nausea and emesis in patients receiving cancer chemotherapy. Furthermore, it has been determined that administration of a protein-rich intake prevents nausea whether given 5 minutes or 45 minutes prior to the nauseating stimuli (i.e. cancer chemotherapy).
It is traditionally thought that gastric emptying in pregnancy is delayed related to changes in hormones such as progesterone as well as the increased abdominal pressure on the gastrum. Perlas et al. has determined that bedside ultrasonography can be a useful non invasive tool to determine gastric content and volume and that the gastric antrum view is the best view to determine gastric volume. In their study of 18 healthy volunteers, a complete cross sectional view of the antrum was obtained 100% of the time, and they found the correlation coefficient to be 0.86 in the right lateral decubitus position. However, their study was not performed on pregnant women.
Wong and colleagues have done several gastric emptying studies after ingestion of water using ultrasound on obese and non-obese non-laboring parturients. In their study of term non laboring women, they found gastric emptying half time was shorter (24 min vs. 33 min) after the ingestion of 300 ml of water than after 50 ml of water. In term obese pregnant women, they did not find any significant difference in gastric emptying after ingestion of 300 ml vs 50 ml. In effect, all water in both studies was back to baseline level at 60 mins post ingestion.
We are unaware of the gastric emptying time of protein solution in pregnant women. Barret et al. has determined that complete gastric emptying of a protein solution takes approximately 2 hours as compared to 1 hour for a glucose solution, and 3 hours for a solid meal in healthy non pregnant adults.
As a follow up to the protein study (PRO10070074), we plan on evaluating the gastric emptying of the protein drink and ice chips using ultrasound to determine gastric volume as described above.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group P: High Protein Drink | – | Other: Protein DrinkPatients receiving the high protein drink with 30 grams of protein in 11 fluid ounces. |
| Group C: Ice Chips | – | Other: Ice ChipsThe control group consisting patient receiving 11 ounces of ice chips |
Who may qualify
- Ages
- 14 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- All women of childbearing age (including children aged 14 years and above) who request epidural analgesia at Magee-Womens Hospital of UPMC will be eligible to participate in the study. The racial, gender and ethnic characteristics of the proposed subject population reflects the demographics of Pittsburgh and the surrounding area and/or the patient population of the University of Pittsburgh Medical Center Health System. Every attempt will be made to recruit subjects in respective proportion to these demographics.
Key inclusion criteria (7 listed)
- All women of childbearing age (including children aged 14 years and above) who request epidural analgesia at Magee-Womens Hospital of UPMC will be eligible to participate in the study
- All participants will be recruited at Magee-Womens Hospital
- All women must present ≤ 5cm cervical dilatation at the time of epidural insertion
- > 36 weeks gestation
- Singleton pregnancy
Key exclusion criteria (9 listed)
- Women with diabetes (at increased risk for gastroparesis and fetal macrosomia)
- Multiple gestation
- Non-vertex fetal presentation
- Chronic opioid use (delayed gastric emptying)
- History of gastric bypass surgery (abnormal anatomical stomach)
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 |
|---|---|---|
| Ice Chips11 ounces of ice chips given to the laboring parturient | Other | Group C: Ice Chips |
| Protein DrinkAlso: Premier Nutrition Protein Shake (TM)Patients will receive 11 ounces of a protein shake which contains 30 grams of protein | Other | Group P: High Protein Drink |
Primary outcome
Gastric Emptying
Time frame: 2 hours
Gastric emptying will be measured with ultrasounds every twenty minutes for two hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2013.
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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.
Manuel C Vallejo, MD principal investigator
Physician Services Division (UPP and CMI) | UPP | Anesthesiology and Pain Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy, run by University of Pittsburgh 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 7 inclusion and 9 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: finished, as of the sponsor's last update on 4 Feb 2013. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Gastric Emptying (time frame: 2 hours). 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 4 Feb 2013.