PregnancyNCT04229043
Gastric Emptying of Water and Sports Drink in Labor
A study testing Sports drink and Water in people with Pregnancy and Gastric Emptying, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial summary
To determine the half time of the emptying of the stomach of women in early labor with and without epidural pain relief when drinking either water or a carbohydrate-based sports drink. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Pregnancy, Gastric Emptying
- What is being tested?
- Sports drink and Water
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 108 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2021to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Gestational age of 36 weeks or greater
- American Society of Anesthesiology Physical Status 2 or 3
- Induction of labor or early labor (cervical dilation < 6cm)
- Singleton gestation
Who cannot join
- Recent food ingestion (<3 hours)
- Preeclampsia
- Receiving magnesium sulfate
- Having received narcotics within 12 hours
- Diabetes mellitus
- Multiple gestations
- Active nausea or reflux symptoms
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Beth Isreal Deaconess Medical Center
Boston, Massachusetts, 02215
Diana Cepeda, 6176674113, dcepeda@bidmc.harvard.edu
Yunping Li, MD
About this study
Official title: Examining the Gastric Emptying Halftime of Water Versus a Carbohydrate in Early Labor
To determine the half time of the emptying of the stomach of women in early labor with and without epidural pain relief when drinking either water or a carbohydrate-based sports drink.
Read the detailed description
This is a randomized un-blinded study comparing the gastric emptying halftime of water versus a carbohydrate-based sports drink.
Cohorts Women in early labor who have not received pain medication will be enrolled in the study. This will be called the 'unmedicated' group. A second cohort of women who have received an epidural in early labor will be enrolled and studied using identical methods. This will be the 'epidural' group.
Study Intervention Subjects in each group will drink one of two drinks: water or sports drink. The changing volume in the stomach will be measured using ultrasound over the next 60 minutes. Subjects will be asked their degree of hunger on a 10-centimeter visual analogue scale prior to drinking, and for the next two hours at regular intervals. Subjects will be free to consume as per obstetric protocols. The study will be finished once the patient consumes food or drink, feels hunger ≥4/10, or two hours after the sports drink.
Hypothesis The primary hypothesis is that water will empty faster than the sports drink. A second hypothesis is that women with epidural pain relief will have similar gastric halftimes as women without pain medications.
- Conditions
- Pregnancy, Gastric Emptying
- Being tested
- Sports drink, Water
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sports drinkDietary supplement
Drink that will be ingested
WaterDietary supplement
Drink that will be ingested
| Study group | Role | What they receive |
|---|---|---|
| Early labor, no analgesia: Sports drink | Active comparator | Subject will ingest 100 ml of a carbohydrate sports drink Receives: Dietary Supplement: Sports drink |
| Early Labor, no analgesia: Water | Placebo comparator | Subject will ingest 100 ml of water Receives: Dietary Supplement: Water |
| Early labor, analgesia: Sports drink | Active comparator | Subject will ingest 100 ml of a carbohydrate sports drink Receives: Dietary Supplement: Sports drink |
| Early labor, analgesia: Water | Placebo comparator | Subject will ingest 100 ml of water Receives: Dietary Supplement: Water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastric emptying half time
The time in minutes that half of the volume of the stomach has emptied
Measured: 60 minutes
Secondary outcomes (1)
Hunger
The amount of hunger that the subject feels measured on a visual analogue 10-centimeter line, with the left (0 cm) being labeled 'No Hunger' and the right (10 cm) being labeled 'Maximum hunger'
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2020
- Study start1 Feb 2021
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
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 Beth Israel Deaconess Medical CenterThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects in each group will drink one of two drinks: water or sports drink. We will measure the changing volume in the stomach using ultrasound over the next 60 minutes.
- Masking
- None (open label)
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Phillip Hess, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04229043
- Sponsor's protocol ID
- 2019P001110
- Status last verified
- Oct 2025
- First submitted
- 10 Jan 2020
- Last updated
- 23 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Gastric Emptying Halftime of Water Versus a Carbohydrate in Early Labor
- ClinicalTrials.gov ID
- NCT04229043
- Acronym / sponsor ID
- 2019P001110
- Conditions
- Pregnancy, Gastric Emptying
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 14 Jan 2020 (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.
To determine the half time of the emptying of the stomach of women in early labor with and without epidural pain relief when drinking either water or a carbohydrate-based sports drink.
Detailed description
This is a randomized un-blinded study comparing the gastric emptying halftime of water versus a carbohydrate-based sports drink.
Cohorts Women in early labor who have not received pain medication will be enrolled in the study. This will be called the 'unmedicated' group. A second cohort of women who have received an epidural in early labor will be enrolled and studied using identical methods. This will be the 'epidural' group.
Study Intervention Subjects in each group will drink one of two drinks: water or sports drink. The changing volume in the stomach will be measured using ultrasound over the next 60 minutes. Subjects will be asked their degree of hunger on a 10-centimeter visual analogue scale prior to drinking, and for the next two hours at regular intervals. Subjects will be free to consume as per obstetric protocols. The study will be finished once the patient consumes food or drink, feels hunger ≥4/10, or two hours after the sports drink.
Hypothesis The primary hypothesis is that water will empty faster than the sports drink. A second hypothesis is that women with epidural pain relief will have similar gastric halftimes as women without pain medications.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Subjects in each group will drink one of two drinks: water or sports drink. We will measure the changing volume in the stomach using ultrasound over the next 60 minutes.
| Arm | Type | Receives |
|---|---|---|
| Early labor, no analgesia: Sports drink | Active comparator | Dietary Supplement: Sports drinkSubject will ingest 100 ml of a carbohydrate sports drink |
| Early Labor, no analgesia: Water | Placebo comparator | Dietary Supplement: WaterSubject will ingest 100 ml of water |
| Early labor, analgesia: Sports drink | Active comparator | Dietary Supplement: Sports drinkSubject will ingest 100 ml of a carbohydrate sports drink |
| Early labor, analgesia: Water | Placebo comparator | Dietary Supplement: WaterSubject will ingest 100 ml of water |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Gestational age of 36 weeks or greater
- American Society of Anesthesiology Physical Status 2 or 3
- Induction of labor or early labor (cervical dilation < 6cm)
- Singleton gestation
Key exclusion criteria (7 listed)
- Recent food ingestion (<3 hours)
- Preeclampsia
- Receiving magnesium sulfate
- Having received narcotics within 12 hours
- Diabetes mellitus
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 |
|---|---|---|
| Sports drinkDrink that will be ingested | Dietary supplement | Early labor, analgesia: Sports drink, Early labor, no analgesia: Sports drink |
| WaterDrink that will be ingested | Dietary supplement | Early Labor, no analgesia: Water, Early labor, analgesia: Water |
Primary outcome
Gastric emptying half time
Time frame: 60 minutes
The time in minutes that half of the volume of the stomach has emptied
1 secondary outcome
Hunger
Time frame: 60 minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sports drink and Water in people with Pregnancy and Gastric Emptying, run by Beth Israel Deaconess 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 4 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 23 Oct 2025. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gastric emptying half time (time frame: 60 minutes). 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 23 Oct 2025.