Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
108 participants
INTERVENTIONAL
2021-02-01
2027-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
The Effects of Increased IV Hydration on Nulliparous Women Undergoing an Induction of Labor
NCT02989571
Intrapartum Hydration
NCT01242293
Effect of Oral Carbohydrate Intake > 44kCal Per Hour During Labour on the Rate of Instrumental Vaginal Delivery
NCT05080309
Ultrasound Assessment of Clear Liquid Intake During Labour
NCT02362815
Gastric Emptying During the Labour
NCT03490682
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Early labor, no analgesia: Sports drink
Subject will ingest 100 ml of a carbohydrate sports drink
Sports drink
Drink that will be ingested
Early Labor, no analgesia: Water
Subject will ingest 100 ml of water
Water
Drink that will be ingested
Early labor, analgesia: Sports drink
Subject will ingest 100 ml of a carbohydrate sports drink
Sports drink
Drink that will be ingested
Early labor, analgesia: Water
Subject will ingest 100 ml of water
Water
Drink that will be ingested
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Sports drink
Drink that will be ingested
Water
Drink that will be ingested
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* American Society of Anesthesiology Physical Status 2 or 3
* Induction of labor or early labor (cervical dilation \< 6cm)
* Singleton gestation
Exclusion Criteria
* Preeclampsia
* Receiving magnesium sulfate
* Having received narcotics within 12 hours
* Diabetes mellitus
* Multiple gestations
* Active nausea or reflux symptoms
18 Years
50 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Beth Israel Deaconess Medical Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Phillip Hess
Principal Investigator
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Beth Isreal Deaconess Medical Center
Boston, Massachusetts, United States
Countries
Review the countries where the study has at least one active or historical site.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2019P001110
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.