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Dopamine Antagonist
Metoclopramide for Cesarean Section
Phase 4
Waitlist Available
Led By Jennifer Banayan, MD
Research Sponsored by Northwestern University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Healthy (ASA Physical Status 2)
Age >18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 48 hours
Awards & highlights
Study Summary
This trial will compare gastric volumes of women who receive metoclopramide versus placebo prior to scheduled cesarean delivery.
Who is the study for?
This trial is for healthy, non-obese women over 18 years old who are at full term (>37 weeks) with a single pregnancy and scheduled for a cesarean delivery without having eaten (NPO). They should not be in labor, have multiple gestations, GI tract abnormalities or surgeries, renal impairment, or systemic diseases like diabetes.Check my eligibility
What is being tested?
The study aims to compare gastric volumes in pregnant women undergoing cesarean sections who receive either metoclopramide or a placebo. The goal is to determine if metoclopramide reduces the risk of aspiration by decreasing stomach volume.See study design
What are the potential side effects?
Potential side effects from metoclopramide may include drowsiness, restlessness, fatigue and sometimes more serious effects like movement disorders. However, individual reactions can vary.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am generally healthy with mild systemic disease.
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I am older than 18 years.
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My BMI is under 40.
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I am older than 18 years.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 48 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~48 hours
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in gastric volume (mL)
Secondary outcome measures
Adverse events
Incidence (number of events) of nausea and vomiting
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: Group 1 Study Drug MetoclopramideActive Control1 Intervention
Intravenous administration of 10 mg metoclopramide
Group II: Group 2 Study Drug PlaceboPlacebo Group1 Intervention
Intravenous administration of sterile normal saline
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Who is running the clinical trial?
Northwestern UniversityLead Sponsor
1,601 Previous Clinical Trials
915,585 Total Patients Enrolled
Jennifer Banayan, MDPrincipal InvestigatorNorthwestern University
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not speak English.I am taking medication to help with stomach movement.I am older than 18 years.I have diabetes (type 1 or 2).You are pregnant with more than one baby.I have an issue with my upper digestive system.I have had surgery on my digestive system.My kidney function is impaired with high creatinine levels.I am generally healthy with mild systemic disease.I am older than 18 years.My BMI is under 40.You have difficulty thinking, remembering, or making decisions.A pregnancy that has reached full term (more than 37 weeks).I will be put to sleep for surgery using general anesthesia.You are pregnant with only one baby.
Research Study Groups:
This trial has the following groups:- Group 1: Group 1 Study Drug Metoclopramide
- Group 2: Group 2 Study Drug Placebo
Awards:
This trial has 2 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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