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Corticosteroid
Dexamethasone vs Ondansetron for Post-Cesarean Nausea
Phase 4
Waitlist Available
Research Sponsored by Beth Israel Deaconess Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 hours
Awards & highlights
Study Summary
This trial tests which drugs work best to reduce nausea and pain after cesarean delivery in women. #clinicaltrials #womenshealth
Who is the study for?
This trial is for healthy women aged 18-45 undergoing a cesarean delivery with spinal or combined-spinal epidural anesthesia. Participants should be having a single baby at term and not in labor. Women with allergies to study drugs, serious medical conditions, recent antiemetic use, insulin-dependent diabetes, chronic steroid or opioid use are excluded.Check my eligibility
What is being tested?
The study compares ondansetron and dexamethasone as first-line treatments to prevent nausea and vomiting after cesarean delivery. Women will report their symptoms post-surgery to determine which drug better improves side effects from pain medications used during the procedure.See study design
What are the potential side effects?
Possible side effects of ondansetron include headaches, constipation, and light-headedness; while dexamethasone may cause increased blood sugar levels, insomnia, and stomach upset. Each woman's experience with these medications can vary.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 hours
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Severity of Nausea
Secondary outcome measures
Severity of Pain
Severity of Vomiting
Trial Design
2Treatment groups
Active Control
Group I: OndansetronActive Control1 Intervention
ondansetron 4 mg intravenous, given once after initiation of anesthesia
Group II: DexamethasoneActive Control1 Intervention
dexamethasone 8 mg intravenous, given once after initiation of anesthesia
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Who is running the clinical trial?
Beth Israel Deaconess Medical CenterLead Sponsor
836 Previous Clinical Trials
13,010,130 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I used opioids during my pregnancy.I have a chronic pain condition or opioid use disorder.I have a serious health condition.I have severe morning sickness or I regularly use medication to prevent vomiting.I am between 18 and 45 years old.I will receive spinal or combined-spinal epidural anesthesia.I am scheduled for a C-section.I am willing to participate in the clinical trial.I am a healthy woman with minimal health risks.I used steroids almost every day during my pregnancy.I am using medication for severe itching or have had severe itching during pregnancy.I am not allergic to any medications used in this study.I have used anti-nausea medication within 24 hours before my cesarean delivery.I use insulin to manage my diabetes.
Research Study Groups:
This trial has the following groups:- Group 1: Ondansetron
- Group 2: Dexamethasone
Awards:
This trial has 3 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this experiment welcome participants aged 50 and over?
"This trial requires that all enrollees are above the age of consent and below 45 years old."
Answered by AI
What potential risks have been associated with Ondansetron therapy?
"There is considerable clinical data confirming the safety of ondansetron, thus it achieved a rating of 3."
Answered by AI
Is this research opportunity available to participants at the present time?
"This medical experiment, first posted on March 1st 2023 and last updated January 11th 2023, is not currently accepting participants. However, there are 138 other trials with open recruitment at this time."
Answered by AI
Could I potentially be a part of this research endeavor?
"The objective of this medical experiment is to enlist a hundred participants, aged 18-45 and suffering from postoperative nausea/vomiting. The trial seeks healthy female individuals (ASA 2) that recently underwent singleton term pregnancies with neuraxial anesthesia via either spinal or combined-spinal epidural methods."
Answered by AI
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