Nausea and Vomiting, PostoperativePhase 4NCT05692245
Dexamethasone vs Ondansetron After Cesarean Delivery
A Phase 4 study testing Ondansetron and Dexamethasone in people with Nausea and Vomiting, Postoperative and Cesarean Section Complications, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial summary
The goal of this clinical trial is to compare medications in women having a cesarean delivery. The main question it aims to answer are: Which medication is better to use as a first-line prevention agent for nausea and vomiting Participants will rate their nausea, pain and other symptoms after surgery Researchers will… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Nausea and Vomiting, Postoperative, Cesarean Section Complications
- What is being tested?
- Ondansetron and Dexamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Mar 2023to 30 Apr 2024
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Healthy women (ASA 2)
- Between 18 and 45 years old
- Singleton term pregnancies
- Scheduled or non-labor cesarean delivery
- Neuraxial (spinal or combined-spinal epidural) anesthesia
Who cannot join
- Refusal to participate
- Known allergy or contraindication to any medication used in the study
- Significant medical or obstetrical disease (ASA ≥ 3)
- Antiemetic use within 24 hours preceding cesarean delivery
- Insulin dependent diabetes
- Hyperemesis gravidarum or chronic antiemetic use
Show all 10Show fewer
- History of daily or near-daily steroid use during pregnancy
- Opioid use disorder or other chronic pain syndrome
- Opioid use during pregnancy
- Use of antipruritus medication, pruritic urticarial papules of pregnancy, or cholestasis of pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
Official title: Dexamethasone vs Ondansetron as the First-line Antiemetic to Prevent Postoperative Nausea and Vomiting After Cesarean Delivery
The goal of this clinical trial is to compare medications in women having a cesarean delivery. The main question it aims to answer are:
- Which medication is better to use as a first-line prevention agent for nausea and vomiting Participants will rate their nausea, pain and other symptoms after surgery Researchers will compare two drugs, ondansetron and dexamethasone to see if the side effects of pain medications are improved after cesarean.
Read the detailed description
Cesarean delivery is the most common surgical procedure performed in the United States, with approximately 1.2 million cesarean deliveries performed in 2020.(1) Cesarean delivery is preferentially performed under neuraxial anesthesia (spinal or epidural anesthesia) to allow mothers to be awake during the delivery of their child and to improve maternal safety. Despite the routine use of neuraxial techniques for most cesarean deliveries in the United States, many patients experience nausea and/or vomiting either during surgery (intraoperative nausea and vomiting, IONV) or after surgery (postoperative nausea and vomiting, PONV).
PONV has traditionally been associated with female gender, history of motion sickness, nonsmoking status, and opioid use.(2) Other authors have shown increased PONV risk with younger age, type of surgery, and general anesthesia as opposed to regional or neuraxial anesthesia.(3,4) Intrathecal opioids, are the gold standard for pain relief after cesarean delivery, and are part of the Society for Obstetric Anesthesia and Perinatology's (SOAP) Early Recover After Cesarean (ERAC) guideline. However, these medications have been implicated in increased rates of PONV.(5) Given the prevalence of cesarean delivery and the importance of maternal well-being, prophylaxis of nausea and vomiting remains an important issue to address.
Medications from multiple classes are commonly administered to prevent and treat PONV after cesarean delivery. These include 5-HT3 antagonists, dopaminergic antagonists, corticosteroids, antihistamines, and anticholinergics. Ondansetron, a 5HT3 antagonist, and dexamethasone, a corticosteroid, are among the most commonly administered medications due to their efficacy and long track record of safety during pregnancy. Indeed, the SOAP ERAC guideline recommends that at least two agents from different classes be administered perioperatively to decrease the rates of IONV and PONV.(6) They further suggest metoclopramide for IONV prophylaxis, ondansetron or dexamethasone for PONV prophylaxis.
The safety and efficacy of ondansetron and dexamethasone are further supported by a 2021 Cochrane Systematic review analyzing medical prophylaxis against IONV and PONV in cesarean delivery.(6) Both ondansetron and dexamethasone decreased postoperative nausea (Ond: RR 0.45; 10 RCT, 1340 total subjects; Dex: RR 0.59; 6 studies, 733 women) and vomiting rates (Ond: RR 0.47, 10 studies, 1450 women; Dex: RR 0.68; 7 RCT, 793 women). No adverse events from 5HT3 blocking agents or corticosteroids were identified.
Dexamethasone is intriguing as a first-line agent for cesarean delivery since it may have the added benefit of improved pain control and/or decreased postoperative opioid requirement. Several studies have addressed the role of dexamethasone in pain management. A 2008 study by Jaafarpour et al.(8) found a decrease in composite rates of nausea and vomiting, as well reduction of ~1 point on the VAS pain scale for 24 hours following surgery. Data from other studies have been mixed (9, 10, 11).
In conclusion, there is a gap in knowledge in defining the optimal first-line antiemetic for prophylaxis of PONV in patients undergoing cesarean delivery. The goal of this study is to evaluate the effectiveness of ondansetron vs. dexamethasone on PONV rates and postoperative pain control.
- Being tested
- Ondansetron, Dexamethasone
- Medical subject headings
- Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OndansetronDrug
Administered Medication
DexamethasoneDrug
Administered Medication
| Study group | Role | What they receive |
|---|---|---|
| Ondansetron | Active comparator | ondansetron 4 mg intravenous, given once after initiation of anesthesia Receives: Drug: Ondansetron |
| Dexamethasone | Active comparator | dexamethasone 8 mg intravenous, given once after initiation of anesthesia Receives: Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medications Received
Total number of unscheduled medications administered by nurses to patients and received in the 24 hours after cesarean for the treatment of Nausea, vomiting, pruritus or pain
Measured: 24 hours
Secondary outcomes (2)
Severity of Nausea
Visual analogue score for Nausea scored on a 10 centimeter line with "No nausea" on the left and "Worst possible nausea" on the right. The minimum score was 0, maximum score was 10, with higher scores represent greater nausea.
Measured: 24 hours
Severity of Pain
Visual analogue score for Pain scored on a 10 centimeter line with "No pain" on the left and "Worst possible pain" on the right. The minimum score was 0, maximum score was 10, with higher scores represent greater pain.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2023
- Study start30 Mar 2023
- Primary completion30 Apr 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Nausea and Vomiting, PostoperativeStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, Double-blind
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
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
- NCT05692245
- Sponsor's protocol ID
- 2023P000019
- Status last verified
- Feb 2026
- First submitted
- 11 Jan 2023
- Last updated
- 13 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexamethasone vs Ondansetron as the First-line Antiemetic to Prevent Postoperative Nausea and Vomiting After Cesarean Delivery
- ClinicalTrials.gov ID
- NCT05692245
- Acronym / sponsor ID
- 2023P000019
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Study start
- 30 Mar 2023 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 20 Jan 2023 (actual)
- Results
- Posted 13 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to compare medications in women having a cesarean delivery. The main question it aims to answer are:
- Which medication is better to use as a first-line prevention agent for nausea and vomiting Participants will rate their nausea, pain and other symptoms after surgery Researchers will compare two drugs, ondansetron and dexamethasone to see if the side effects of pain medications are improved after cesarean.
Detailed description
Cesarean delivery is the most common surgical procedure performed in the United States, with approximately 1.2 million cesarean deliveries performed in 2020.(1) Cesarean delivery is preferentially performed under neuraxial anesthesia (spinal or epidural anesthesia) to allow mothers to be awake during the delivery of their child and to improve maternal safety. Despite the routine use of neuraxial techniques for most cesarean deliveries in the United States, many patients experience nausea and/or vomiting either during surgery (intraoperative nausea and vomiting, IONV) or after surgery (postoperative nausea and vomiting, PONV).
PONV has traditionally been associated with female gender, history of motion sickness, nonsmoking status, and opioid use.(2) Other authors have shown increased PONV risk with younger age, type of surgery, and general anesthesia as opposed to regional or neuraxial anesthesia.(3,4) Intrathecal opioids, are the gold standard for pain relief after cesarean delivery, and are part of the Society for Obstetric Anesthesia and Perinatology's (SOAP) Early Recover After Cesarean (ERAC) guideline. However, these medications have been implicated in increased rates of PONV.(5) Given the prevalence of cesarean delivery and the importance of maternal well-being, prophylaxis of nausea and vomiting remains an important issue to address.
Medications from multiple classes are commonly administered to prevent and treat PONV after cesarean delivery. These include 5-HT3 antagonists, dopaminergic antagonists, corticosteroids, antihistamines, and anticholinergics. Ondansetron, a 5HT3 antagonist, and dexamethasone, a corticosteroid, are among the most commonly administered medications due to their efficacy and long track record of safety during pregnancy. Indeed, the SOAP ERAC guideline recommends that at least two agents from different classes be administered perioperatively to decrease the rates of IONV and PONV.(6) They further suggest metoclopramide for IONV prophylaxis, ondansetron or dexamethasone for PONV prophylaxis.
The safety and efficacy of ondansetron and dexamethasone are further supported by a 2021 Cochrane Systematic review analyzing medical prophylaxis against IONV and PONV in cesarean delivery.(6) Both ondansetron and dexamethasone decreased postoperative nausea (Ond: RR 0.45; 10 RCT, 1340 total subjects; Dex: RR 0.59; 6 studies, 733 women) and vomiting rates (Ond: RR 0.47, 10 studies, 1450 women; Dex: RR 0.68; 7 RCT, 793 women). No adverse events from 5HT3 blocking agents or corticosteroids were identified.
Dexamethasone is intriguing as a first-line agent for cesarean delivery since it may have the added benefit of improved pain control and/or decreased postoperative opioid requirement. Several studies have addressed the role of dexamethasone in pain management. A 2008 study by Jaafarpour et al.(8) found a decrease in composite rates of nausea and vomiting, as well reduction of ~1 point on the VAS pain scale for 24 hours following surgery. Data from other studies have been mixed (9, 10, 11).
In conclusion, there is a gap in knowledge in defining the optimal first-line antiemetic for prophylaxis of PONV in patients undergoing cesarean delivery. The goal of this study is to evaluate the effectiveness of ondansetron vs. dexamethasone on PONV rates and postoperative pain control.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, Double-blind
| Arm | Type | Receives |
|---|---|---|
| Ondansetron | Active comparator | Drug: Ondansetronondansetron 4 mg intravenous, given once after initiation of anesthesia |
| Dexamethasone | Active comparator | Drug: Dexamethasonedexamethasone 8 mg intravenous, given once after initiation of anesthesia |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy women (ASA 2)
- Between 18 and 45 years old
- Singleton term pregnancies
- Scheduled or non-labor cesarean delivery
- Neuraxial (spinal or combined-spinal epidural) anesthesia
Key exclusion criteria (10 listed)
- Refusal to participate
- Known allergy or contraindication to any medication used in the study
- Significant medical or obstetrical disease (ASA ≥ 3)
- Antiemetic use within 24 hours preceding cesarean delivery
- Insulin dependent diabetes
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 |
|---|---|---|
| OndansetronAdministered Medication | Drug | Ondansetron |
| DexamethasoneAdministered Medication | Drug | Dexamethasone |
Primary outcome
Medications Received
Time frame: 24 hours
Total number of unscheduled medications administered by nurses to patients and received in the 24 hours after cesarean for the treatment of Nausea, vomiting, pruritus or pain
2 secondary outcomes
Severity of Nausea
Time frame: 24 hours
Severity of Pain
Time frame: 24 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ondansetron and Dexamethasone in people with Nausea and Vomiting, Postoperative and Cesarean Section Complications, 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 5 inclusion and 10 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 13 Mar 2026. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Medications Received (time frame: 24 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 13 Mar 2026.