Dexamethasone vs Ondansetron After Cesarean Delivery

NCT05692245 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 2023P000019
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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 compare two drugs, ondansetron and dexamethasone to see if the side effects of pain medications are improved after cesarean.

Conditions

Cesarean Section Complications; Nausea and Vomiting, Postoperative

Outcome Measures

Primary Outcomes (1)

• 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

  24 hours

Secondary Outcomes (2)

• Severity of Nausea

  24 hours

• Severity of Pain

  24 hours

Study Arms (2)

Ondansetron

ACTIVE COMPARATOR

ondansetron 4 mg intravenous, given once after initiation of anesthesia

Drug: Ondansetron

Dexamethasone

ACTIVE COMPARATOR

dexamethasone 8 mg intravenous, given once after initiation of anesthesia

Drug: Dexamethasone

Interventions

Dexamethasone DRUG

Administered Medication

Dexamethasone

Ondansetron DRUG

Administered Medication

Ondansetron

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Interventions

Ondansetron; Dexamethasone

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Results Point of Contact

• Title: Philip Hess
• Organization: Beth Israel Deaconess Medical Center

phess@bidmc.harvard.edu

6172832126

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Randomized assignment maintained in a sealed envelop. Study medication provided by a independent party. Investigators remain blinded until completion of analysis.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff

Model Details: Randomized, Double-blind

Study Record Dates

• First Submitted: January 11, 2023
• First Posted: January 20, 2023
• Study Start: March 30, 2023
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2024
• Last Updated: March 13, 2026
• Results First Posted: March 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)