Ondansetron VS Doxylamine and Pyridoxine in Treating Nausea of Pregnancy

Vomiting of Pregnancy Clinical Trial

Official title: Is Zofran Superior to Pyridoxine at Reducing Nausea and Vomiting in Pregnancy

Status Completed

Clinical Trial Summary

Our purpose is to determine whether ondansetron, a commonly used antiemetic, is equivalent in efficacy to the combination of pyridoxine and doxylamine, the currently recommended first line therapy for nausea and vomiting in pregnancy by the American Congress of Obstetricians and Gynecologists (ACOG). Since both treatments are safe in pregnancy, many physicians are using ondansetron as first line in practice. Despite this practice and the recommendations from ACOG, there is not data to suggest that ether practice is superior. This will be the first prospective, randomized, double blind, controlled trial comparing the two treatments. We hypothesize that ondansetron will be equally efficacious in reducing nausea and episodes of emesis. By alleviating nausea and vomiting associated with pregnancy, patients will likely benefit from less Emergency Department visits, urgent clinic visits, and admissions for progression to hyperemesis gravidarum.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Vomiting
• Vomiting of Pregnancy

• NCT number: NCT01668069
• Study type: Interventional
• Source: United States Naval Medical Center, San Diego
• Status: Completed
• Phase: N/A
• Start date: October 2012
• Completion date: April 2013