Ondansetron VS Doxylamine and Pyridoxine in Treating Nausea of Pregnancy
Status:
Completed
Trial end date:
2013-04-01
Target enrollment:
Participant gender:
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.
Phase:
N/A
Details
Lead Sponsor:
United States Naval Medical Center, San Diego
Treatments:
Dicyclomine Dicyclomine, doxylamine, pyridoxine drug combination Doxylamine Doxylamine succinate Ondansetron Pyridoxal Pyridoxine Vitamin B 6