Ondansetron VS Doxylamine and Pyridoxine in Treating Nausea of Pregnancy
Information source: United States Naval Medical Center, San Diego
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Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Vomiting of Pregnancy
Intervention: Ondansetron (Drug); Doxylamine and pyridoxine (Drug)
Sponsored by: United States Naval Medical Center, San Diego
Official(s) and/or principal investigator(s):
Lauren G Oliveira, DO, Principal Investigator, Affiliation: United States Naval Medical Center, San Diego
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.
Official title: Is Zofran Superior to Pyridoxine at Reducing Nausea and Vomiting in Pregnancy
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Reduction of nausea on the VAS (Visual Analog Scale)
Reduction in vomiting on the VAS
Any adverse effects caused by the study medications.
Minimum age: 18 Years.
Maximum age: 90 Years.
- Women who are less than 16 weeks pregnant by last menstrual period or ultrasound
- Greater than 18 years of age
- English speaking
- No significant visual or hearing impairment
- Requesting treatment for nausea associated with pregnancy
- If nausea or vomiting preexisted the pregnancy
- Requires hospitalization at the time of initial enrollment
- Already taking anti-emetics to include metoclopramide, ondansetron, doxylamine,
pyridoxine, or promethazine
- The patient has an allergy to either study regimen
- If they are unable to return for a follow up visit in 1 week
Locations and Contacts
Naval Medical Center, San Diego, San Diego, California 92134, United States
Starting date: October 2012
Last updated: July 11, 2013