Ondansetron VS Doxylamine and Pyridoxine in Treating Nausea of Pregnancy
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Is Zofran Superior to Pyridoxine at Reducing Nausea and Vomiting in Pregnancy|
- Reduction of nausea on the VAS (Visual Analog Scale) [ Time Frame: 5 days ] [ Designated as safety issue: No ]
- Reduction in vomiting on the VAS [ Time Frame: 5 days ] [ Designated as safety issue: No ]
- Any adverse effects caused by the study medications. [ Time Frame: 5 days ] [ Designated as safety issue: No ]
|Study Start Date:||October 2012|
|Study Completion Date:||April 2013|
|Primary Completion Date:||October 2012 (Final data collection date for primary outcome measure)|
Ondansetron 4mg and a placebo capsule to be taken orally every 8 hours for 5 days.
Other Name: Zofran
|Experimental: Doxylamine and Pyridoxine (vitamin B6)||
Drug: Doxylamine and pyridoxine
Pyridoxine 25mg and doxylamine 12.5mg to be taken orally every 8 hours for 5 days.
Other Name: Vitamin B6
|United States, California|
|Naval Medical Center, San Diego|
|San Diego, California, United States, 92134|
|Principal Investigator:||Lauren G Oliveira, DO||United States Naval Medical Center, San Diego|