Ondansetron VS Doxylamine and Pyridoxine in Treating Nausea of Pregnancy

Study Overview
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Brief Summary
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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
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Is Zofran Superior to Pyridoxine at Reducing Nausea and Vomiting in Pregnancy

Conditions
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Vomiting of Pregnancy

Intervention / Treatment
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* Drug: Ondansetron


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ondansetron<br>study drug | Drug: Ondansetron<br>* Ondansetron 4mg and a placebo capsule to be taken orally every 8 hours for 5 days.<br>* Other names: Zofran;|
| No Intervention: Doxylamine and Pyridoxine (vitamin B6)<br>other nausea treatment in use | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of nausea on the VAS (Visual Analog Scale) |  | 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in vomiting on the VAS |  | 5 days | 
| Any adverse effects caused by the study medications. |  | 5 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nausea, vomiting, pregnancy, ondansetron, doxylamine, vitamin B6, pyridoxine