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Ondansetron VS Doxylamine and Pyridoxine in Treating Nausea of Pregnancy

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StatusCompleted
Sponsors
United States Naval Medical Center, San Diego

Keywords

Abstract

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.

Dates

Last Verified: 03/31/2016
First Submitted: 08/14/2012
Estimated Enrollment Submitted: 08/14/2012
First Posted: 08/16/2012
Last Update Submitted: 04/03/2016
Last Update Posted: 04/05/2016
Actual Study Start Date: 09/30/2012
Estimated Primary Completion Date: 09/30/2012
Estimated Study Completion Date: 03/31/2013

Condition or disease

Vomiting of Pregnancy

Intervention/treatment

Drug: Ondansetron

Phase

-

Arm Groups

ArmIntervention/treatment
Experimental: Ondansetron
study drug
Drug: Ondansetron
Ondansetron 4mg and a placebo capsule to be taken orally every 8 hours for 5 days.
No Intervention: Doxylamine and Pyridoxine (vitamin B6)
other nausea treatment in use

Eligibility Criteria

Ages Eligible for Study 18 Years To 18 Years
Sexes Eligible for StudyFemale
Accepts Healthy VolunteersYes
Criteria

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

Outcome

Primary Outcome Measures

1. Reduction of nausea on the VAS (Visual Analog Scale) [5 days]

Secondary Outcome Measures

1. Reduction in vomiting on the VAS [5 days]

2. Any adverse effects caused by the study medications. [5 days]

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