Ondansetron VS Doxylamine and Pyridoxine in Treating Nausea of Pregnancy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2013-04-30

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.

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Detailed Description

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Conditions

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Vomiting of Pregnancy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Ondansetron

study drug

Group Type EXPERIMENTAL

Ondansetron

Intervention Type DRUG

Ondansetron 4mg and a placebo capsule to be taken orally every 8 hours for 5 days.

Doxylamine and Pyridoxine (vitamin B6)

other nausea treatment in use

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Ondansetron

Ondansetron 4mg and a placebo capsule to be taken orally every 8 hours for 5 days.

Intervention Type DRUG

Other Intervention Names

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Zofran

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No