Ondansetron VS Doxylamine and Pyridoxine in Treating Nausea of Pregnancy

Naval Medical Center

Status

Completed

Conditions

Vomiting of Pregnancy

Treatments

Drug: Ondansetron

Study type

Interventional

Funder types

Other U.S. Federal agency

Identifiers

NCT01668069

CIP#NMCSD.2011.0151

Details and patient eligibility

About

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.

Enrollment

36 patients

Sex

Female

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

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