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Ondansetron VS Doxylamine and Pyridoxine in Treating Nausea of Pregnancy

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EstatiKonplete
Patwone
United States Naval Medical Center, San Diego

Mo kle

Abstrè

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.

Dat

Dènye verifye: 03/31/2016
Premye Soumèt: 08/14/2012
Enskripsyon Estimasyon Soumèt: 08/14/2012
Premye afiche: 08/16/2012
Dènye Mizajou Soumèt: 04/03/2016
Dènye Mizajou afiche: 04/05/2016
Dat aktyèl kòmanse etid la: 09/30/2012
Dat Estimasyon Prensipal Estimasyon an: 09/30/2012
Dat estime fini etid la: 03/31/2013

Kondisyon oswa maladi

Vomiting of Pregnancy

Entèvansyon / tretman

Drug: Ondansetron

Faz

-

Gwoup bra

BraEntèvansyon / tretman
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

Kritè kalifikasyon yo

Laj ki kalifye pou etid 18 Years Pou 18 Years
Sèks ki kalifye pou etidFemale
Aksepte Volontè HealthyWi
Kritè

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

Rezilta

Mezi Rezilta Prensipal yo

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

Mezi Rezilta Segondè

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

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

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