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Ondansetron VS Doxylamine and Pyridoxine in Treating Nausea of Pregnancy

Information source: United States Naval Medical Center, San Diego
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Vomiting of Pregnancy

Intervention: Ondansetron (Drug); Doxylamine and pyridoxine (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: United States Naval Medical Center, San Diego

Official(s) and/or principal investigator(s):
Lauren G Oliveira, DO, Principal Investigator, Affiliation: United States Naval Medical Center, San Diego

Overall contact:
Lauren G Oliveira, DO, Phone: 619 9615715, Email: Lauren.G.Oliveira@gmail.com

Summary

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.

Clinical Details

Official title: Is Zofran Superior to Pyridoxine at Reducing Nausea and Vomiting in Pregnancy

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Reduction of nausea on the VAS (Visual Analog Scale)

Secondary outcome:

Reduction in vomiting on the VAS

Any adverse effects caused by the study medications.

Eligibility

Minimum age: 18 Years. Maximum age: 90 Years. Gender(s): Female.

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

Locations and Contacts

Lauren G Oliveira, DO, Phone: 619 9615715, Email: Lauren.G.Oliveira@gmail.com

Naval Medical Center, San Diego, San Diego, California 92134, United States; Recruiting
Additional Information

Starting date: April 2012
Last updated: August 15, 2012

Page last updated: February 07, 2013

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