Ondansetron VS Doxylamine and Pyridoxine in Treating Nausea of Pregnancy

Not Applicable

Completed

• Conditions: Vomiting of Pregnancy
• Interventions: Drug: Ondansetron

• Registration Number: NCT01668069
• Lead Sponsor: United States Naval Medical Center, San Diego

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-08-15
• Study First Submitted QC: 2012-08-15
• Study First Posted: 2012-08-17
• Study Start: 2012-10
• Primary Completion: 2012-10
• Study Completion: 2013-04
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-04
• Last Update Posted: 2016-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ondansetron	Ondansetron	study drug

Primary Outcome Measures

Name	Time	Method
Reduction of nausea on the VAS (Visual Analog Scale)	5 days

Secondary Outcome Measures

Name	Time	Method
Reduction in vomiting on the VAS	5 days
Any adverse effects caused by the study medications.	5 days

Trial Locations

Locations (1)

Naval Medical Center, San Diego; 🇺🇸 San Diego, California, United States