Ondansetron VS Doxylamine and Pyridoxine in Treating Nausea of Pregnancy

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


Lead Sponsor: United States Naval Medical Center, San Diego

Source 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.

Overall Status Completed
Start Date October 2012
Completion Date April 2013
Primary Completion Date October 2012
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Reduction of nausea on the VAS (Visual Analog Scale) 5 days
Secondary Outcome
Measure Time Frame
Reduction in vomiting on the VAS 5 days
Any adverse effects caused by the study medications. 5 days
Enrollment 36

Intervention Type: Drug

Intervention Name: Ondansetron

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

Arm Group Label: Ondansetron

Other Name: Zofran



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

Gender: Female

Minimum Age: 18 Years

Maximum Age: 90 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Lauren G Oliveira, DO Principal Investigator United States Naval Medical Center, San Diego
Facility: Naval Medical Center, San Diego
Location Countries

United States

Verification Date

April 2016

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Ondansetron

Type: Experimental

Description: study drug

Label: Doxylamine and Pyridoxine (vitamin B6)

Type: No Intervention

Description: other nausea treatment in use

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov