Ondansetron VS Doxylamine and Pyridoxine in Treating Nausea of Pregnancy

Vomiting of Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01668069
• Other study ID #: CIP#NMCSD.2011.0151
• Status: Completed
• Phase: N/A
• First received: August 15, 2012
• Last updated: April 4, 2016
• Start date: October 2012
• Est. completion date: April 2013

Study information

• Verified date: April 2016
• Source: United States Naval Medical Center, San Diego
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: April 2013
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 90 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Vomiting
• Vomiting of Pregnancy

Intervention

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

Locations

Country	Name	City	State
United States	Naval Medical Center, San Diego	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
United States Naval Medical Center, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of nausea on the VAS (Visual Analog Scale)		5 days	No
Secondary	Reduction in vomiting on the VAS		5 days	No
Secondary	Any adverse effects caused by the study medications.		5 days	No