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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01668069
Other study ID # CIP#NMCSD.2011.0151
Secondary ID
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


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
See also
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Terminated NCT03785691 - Validating the Effect og Ondansetron and Mirtazapine in Treating Hyperemesis Gravidarum Phase 2
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