Ondansetron VS Doxylamine and Pyridoxine in Treating Nausea of Pregnancy
Keywords
Abstract
Dates
Last Verified: | 03/31/2016 |
First Submitted: | 08/14/2012 |
Estimated Enrollment Submitted: | 08/14/2012 |
First Posted: | 08/16/2012 |
Last Update Submitted: | 04/03/2016 |
Last Update Posted: | 04/05/2016 |
Actual Study Start Date: | 09/30/2012 |
Estimated Primary Completion Date: | 09/30/2012 |
Estimated Study Completion Date: | 03/31/2013 |
Condition or disease
Intervention/treatment
Drug: Ondansetron
Phase
Arm Groups
Arm | Intervention/treatment |
---|---|
Experimental: Ondansetron study drug | Drug: Ondansetron Ondansetron 4mg and a placebo capsule to be taken orally every 8 hours for 5 days. |
No Intervention: Doxylamine and Pyridoxine (vitamin B6) other nausea treatment in use |
Eligibility Criteria
Ages Eligible for Study | 18 Years To 18 Years |
Sexes Eligible for Study | Female |
Accepts Healthy Volunteers | Yes |
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 |
Outcome
Primary Outcome Measures
1. Reduction of nausea on the VAS (Visual Analog Scale) [5 days]
Secondary Outcome Measures
1. Reduction in vomiting on the VAS [5 days]
2. Any adverse effects caused by the study medications. [5 days]