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Ondansetron VS Doxylamine and Pyridoxine in Treating Nausea of Pregnancy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01668069
Recruitment Status : Completed
First Posted : August 17, 2012
Last Update Posted : April 6, 2016
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Vomiting of Pregnancy Drug: Ondansetron Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Is Zofran Superior to Pyridoxine at Reducing Nausea and Vomiting in Pregnancy
Study Start Date : October 2012
Actual Primary Completion Date : October 2012
Actual Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

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.
Other Name: Zofran

No Intervention: Doxylamine and Pyridoxine (vitamin B6)
other nausea treatment in use

Primary Outcome Measures :
  1. Reduction of nausea on the VAS (Visual Analog Scale) [ Time Frame: 5 days ]

Secondary Outcome Measures :
  1. Reduction in vomiting on the VAS [ Time Frame: 5 days ]
  2. Any adverse effects caused by the study medications. [ Time Frame: 5 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01668069

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United States, California
Naval Medical Center, San Diego
San Diego, California, United States, 92134
Sponsors and Collaborators
United States Naval Medical Center, San Diego
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Principal Investigator: Lauren G Oliveira, DO United States Naval Medical Center, San Diego
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: United States Naval Medical Center, San Diego Identifier: NCT01668069    
Other Study ID Numbers: CIP#NMCSD.2011.0151
First Posted: August 17, 2012    Key Record Dates
Last Update Posted: April 6, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by United States Naval Medical Center, San Diego:
vitamin B6
Additional relevant MeSH terms:
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Signs and Symptoms, Digestive
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Dermatologic Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Anti-Anxiety Agents