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Ondansetron VS Doxylamine and Pyridoxine in Treating Nausea of Pregnancy

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ClinicalTrials.gov Identifier: NCT01668069
Recruitment Status : Completed
First Posted : August 17, 2012
Last Update Posted : April 6, 2016
Sponsor:
Information provided by (Responsible Party):
United States Naval Medical Center, San Diego

Tracking Information
First Submitted Date  ICMJE August 15, 2012
First Posted Date  ICMJE August 17, 2012
Last Update Posted Date April 6, 2016
Study Start Date  ICMJE October 2012
Actual Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 15, 2012)
Reduction of nausea on the VAS (Visual Analog Scale) [ Time Frame: 5 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 15, 2012)
  • Reduction in vomiting on the VAS [ Time Frame: 5 days ]
  • Any adverse effects caused by the study medications. [ Time Frame: 5 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ondansetron VS Doxylamine and Pyridoxine in Treating Nausea of Pregnancy
Official Title  ICMJE Is Zofran Superior to Pyridoxine at Reducing Nausea and Vomiting in Pregnancy
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Vomiting of Pregnancy
Intervention  ICMJE Drug: Ondansetron
Ondansetron 4mg and a placebo capsule to be taken orally every 8 hours for 5 days.
Other Name: Zofran
Study Arms  ICMJE
  • Experimental: Ondansetron
    study drug
    Intervention: Drug: Ondansetron
  • No Intervention: Doxylamine and Pyridoxine (vitamin B6)
    other nausea treatment in use
Publications * Oliveira LG, Capp SM, You WB, Riffenburgh RH, Carstairs SD. Ondansetron compared with doxylamine and pyridoxine for treatment of nausea in pregnancy: a randomized controlled trial. Obstet Gynecol. 2014 Oct;124(4):735-742. doi: 10.1097/AOG.0000000000000479.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 15, 2012)
36
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2013
Actual Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01668069
Other Study ID Numbers  ICMJE CIP#NMCSD.2011.0151
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party United States Naval Medical Center, San Diego
Study Sponsor  ICMJE United States Naval Medical Center, San Diego
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Lauren G Oliveira, DO United States Naval Medical Center, San Diego
PRS Account United States Naval Medical Center, San Diego
Verification Date April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP