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OpenTrials
Completed

NCT Number: NCT01668069

Ondansetron VS Doxylamine and Pyridoxine in Treating Nausea of Pregnancy

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.

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Key information

Conditions

Vomiting of Pregnancy Nausea Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

18 year–90 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Naval Medical Center, San Diego

San Diego, California, 92134, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ondansetron

Drug

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

Other names: Zofran

Primary outcomes

  1. Reduction of nausea on the VAS (Visual Analog Scale)

    Time frame: 5 days

Secondary outcomes

  1. Reduction in vomiting on the VAS

    Time frame: 5 days

  2. Any adverse effects caused by the study medications.

    Time frame: 5 days

Sponsors and collaborators

Lead sponsor

United States Naval Medical Center, San Diego

Fed

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2012
Study completion
2013
First posted
Aug 17, 2012
Registry last updated
Apr 6, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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