Vomiting of PregnancyNCT01668069
Ondansetron VS Doxylamine and Pyridoxine in Treating Nausea of Pregnancy
A study testing Ondansetron in people with Vomiting of Pregnancy, run by United States Naval Medical Center, San Diego at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 to 90 years, women only
- Conditions the study is for
- Vomiting of Pregnancy
- What is being tested?
- Ondansetron
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to Apr 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Naval Medical Center, San Diego
San Diego, California, 92134
About this study
Official title: Is Zofran Superior to Pyridoxine at Reducing Nausea and Vomiting in 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.
- Conditions
- Vomiting of Pregnancy
- Being tested
- Ondansetron
- Keywords
- nausea, vomiting, pregnancy, ondansetron, doxylamine, vitamin B6, pyridoxine
- Medical subject headings
- Nausea, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OndansetronDrug
Also called Zofran
Ondansetron 4mg and a placebo capsule to be taken orally every 8 hours for 5 days.
| Study group | Role | What they receive |
|---|---|---|
| Ondansetron | Experimental | study drug Receives: Drug: Ondansetron |
| Doxylamine and Pyridoxine (vitamin B6) | No intervention | other nausea treatment in use |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of nausea on the VAS (Visual Analog Scale)
Measured: 5 days
Secondary outcomes (2)
Reduction in vomiting on the VAS
Measured: 5 days
Any adverse effects caused by the study medications.
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2012 (estimated)
- Study startOct 2012
- Primary completionOct 2012
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vomiting of PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- United States Naval Medical Center, San Diego
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Lauren G Oliveira, DO, Principal investigator, United States Naval Medical Center, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01668069
- Sponsor's protocol ID
- CIP#NMCSD.2011.0151
- Status last verified
- Apr 2016
- First submitted
- 15 Aug 2012
- Last updated
- 6 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
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.
PubMed 25198265
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Zofran Superior to Pyridoxine at Reducing Nausea and Vomiting in Pregnancy
- ClinicalTrials.gov ID
- NCT01668069
- Acronym / sponsor ID
- CIP#NMCSD.2011.0151
- Conditions
- Vomiting of Pregnancy
- Keywords
- nausea, vomiting, pregnancy, ondansetron, doxylamine, vitamin B6, pyridoxine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- United States Naval Medical Center, San DiegoUS federal agency
- Study start
- Oct 2012
- Primary completion
- Oct 2012 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 17 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ondansetron | Experimental | Drug: Ondansetronstudy drug |
| Doxylamine and Pyridoxine (vitamin B6) | No intervention | –other nausea treatment in use |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OndansetronAlso: ZofranOndansetron 4mg and a placebo capsule to be taken orally every 8 hours for 5 days. | Drug | Ondansetron |
Primary outcome
Reduction of nausea on the VAS (Visual Analog Scale)
Time frame: 5 days
2 secondary outcomes
Reduction in vomiting on the VAS
Time frame: 5 days
Any adverse effects caused by the study medications.
Time frame: 5 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2016.
- Derived from this study: PubMed 25198265Oliveira 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lauren G Oliveira, DO principal investigator
United States Naval Medical Center, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ondansetron in people with Vomiting of Pregnancy, run by United States Naval Medical Center, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of nausea on the VAS (Visual Analog Scale) (time frame: 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01668069, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2016.