Postoperative Nausea and VomitingNCT03171688
Risk Factors for Nausea and Vomiting After Cesarean
An observational study of Postoperative Nausea and Vomiting, run by Brasilia University Hospital at 1 site in Brazil.
Trial summary
Investigators will observe the incidence of post-cesarean nausea or vomiting and try to associate it with some risk factors. Read more about this study
- Who is it for?
- Ages 18 to 100 years, women only
- Conditions the study is for
- Postoperative Nausea and Vomiting
- How many people
- 361 participants
- Where
- 1 siteBrazil
- Study dates
- 1 May 2016to 1 Nov 2018
- Phase
- Observational
- 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 100 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Pregnant women with indication for cesarean section in the University Hospital of University of Brasilia.
Who may be able to join
- Cesarean section indicated
- Spinal anesthesia indicated
Who cannot join
- Cesarean section did not occur
- Spinal anesthesia was not provided
- Another spinal technique was added to spinal
Trial locations and contacts
1 site in 1 country.
Brazil1 site
University Hospital of Brasilia University
Brasília, Federal District, 7000000
About this study
Official title: Risk Factors for Nausea and Vomiting After Cesarean: Observational Prospective Study
Investigators will observe the incidence of post-cesarean nausea or vomiting and try to associate it with some risk factors.
Read the detailed description
A single prospective cohort of women submitted to cesarean section who received spinal anesthesia will be assessed for the proposed risk factors and the incidence of nausea or vomiting will be observed during the first 48 hours.
- Conditions
- Postoperative Nausea and Vomiting
- Keywords
- Postoperative Nausea and Vomiting, cesarean, risk factors
- Medical subject headings
- Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Modeling | It is the cohort that will be used for selecting risk factors and models for predicting postoperative nausea and vomiting. | |
| Validation | It is the cohort that will be used for validation of risk factors and models selected in the modeling group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Nausea or vomiting
The occurrence of postoperative nausea or vomiting, reported by the patient or witnessed by a healthcare provider during the first 48 hours after the cesarean. It is a dichotomic (true or false) outcome.
Measured: 48 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2017
- Study start1 May 2016
- Primary completion1 Aug 2018
- Study completion1 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Nausea and VomitingStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 361 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brasilia University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gabriel Magalhaes Nunes Guimaraes, Brasilia University Hospital
- Investigators
- Gabriel MN Guimaraes, MD, Study chair, University of Brasilia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03171688
- Sponsor's protocol ID
- NVPOCesarianasGabriel2017
- Status last verified
- Dec 2018
- First submitted
- 27 May 2017
- Last updated
- 2 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Plan to share excel sheets to allow meta-analysis.
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors for Nausea and Vomiting After Cesarean: Observational Prospective Study
- ClinicalTrials.gov ID
- NCT03171688
- Acronym / sponsor ID
- NVPOCesarianasGabriel2017
- Conditions
- Postoperative Nausea and Vomiting
- Keywords
- Postoperative Nausea and Vomiting, cesarean, risk factors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 361 participants (actual)
- Lead sponsor
- Brasilia University HospitalUniversity, hospital or other
- Study start
- 1 May 2016 (actual)
- Primary completion
- 1 Aug 2018 (actual)
- Study completion
- 1 Nov 2018 (actual)
- First posted
- 31 May 2017 (actual)
- 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.
Investigators will observe the incidence of post-cesarean nausea or vomiting and try to associate it with some risk factors.
Detailed description
A single prospective cohort of women submitted to cesarean section who received spinal anesthesia will be assessed for the proposed risk factors and the incidence of nausea or vomiting will be observed during the first 48 hours.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Modeling | – | –It is the cohort that will be used for selecting risk factors and models for predicting postoperative nausea and vomiting. |
| Validation | – | –It is the cohort that will be used for validation of risk factors and models selected in the modeling group. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant women with indication for cesarean section in the University Hospital of University of Brasilia.
Key inclusion criteria (2 listed)
- Cesarean section indicated
- Spinal anesthesia indicated
Key exclusion criteria (3 listed)
- Cesarean section did not occur
- Spinal anesthesia was not provided
- Another spinal technique was added to spinal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Postoperative Nausea or vomiting
Time frame: 48 hours.
The occurrence of postoperative nausea or vomiting, reported by the patient or witnessed by a healthcare provider during the first 48 hours after the cesarean. It is a dichotomic (true or false) outcome.
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 2 Jan 2019.
- Individual participant dataSharing planned: Yes. Plan to share excel sheets to allow meta-analysis.
Related trials for Postoperative Nausea and Vomiting
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Amisulpride Injection for the Prevention of Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Surgery
PONV
Not yet recruiting
Binaural Beats and Postoperative Nausea and Vomiting in Laparoscopic Cholecystectomy
Laparoscopic Cholecystectomy
Active, not recruiting
Advancing Strategies to Optimize the PerIopeRativE Management of PostOperative Nausea and Vomiting (ASPIRE-PONV) Trial
Postoperative Nausea, Postoperative Vomiting
Active, not recruitingPhase 4
A Randomized Controlled Trial Comparing the Effects of Different Anesthetic Sedatives on PONV in Laparoscopic Cholecystectomy
Cholelithiasis, Postoperative Nausea and Vomiting
Not yet recruitingPhase 4
Effect of Ketamine-Propofol Total Intravenous Anesthesia Versus Sevoflurane-Based Anesthesia on Postoperative Vomiting in Children Undergoing Strabismus Surgery
Postoperative Vomiting, Postoperative Nausea and Vomiting
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.
Gabriel MN Guimaraes, MD study chair
University of Brasilia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Nausea and Vomiting, run by Brasilia University Hospital at 1 site in Brazil.
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 2 inclusion and 3 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 2 Jan 2019. 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 Brazil. 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?
Postoperative Nausea or vomiting (time frame: 48 hours.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Jan 2019.