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Risk Factors for Nausea and Vomiting After Cesarean

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ClinicalTrials.gov Identifier: NCT03171688
Recruitment Status : Recruiting
First Posted : May 31, 2017
Last Update Posted : September 13, 2017
Sponsor:
Information provided by (Responsible Party):
Gabriel Magalhaes Nunes Guimaraes, Brasilia University Hospital

Brief Summary:
Investigators will observe the incidence of post-cesarean nausea or vomiting and try to associate it with some risk factors.

Condition or disease
Postoperative Nausea and Vomiting

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 Type : Observational
Estimated Enrollment : 230 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Risk Factors for Nausea and Vomiting After Cesarean: Observational Prospective Study
Actual Study Start Date : May 1, 2016
Estimated Primary Completion Date : June 1, 2018
Estimated Study Completion Date : June 1, 2018

Resource links provided by the National Library of Medicine


Group/Cohort
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.



Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Pregnant women with indication for cesarean section in the University Hospital of University of Brasilia.
Criteria

Inclusion Criteria:

  • Cesarean section indicated
  • Spinal anesthesia indicated

Exclusion Criteria:

  • Cesarean section did not occur
  • Spinal anesthesia was not provided
  • Another spinal technique was added to spinal

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 ClinicalTrials.gov identifier (NCT number): NCT03171688


Contacts
Contact: Gabriel MN Guimaraes, MD +55 61 99645-5997 gabrielmng@gmail.com

Locations
Brazil
University Hospital of Brasilia University Recruiting
Brasilia, Distrito Federal, Brazil, 7000000
Contact: Gabriel MN Guimaraes, MD    +55 61 99645-5997    gabrielmng@gmail.com   
Sponsors and Collaborators
Brasilia University Hospital
Investigators
Study Chair: Gabriel MN Guimaraes, MD University of Brasilia

Responsible Party: Gabriel Magalhaes Nunes Guimaraes, Head of Anesthesiology, Brasilia University Hospital
ClinicalTrials.gov Identifier: NCT03171688     History of Changes
Other Study ID Numbers: NVPOCesarianasGabriel2017
First Posted: May 31, 2017    Key Record Dates
Last Update Posted: September 13, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Plan to share excel sheets to allow meta-analysis.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Gabriel Magalhaes Nunes Guimaraes, Brasilia University Hospital:
Postoperative Nausea and Vomiting
cesarean
risk factors

Additional relevant MeSH terms:
Nausea
Vomiting
Postoperative Nausea and Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Postoperative Complications
Pathologic Processes