Risk Factors for Nausea and Vomiting After Cesarean

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.

Study Overview

• Status: Completed
• Conditions: 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
• Enrollment (Actual): 361

Contacts and Locations

Study Locations

• Brazil
  • Distrito Federal
    • Brasilia, Distrito Federal, Brazil, 7000000
      • University Hospital of Brasilia University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 98 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Pregnant women with indication for cesarean section in the University Hospital of University of Brasilia.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	48 hours.

Collaborators and Investigators

• Sponsor: Brasilia University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2016
• Primary Completion (Actual): August 1, 2018
• Study Completion (Actual): November 1, 2018

Study Registration Dates

• First Submitted: May 27, 2017
• First Submitted That Met QC Criteria: May 30, 2017
• First Posted (Actual): May 31, 2017

Study Record Updates

• Last Update Posted (Actual): January 2, 2019
• Last Update Submitted That Met QC Criteria: December 28, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: risk factors; Postoperative Nausea and Vomiting; cesarean
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Signs and Symptoms, Digestive; Nausea; Vomiting; Postoperative Nausea and Vomiting
• Other Study ID Numbers: NVPOCesarianasGabriel2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Plan to share excel sheets to allow meta-analysis.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No