NCT03171688

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
361

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

May 27, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 31, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2018

Completed
Last Updated

January 2, 2019

Status Verified

December 1, 2018

Enrollment Period

2.3 years

First QC Date

May 27, 2017

Last Update Submit

December 28, 2018

Conditions

Keywords

Postoperative Nausea and Vomitingcesareanrisk factors

Outcome Measures

Primary Outcomes (1)

  • 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.

Study Arms (2)

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.

Eligibility Criteria

Age18 Years - 100 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • Cesarean section indicated
  • Spinal anesthesia indicated

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Brasilia University

Brasília, Federal District, 7000000, Brazil

Location

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNauseaSigns and Symptoms, DigestiveSigns and SymptomsVomiting

Study Officials

  • Gabriel MN Guimaraes, MD

    University of Brasilia

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Anesthesiology

Study Record Dates

First Submitted

May 27, 2017

First Posted

May 31, 2017

Study Start

May 1, 2016

Primary Completion

August 1, 2018

Study Completion

November 1, 2018

Last Updated

January 2, 2019

Record last verified: 2018-12

Data Sharing

IPD Sharing
Will share

Plan to share excel sheets to allow meta-analysis.

Locations