Obstetric Anesthesia Experiences in COVID-19 Positive Patients

December 30, 2020 updated by: Derya Karasu, MD, Turkiye Yuksek Ihtisas Education and Research Hospital

Our Anesthesia Experiences in COVID-19 Positive Patients Undergoing Cesarean Section: A Retrospective Single-center Cohort Study

At the end of 2019, a new coronavirus named COVID-19 (SARS-CoV-2), one of the lower respiratory tract samples was detected in China. The World Health Organization (WHO) declared it a global epidemic on March 11, 2020, due to the emergence of COVID-19 cases in 113 countries other than China, where the first epidemic occurred, and the spread and severity of the virus. Pregnancy increases susceptibility to respiratory complications of viral diseases.

This study aimed to retrospectively evaluate the demographic data of COVID-19 patients undergoing cesarean section, our anesthesia practices, complications, and condition of neonates, and to summarize up-to-date information on COVID-19 in obstetric anesthesia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Our study was a single-center, retrospective, and observational trial and carried out with the principles of the Declaration of Helsinki. All patient demographics and information about anesthesia were analyzed retrospectively from the patient files.

All patients were operated in negative pressure operating theatres reserved for them. The whole team was equipped with Level 3 personal protective equipment (PPE) (liquid-proof apron, N-95 mask, goggles, visor, overshoes). Anesthesia was administered by 2 healthcare professionals from the anesthesia team, including an experienced anesthesiologist and an assistant anesthesia technician. A third person was kept ready outside to help in case of need.

Study Type

Observational

Enrollment (Actual)

61

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Yıldırım
      • Bursa, Yıldırım, Turkey, 16290
        • University of Health Sciences Turkey, Bursa Yuksek Ihtisas Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Patients who underwent cesarean section and had positive PCR nasopharyngeal swabs for COVID-19

Description

Inclusion Criteria:

  • Patients who underwent cesarean section
  • Patients who had positive PCR nasopharyngeal swabs for COVID-19

Exclusion Criteria:

  • Patients who tested negative and were clinically suspicious

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
obstetric anesthesia practices
Time Frame: until 30 minutes after arrival in the operating room
the type of anesthesia was investigated
until 30 minutes after arrival in the operating room

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
anesthesia complications
Time Frame: up to 1 hour after anesthesia
hypotension, nausea, vomiting, allergies
up to 1 hour after anesthesia

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Turkiye Yuksek Ihtisas Education and Research Hospital

Investigators

  • Principal Investigator: Derya Karasu, BursaYuksek Ihtisas Training and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 11, 2020

Primary Completion (Actual)

December 25, 2020

Study Completion (Actual)

December 25, 2020

Study Registration Dates

First Submitted

December 29, 2020

First Submitted That Met QC Criteria

December 30, 2020

First Posted (Actual)

December 31, 2020

Study Record Updates

Last Update Posted (Actual)

December 31, 2020

Last Update Submitted That Met QC Criteria

December 30, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • U1111-1263-2201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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