Obstetric Anesthesia Experiences in COVID-19 Positive Patients

Sponsor

Turkiye Yuksek Ihtisas Education and Research Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT04691934

Collaborator

(none)

Enrollment

Location

9.5

Actual Duration (Months)

6.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Covid19 Obstetric Anesthesia	Procedure: Anesthesia management

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 Design

Study Type:

Observational

Actual Enrollment :

61 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Mar 11, 2020

Actual Primary Completion Date :

Dec 25, 2020

Actual Study Completion Date :

Dec 25, 2020

Outcome Measures

Primary Outcome Measures

obstetric anesthesia practices [until 30 minutes after arrival in the operating room]
the type of anesthesia was investigated

Secondary Outcome Measures

anesthesia complications [up to 1 hour after anesthesia]
hypotension, nausea, vomiting, allergies

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Health Sciences Turkey, Bursa Yuksek Ihtisas Training and Research Hospital	Bursa	Yıldırım	Turkey	16290

Sponsors and Collaborators

Turkiye Yuksek Ihtisas Education and Research Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Derya Karasu, MD, Assoc Prof., Turkiye Yuksek Ihtisas Education and Research Hospital

ClinicalTrials.gov Identifier:

NCT04691934

Other Study ID Numbers:

U1111-1263-2201

First Posted:

Dec 31, 2020

Last Update Posted:

Dec 31, 2020

Last Verified:

Dec 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Derya Karasu, MD, Assoc Prof., Turkiye Yuksek Ihtisas Education and Research Hospital

Additional relevant MeSH terms:

COVID-19

Anesthetics

Study Results

No Results Posted as of Dec 31, 2020