Obstetric Anesthesia Experiences in COVID-19 Positive Pat... | NCT04691934

Studies
Obstetric Anesthesia Experiences in COVID-19 Positive Patients

NCT04691934

Sponsor

Turkiye Yuksek Ihtisas Education and Research Hospital

Status

Completed

Last Update Posted

Dec 31, 2020Actual

Enrollment

61Actual

Phase

Not provided

Conditions

Covid19
Obstetric Anesthesia

Interventions

Anesthesia management

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 11, 2020Actual

Primary Completion Date

Dec 25, 2020Actual

Completion Date

Dec 25, 2020Actual

First Submitted Date

Dec 29, 2020

First Submission Date that Met QC Criteria

Dec 30, 2020

First Posted Date

Dec 31, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 30, 2020

Last Update Posted Date

Dec 31, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

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

Lead Sponsor

Turkiye Yuksek Ihtisas Education and Research HospitalOTHER_GOV

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

61Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Anesthesia management	Procedure	Patients who underwent cesarean section and had positive PCR nasopharyngeal swabs for COVID-19 were included in the study. Patients who tested negative and were clinically suspicious were excluded from the study. PCR test was not performed on all elective and emergency pregnant women to be taken for cesarean section in our hospital. It was only applied to patients with symptoms or patients who were suspected. All patient demographics and information about anesthesia were analyzed retrospectively from the patient files.

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Patients who underwent cesarean section were included in the study

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Derya Karasu	BursaYuksek Ihtisas Training and Research Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Health Sciences Turkey, Bursa Yuksek Ihtisas Training and Research Hospital		Bursa	Yıldırım	16290	Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000086382	COVID-19
D011014	Pneumonia

Ancestor Terms

ID	Term
D011024	Pneumonia, Viral
D012141	Respiratory Tract Infections
D007239	Infections
D014777	Virus Diseases

Browse Leaves

Not provided

Browse Branches

Not provided