NCT04691934

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
61

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2020

Shorter than P25 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 11, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 25, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 25, 2020

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

December 29, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 31, 2020

Completed
Last Updated

December 31, 2020

Status Verified

December 1, 2020

Enrollment Period

10 months

First QC Date

December 29, 2020

Last Update Submit

December 30, 2020

Conditions

Keywords

COVID-19AnesthesiaCesarean SectionPneumonia

Outcome Measures

Primary Outcomes (1)

  • obstetric anesthesia practices

    the type of anesthesia was investigated

    until 30 minutes after arrival in the operating room

Secondary Outcomes (1)

  • anesthesia complications

    up to 1 hour after anesthesia

Interventions

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.

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPatients who underwent cesarean section were included in the study
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Patients who tested negative and were clinically suspicious

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Bursa, Yıldırım, 16290, Turkey (Türkiye)

Location

MeSH Terms

Conditions

COVID-19Pneumonia

Condition Hierarchy (Ancestors)

Pneumonia, ViralRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Derya Karasu

    BursaYuksek Ihtisas Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc Prof.

Study Record Dates

First Submitted

December 29, 2020

First Posted

December 31, 2020

Study Start

March 11, 2020

Primary Completion

December 25, 2020

Study Completion

December 25, 2020

Last Updated

December 31, 2020

Record last verified: 2020-12

Locations