Obstetric Anesthesia Experiences in COVID-19 Positive Patients

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04691934
• Other study ID #: U1111-1263-2201
• Status: Completed
• Start date: March 11, 2020
• Est. completion date: December 25, 2020

Study information

• Verified date: December 2020
• Source: Turkiye Yuksek Ihtisas Education and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: December 25, 2020
• Est. primary completion date: December 25, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Covid19
• Obstetric Anesthesia

Intervention

Procedure:
• Anesthesia management
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.

Locations

Country	Name	City	State
Turkey	University of Health Sciences Turkey, Bursa Yuksek Ihtisas Training and Research Hospital	Bursa	Yildirim

Sponsors (1)

Lead Sponsor	Collaborator
Turkiye Yuksek Ihtisas Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	obstetric anesthesia practices	the type of anesthesia was investigated	until 30 minutes after arrival in the operating room
Secondary	anesthesia complications	hypotension, nausea, vomiting, allergies	up to 1 hour after anesthesia