Post-intensive Care Syndromes in Pregnant Patients With Respiratory Failure and COVID-19 Compared to Non-pregnant Patients With Respiratory Failure and COVID-19

NCT ID: NCT07051967

Last Updated: 2025-09-25

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-09-22
• Study Completion Date: 2026-06-30

Brief Summary

The aim of this study is to characterize patients in the Post-Intensive-Care-Syndrome (PICS) outpatient clinic based on routine data and to evaluate their treatment outcome over the course of their treatment. For this purpose, data sets from approx. 40 patients who were treated in the intensive care unit subsequently evaluated in the PICS outpatient clinic between March 27, 2020, and May 6, 2024, will be analyzed.

Detailed Description

This is a retrospective comparison of approximately 13 pregnant patients and approximately 27 non-pregnant patients who developed respiratory failure (also known as acute respiratory distress syndrome, or ARDS) due to COVID-19 infection. The analysis is based on routine treatment data from the Post-Intensive Care Syndrome (PICS) outpatient clinic of the Department of Anesthesiology and Intensive Care Medicine (CCM/CVK), as well as intensive care treatment data, primarily from the Department of Anesthesiology and Intensive Care Medicine (CCM/CVK). In some cases, additional data were obtained from the Medical Clinic for Nephrology and Internal Intensive Care Medicine (CCM/CVK/CBF), the Medical Clinic specializing in Hepatology and Gastroenterology (CCM/CVK), and the Department of Infectiology, Pulmonology, and Intensive Care Medicine (CCM).

Conditions

COVID-19; Acute Respiratory Distress Syndrome Due to COVID-19; Pregnancy Related

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Female pregnant patients with COVID-19 related Acute respiratory distress syndrome

• Pregnancy at the time of initial hospital admission (not necessarily at the time of transfer to Charité - Universitätsmedizin Berlin).
• Age: 18 years and older
• Admission to a Charité intensive care unit and follow-up examination by the Post-Intensive-Care-Syndrome (PICS) outpatient clinic of the Department of Anesthesiology and Intensive Care Medicine between March 27, 2020 and May 6, 2024.
• COVID-19 infection in temporal association with the intensive care unit admission.
• Intensive care unit admission with lung failure or development of lung failure in the course of intensive care unit treatment.
• Admission to the intensive care unit with lung failure or development of lung failure during intensive care unit stay

No interventions assigned to this group

Female non-pregnant patients with COVID-19 related Acute respiratory distress syndrome

• No pregnancy at the time of admission.
• Age: 18 years and older
• Admission to a Charité intensive care unit and follow-up examination by the Post-Intensive-Care-Syndrome (PICS) outpatient clinic of the Department of Anesthesiology and Intensive Care Medicine between March 27, 2020 and May 6, 2024.
• COVID-19 infection in temporal association with the intensive care unit admission.
• Intensive care unit admission with lung failure or development of lung failure in the course of intensive care unit treatment.
• Admission to the intensive care unit with lung failure or development of lung failure during intensive care unit stay

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Age: 18 years and older
• Admission to a Charité intensive care unit and follow-up examination by the Post-Intensive-Care-Syndrome (PICS) outpatient clinic of the Department of Anesthesiology and Intensive Care Medicine between March 27, 2020 and May 6, 2024.
• COVID-19 infection in temporal assocoation with the intensive care unit admission.
• Intensive care unit admission with lung failure or development of lung failure in the course of intensive care unit treatment.
• Admission to the intensive care unit with lung failure or development of lung failure during intensive care unit stay.

Exclusion Criteria

• Gender: Male
• Diagnosis: Non-COVID or no respiratory failure

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Charite University, Berlin, Germany

OTHER

Sponsor Role: lead

Responsible Party

Claudia Spies

Head of the Department of Anesthesiology and Intensive Care Medicine (CCM/CVK), Charité - Universitaetsmedizin Berlin

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Claudia Spies, MD, Prof.

Role: STUDY_DIRECTOR

Charite University, Berlin, Germany

Locations

Department of Anesthesiology and Intensive Care Medicine (CCM/CVK), Charité - Universitätsmedizin Berlin

Berlin, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Claudia Spies, MD Prof.

Role: CONTACT

claudia.spies@charite.de

+49 30 450 551102

Facility Contacts

Claudia Spies, MD. Prof.

Role: primary

claudia.spies@charite.de

+49 30 450 55 11 02

Other Identifiers

CovPreg

Identifier Type: -

Identifier Source: org_study_id