NCT05264987

Brief Summary

Although several studies are conducted in the general population researching the clinical and laboratory parameters predicting the progression to severe disease in COVID-19, the data are very few in obstetric patients. Therefore,the investigators aimed to evaluate the characteristics, prognosis, laboratory parameters, and mortality of obstetric patients followed up in the intensive care unit (ICU) due to severe COVID-19 disease and to determine the factors affecting mortality.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2020

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 11, 2020

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 28, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 24, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 3, 2022

Completed
Last Updated

March 3, 2022

Status Verified

March 1, 2022

Enrollment Period

1.5 years

First QC Date

February 24, 2022

Last Update Submit

March 2, 2022

Conditions

COVID-19Obstetric Anesthesia ProblemsIntensive Care UnitMorality

Outcome Measures

Primary Outcomes (1)

  • intensive care follow-up

    mortality

    up to 200 days

Interventions

intensive care follow-upOTHER

The need for the mechanical ventilator, the length of stay in the intensive care unit, and outcomes of mothers were recorded. Deceased patients were evaluated in detail.

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsobstetric patients
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Obstetric patients (during the pregnancy and postpartum period, from the beginning of pregnancy and up to 42 days after delivery) hospitalized in the intensive care unit of our tertiary care hospital

You may qualify if:

  • Obstetric patients (during the pregnancy and postpartum period, from the beginning of pregnancy and up to 42 days after delivery) hospitalized in the intensive care unit of our tertiary care hospital
  • Patients who had positive PCR nasopharyngeal swabs for COVID-19

You may not qualify if:

  • Patients who had negative PCR nasopharyngeal swabs for COVID-19 and were clinically suspicious

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Derya Karasu

Bursa, Yıldırım, Turkey (Türkiye)

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 24, 2022

First Posted

March 3, 2022

Study Start

March 11, 2020

Primary Completion

September 15, 2021

Study Completion

December 28, 2021

Last Updated

March 3, 2022

Record last verified: 2022-03

Locations

TU(1)