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CompletedNCT05264987Updated Mar 3, 2022

Outcomes of Obstetric Patients With COVID-19 Disease in the ICU

An observational study in COVID-19, Obstetric Anesthesia Problems and Intensive Care Unit, sponsored by Turkiye Yuksek Ihtisas Education and Research Hospital. Completed at 1 site in Turkey (Türkiye). Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-03-03.

Sponsored by Turkiye Yuksek Ihtisas Education and Research Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
28
Ages
18 Years and older
Sex
Female
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Study 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.

Read the detailed description

This 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 were analyzed retrospectively from the patient files.

Demographic data, obstetric histories, comorbidities, treatments received in the intensive care unit (ICU), delivery types, anesthesia types, and outcomes of newborns and mothers were retrospectively evaluated from the medical records. The need for the mechanical ventilator, the length of stay in the ICU, and outcomes of mothers were recorded. Laboratory findings were noted on the first day of admission to the ICU, including routine complete blood count, liver and kidney function, coagulation parameters, C-reactive protein (CRP), and albumin levels. Then neutrophil to lymphocyte (N/L) ratio, platelet to lymphocyte (P/L) ratio, and CRP to albumin (CRP/Alb) ratio were calculated. Deceased patients were evaluated in detail.

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Conditions studied

  • COVID-19
  • Obstetric Anesthesia Problems
  • Intensive Care Unit
  • Morality

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03

In context

COVID-19

7,775 studies on the registry are indexed under COVID-19; 482 are open to participants now.

This study's enrollment of 28 is below the median of 260 across 3,188 observational studies indexed under COVID-19.

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Lead sponsor

Turkiye Yuksek Ihtisas Education and Research Hospital is the lead sponsor of 10 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • Patients who had negative PCR nasopharyngeal swabs for COVID-19 and were clinically suspicious
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
28 participants (actual)
Patient registry
No

Interventions

  • Otherintensive care follow-up

    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.

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What researchers measure

Primary outcomes

  1. intensive care follow-up

    mortality

    Time frame: up to 200 days

07

Study locations

1 site
  • Derya Karasu
    Bursa, Yıldırım, Turkey (Türkiye)
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 3, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05264987
Lead sponsor
Turkiye Yuksek Ihtisas Education and Research Hospital
Responsible party
Derya Karasu, MD (Principal Investigator, Turkiye Yuksek Ihtisas Education and Research Hospital) — Principal investigator
First posted
Mar 3, 2022
Start date
Mar 11, 2020
Primary completion
Sep 15, 2021
Completion
Dec 28, 2021
Last update
Mar 3, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

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