COVID-19NCT05264987
Outcomes of Obstetric Patients With COVID-19 Disease in the ICU
An observational study of COVID-19 and Obstetric Anesthesia Problems, run by Turkiye Yuksek Ihtisas Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- COVID-19, Obstetric Anesthesia Problems, Intensive Care Unit
- What is being tested?
- intensive care follow-up
- How many people
- 28 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Mar 2020to 28 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- Patients who had negative PCR nasopharyngeal swabs for COVID-19 and were clinically suspicious
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Outcomes of Obstetric Patients With COVID-19 Disease Followed up in the Intensive Care Unit
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.
- Conditions
- COVID-19, Obstetric Anesthesia Problems, Intensive Care Unit, Morality
- Being tested
- intensive care follow-up
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
intensive care follow-up
mortality
Measured: up to 200 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2022
- Study start11 Mar 2020
- Primary completion15 Sep 2021
- Study completion28 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Turkiye Yuksek Ihtisas Education and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Derya Karasu, MD, Turkiye Yuksek Ihtisas Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05264987
- Sponsor's protocol ID
- 2011-KAEK-25 2021/06-20
- Status last verified
- Mar 2022
- First submitted
- 24 Feb 2022
- Last updated
- 3 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Outcomes of Obstetric Patients With COVID-19 Disease Followed up in the Intensive Care Unit
- ClinicalTrials.gov ID
- NCT05264987
- Acronym / sponsor ID
- 2011-KAEK-25 2021/06-20
- Conditions
- COVID-19, Obstetric Anesthesia Problems, Intensive Care Unit, Morality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Turkiye Yuksek Ihtisas Education and Research HospitalOther government
- Study start
- 11 Mar 2020 (actual)
- Primary completion
- 15 Sep 2021 (actual)
- Study completion
- 28 Dec 2021 (actual)
- First posted
- 3 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Patients who had negative PCR nasopharyngeal swabs for COVID-19 and were clinically suspicious
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intensive care follow-upThe 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. | Other | – |
Primary outcome
intensive care follow-up
Time frame: up to 200 days
mortality
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 and Obstetric Anesthesia Problems, run by Turkiye Yuksek Ihtisas Education and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
intensive care follow-up (time frame: up to 200 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2022.