COVID-19NCT04409249
Prognosis in Pregnant With COVID-19
An observational study of COVID-19 and Prognostic Factors, run by Kanuni Sultan Suleyman Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
COVID-19 is a disease whose development, prognosis mechanism and immune status are still unknown. The aim of the study is to determine the relationship between clinical and laboratory data and the severity of the disease by evaluating the hematological and radiological features of the patients. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- COVID-19, Prognostic Factors, Pregnancy
- What is being tested?
- imaging, blood tests
- How many people
- 155 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Mar 2020to 28 May 2020
- 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 to 45 years
- Women only
- Adult
Study population: Tertiary center data
Who may be able to join
- Being pregnant with a diagnosis of COVID-19 between the ages of 18-45
Who cannot join
- Suspected COVID-19 diagnosis
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kanuni Sultan Suleyman Training and Research Hospital
Istanbul, Halkali, 34307
About this study
Official title: Prognostic Factors in Pregnant Women With COVID-19
COVID-19 is a disease whose development, prognosis mechanism and immune status are still unknown. The aim of the study is to determine the relationship between clinical and laboratory data and the severity of the disease by evaluating the hematological and radiological features of the patients. The secondary aim is to determine the predictive values of clinical and laboratory data for the severity of COVID-19.
- Conditions
- COVID-19, Prognostic Factors, Pregnancy
- Being tested
- imaging, blood tests
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
imaging, blood testsDiagnostic test
PCR and CT results, hemogram, urea, creatinine, AST, ALT, LDH, D-Dimer, ferritin, lipase, amylase, CRP, procalcitonin, albumin, total protein, coagulation tests-PT, APTT, Fibrinogen-, Troponin T, CK , electrolytes, blood gas, bilirubins
What is being measured
The primary outcome is the main question the study is designed to answer.
the factors affecting prognosis in pregnant women diagnosed with COVID-19
Measured: 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2020
- Study start15 Mar 2020
- Primary completion25 May 2020
- Study completion28 May 2020
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
- Other
- Time perspective
- Retrospective
- Enrolment
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merve Aldikactioglu Talmac, MD, Kanuni Sultan Suleyman Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04409249
- Sponsor's protocol ID
- Mtalmacprognosis
- Status last verified
- Jul 2020
- First submitted
- 28 May 2020
- Last updated
- 2 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Factors in Pregnant Women With COVID-19
- ClinicalTrials.gov ID
- NCT04409249
- Acronym / sponsor ID
- Mtalmacprognosis
- Conditions
- COVID-19, Prognostic Factors, Pregnancy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- Kanuni Sultan Suleyman Training and Research HospitalUniversity, hospital or other
- Study start
- 15 Mar 2020 (actual)
- Primary completion
- 25 May 2020 (actual)
- Study completion
- 28 May 2020 (actual)
- First posted
- 1 Jun 2020 (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.
COVID-19 is a disease whose development, prognosis mechanism and immune status are still unknown. The aim of the study is to determine the relationship between clinical and laboratory data and the severity of the disease by evaluating the hematological and radiological features of the patients. The secondary aim is to determine the predictive values of clinical and laboratory data for the severity of COVID-19.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Tertiary center data
Key inclusion criteria (1 listed)
- Being pregnant with a diagnosis of COVID-19 between the ages of 18-45
Key exclusion criteria (1 listed)
- Suspected COVID-19 diagnosis
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 |
|---|---|---|
| imaging, blood testsPCR and CT results, hemogram, urea, creatinine, AST, ALT, LDH, D-Dimer, ferritin, lipase, amylase, CRP, procalcitonin, albumin, total protein, coagulation tests-PT, APTT, Fibrinogen-, Troponin T, CK , electrolytes, blood gas, bilirubins | Diagnostic test | – |
Primary outcome
the factors affecting prognosis in pregnant women diagnosed with COVID-19
Time frame: 3 Months
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 2 Jul 2020.
- Individual participant dataSharing planned: Yes
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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 Prognostic Factors, run by Kanuni Sultan Suleyman Training 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 1 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 2 Jul 2020. 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?
the factors affecting prognosis in pregnant women diagnosed with COVID-19 (time frame: 3 Months). 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 2 Jul 2020.