Covid-19NCT04443140
Preeclampsia-like Syndrome Induced by COVID-19: Is it a Real Public Health Issue in Pregnancy During the Pandemic?
An observational study of Covid-19 and Preeclampsia, run by Zeynep Kamil Maternity and Pediatric Research and Training Hospital at 1 site in Turkey (Türkiye).
Trial summary
By applying polymerase chain reaction (PCR) test for Covid-19 to preeclampsia patients who applied to our hospital during the Covid-19 pandemic period, we investigated the frequency of Covid-19 related preeclampsia-like syndrome in this patient group. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Covid-19, Preeclampsia, Pregnancy Related
- What is being tested?
- PCR, lung ultrasound
- How many people
- 131 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Mar 2020to 10 Jul 2020
- How long will I take part?
- 5 Months
- 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 40 years
- Women only
- No healthy volunteers
- Adult
Study population: First consecutive 100 preeclamptic pregnant women applied to our hospital during covid-19 pandemic
Who may be able to join
- First consecutive 100 pregnant women presenting with preeclamptic symptoms and signs between March 15, 2020 and June 1, 2020.
Who cannot join
- The pregnancies with known diagnosis of preeclampsia before Covid-19 pandemic
- Preeclamptic patient without a Covid-19 PCR test result
- Pregnant women who does not want to participate in study or does not want their personal informations to be shared
- Pregnant women less than 18 years old and more than 40 years old are excluded
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Zeynep Kamil Maternity and Childrens Training and Research Hospital
Istanbul, 34660
About this study
Official title: Evaluation of COVID-19 Incidence in Patients With Preeclampsia During Pandemic
By applying polymerase chain reaction (PCR) test for Covid-19 to preeclampsia patients who applied to our hospital during the Covid-19 pandemic period, we investigated the frequency of Covid-19 related preeclampsia-like syndrome in this patient group.
Read the detailed description
The investigators studied the frequency of Covid-19 related preeclampsia-like syndrome by PCR test and lung ultrasound for Covid-19 to preeclampsia patients presenting to the instutution during the Covid-19 pandemic period. The first consecutive 100 preeclampsia patients presented to our hospital during the pandemic will be involved in our study. The primary outcome measure is to detect Covid-19 positivity among the preeclamptic pregnant women..
- Conditions
- Covid-19, Preeclampsia, Pregnancy Related
- Being tested
- PCR, lung ultrasound
- Keywords
- covıd-19, pregnancy, preeclampsia, preeclampsia-like syndrome
- Medical subject headings
- COVID-19, Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCR, lung ultrasoundDiagnostic test
PCR for Covid-19
What is being measured
The primary outcome is the main question the study is designed to answer.
PCR positivity
To detect Covid-19 PCR test positivity among preeclamptic pregnant women
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 posted23 Jun 2020
- Study start15 Mar 2020
- Primary completion1 Jul 2020
- Study completion10 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Prospective
- Enrolment
- 131 participants (actual)
- Target duration
- 5 Months
Sponsor and investigators
- Lead sponsor
- Zeynep Kamil Maternity and Pediatric Research and Training Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Resul Karakuş, Zeynep Kamil Maternity and Pediatric Research and Training Hospital
- Investigators
- Resul Karakus, MD, Principal investigator, Zeynep Kamil Maternity and Childrens Hospital Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04443140
- Sponsor's protocol ID
- 70/2020
- Status last verified
- Jul 2020
- First submitted
- 21 Jun 2020
- Last updated
- 28 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: demographic data of the participants and diagnostic test results will be shared
Publications
Mendoza M, Garcia-Ruiz I, Maiz N, Rodo C, Garcia-Manau P, Serrano B, Lopez-Martinez RM, Balcells J, Fernandez-Hidalgo N, Carreras E, Suy A. Pre-eclampsia-like syndrome induced by severe COVID-19: a prospective observational study. BJOG. 2020 Oct;127(11):1374-1380. doi: 10.1111/1471-0528.16339. Epub 2020 Jun 21.
PubMed 32479682
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of COVID-19 Incidence in Patients With Preeclampsia During Pandemic
- ClinicalTrials.gov ID
- NCT04443140
- Acronym / sponsor ID
- 70/2020
- Conditions
- Covid-19, Preeclampsia, Pregnancy Related
- Keywords
- covıd-19, pregnancy, preeclampsia, preeclampsia-like syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- Zeynep Kamil Maternity and Pediatric Research and Training HospitalUniversity, hospital or other
- Study start
- 15 Mar 2020 (actual)
- Primary completion
- 1 Jul 2020 (actual)
- Study completion
- 10 Jul 2020 (actual)
- First posted
- 23 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.
By applying polymerase chain reaction (PCR) test for Covid-19 to preeclampsia patients who applied to our hospital during the Covid-19 pandemic period, we investigated the frequency of Covid-19 related preeclampsia-like syndrome in this patient group.
Detailed description
The investigators studied the frequency of Covid-19 related preeclampsia-like syndrome by PCR test and lung ultrasound for Covid-19 to preeclampsia patients presenting to the instutution during the Covid-19 pandemic period. The first consecutive 100 preeclampsia patients presented to our hospital during the pandemic will be involved in our study. The primary outcome measure is to detect Covid-19 positivity among the preeclamptic pregnant women..
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Months
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- First consecutive 100 preeclamptic pregnant women applied to our hospital during covid-19 pandemic
Key inclusion criteria (1 listed)
- First consecutive 100 pregnant women presenting with preeclamptic symptoms and signs between March 15, 2020 and June 1, 2020.
Key exclusion criteria (4 listed)
- The pregnancies with known diagnosis of preeclampsia before Covid-19 pandemic
- Preeclamptic patient without a Covid-19 PCR test result
- Pregnant women who does not want to participate in study or does not want their personal informations to be shared
- Pregnant women less than 18 years old and more than 40 years old are excluded
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 |
|---|---|---|
| PCR, lung ultrasoundPCR for Covid-19 | Diagnostic test | – |
Primary outcome
PCR positivity
Time frame: 3 months
To detect Covid-19 PCR test positivity among preeclamptic pregnant women
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 28 Jul 2020.
- Results publication: PubMed 32479682Mendoza M, Garcia-Ruiz I, Maiz N, Rodo C, Garcia-Manau P, Serrano B, Lopez-Martinez RM, Balcells J, Fernandez-Hidalgo N, Carreras E, Suy A. Pre-eclampsia-like syndrome induced by severe COVID-19: a prospective observational study. BJOG. 2020 Oct;127(11):1374-1380. doi: 10.1111/1471-0528.16339. Epub 2020 Jun 21.
- Individual participant dataSharing planned: Undecided. demographic data of the participants and diagnostic test results will be shared
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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.
Resul Karakus, MD principal investigator
Zeynep Kamil Maternity and Childrens Hospital Training and Research Hospital
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 Preeclampsia, run by Zeynep Kamil Maternity and Pediatric Research and Training 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 4 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 28 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?
PCR positivity (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04443140, which also lists 1 linked publication.
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 28 Jul 2020.