- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04443140
Preeclampsia-like Syndrome Induced by COVID-19: Is it a Real Public Health Issue in Pregnancy During the Pandemic?
July 26, 2020 updated by: Resul Karakuş, Zeynep Kamil Maternity and Pediatric Research and Training Hospital
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
131
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Istanbul, Turkey, 34660
- Zeynep Kamil Maternity and Childrens Training and Research Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Probability Sample
Study Population
First consecutive 100 preeclamptic pregnant women applied to our hospital during covid-19 pandemic
Description
Inclusion Criteria:
- First consecutive 100 pregnant women presenting with preeclamptic symptoms and signs between March 15, 2020 and June 1, 2020.
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PCR positivity
Time Frame: 3 months
|
To detect Covid-19 PCR test positivity among preeclamptic pregnant women
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Resul Karakus, MD, Zeynep Kamil Maternity and Childrens Hospital Training and Research Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 15, 2020
Primary Completion (Actual)
July 1, 2020
Study Completion (Actual)
July 10, 2020
Study Registration Dates
First Submitted
June 21, 2020
First Submitted That Met QC Criteria
June 22, 2020
First Posted (Actual)
June 23, 2020
Study Record Updates
Last Update Posted (Actual)
July 28, 2020
Last Update Submitted That Met QC Criteria
July 26, 2020
Last Verified
July 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 70/2020
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
demographic data of the participants and diagnostic test results will be shared
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Covid-19
-
University of Roma La SapienzaQueen Mary University of London; Università degli studi di Roma Foro Italico; Bios Prevention SrlCompletedPost Acute Sequelae of COVID-19 | Post COVID-19 Condition | Long-COVID | Chronic COVID-19 SyndromeItaly
-
Yang I. PachankisActive, not recruitingCOVID-19 Respiratory Infection | COVID-19 Stress Syndrome | COVID-19 Vaccine Adverse Reaction | COVID-19-Associated Thromboembolism | COVID-19 Post-Intensive Care Syndrome | COVID-19-Associated StrokeChina
-
Massachusetts General HospitalRecruitingPost Acute COVID-19 Syndrome | Long COVID | Post Acute Sequelae of COVID-19 | Long COVID-19United States
-
Indonesia UniversityRecruitingPost-COVID-19 Syndrome | Long COVID | Post COVID-19 Condition | Post-COVID Syndrome | Long COVID-19Indonesia
-
Erasmus Medical CenterDa Vinci Clinic; HGC RijswijkNot yet recruitingPost-COVID-19 Syndrome | Long COVID | Long Covid19 | Post COVID-19 Condition | Post-COVID Syndrome | Post COVID-19 Condition, Unspecified | Post-COVID ConditionNetherlands
-
Dr. Soetomo General HospitalIndonesia-MoH; Universitas Airlangga; Biotis Pharmaceuticals, IndonesiaRecruitingCOVID-19 Pandemic | COVID-19 Vaccines | COVID-19 Virus DiseaseIndonesia
-
University of Witten/HerdeckeInstitut für Rehabilitationsforschung NorderneyCompletedPost-COVID-19 Syndrome | Long-COVID-19 SyndromeGermany
-
Jonathann Kuo, MDActive, not recruitingSARS-CoV2 Infection | Post-COVID-19 Syndrome | Dysautonomia | Post Acute COVID-19 Syndrome | Long COVID | Long Covid19 | COVID-19 Recurrent | Post-Acute COVID-19 | Post-Acute COVID-19 Infection | Post Acute Sequelae of COVID-19 | Dysautonomia Like Disorder | Dysautonomia Orthostatic Hypotension Syndrome | Post... and other conditionsUnited States
-
University Hospital, Ioannina1st Division of Internal Medicine, University Hospital of IoanninaRecruitingCOVID-19 Pneumonia | COVID-19 Respiratory Infection | COVID-19 Pandemic | COVID-19 Acute Respiratory Distress Syndrome | COVID-19-Associated Pneumonia | COVID 19 Associated Coagulopathy | COVID-19 (Coronavirus Disease 2019) | COVID-19-Associated ThromboembolismGreece
Clinical Trials on PCR, lung ultrasound
-
Centre Hospitalier Universitaire, AmiensCompletedCovid19 | Respiratory Complication | Lung UltrasoundFrance
-
Centre Hospitalier Universitaire, AmiensCompletedCovid-19 | Respiratory Complication | Lung UltrasoundFrance
-
Kasr El Aini HospitalCompletedExta Vascular Lung WaterEgypt
-
Yale UniversityCompletedPneumonia | Pulmonary Edema | DyspneaUnited States
-
Assiut UniversityCompleted
-
University of MilanCompletedLung Cancer | Community Acquired Pneumonia | Pulmonary Embolism | PleuritisItaly
-
Groupe Hospitalier Paris Saint JosephHopital ForcillesActive, not recruitingCOVID-19 | Weaning Failure | ICU Acquired WeaknessFrance
-
Xiangtan Central HospitalActive, not recruitingHeart Failure | Lung UltrasoundChina
-
Cliniques universitaires Saint-Luc- Université...RecruitingInterstitial Lung DiseaseBelgium
-
Phoenix Children's HospitalChildren's Hospital Los Angeles; Baylor Scott and White Health; St. Joseph's... and other collaboratorsEnrolling by invitationBronchopulmonary DysplasiaUnited States