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Clinical Trials/NCT04319016
NCT04319016
Unknown
Not Applicable

Clinical Characteristics of Coronavirus Disease 2019 (COVID-19) in Pregnancy

Federico II University1 site in 1 country200 target enrollmentJanuary 1, 2020
ConditionsInfection Viral

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Infection Viral
Sponsor
Federico II University
Enrollment
200
Locations
1
Primary Endpoint
Maternal and perinatal outcomes
Last Updated
6 years ago

Overview

Brief Summary

The Novel Coronavirus (2019-nCoV), also known as Wuhan coronavirus, causes the 2019-nCoV acute respiratory disease.

Detailed Description

Coronaviruses (CoVs) are the largest group of viruses belonging to the Nidovirales order. They are enveloped, non-segmented positive-sense RNA viruses. Coronavirus are believed to cause a significant proportion of all common colds in adults and children. The Novel Coronavirus (2019-nCoV), also known as Wuhan coronavirus, causes the 2019-nCoV acute respiratory disease. The initial cases of 2019-nCoV occurred in Wuahn, China in December 2019. A recent review evaluated the potential impact of 2019-nCoV in pregnancy. The authors reported published data on CoVs in pregnant women, including 2019-nCoV, severe acute respiratory syndrome (SARS-COV) and Middle East respiratory syndrome (MERS-COV). The review included 12 women with SARS-COV,4 11 women MERS-COV,5 and 9 women with 2019-n-CoV6 in pregnancy. No cases of vertical trasmission were reported, but the authors showed an high rate of preterm birth (45.8%), cesarean delivery (70.8%), maternal admission to intensive care unit (ICU) (63.3%), and maternal death (18.8%). The aim of this study was to evaluate the pregnancy and perinatal outcomes of pregnant women with 2019-n-CoV. This was a multicenter, retrospective, cohort study. Clinical records and compiled data of all consecutive hospitalized and outpatient pregnant women with laboratory-confirmed 2019-n-CoV Data on recent exposure history, clinical symptoms or signs, laboratory findings, and maternal and perinatal outcomes were collected. All medical recors were sent to the coordinator center. Data were entered into a computerized database and cross-checked. If the core data were missing, requests for clarification were sent to the coordinators.

Registry
clinicaltrials.gov
Start Date
January 1, 2020
End Date
May 1, 2020
Last Updated
6 years ago
Study Type
Observational
Sex
Female

Investigators

Sponsor
Federico II University
Responsible Party
Principal Investigator
Principal Investigator

Gabriele Saccone

principal investigator, medical doctor

Federico II University

Eligibility Criteria

Inclusion Criteria

  • pregnant women with laboratory-confirmed 2019-n-CoV

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Maternal and perinatal outcomes

Time Frame: at the time of delivery

different maternal and perinatal outcomes were evaluated including: admission to ICU, use of mechanical ventilation, maternal death, early pregnany loss, perinatal death, intrauterine growth restriction (IUGR), preterm birth, mode of delivery, LBW, admission to neonatal ICU (NICU), and clinical or serologic evidence of vertical trasmission

Study Sites (1)

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