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Clinical Characteristics of Coronavirus Disease 2019 (COVID-19) in Pregnancy: The Italian Registry on Coronavirus in Pregnancy.

Clinical Characteristics of Coronavirus Disease 2019 (COVID-19) in Pregnancy: The Italian Registry on Coronavirus in Pregnancy

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04315870
Acronym
I-COVID
Enrollment
20
Registered
2020-03-20
Start date
2020-01-01
Completion date
2020-04-30
Last updated
2020-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infection Viral

Brief summary

The Novel Coronavirus (2019-nCoV), also known as Wuhan coronavirus, causes the 2019-nCoV acute respiratory disease. The number of patients infected by 2019-nCoV in Italy closely followed an exponential trend, and Italy reported the highest number of infected patients and deaths in the world excluding China.

Detailed description

Coronaviruses (CoVs) are the largest group of viruses belonging to the Nidovirales order. They are enveloped, non-segmented positive-sense RNA viruses.1 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 2019.2 A recent review evaluated the potential impact of 2019-nCoV in pregnancy.3 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 number of patients infected in Italy closely followed an exponential trend, and Italy reported the highest number of infected patients and deaths in the world excluding China.7 Therefore, Italy can be a great source of data, including data on pregnant women. 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 at University of Naples Federico II. Data were entered into a computerized database and cross-checked. If the core data were missing, requests for clarification were sent to the coordinators.

Interventions

Clinical records and compiled data of all consecutive hospitalized and outpatient pregnant women with laboratory-confirmed 2019-n-CoV were included in a merged database

Sponsors

Federico II University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Maternal and perinatal outcomesduring gestation and at the time of delivery of the babydifferent 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

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026