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

NCT ID: NCT04315870

Last Updated: 2020-03-20

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-01-01
• Study Completion Date: 2020-04-30

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.

Conditions

Infection Viral

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Interventions

pregnant women with laboratory-confirmed 2019-n-CoV

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Federico II University

OTHER

Sponsor Role: lead

Responsible Party

Gabriele Saccone

principal investigator, medical doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Naples Federico II

Napoli, , Italy

Site Status: RECRUITING

Countries

Italy

Facility Contacts

Gabriele Saccone, MD

Role: primary

gabriele.saccone@unina.it

0817462202

Other Identifiers

5/20

Identifier Type: -

Identifier Source: org_study_id