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

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

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.

Study Overview

• Status: Unknown
• Conditions: Infection Viral
• Intervention / Treatment: Other: pregnant women with laboratory-confirmed 2019-n-CoV

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.

• Study Type: Observational
• Enrollment (Anticipated): 20

Contacts and Locations

Study Locations

• Italy
  • Napoli, Italy, 80100
    • Recruiting
    • University of Naples Federico II
    • Contact: Gabriele Saccone, MD; Phone Number: 0817462202; Email: gabriele.saccone@unina.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

pregnant women with laboratory-confirmed 2019-n-CoV

Description

Inclusion Criteria:

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maternal and perinatal outcomes	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	during gestation and at the time of delivery of the baby

Collaborators and Investigators

• Sponsor: Federico II University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Anticipated): April 20, 2020
• Study Completion (Anticipated): April 30, 2020

Study Registration Dates

• First Submitted: March 18, 2020
• First Submitted That Met QC Criteria: March 19, 2020
• First Posted (Actual): March 20, 2020

Study Record Updates

• Last Update Posted (Actual): March 20, 2020
• Last Update Submitted That Met QC Criteria: March 19, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Coronavirus Infections; Virus Diseases
• Other Study ID Numbers: 5/20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: not decided yet

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No