COVID-19 Infection and Fetal-neonatal Outcomes

Summary

COVID-19, the coronavirus responsible for the pandemic that began at the end of 2019 in China, spreads through respiratory droplets and direct contact. The most common symptoms of the disease include fever, cough, asthenia or myalgia, wheezing and headache, and the most serious complication is acute respiratory distress syndrome (ARDS). The new coronavirus has continued to spread to multiple countries and continents so much so that the epidemic was declared a Public Health Emergency of International Interest (PHEIC) by the World Health Organization (WHO) on January 30, 2020. In the first phase of emergency worldwide, characterized by high morbidity and mortality, scientific interest has been mainly directed to the study of the transmission mechanisms of the infection, diagnostic tools and therapies for ARDS, especially in elderly and co-morbid patients. Interest has rapidly spread to other categories of patients and in particular to pregnancy, on which the virus could impact in different ways, with consequences for both the mother and the fetus. A recent systematic review that included all published reports on Coronaviruses (COVID-19, SARS, and MERS) in pregnancy showed that preterm delivery is the most frequently reported adverse event in these women, and that COVID-19 is associated with an increased risk of preeclampsia and caesarean section. Nonetheless, the limited sample size, the main inclusion of cases reported for acute respiratory symptoms, the lack of information on previous pathologies potentially capable of complicating pregnancy, do not allow for the extrapolation of strong evidence on the course of infection in pregnancy. Therefore, the current status of the scientific literature does not allow for general and wide-ranging implications. THe investigators therefore believe it is particularly useful to investigate maternal and fetal outcomes in this new broader scenario, including all pregnancies associated with asymptomatic or symptomatic SARS-CoV-2 infection, found in any gestational period, in order to evaluate in a "real world scenario" "Actual rates of maternal-fetal and neonatal adverse events

Conditions

• Covid19
• Obstetric Complication
• SARS-CoV Infection
• Preterm Birth
• Miscarriage
• Placenta Diseases

Interventions

DIAGNOSTIC_TEST

Covid-19 positive

All pregnant women at any stage of pregnancy afferent to obstetrics services who tested positive in confirmation tests by nasopharyngeal swab for viral RNA detection through real-time reverse transcriptase - polymerase chain reaction (rRT-PCR) will be included.

Sponsors & Collaborators

• University of Campania Luigi Vanvitelli

  lead OTHER

Principal Investigators

• Nicola Colacurci, Professor · University of Campania Luigi Vanvitelli

• Fabiana Savoia · University of Campania Luigi Vanvitelli

• Alessandra Familiari · Università Cattolica del Sacro Cuore - Dipartimento scienze della salute della donna e del bambino

• Antonio Lanzone, Professor · Università Cattolica del Sacro Cuore - Dipartimento scienze della salute della donna e del bambino

• Antonio Schiattarella, MD · University of Campania Luigi Vanvitelli

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-12-28

Primary Completion

2021-12-31

Completion

2022-05-01

Countries

• Italy

Study Locations