COVID-19 Infection and Fetal-neonatal Outcomes

NCT04699578 | Unknown DMC

• 1 other identifier: 8453
• Study Type: observational
• Target: 230
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

obstetric; Covid19; SARS-CoV Infection; placenta; preterm birth

Outcome Measures

Primary Outcomes (1)

• Preterm birth rate

  Less than 37 weeks gestation

Secondary Outcomes (6)

• Gestational age at delivery

  Time of delivery

• Preterm birth rates

  Less than 24, 28, 34 weeks gestation

• Birth weight

  Time of delivery

• Composite adverse neonatal outcomes

  Between birth and 28 days of age

• Maternal outcomes

  Between birth and 28 days after the birth

Interventions

Covid-19 positive DIAGNOSTIC_TEST

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.

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Pregnant women
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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. Upon confirmation, women will be placed in a specific pregnancy monitoring program that will be defined as "at risk for SARS-COVID2", regardless of participation in this study. For women recruited in the study, no additional instrumental or laboratory investigations are required to be performed in addition to those already provided for in the normal clinical management of COVID-positive patients.

You may qualify if:

• Maternal age\> 18 years
• Women with single or multiple pregnancy at any stage of gestation, with first ascertained positivity to the nasopharyngeal swab for SARS-CoV-2 during pregnancy, regardless of the presence of symptoms.

You may not qualify if:

• age under 18.
• Women with an altered state of consciousness, seriously ill, with mental handicaps;
• Women with serious systemic diseases that can negatively affect the pregnancy outcome.
• Women for whom the treating doctor contraindicates participation in the study.

Sponsors & Collaborators

• University of Campania Luigi Vanvitelli: lead

Study Sites (1)

University of Campania Luigi Vanvitelli

Naples, 80138, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Nasopharyngeal swab with rRT-PCR as per ministerial protocol and in any case repeated at any admission to the hospital ward

MeSH Terms

Conditions

COVID-19; Severe Acute Respiratory Syndrome; Premature Birth; Abortion, Spontaneous; Placenta Diseases

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Nicola Colacurci, Professor

  University of Campania Luigi Vanvitelli

  STUDY DIRECTOR

• Fabiana Savoia

  University of Campania Luigi Vanvitelli

  STUDY CHAIR

• Alessandra Familiari

  Università Cattolica del Sacro Cuore - Dipartimento scienze della salute della donna e del bambino

  PRINCIPAL INVESTIGATOR

• Antonio Lanzone, Professor

  Università Cattolica del Sacro Cuore - Dipartimento scienze della salute della donna e del bambino

  STUDY DIRECTOR

• Antonio Schiattarella, MD

  University of Campania Luigi Vanvitelli

  STUDY CHAIR

Central Study Contacts

Maddalena Morlando, Assistant Professor

CONTACT

+39 333 426 3110; madmorlando@gmail.com

Antonio Schiattarella, MD

CONTACT

+39 392 16 53 275; aschiattarella@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 1, 2021
• First Posted: January 7, 2021
• Study Start: December 28, 2020
• Primary Completion: December 31, 2021
• Study Completion: May 1, 2022
• Last Updated: January 7, 2021

Record last verified: 2021-01

Locations

IT (1)