Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04315870 |
| Other study ID # |
5/20 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2020 |
| Est. completion date |
April 30, 2020 |
Study information
| Verified date |
March 2020 |
| Source |
Federico II University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial 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.
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.
