Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT04319016 |
Other study ID # |
145/20 |
Secondary ID |
|
Status |
Recruiting |
Phase |
|
First received |
|
Last updated |
|
Start date |
January 1, 2020 |
Est. completion date |
May 1, 2020 |
Study information
Verified date |
April 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.
Description:
Coronaviruses (CoVs) are the largest group of viruses belonging to the Nidovirales order.
They are enveloped, non-segmented positive-sense RNA viruses.
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.
A recent review evaluated the potential impact of 2019-nCoV in pregnancy. 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 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. Data were entered into a computerized database and cross-checked. If the
core data were missing, requests for clarification were sent to the coordinators.