Clinical Characteristics of Coronavirus Disease 2019 (COVID-19) in Pregnancy (COVID-preg)
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|ClinicalTrials.gov Identifier: NCT04319016|
Recruitment Status : Recruiting
First Posted : March 24, 2020
Last Update Posted : April 28, 2020
|Condition or disease||Intervention/treatment|
|Infection Viral||Other: pregnant women with laboratory-confirmed 2019-n-CoV|
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.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||200 participants|
|Target Follow-Up Duration:||3 Months|
|Official Title:||Clinical Characteristics of Coronavirus Disease 2019 (COVID-19) in Pregnancy|
|Actual Study Start Date :||January 1, 2020|
|Estimated Primary Completion Date :||April 30, 2020|
|Estimated Study Completion Date :||May 1, 2020|
- Other: pregnant women with laboratory-confirmed 2019-n-CoV
Clinical records and compiled data of all consecutive hospitalized and outpatient pregnant women with laboratory-confirmed 2019-n-CoV were included in a merged database
- Maternal and perinatal outcomes [ Time Frame: at the time of delivery ]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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04319016
|Napoli, Italy, 80129|
|Contact: Gabriele Saccone 3394685179 email@example.com|