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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
Sponsor:
Information provided by (Responsible Party):
Gabriele Saccone, Federico II University

Brief Summary:
The Novel Coronavirus (2019-nCoV), also known as Wuhan coronavirus, causes the 2019-nCoV acute respiratory disease.

Condition or disease Intervention/treatment
Infection Viral Other: pregnant women with laboratory-confirmed 2019-n-CoV

Detailed 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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Other
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

Resource links provided by the National Library of Medicine



Intervention Details:
  • 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


Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   pregnant women
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
pregnant women with laboratory-confirmed 2019-n-CoV
Criteria

Inclusion Criteria:

  • pregnant women with laboratory-confirmed 2019-n-CoV

Information from the National Library of Medicine

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


Locations
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Italy
Gabriele Saccone Recruiting
Napoli, Italy, 80129
Contact: Gabriele Saccone    3394685179    gabriele.saccone@libero.it   
Sponsors and Collaborators
Federico II University
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Responsible Party: Gabriele Saccone, principal investigator, medical doctor, Federico II University
ClinicalTrials.gov Identifier: NCT04319016    
Other Study ID Numbers: 145/20
First Posted: March 24, 2020    Key Record Dates
Last Update Posted: April 28, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: not planned yet

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Virus Diseases