NCT04315870

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 18, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 20, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 20, 2020

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2020

Completed
Last Updated

March 20, 2020

Status Verified

March 1, 2020

Enrollment Period

4 months

First QC Date

March 18, 2020

Last Update Submit

March 19, 2020

Conditions

Infection Viral

Outcome Measures

Primary Outcomes (1)

  • Maternal and perinatal outcomes

    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

    during gestation and at the time of delivery of the baby

Interventions

pregnant women with laboratory-confirmed 2019-n-CoVOTHER

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

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailspregnant women
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

pregnant women with laboratory-confirmed 2019-n-CoV

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Naples Federico II

Napoli, 80100, Italy

RECRUITING

MeSH Terms

Conditions

Virus Diseases

Condition Hierarchy (Ancestors)

Infections

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator, medical doctor

Study Record Dates

First Submitted

March 18, 2020

First Posted

March 20, 2020

Study Start

January 1, 2020

Primary Completion

April 20, 2020

Study Completion

April 30, 2020

Last Updated

March 20, 2020

Record last verified: 2020-03

Locations

IT(1)