NCT04402918

Brief Summary

The study evaluates the distribution of immunological and virological profiles of newborns patients. Mothers of these children have a proven infection to SARS Cov-2 during pregnancy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2020

Geographic Reach
1 country

1 active site

Status
completed

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

May 17, 2020

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

May 18, 2020

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 19, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 27, 2020

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 2, 2021

Completed
Last Updated

August 3, 2021

Status Verified

July 1, 2021

Enrollment Period

2 days

First QC Date

May 18, 2020

Last Update Submit

August 2, 2021

Conditions

Sars-CoV2

Outcome Measures

Primary Outcomes (2)

  • Vrological profile of newborns.

    Describe the virological profile of newborns whose mother have been diagnosed with Sars Cov2 during pregnancy : Covid+ or covid-

    day of delivery

  • Immunological profile of newborns.

    Describe the immunological profile of newborns whose mother have been diagnosed with Sars Cov2 during pregnancy : IgG and/or IgM or absence

    day of delivery

Study Arms (1)

pregnancy patients diagnosed with SARS Cov2 during pregnancy

OTHER

Delivery day biological samples from the mother and the newborn will be performed

Diagnostic Test: biological samples day of delivery

Interventions

biological samples day of deliveryDIAGNOSTIC_TEST

mother samples: serology, viremia, nasopharyngeal swab, vaginal swab, placenta swab, piece of placenta newborn: serology, viremia, nasopharyngeal aspiration

pregnancy patients diagnosed with SARS Cov2 during pregnancy

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailspregnant women
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • pregnant woman
  • diagnosed with Sars Cov-2 during pregnancy
  • singleton or twin pregnancy
  • informed consent

You may not qualify if:

  • virological or serological samples not done the day of delivery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Besancon

Besançon, 25000, France

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 18, 2020

First Posted

May 27, 2020

Study Start

May 17, 2020

Primary Completion

May 19, 2020

Study Completion

August 2, 2021

Last Updated

August 3, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)