TRANSCOVID: Study of Viral Load and Maternal-fetal Serology in the Interpretation of the Vertical Transmission of SARS Cov-2 (COVID-19) During Pregnancy
Sponsor
Centre Hospitalier Universitaire de Besancon (Other)
Overall Status
Completed
CT.gov ID
NCT04402918
Collaborator
(none)
160
1
1
14.5
11
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Actual Enrollment
:
160 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Study of Viral Load and Maternal-fetal Serology in the Interpretation of the Vertical Transmission of SARS Cov-2 During Pregnancy
Actual Study Start Date
:
May 17, 2020
Actual Primary Completion Date
:
May 19, 2020
Actual Study Completion Date
:
Aug 2, 2021
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: pregnancy patients diagnosed with SARS Cov2 during pregnancy Delivery day biological samples from the mother and the newborn will be performed |
Diagnostic Test: biological samples day of delivery
mother samples: serology, viremia, nasopharyngeal swab, vaginal swab, placenta swab, piece of placenta newborn: serology, viremia, nasopharyngeal aspiration
|
Outcome Measures
Primary Outcome Measures
- Vrological profile of newborns. [day of delivery]
Describe the virological profile of newborns whose mother have been diagnosed with Sars Cov2 during pregnancy : Covid+ or covid-
- Immunological profile of newborns. [day of delivery]
Describe the immunological profile of newborns whose mother have been diagnosed with Sars Cov2 during pregnancy : IgG and/or IgM or absence
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
pregnant woman
-
diagnosed with Sars Cov-2 during pregnancy
-
singleton or twin pregnancy
-
informed consent
Exclusion Criteria:
- virological or serological samples not done the day of delivery
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Chu Besancon | Besancon | France | 25000 |
Sponsors and Collaborators
- Centre Hospitalier Universitaire de Besancon
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier:
NCT04402918
Other Study ID Numbers:
- 2020/500
First Posted:
May 27, 2020
Last Update Posted:
Aug 3, 2021
Last Verified:
Jul 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No