NCT04360811

Brief Summary

A new coronavirus (COVID-19) highlighted at the end of 2019 in China is spreading across all continents. Most often at the origin of a mild infectious syndrome, associating benign symptoms (such as fever, cough, and headache) to different degrees, COVID-19 can cause serious pulmonary pathologies and sometimes death. Data on the consequences during pregnancy are limited. The first Chinese data published seem to show that the symptoms in pregnant women are the same as those of the general population. There are no cases of intrauterine maternal-fetal transmission, but cases of newborns infected early suggest that there could be vertical intrauterine, perpartum or neonatal transmission. Prematurity and cases of respiratory distress in newborns of infected mothers have been described. Subsequently, an in-depth analysis of cases in pregnant women and pregnancy issues are necessary in order to improve knowledge on the subject.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,494

participants targeted

Target at P75+ for not_applicable pregnancy

Timeline
Completed

Started Apr 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

April 17, 2020

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

April 22, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 24, 2020

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2022

Completed
Last Updated

July 19, 2022

Status Verified

July 1, 2022

Enrollment Period

2 years

First QC Date

April 22, 2020

Last Update Submit

July 18, 2022

Conditions

Pregnancy

Keywords

Pregnant womenpandemicCOVID-19vertical mother-fetal transmissionSARS-CoV-2

Outcome Measures

Primary Outcomes (1)

  • number of positive COVID-19 women

    Exposure to SARS-CoV-2 will be measured the day of delivery by RT-PCR on maternal saliva and by serology on maternal blood

    Day 0

Secondary Outcomes (1)

  • number of positive COVID-19 women

    Day 0

Study Arms (2)

Unexposed group : COVID 19 negatif pregant woman

OTHER

COVID-19 negative women (not immunize

Diagnostic Test: COVID 19 diagnostic test by PCR

Exposed group : COVID 19 positif pregant woman

OTHER

Women positive for COVID-19 (symptomatic and asymptomatic) COVID-19 negative women with long-standing immunity

Diagnostic Test: COVID 19 diagnostic test by PCR

Interventions

COVID 19 diagnostic test by PCRDIAGNOSTIC_TEST

1. Inclusion of patients with clinical data (in a eCRF) and various samples collection according to the outcome of pregnancy 2. Storage and freezing samples for subsequent analysis by RT-PCR COVID-19 (maternal saliva, cord blood, fetal stools, placenta, fetal tissue, amniotic fluid according to pregnancy outcomes) and by maternal and newborn and / or fetal serologies testing 3. Pathological study of placentas and fetal autopsies * Histology of positive COVID-19 placentas * Brain and visceral histology of positive COVID-19 fetuses autopsied 4. Analysis of patient comorbidities and comparison in the different groups 5. Final statistical analysis

Exposed group : COVID 19 positif pregant womanUnexposed group : COVID 19 negatif pregant woman

Eligibility Criteria

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

You may qualify if:

  • Pregnant women coming to deliver in the Paule de Viguier maternity unit of Toulouse's University Hospital between April 2020 and April 2021 regardless the pregnancy outcomes (live births, IUFD, miscarriages, medical termination of pregnancy ) and the term
  • Women affiliated to a social security system (including AME)

You may not qualify if:

  • Voluntary termination of pregnancy
  • Language barrier
  • Patient under a legal protection measure (guardianship, curatorship, or safeguard of justice)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Toulouse

Toulouse, 31000, France

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Charlotte Dubucs, MD

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 22, 2020

First Posted

April 24, 2020

Study Start

April 17, 2020

Primary Completion

March 31, 2022

Study Completion

March 31, 2022

Last Updated

July 19, 2022

Record last verified: 2022-07

Locations

FR(1)