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Assessment of Obstetric, Fetal and Neonatal Risks and Vertical SARS-CoV-2 Transmission During COVID-19 Pandemic

NCT04360811 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2494

Last updated 2022-07-19

No results posted yet for this study

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.

Conditions

  • Pregnancy

Interventions

DIAGNOSTIC_TEST

COVID 19 diagnostic test by PCR

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

Sponsors & Collaborators

  • University Hospital, Toulouse

    lead OTHER

Principal Investigators

  • Charlotte Dubucs, MD · University Hospital, Toulouse

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-17
Primary Completion
2022-03-31
Completion
2022-03-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04360811 on ClinicalTrials.gov