NCT04355234

Brief Summary

A novel human coronavirus, named SevereAcute Respiratory Syndrome coronavirus 2 (SARS-CoV-2), emerged in China, in late 2019, and is now spreading quickly causing a pandemic. It is usually responsible for a mild infectious syndrome, but patients can also develop pneumonia, acute respiratory failure and other serious complications. To date, very little and controversial literature is available on the impact of SARS-CoV-2 infection on pregnancy, and the potential risk of vertical transmission. Therefore, the first part of the study, will evaluate the proportion of pregnant woman infected by SARS-CoV-2 during pregnancy over the next six months by performing SARS-CoV-2 serology during pregnancy and at delivery . This information will be correlated to pregnancy and neonatal outcome. The second part of the study 2 will collect sera from several mandatory screening that are kept for one year. Those will be used for assessing the time of the seroconversion and variations of susceptibility to infection with gestational age as well as the impact of social distancing measures. Concerning neonates born to mothers with documented SARS-CoV-2 infection during pregnancy, only few cases of congenital infections were recently reported because of pneumonia related to SARS-CoV-2 infection and/or positive IgM at birth. It remains unclear whether neonatal infection can follow transplacental transmission of SARS-CoV-2 during pregnancy and/or through early per- and postnatal exposure, including breast-feeding. In order to investigate these hypotheses, the third part of the study will perform, SARS-CoV-2 PCR tests in a variety of samples collected from infected-mother (symptomatic during the pregnancy and PCR confirmed) and child pairs, at delivery and in the postpartum period.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,446

participants targeted

Target at P75+ for not_applicable pregnancy

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

First Submitted

Initial submission to the registry

April 17, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 21, 2020

Completed
13 days until next milestone

Study Start

First participant enrolled

May 4, 2020

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2021

Completed
Last Updated

June 22, 2022

Status Verified

April 1, 2020

Enrollment Period

1.3 years

First QC Date

April 17, 2020

Last Update Submit

June 20, 2022

Conditions

Pregnancy

Keywords

pregnancy; SARS-CoV-2; COVID-19

Outcome Measures

Primary Outcomes (1)

  • Seroprevalence or Number of women who are positive for SARS-CoV-2 in parturient woman

    Number of women who are positive for SARS-CoV-2

    at delivery

Secondary Outcomes (9)

  • Consequences of SARS-CoV-2 infection in pregnant women and their newborns : Pregnancy outcome, maternal or neonatal complications

    2 months after delivery

  • Assessment of the vertical transmission of SARS-CoV-2 and the possible routes of this transmission in women who are positive for SARS-CoV-2 during pregnancy

    at delivery

  • Assessment of the vertical transmission of SARS-CoV-2 and the possible routes of this transmission in women who are positive for SARS-CoV-2 during pregnancy

    5 days after delivery

  • Assessment of susceptibility to infection during the 3 trimesters of pregnancy

    5 days after delivery

  • Evaluation of the confinement on the risk of exposure to the virus during pregnancy .

    5 days after delivery

  • +4 more secondary outcomes

Study Arms (2)

all patients

EXPERIMENTAL
Diagnostic Test: identify SARS-CoV-2 infection by serology

patients who presented a SARS-CoV-2 infection confirmed by PCR

EXPERIMENTAL
Biological: collection of biological samples

Interventions

identify SARS-CoV-2 infection by serologyDIAGNOSTIC_TEST

Blood samples at delivery to identify SARS-CoV-2 infection by serology

all patients
collection of biological samplesBIOLOGICAL

Creation of a specific collection of biological samples for new investigations thanks to the collection of several biological samples at the time of maternal SARS-CoV-2 infection, at delivery and in the postpartum period in the parturient and her newborn.

patients who presented a SARS-CoV-2 infection confirmed by PCR

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:

  • Any pregnant woman giving birth or having a miscarriage after 15 weeks.
  • Major patient

You may not qualify if:

  • Patients not speaking French and not accompanied by a translator
  • Patients under curatorship / guardianship
  • Refusal to participate in research

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tsastaris Vassillis

Paris, France

Location

Related Publications (2)

  • Vivanti AJ, Couffignal C, Sibiude J, Cordier AG, Tsatsaris V, Rozenberg F, Launay O, Benachi A, De Luca D, Ancel PY, Marcault E, Ville Y, Carrara J, Luton D, Dommergues M, Borie C, Kayem G, Lecomte L, Leruez-Ville M, Perillaud-Dubois C, Biran V, Manchon P, Picone O, Vauloup-Fellous C. Maternal and neonatal outcomes of French prospective multicenter cohort study COVIPREG during the first two COVID-19 waves. J Gynecol Obstet Hum Reprod. 2024 Jun;53(6):102764. doi: 10.1016/j.jogoh.2024.102764. Epub 2024 Mar 16.

    PMID: 38492667DERIVED

  • Brebant D, Couffignal C, Manchon P, Duquesne S, Picone O, Vauloup-Fellous C. Transplacental transfer of anti-SARS-CoV-2 neutralizing antibodies in comparison to other pathogens total antibodies. J Clin Virol. 2023 Aug;165:105495. doi: 10.1016/j.jcv.2023.105495. Epub 2023 May 26.

    PMID: 37295035DERIVED

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

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

Study Officials

  • Christelle Vauloup Fellous

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Model Details: Prospective, multicenter, open study with inclusions of 2200 parturients. All parturients divided into 2 groups: * 2200 patients whose SARS-Cov-2 status is unknown during pregnancy * 300 patients who presented a SARS-CoV-2 infection confirmed by PCR during pregnancy whatever the term
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2020

First Posted

April 21, 2020

Study Start

May 4, 2020

Primary Completion

August 31, 2021

Study Completion

August 31, 2021

Last Updated

June 22, 2022

Record last verified: 2020-04

Locations

FR(1)