Prevalence and Impact of COVID-19 Infection in Pregnant W... | NCT04355234

Studies
Prevalence and Impact of COVID-19 Infection in Pregnant Women, Fetuses and Newborns

NCT04355234

Sponsor

Assistance Publique - Hôpitaux de Paris

Status

Completed

Last Update Posted

Jun 22, 2022Actual

Enrollment

2,446Actual

Phase

Not Applicable

Conditions

Pregnancy

Interventions

identify SARS-CoV-2 infection by serology
collection of biological samples

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 4, 2020Actual

Primary Completion Date

Aug 31, 2021Actual

Completion Date

Aug 31, 2021Actual

First Submitted Date

Apr 17, 2020

First Submission Date that Met QC Criteria

Apr 17, 2020

First Posted Date

Apr 21, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 20, 2022

Last Update Posted Date

Jun 22, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

2,446Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
identify SARS-CoV-2 infection by serology	Diagnostic Test	Blood samples at delivery to identify SARS-CoV-2 infection by serology	all patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Consequences of SARS-CoV-2 infection in pregnant women and their newborns : Pregnancy outcome, maternal or neonatal complications	Correlation between exposure to the virus (confirmed by serology) and its impact on pregnancy and its outcome : Pregnancy outcome, maternal or neonatal complications	2 months after delivery

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

pregnant women

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Christelle Vauloup Fellous	Assistance Publique - Hôpitaux de Paris	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tsastaris Vassillis		Paris			France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
38492667	Derived	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.
37295035

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections