NCT04463758

Brief Summary

The purpose of this study is to characterize the incidence and clinical features of the maternal COVID 19 infection, as well as the associated morbidity of the mother and the child, in the French context

Trial Health

87
On Track

Trial Health Score

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

Enrollment
6,015

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2020

Typical duration for all trials

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

May 11, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 8, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 9, 2020

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 27, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 27, 2022

Completed
Last Updated

July 1, 2026

Status Verified

June 1, 2026

Enrollment Period

2.4 years

First QC Date

July 8, 2020

Last Update Submit

June 29, 2026

Conditions

covid19 InfectionPregnancy ComplicationsNeonatal Complications

Keywords

Covid19PregnancyMaternal morbidityPerinatal mortalityNeonatal morbidity

Outcome Measures

Primary Outcomes (1)

  • Joint evaluation of morbi-mortality for mother and child up to 12 weeks postpartum

    Maternal Criterion: Validated Composite Criterion of Severe Maternal Morbidity (Epimoms study ref 7). Neonatal Criterion: Mortality and Composite Criterion of Severe Neonatal Morbidity Perinatal asphyxia (arterial pH to cord-7.15 and/or an excess base - 10mmol/L and/or lactates-6 mmol/L, Apgar score at 5 minutes -7), neonatal encephalopathy, seizures, intraventricular hemorrhage, cerebral infarction, periventricular leucomalacia, ulcerative enterocolite, sepsis, respiratory distress syndrome, bronchopulmonary dysplasia, central catheter, ventilatory support, transfusion

    At12 weeks after delivery

Secondary Outcomes (3)

  • Number of women infection COVID-19

    During pregnancy and up to 12 weeks

  • Severe forms of COVID-19 infection in the mother

    Until 12 weeks after delivery

  • Severe neonatal morbidity

    Until 12 weeks after delivery

Interventions

An auto-questionnaire comprising three psychometric scalesOTHER

three psychometric scales validated in French: \_depression (Edinburgh Postpartum Depression Scale (EPDS)), anxiety (State-Trait Anxiety Inventory (STAI) \- and Impact of Event Scale (Revised) (IES-R)

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All pregnant or recently pregnant women managed in one maternity unit of the 16 participating perinatal networks

You may qualify if:

  • Any woman with :
  • either proven COVID-19 infection= positive PCR test, OR probable COVID-19 infection = typical clinical symptoms AND typical pulmonary radiology
  • during pregnancy or within 42 days postpartum,
  • whether or not this diagnosis is followed by hospitalization,

You may not qualify if:

  • Refusal to participate
  • Major protected (curator, trusteeship)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AP-HP Cochin

Paris, 75014, France

Location

Related Publications (1)

  • Diguisto C, Ancel PY, Seco A, Baunot N, Caze C, Crenn-Hebert C, Dupont C, Garabedian C, Lebeaux C, Le Ray C, Letouzey M, Lorthe E, Marrer E, Rouger V, Vayssiere C, Vauloup Fellous C, Bonnet MP, Deneux-Tharaux C. Incidence, Risk Factors and Outcomes of SARS-CoV-2 Infection in Pregnant Women: The COROPREG Population-Based Study. Paediatr Perinat Epidemiol. 2025 Jul;39(5):477-494. doi: 10.1111/ppe.70028. Epub 2025 May 21.

    PMID: 40396221RESULT

MeSH Terms

Conditions

COVID-19Pregnancy ComplicationsPerinatal Death

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDeathPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Pierre Yv Ancel, MD, PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 8, 2020

First Posted

July 9, 2020

Study Start

May 11, 2020

Primary Completion

September 27, 2022

Study Completion

September 27, 2022

Last Updated

July 1, 2026

Record last verified: 2026-06

Locations

FR(1)