Covid-19 in Pregnancy: a French Population-based Cohort of Women and Newborns

NCT04463758 | Unknown

• 1 other identifier: APHP200513
• Study Type: observational
• Target: 3,060
• Locations: 1 country
• Sites: 1

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

Conditions

covid19 Infection; Pregnancy Complications; Neonatal Complications

Keywords

Covid19; Pregnancy; Maternal morbidity; Perinatal mortality; Neonatal 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 scales OTHER

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

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-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)

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• INSERM, Epopé team: collaborator

Study Sites (1)

AP-HP Cochin

Paris, 75014, France

RECRUITING

MeSH Terms

Conditions

COVID-19; Pregnancy Complications; Perinatal Death

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Pierre Yv Ancel, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Catherine Deneux-Tharaux, MD, PhD

CONTACT

+33 1 42 34 55 79; catherine.deneux-tharaux@inserm.fr

Laurence Lecomte, PhD

CONTACT

+33 1 58 41 34 78; laurence.lecomte@aphp.fr

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: February 1, 2022
• Study Completion: October 1, 2022
• Last Updated: October 4, 2021

Record last verified: 2021-09

Locations

FR (1)