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| Name | Class |
|---|---|
| INSERM, Epopé team | UNKNOWN |
| URC-CIC Paris Descartes Necker Cochin | OTHER |
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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
In the overall context of uncertainty about the morbidity associated with COVID-19 infection and its optimal management, knowledge is urgently required on infection during pregnancy.
First, pregnant women and newborns can have specific and severe reactions to infectious diseases, as seen in previous pandemics which justifies targeted surveillance. Second, optimal management must minimize the health risks of transmission to the newborn. While initial studies did not provide evidence for transmission in utero or during delivery, more recent data suggest that transmission is possible. The virus is present in vaginal secretions and stool, making vertical contamination possible during vaginal delivery. Similarly, transmission may occur during breastfeeding. These risks, which remain theoretical, must be weighed against known harmful consequences of mitigating strategies such as systematic caesarean (increase in maternal morbidity) and separating the child from the mother and contraindicating breastfeeding (negative impact on maternal-child bonding and optimal nutrition). In the absence of reliable data, some maternity hospitals have adopted a maximum precautionary principle, recommending caesarean for all COVID-19 positive women and imposing immediate mother-child separation after childbirth. These approaches are strongly debated in France. Third, optimal management of COVID-19 during pregnancy requires balancing maternal and newborn risks. Risks of maternal deterioration in the event of continuing pregnancy must be weighed against those to the child resulting from indicated preterm birth. This tradeoff is even more complex as evidence-based interventions to protect preterm infants, such as antenatal corticosteroid, may aggravate maternal infection. Finally, childbirth is not an elective procedure and requires managing large numbers of healthy women and newborns in a hospital setting where they are exposed to risks of infection.
Population-based research that captures the diversity of organizational structures and practices within maternity units is needed to guide management during the current epidemic and draw lessons for future infectious pandemics.
Principal innovative features are:
The results of this study will make it possible to:
The objective of this multi-regional population-based cohort is to assess the impact of COVID-19 infection during pregnancy on maternal and neonatal health, including rates of perinatal transmission and the influence of diverse management practices on morbidity. The study's focus on this specific population and its population-based coverage complement other facility-based surveillance systems on all cases in France.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
either proven COVID-19 infection= positive PCR test, OR probable COVID-19 infection = typical clinical symptoms AND typical pulmonary radiology
Exclusion Criteria:
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All pregnant or recently pregnant women managed in one maternity unit of the 16 participating perinatal networks
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| Name | Affiliation | Role |
|---|---|---|
| Pierre Yv Ancel, MD, PhD | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AP-HP Cochin | Paris | 75014 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40396221 | Result | 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. |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D011248 | Pregnancy Complications |
| D066087 | Perinatal Death |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| Until 12 weeks after delivery |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D003643 | Death |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |