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

 -  A population-based approach: Current data systems will include a limited number of
 pregnant women, principally from university hospitals with specific patient populations
 and management strategies. Because all maternity hospitals care for COVID-19+ pregnant
 women, a population-based approach is needed to calculate reliable incidence rates,
 assess practice variability and measure the impact of differences in management on
 maternal and newborn infection rates and health.

 -  The inclusion of infected pregnant women who are not hospitalized and who recover before
 delivery will provide comprehensive data and measure early fetal in-utero exposure.

 -  Immediate feedback to clinicians on their practices will inform current controversies
 about optimal management.

 -  Joint follow-up of mother and child to 12 weeks after delivery, and longer if indicated,
 will document the medium-term impact of infection.

 -  Inclusion of regions with time-varying exposure to the epidemic will provide information
 to evaluate public health policies.

 The results of this study will make it possible to:

 1. guide care for COVID-19 + mothers and their newborns in real time, through a targeted
 analysis of key minimum data items, on a bimonthly basis during the epidemic. To achieve
 this objective, rapid deployment of the data collection system is necessary.

 2. generate knowledge on the morbidity profile of maternal COVID-19 infection for mother
 and child, the subgroups at risk, and the impact of management options in real life
 settings;

 3. document risks of intrapartum, peri-partum and postpartum transmission based on viral
 tests performed in the course of routine care; this approach is complementary to the
 biological collections set up in other projects, which aim to determine the infectious
 status of pregnant women from specialized centers that are not representative of the
 general population of pregnant women.

 4. carry out comparative international research through collaboration with the
 international INOSS network which is coordinating similar data collection protocols and
 designs worldwide. The investigators are French INOSS partners.

 5. evaluate the impact of the epidemic on the organization of care for all pregnant women
 and newborns. Major and rapid changes to prenatal and childbirth care have been made in
 response to the epidemic, including spacing out consultations, using teleconsultation
 instead of in-person visits, restricting the presence of relatives and early discharge.
 These changes may induce negative consequences, notably delays in the diagnosis of
 obstetrical complications. It is therefore crucial to document the impact of the
 epidemic and the resulting measures on the health of all women and newborns. For all
 pregnant women and newborns monitored in participating maternity hospitals, we will
 extract routinely collected data from the computerized records of the maternity
 hospitals and/or via the SNDS-PMSI databases. These data will also be collected for
 periods before the epidemic to enable comparisons with overall pregnancy outcomes
 between the two periods. These results can be placed in an international context through
 collaboration with the European Euro-Peristat network, coordinated by the investigators'
 research team.

 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.
Inclusion Criteria:

 -  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,

 Exclusion Criteria:

 -  Refusal to participate

 -  Major protected (curator, trusteeship)