It is unknown how the COVID-19 pandemic affects pregnant women and their offspring. Previous research has linked fever and infection during pregnancy to increased risk of neurodevelopmental and psychiatric conditions in offspring, including autism spectrum disorder (ASD).

This study investigates how SARS-CoV-2 affects pregnancy outcome and maternal and child health by forming a database and biobank and following up on the child’s neurocognitive development and neuropsychiatric health in questionnaires and registers. Its specific aims are to investigate the association between exposure to SARS-CoV-2 in utero and neurodevelopmental outcome in the offspring by specified Ages and Stages Questionnaires, as well as the incidence of ASD in offspring.

COPE (COVID-19 in pregnancy and early childhood) is a multicenter study in Sweden including both healthy women and women who test positive for SARS-CoV-2. Hospitals that are responsible for more than 75 percent of the yearly 114,000 deliveries in Sweden are currently participating in data collection. The study comprises a biobank and a survey. The study recruits in the most commonly spoken languages in Sweden: Swedish, English, Arabic and Somali.

Biological samples from mother and child are obtained at several timepoints during pregnancy and until two months after delivery and stored at Biobank Sweden. For the screening group, maternal blood samples and nasopharyngeal (NPH) swabs are collected at inclusion and upon delivery as well as umbilical cord blood at delivery. Women in the COVID-19 group additionally provide rectal and vaginal swabs, a urine sample, breast milk and blood samples two months after delivery and cerebrospinal and amniotic fluid in the case of C-section delivery. For the child, umbilical cord blood, NPH and rectal swabs, and blood samples at two months are collected. In the case of acute COVID-19 at delivery, placental swabs and a blood sample two days after delivery are also collected. Samples will be analyzed for the presence of SARS-CoV-2 and antibodies against SARS-CoV-2.

Survey-based infant follow-up will continue up to four years based on an Ages and Stages Questionnaire. Maternal health and parent child interaction will be followed by surveys including the Hospital Anxiety and Depression Scale and the Postpartum bonding questionnaire. Data will be synchronized to Swedish quality and mandatory health registers, enabling nearly complete and long-term follow-up of child and mother.

The study design enables Verena Sengpiel and colleagues to study the impact of both symptomatic and asymptomatic COVID-19 on neurocognitive development and neuropsychiatric health in the offspring, including risk for ASD. As diagnosis and procedures from all visits to specialists in psychiatry as well as all inpatient care are transferred to the mandatory Swedish patient register, they will have almost full coverage of neurodevelopment and psychiatric diagnoses in the cohort. Milder developmental delays or deviations would be captured by the Ages and Stages Questionnaire during preschool age, delivered as part of this study. Further, the impact of timepoint for and severity of infection, viral load and occurrence in different tissues/bodily fluids, maternal and child immune response, pregnancy complications, socioeconomic status, parent psychiatric health and parent child interaction on autism risk can be studied.