COVID-19 in Pregnancy and Early Childhood (COPE): study protocol for a prospective, multicentre biobank, survey and database cohort study.

INTRODUCTION: There is limited knowledge on how the SARS-CoV-2 affects pregnancy outcomes. Studies investigating the impact of COVID-19 in early pregnancy are scarce and information on long-term follow-up is lacking.The purpose of this project is to study the impact of COVID-19 on pregnancy outcomes and long-term maternal and child health by: (1) establishing a database and biobank from pregnant women with COVID-19 and presumably non-infected women and their infants and (2) examining how women and their partners experience pregnancy, childbirth and early parenthood in the COVID-19 pandemic. METHODS AND ANALYSIS: This is a national, multicentre, prospective cohort study involving 27 Swedish maternity units accounting for over 86 000 deliveries/year. Pregnant women are included when they: (1) test positive for SARS-CoV-2 (COVID-19 group) or (2) are non-infected and seek healthcare at one of their routine antenatal visits (screening group). Blood, as well as other biological samples, are collected at different time points during and after pregnancy. Child health up to 4 years of age and parent experience of pregnancy, delivery, early parenthood, healthcare and society in general will be examined using web-based questionnaires based on validated instruments. Short- and long-term health outcomes will be collected from Swedish health registers and the parents' experiences will be studied by performing qualitative interviews. ETHICS AND DISSEMINATION: Confidentiality aspects such as data encryption and storage comply with the General Data Protection Regulation and with ethical committee requirements. This study has been granted national ethical approval by the Swedish Ethical Review Authority (dnr 2020-02189 and amendments 2020-02848, 2020-05016, 2020-06696 and 2021-00870) and national biobank approval by the Biobank Väst (dnr B2000526:970). Results from the project will be published in peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT04433364.

Characteristics and short-term obstetric outcomes in a case series of 67 women test-positive for SARS-CoV-2 in Stockholm, Sweden.

INTRODUCTION: The Stockholm region was the first area in Sweden to be hit by the pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The national guidelines on the care of women with a positive test for SARS-CoV-2 (detection with polymerase chain reaction [PCR]) recommend individualized antenatal care, mode of delivery based on obstetric considerations, and no routine separation of the mother and the newborn. Breastfeeding is encouraged, and although there is no specific recommendation regarding wearing a face mask to prevent viral transmission to the newborn while nursing, instructions are given to keep high hygiene standards. All studies based on cases tested on hospital admission will capture more women with pregnancy complications than in the general population. Our aim was to describe the clinical characteristics of SARS-CoV-2-positive women and their neonates, and to report short-term maternal and neonatal outcomes. MATERIAL AND METHODS: A retrospective case series with data from medical records including all test-positive women (n = 67) who gave birth to 68 neonates from 19 March to 26 April 2020 in Stockholm, Sweden. Means, proportions and percentages were calculated for clinical characteristics and outcomes. RESULTS: The mean age was 32 years, 40% were nulliparous and 61% were overweight or obese. Further, 15% had diabetes and 21% a hypertensive disease. Seventy percent of the women had a vaginal birth. Preterm delivery occurred in 19% of the women. The preterm deliveries were mostly medically indicated, including two women who were delivered preterm due to severe coronavirus disease 19 (COVID-19), corresponding to 15% of the preterm births. Four women (6%) were admitted to the intensive care unit postpartum but there were no maternal deaths. There were two perinatal deaths (one stillbirth and one neonatal death). Three neonates were PCR-positive for SARS-CoV-2 after birth. CONCLUSIONS: In this case series of 67 women testing positive for SARS-CoV-2 with clinical presentations ranging from asymptomatic to manifest COVID-19 disease, few women presented with severe COVID-19 illness. The majority had a vaginal birth at term with a healthy neonate that was negative for SARS-CoV-2.