Purpose: The emergence of a new coronavirus SARS-CoV-2 causing a novel infection in the human race resulting in a world-spanning pandemic came as a surprise and at a tremendous cost both for individual human lives as well as for the society and the health care sector. The knowledge on how this new infection affects both the mother and the unborn child as well as the outcomes for the mother and the child in the long run are unknown. What is known is based on case-reports and small case-series solely. Both the coronaviruses causing Middle East Respiratory Syndrome (MERS) and Severe Acute Respiratory Syndrome (SARS) can cause a threat to pregnant women and their offspring, which leads to the question whether this could be the case also for SARS-CoV-2. Aims: To establish a biobank of biological material from infected as well as non-infected pregnant women and their offspring. To combine this biobank with Swedish quality and health care registers, computerized patient charts and questionnaire data, enabling both short-term follow up, such as obstetric outcomes, as well as long-term outcomes both for mother and child. To study how the pandemic situation affects both the mother and her partner in their experience of pregnancy, childbirth, and early parenthood. Design: A national Swedish multicentre study. Women are included when they have a positive test for SARS-CoV-2 or a clinical suspicion of coronavirus disease 2019 (COVID-19) (COVID-19 group). Pregnant women without COVID-19 symptoms will be included at their routine visits (Screening group). Blood samples and other biological material will be collected at different time-points. Additional predictors and outcomes are collected from the Swedish Pregnancy Register as well as obligatory Swedish health registers. The biobank and its linkage to health registers through the Swedish personal identification number will enable future research. Child development will be followed during the first year of life by questionnaires to the parents. Womens' and their partners' experience of childbirth and parenthood will be studied in form of questionnaires as well as in form of interviews. Conclusion: This project will help obstetricians and neonatologists better recognize clinical manifestations of the virus, identify possible risk factors during pregnancy and tailor therapies alongside providing right level of surveillance and management during pregnancy, delivery, and child health care.
Other: biological samples, questionnaires and interviews
Biological samples: to study impact of testing positive for SARS-CoV-2 during pregnancy samples taken in routine clinical care, samples from already existing research biobanks and the newly established COPE biobank will be used. Time-points: inclusion, at delivery mother and fetus. Covid-19 positive group only: 48-96 h, 2 months postpartum for mother and fetus.
Questionnaires: Women and partners in both groups will fill out electronical questionnaires at different time points during pregnancy and until 12 months postpartum based on validated instruments to test for differences in Self-Efficacy, Anxiety and Depression, Health-related quality of life, Sense of Coherence, PTSD Symptoms, Postpartum Bonding, Childbirth experiences and Self-Efficacy of Breastfeeding. The child's health will be assessed regarding infection until 6 weeks of age and development until 4 years.
Interviews: 24-40 women and partners in both groups. Interviews will be conducted 3 to 6 months after childbirth.
Inclusion Criteria:
- Pregnant women 18 years of age and above
- Attending routine antenatal visits at a participating hospital during the study period
or are strongly suspicious of or diagnosed with Covid-19 during pregnancy.
- For the questionnaire part: language knowledge (Swedish, English, Arabic, Somali)
- For the interview part: Swedish language knowledge
Exclusion Criteria:
• Another language but selected ones
Falu Hospital
Falun, Dalarna, Sweden
Halmstad lasarett
Halmstad, Halland, Sweden
Varbergs sjukhus
Varberg, Halland, Sweden
Helsingborgs lasarett
Helsingborg, Skåne, Sweden
Skåne Universitetssjukhus
Lund, Skåne, Sweden
Eskiltuna hospital
Eskilstuna, Södermanland, Sweden
Boras hospital
Boras, VGR, Sweden
Sahlgrenska Univeristy Hospital
Gothenburg, VGR, Sweden
Ryhovs sjukhus
Jönköping, Sweden
Kalmar Lasarett
Kalmar, Sweden
Karlstad lasarett
Karlstad, Sweden
Kristiandstad länssjukhus
Kristianstad, Sweden
Skaraborgs sjukhus Skövde
Skövde, Sweden
BB Stockholm
Stockholm, Sweden
Danderyd
Stockholm, Sweden
Karolinska University Hospital Solna
Stockholm, Sweden
Karolinska University Hospital- Huddinge
Stockholm, Sweden
Södersjukhuset
Stockholm, Sweden
Södertälje
Stockholm, Sweden
Sundsvall
Sundsvall, Sweden
Umeå University Hospital
Umeå, Sweden
Uppsala University Hospital
Uppsala, Sweden
Västerås
Västerås, Sweden
Ystad
Ystad, Sweden
Örebro University Hospital
Örebro, Sweden
Linköping University Hospital
Linköping, Östergötland, Sweden
Vrinnevisjukhuset
Norrköping, Östergötland, Sweden
Verena Sengpiel, MD, PhD, Principal Investigator
Sahlgrenska University Hospital, Sweden