Purpose: The emergence of a new coronavirus SARS-CoV-2 causing a novel infection in thehuman race resulting in a world-spanning pandemic came as a surprise and at a tremendouscost both for individual human lives as well as for the society and the health caresector. The knowledge on how this new infection affects both the mother and the unbornchild 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 thecoronaviruses causing Middle East Respiratory Syndrome (MERS) and Severe AcuteRespiratory 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-infectedpregnant women and their offspring. To combine this biobank with Swedish quality andhealth care registers, computerized patient charts and questionnaire data, enabling bothshort-term follow up, such as obstetric outcomes, as well as long-term outcomes both formother and child. To study how the pandemic situation affects both the mother and herpartner in their experience of pregnancy, childbirth, and early parenthood.Design: A national Swedish multicentre study. Women are included when they have apositive 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 attheir routine visits (Screening group). Blood samples and other biological material willbe collected at different time-points. Additional predictors and outcomes are collectedfrom the Swedish Pregnancy Register as well as obligatory Swedish health registers. Thebiobank and its linkage to health registers through the Swedish personal identificationnumber will enable future research. Child development will be followed during the firstyear of life by questionnaires to the parents. Womens' and their partners' experience ofchildbirth and parenthood will be studied in form of questionnaires as well as in form ofinterviews.Conclusion: This project will help obstetricians and neonatologists better recognizeclinical manifestations of the virus, identify possible risk factors during pregnancy andtailor therapies alongside providing right level of surveillance and management duringpregnancy, 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