Official Title
COPE - COVID-19 in Pregnancy and Early Childhood - a Study Protocol for a Prospective Multicentre Cohort Study
Brief Summary

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.

Active, not recruiting
SARS-COV2
COVID-19
Pregnancy Complications
Pregnancy Preterm
Pregnancy in Diabetic
Neonatal Infection

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.

Eligibility Criteria

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

Eligibility Gender
Female
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
Sweden
Locations

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

Sahlgrenska University Hospital, Sweden
NCT Number
Keywords
SARS-CoV2
Covid-19
pregnancy
neonatal
long-term follow-up
complications
MeSH Terms
COVID-19
Pregnancy Complications
Pregnancy in Diabetics