COPE - COVID-19 in Pregnancy and Early Childhood
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- STATUS
- Recruiting
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- End date
- Jun 2, 2041
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- participants needed
- 1200
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- sponsor
- Sahlgrenska University Hospital, Sweden
Summary
Purpose: The emergence of a new coronavirus, coronavirus 2 (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 for 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 based on validated instruments as well as in form of interviews. Sweden is one of few countries with prerequisites enabling a nearly population-based follow-up, even under the pandemic condition with considerable strains for the health care system.
Conclusion: This project will help obstetricians and neonatologists in better recognizing the clinical manifestations of the virus, identify possible risk factors during pregnancy and tailor therapies along with providing the right level of surveillance and management during pregnancy, delivery, and child health care. The project will also enable sharing important unusual outcome data with other research collaborators, e.g. outcome for pregnant women with diabetes.
Details
| Condition | Pregnancy in Diabetics, Pregnancy Complications, Pregnancy Complications, Covid 19, Sars-CoV2, Pregnancy Preterm, Neonatal Infection |
|---|---|
| Age | 18-100 years |
| Treatment | biological samples, questionnaires and interviews |
| Clinical Study Identifier | NCT04433364 |
| Sponsor | Sahlgrenska University Hospital, Sweden |
| Last Modified on | 19 February 2024 |
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