Ignite Creation Date:
2024-05-06 @ 2:50 PM
Last Modification Date:
2024-10-26 @ 1:37 PM
Study NCT ID:
NCT04433364
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-16
First Post:
2020-06-15
Brief Title:
COPE - COVID-19 in Pregnancy and Early Childhood
Sponsor:
Sahlgrenska University Hospital Sweden
Organization:
Sahlgrenska University Hospital Sweden
Study Overview
Official Title:
COPE - COVID-19 in Pregnancy and Early Childhood - a Study Protocol for a Prospective Multicentre Cohort Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COPE
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None