- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04433364
COPE - COVID-19 in Pregnancy and Early Childhood (COPE)
COPE - COVID-19 in Pregnancy and Early Childhood - a Study Protocol for a Prospective Multicentre Cohort Study
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Contact
- Name: Verena Sengpiel, MD, PhD
- Phone Number: +46704223475
- Email: verena.sengpiel@obgyn.gu.se
Study Contact Backup
- Name: Ylva Carlsson, MD, PhD
- Phone Number: +46730706546
- Email: ylva.carlsson@vgregion.se
Study Locations
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Jönköping, Sweden
- Ryhovs sjukhus
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Kalmar, Sweden
- Kalmar Lasarett
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Karlstad, Sweden
- Karlstad lasarett
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Kristianstad, Sweden
- Kristiandstad länssjukhus
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Skövde, Sweden
- Skaraborgs sjukhus Skövde
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Stockholm, Sweden
- Södersjukhuset
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Stockholm, Sweden
- Karolinska University Hospital Solna
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Stockholm, Sweden
- BB Stockholm
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Stockholm, Sweden
- Danderyd
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Stockholm, Sweden
- Karolinska University Hospital- Huddinge
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Stockholm, Sweden
- Södertälje
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Sundsvall, Sweden
- Sundsvall
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Umeå, Sweden
- Umeå University Hospital
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Uppsala, Sweden
- Uppsala University Hospital
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Västerås, Sweden
- Västerås
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Ystad, Sweden
- Ystad
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Örebro, Sweden
- Örebro University Hospital
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Dalarna
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Falun, Dalarna, Sweden, 79182
- Falu Hospital
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Halland
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Halmstad, Halland, Sweden, 30233
- Halmstad lasarett
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Varberg, Halland, Sweden, 43237
- Varbergs sjukhus
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Skåne
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Helsingborg, Skåne, Sweden, 25223
- Helsingborgs lasarett
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Lund, Skåne, Sweden
- Skåne universitetssjukhus
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Södermanland
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Eskilstuna, Södermanland, Sweden, 63003
- Eskiltuna hospital
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VGR
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Boras, VGR, Sweden, 50182
- Borås Hospital
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Gothenburg, VGR, Sweden, 41685
- Sahlgrenska Univeristy Hospital
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Östergötland
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Linköping, Östergötland, Sweden
- Linkoping University Hospital
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Norrköping, Östergötland, Sweden
- Vrinnevisjukhuset
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Screening group
a general population of women giving birth, called "screening group" included at routine antenatal visits, their partners, and children
|
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. |
COVID-19 group
group of women testing positive for SARS-CoV-2 or falling ill with COVID-19, called "COVID-19 group", their partners, and children
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Biobank with linkage to registers
Time Frame: 1-20 years
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establish a biobank and database with bio-samples from both women that are not tested and presumed healthy as well as possibly ill and women confirmed tested positive for SARS-CoV-2 and their infants linked to Swedish health care registers including socio-economic factors and use serological and viral analyses from the biological samples to evaluate maternal, fetal and neonatal outcomes.
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1-20 years
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Experiences of pregnancy during a pandemic
Time Frame: 1 year
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study how women and their partners experience pregnancy, childbirth and early parenthood in the COVID-19-pandemic, both for women not tested and for women tested positive for SARS-CoV-2.
|
1 year
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020-02848 0604
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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