COPE - COVID-19 in Pregnancy and Early Childhood
COPE
1 other identifier
observational
3,834
1 country
27
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2020
Longer than P75 for all trials
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 2, 2020
CompletedFirst Submitted
Initial submission to the registry
June 15, 2020
CompletedFirst Posted
Study publicly available on registry
June 16, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2040
April 16, 2024
April 1, 2024
6.6 years
June 15, 2020
April 15, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Biobank with linkage to registers
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.
1-20 years
Experiences of pregnancy during a pandemic
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
Study Arms (2)
Screening group
a general population of women giving birth, called "screening group" included at routine antenatal visits, their partners, and children
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
Interventions
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
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.
You may qualify if:
- 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
You may not qualify if:
- Another language but selected ones
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (27)
Falu Hospital
Falun, Dalarna County, 79182, Sweden
Halmstad lasarett
Halmstad, Halland County, 30233, Sweden
Varbergs sjukhus
Varberg, Halland County, 43237, Sweden
Helsingborgs lasarett
Helsingborg, Skåne County, 25223, Sweden
Skåne Universitetssjukhus
Lund, Skåne County, Sweden
Eskiltuna hospital
Eskilstuna, Södermanland County, 63003, Sweden
Boras hospital
Borås, VGR, 50182, Sweden
Sahlgrenska Univeristy Hospital
Gothenburg, VGR, 41685, Sweden
Ryhovs sjukhus
Jönköping, Sweden
Kalmar Lasarett
Kalmar, Sweden
Karlstad lasarett
Karlstad, Sweden
Kristiandstad länssjukhus
Kristianstad, Sweden
Örebro University Hospital
Örebro, 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
Linköping University Hospital
Linköping, Östergötland County, Sweden
Vrinnevisjukhuset
Norrköping, Östergötland County, Sweden
Related Publications (1)
Carlsson Y, Bergman L, Zaigham M, Linden K, Andersson O, Veje M, Sandstrom A, Wikstrom AK, Ostling H, Fadl H, Domellof M, Blomberg M, Brismar Wendel S, Aden U, Sengpiel V; COPE study group. COVID-19 in Pregnancy and Early Childhood (COPE): study protocol for a prospective, multicentre biobank, survey and database cohort study. BMJ Open. 2021 Sep 14;11(9):e049376. doi: 10.1136/bmjopen-2021-049376.
PMID: 34521667DERIVED
Biospecimen
Bloodsample from the mother antenatally, at inclusion and at delivery from healthy women, as well as NPH-swab and placenta at delivery. Naval cord blood from healthy infants. From covid-19 pos women: blood sample antenatally and at diagnosis as well as vaginal, rectal and NPH swab and urinary sample. At delivery NPH-swabs as well as vaginal and rectal swabs and urinary samples and blood and in case of caesarean section amnion fluid and spinal fluid. Breastmilk at 48-96 hours after delivery. From the infant naval cord blood and at 48-96 hours after delivery NPH-swab and rectal swab as well as blood sample. For the COVID-19 group a follow-up visit during the first year after delivery for bloodsamples of mother and child/children.
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Verena Sengpiel, MD, PhD
Sahlgrenska University Hospital
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 20 Years
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD, Senior Consultant
Study Record Dates
First Submitted
June 15, 2020
First Posted
June 16, 2020
Study Start
June 2, 2020
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2040
Last Updated
April 16, 2024
Record last verified: 2024-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF
- Time Frame
- 2024
- Access Criteria
- Ethical permission
Outcome variables