Sars-CoV2COPENCT04433364
COPE - COVID-19 in Pregnancy and Early Childhood
An observational study of Sars-CoV2 and Covid-19, run by Sahlgrenska University Hospital at 27 sites in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sars-CoV2, Covid-19, Pregnancy Complications
- What is being tested?
- biological samples, questionnaires and interviews
- How many people
- 3,834 participants
- Where
- 27 sitesSweden
- Study dates
- 2 Jun 2020to 31 Dec 2040
- How long will I take part?
- 20 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- Another language but selected ones
Trial locations and contacts
27 sites in 1 country.
27 sites in 1 country
Sweden27 sites
Boras hospital
Borås, VGR, 50182
Eskiltuna hospital
Eskilstuna, Södermanland County, 63003
Falu Hospital
Falun, Dalarna County, 79182
Sahlgrenska Univeristy Hospital
Gothenburg, VGR, 41685
Halmstad lasarett
Halmstad, Halland County, 30233
Helsingborgs lasarett
Helsingborg, Skåne County, 25223
Ryhovs sjukhus
Jönköping
Kalmar Lasarett
Kalmar
Karlstad lasarett
Karlstad
Kristiandstad länssjukhus
Kristianstad
Linköping University Hospital
Linköping, Östergötland County
Skåne Universitetssjukhus
Lund, Skåne County
Vrinnevisjukhuset
Norrköping, Östergötland County
Örebro University Hospital
Örebro
Skaraborgs sjukhus Skövde
Skövde
BB Stockholm
Stockholm
Danderyd
Stockholm
Karolinska University Hospital Solna
Stockholm
Karolinska University Hospital- Huddinge
Stockholm
Södersjukhuset
Stockholm
Södertälje
Stockholm
Sundsvall
Sundsvall
Umeå University Hospital
Umeå
Uppsala University Hospital
Uppsala
Varbergs sjukhus
Varberg, Halland County, 43237
Västerås
Västerås
Ystad
Ystad
About this study
Official title: 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.
Read more
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.
- Conditions
- Sars-CoV2, Covid-19, Pregnancy Complications, Pregnancy Preterm, Pregnancy in Diabetic, Neonatal Infection
- Being tested
- biological samples, questionnaires and interviews
- Keywords
- sars-cov2, covid-19, pregnancy, neonatal, long-term follow-up, complications
- Medical subject headings
- COVID-19, Pregnancy Complications, Pregnancy in Diabetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biological samples, questionnaires and interviewsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Screening group | a general population of women giving birth, called "screening group" included at routine antenatal visits, their partners, and children Receives: Other: biological samples, questionnaires and interviews | |
| 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 Receives: Other: biological samples, questionnaires and interviews |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2020
- Study start2 Jun 2020
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2040 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Sars-CoV2Studies of the same condition, open and under way.
- More trials run by Sahlgrenska University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,834 participants (actual)
- Target duration
- 20 Years
Sponsor and investigators
- Lead sponsor
- Sahlgrenska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Verena Sengpiel, Sahlgrenska University Hospital
- Investigators
- Verena Sengpiel, MD, PhD, Principal investigator, Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04433364
- Sponsor's protocol ID
- 2020-02848 0604
- Acronym
- COPE
- Status last verified
- Apr 2024
- First submitted
- 15 Jun 2020
- Last updated
- 16 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Outcome variables
Publications
Uhlander E, Isell S, Arnkil S, Berg J, Biasoletto G, Blomberg M, Carlsson Y, Hjertberg L, Sand A, Wikstrom AK, Zaigham M, Sengpiel V, Linden K. Partners' childbirth experiences during the COVID-19 pandemic - findings from the Swedish COPE prospective cohort study. BMC Pregnancy Childbirth. 2026 Feb 27;26(1):223. doi: 10.1186/s12884-026-08862-3.
PubMed 41761124Carlsson 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.
PubMed 34521667
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COPE - COVID-19 in Pregnancy and Early Childhood - a Study Protocol for a Prospective Multicentre Cohort Study
- ClinicalTrials.gov ID
- NCT04433364
- Acronym / sponsor ID
- COPE / 2020-02848 0604
- Conditions
- Sars-CoV2, Covid-19, Pregnancy Complications, Pregnancy Preterm, Pregnancy in Diabetic, Neonatal Infection
- Keywords
- sars-cov2, covid-19, pregnancy, neonatal, long-term follow-up, complications
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 3,834 participants (actual)
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Study start
- 2 Jun 2020 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2040 (estimated)
- First posted
- 16 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 20 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Screening group | – | Other: biological samples, questionnaires and interviewsa general population of women giving birth, called "screening group" included at routine antenatal visits, their partners, and children |
| COVID-19 group | – | Other: biological samples, questionnaires and interviewsgroup of women testing positive for SARS-CoV-2 or falling ill with COVID-19, called "COVID-19 group", their partners, and children |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Another language but selected ones
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| biological samples, questionnaires and interviewsBiological 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. | Other | COVID-19 group, Screening group |
Primary outcome
Biobank with linkage to registers
Time frame: 1-20 years
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.
Experiences of pregnancy during a pandemic
Time frame: 1 year
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2024.
- Derived from this study: PubMed 41761124Uhlander E, Isell S, Arnkil S, Berg J, Biasoletto G, Blomberg M, Carlsson Y, Hjertberg L, Sand A, Wikstrom AK, Zaigham M, Sengpiel V, Linden K. Partners' childbirth experiences during the COVID-19 pandemic - findings from the Swedish COPE prospective cohort study. BMC Pregnancy Childbirth. 2026 Feb 27;26(1):223. doi: 10.1186/s12884-026-08862-3.
- Derived from this study: PubMed 34521667Carlsson 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.
- Individual participant dataSharing planned: Yes. Outcome variables
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Verena Sengpiel, MD, PhD principal investigator
Sahlgrenska University Hospital
27 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sars-CoV2 and Covid-19, run by Sahlgrenska University Hospital at 27 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biobank with linkage to registers (time frame: 1-20 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04433364, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2024.