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COPE - COVID-19 in Pregnancy and Early Childhood (COPE)

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ClinicalTrials.gov Identifier: NCT04433364
Recruitment Status : Recruiting
First Posted : June 16, 2020
Last Update Posted : June 16, 2020
Sponsor:
Information provided by (Responsible Party):
Ylva Carlsson, Sahlgrenska University Hospital, Sweden

Brief 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.


Condition or disease Intervention/treatment
Sars-CoV2 Covid-19 Pregnancy Complications Pregnancy Preterm Pregnancy in Diabetic Neonatal Infection Other: biological samples, questionnaires and interviews

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1200 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 20 Years
Official Title: COPE - COVID-19 in Pregnancy and Early Childhood - a Study Protocol for a Prospective Multicentre Cohort Study
Actual Study Start Date : June 2, 2020
Estimated Primary Completion Date : June 2, 2021
Estimated Study Completion Date : June 2, 2041

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
Other: biological samples, questionnaires and interviews

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 12 months.

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
Other: biological samples, questionnaires and interviews

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 12 months.

Interviews: 24-40 women and partners in both groups. Interviews will be conducted 3 to 6 months after childbirth.





Primary Outcome Measures :
  1. 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.

  2. 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.


Biospecimen Retention:   Samples Without DNA
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.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
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.
Criteria

Inclusion 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.

For the questionnaire part: language knowledge (translation to several languages planned) For the interview part: Swedish language knowledge

Exclusion Criteria: -


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04433364


Contacts
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Contact: Verena Sengpiel, MD, PhD +46704223475 verena.sengpiel@obgyn.gu.se
Contact: Ylva Carlsson, MD, PhD +46730706546 ylva.carlsson@vgregion.se

Locations
Show Show 27 study locations
Sponsors and Collaborators
Sahlgrenska University Hospital, Sweden
Investigators
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Principal Investigator: Verena Sengpiel, MD, PhD Sahlgrenska University Hospital, Sweden
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Responsible Party: Ylva Carlsson, MD, PhD, Senior Consultant, Sahlgrenska University Hospital, Sweden
ClinicalTrials.gov Identifier: NCT04433364    
Other Study ID Numbers: 2020-02848 0604
First Posted: June 16, 2020    Key Record Dates
Last Update Posted: June 16, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Outcome variables
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Time Frame: 2024
Access Criteria: Ethical permission
URL: http://www.optionstudien.se

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ylva Carlsson, Sahlgrenska University Hospital, Sweden:
sars-cov2
covid-19
pregnancy
neonatal
long-term follow-up
complications
Additional relevant MeSH terms:
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Pregnancy Complications
Pregnancy in Diabetics