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

March 15, 2023 updated by: Verena Sengpiel, Sahlgrenska University Hospital, Sweden

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

Study Type

Observational

Enrollment (Actual)

3834

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Jönköping, Sweden
        • Ryhovs sjukhus
      • Kalmar, Sweden
        • Kalmar Lasarett
      • Karlstad, Sweden
        • Karlstad lasarett
      • Kristianstad, Sweden
        • Kristiandstad länssjukhus
      • Skövde, Sweden
        • Skaraborgs sjukhus Skövde
      • Stockholm, Sweden
        • Södersjukhuset
      • Stockholm, Sweden
        • Karolinska University Hospital Solna
      • Stockholm, Sweden
        • BB Stockholm
      • Stockholm, Sweden
        • Danderyd
      • Stockholm, Sweden
        • Karolinska University Hospital- Huddinge
      • Stockholm, Sweden
        • Södertälje
      • Sundsvall, Sweden
        • Sundsvall
      • Umeå, Sweden
        • Umeå University Hospital
      • Uppsala, Sweden
        • Uppsala University Hospital
      • Västerås, Sweden
        • Västerås
      • Ystad, Sweden
        • Ystad
      • Örebro, Sweden
        • Örebro University Hospital
    • Dalarna
      • Falun, Dalarna, Sweden, 79182
        • Falu Hospital
    • Halland
      • Halmstad, Halland, Sweden, 30233
        • Halmstad lasarett
      • Varberg, Halland, Sweden, 43237
        • Varbergs sjukhus
    • Skåne
      • Helsingborg, Skåne, Sweden, 25223
        • Helsingborgs lasarett
      • Lund, Skåne, Sweden
        • Skåne universitetssjukhus
    • Södermanland
      • Eskilstuna, Södermanland, Sweden, 63003
        • Eskiltuna hospital
    • VGR
      • Boras, VGR, Sweden, 50182
        • Borås Hospital
      • Gothenburg, VGR, Sweden, 41685
        • Sahlgrenska Univeristy Hospital
    • Östergötland
      • Linköping, Östergötland, Sweden
        • Linkoping University Hospital
      • Norrköping, Östergötland, Sweden
        • Vrinnevisjukhuset

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

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.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
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
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.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 2, 2020

Primary Completion (Anticipated)

June 30, 2023

Study Completion (Anticipated)

June 2, 2041

Study Registration Dates

First Submitted

June 15, 2020

First Submitted That Met QC Criteria

June 15, 2020

First Posted (Actual)

June 16, 2020

Study Record Updates

Last Update Posted (Actual)

March 16, 2023

Last Update Submitted That Met QC Criteria

March 15, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Outcome variables

IPD Sharing Time Frame

2024

IPD Sharing Access Criteria

Ethical permission

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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