COPE - COVID-19 in Pregnancy and Early Childhood

Covid-19 Clinical Trial

— COPE  

Official title:

COPE - COVID-19 in Pregnancy and Early Childhood - a Study Protocol for a Prospective Multicentre Cohort Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04433364
• Other study ID #: 2020-02848 0604
• Status: Active, not recruiting
• Start date: June 2, 2020
• Est. completion date: December 31, 2040

Study information

• Verified date: April 2024
• Source: Sahlgrenska University Hospital, Sweden
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 3834
• Est. completion date: December 31, 2040
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Covid-19
• Neonatal Infection
• Pregnancy Complications
• Pregnancy in Diabetic
• Pregnancy in Diabetics
• Pregnancy Preterm
• Sars-CoV2

Intervention

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

Locations

Country	Name	City	State
Sweden	Boras hospital	Boras	VGR
Sweden	Eskiltuna hospital	Eskilstuna	Södermanland
Sweden	Falu Hospital	Falun	Dalarna
Sweden	Sahlgrenska Univeristy Hospital	Gothenburg	VGR
Sweden	Halmstad lasarett	Halmstad	Halland
Sweden	Helsingborgs lasarett	Helsingborg	Skåne
Sweden	Ryhovs sjukhus	Jönköping
Sweden	Kalmar Lasarett	Kalmar
Sweden	Karlstad lasarett	Karlstad
Sweden	Kristiandstad länssjukhus	Kristianstad
Sweden	Linköping University Hospital	Linköping	Östergötland
Sweden	Skåne Universitetssjukhus	Lund	Skåne
Sweden	Vrinnevisjukhuset	Norrköping	Östergötland
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	Varbergs sjukhus	Varberg	Halland
Sweden	Västerås	Västerås
Sweden	Ystad	Ystad

Sponsors (1)

Lead Sponsor	Collaborator
Sahlgrenska University Hospital, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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