Clinical trial NCT04433364: COPE - COVID-19 in Pregnancy and Early Childhood
Official title: COPE - COVID-19 in Pregnancy and Early Childhood - a Study Protocol for a Prospective Multicentre Cohort Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
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
Lead sponsor: Sahlgrenska University Hospital
Sponsor class: OTHER
First posted: 2020-06-16
Enrollment: 3834
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Biobank with linkage to registers
timeFrame: 1-20 years
measure: Experiences of pregnancy during a pandemic
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Falun
country: Sweden
facility: Falu Hospital
state: Dalarna
city: Halmstad
country: Sweden
facility: Halmstad lasarett
state: Halland
city: Varberg
country: Sweden
facility: Varbergs sjukhus
state: Halland
city: Helsingborg
country: Sweden
facility: Helsingborgs lasarett
state: Skåne
city: Lund
country: Sweden
facility: Skåne Universitetssjukhus
state: Skåne
city: Eskilstuna
country: Sweden
facility: Eskiltuna hospital
state: Södermanland
city: Boras
country: Sweden
facility: Boras hospital
state: VGR
city: Gothenburg
country: Sweden
facility: Sahlgrenska Univeristy Hospital
state: VGR
city: Jönköping
country: Sweden
facility: Ryhovs sjukhus
city: Kalmar
country: Sweden
facility: Kalmar Lasarett
city: Karlstad
country: Sweden
facility: Karlstad lasarett
city: Kristianstad
country: Sweden
facility: Kristiandstad länssjukhus
city: Skövde
country: Sweden
facility: Skaraborgs sjukhus Skövde
city: Stockholm
country: Sweden
facility: BB Stockholm
city: Stockholm
country: Sweden
facility: Danderyd
city: Stockholm
country: Sweden
facility: Karolinska University Hospital Solna
city: Stockholm
country: Sweden
facility: Karolinska University Hospital- Huddinge
city: Stockholm
country: Sweden
facility: Södersjukhuset
city: Stockholm
country: Sweden
facility: Södertälje
city: Sundsvall
country: Sweden
facility: Sundsvall
city: Umeå
country: Sweden
facility: Umeå University Hospital
city: Uppsala
country: Sweden
facility: Uppsala University Hospital
city: Västerås
country: Sweden
facility: Västerås
city: Ystad
country: Sweden
facility: Ystad
city: Örebro
country: Sweden
facility: Örebro University Hospital
city: Linköping
country: Sweden
facility: Linköping University Hospital
state: Östergötland
city: Norrköping
country: Sweden
facility: Vrinnevisjukhuset
state: Östergötland
Study officials:
affiliation: Sahlgrenska University Hospital
name: Verena Sengpiel, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.