Study identification

PURI

https://redirect.ema.europa.eu/resource/40490

EU PAS number

EUPAS40489

Study ID

40490

Official title and acronym

COVID-19 infections and medicines in pregnancy- the INOSS collaboration (INOSS CONSIGN)

DARWIN EU® study

No

Study countries

Belgium
Denmark
Finland
France
Iceland
Italy
Norway
Slovakia
Spain
Sweden
United Kingdom

Study description

Few studies about the consequences of COVID-19 infection in pregnancy are population based. Countries participating in the International Network of Obstetric Survey Systems (INOSS) conduct national or regional, population-based studies of severe pregnancy complications. The network was established in 2010 and has established protocols and core data items, enabling both prospective and retrospective individual patient data meta-analyses. All the INOSS national teams have established studies of COVID-19 in pregnancy. Previous projects have demonstrated that these systems can be used to rapidly collect information to inform policy and guidance in previous pandemics and in other emerging infections. These experiences enabled the network to commence unified, comparable national studies with common protocols and definitions in response to the SARS-CoV-2 pandemic. Crucially, these studies cover the entire national or regional populations, thus we can be confident that all women with SARS-CoV-2 complications in pregnancy are identified and estimated complication rates are accurate and not subject to case ascertainment or reporting bias. The study population in the current study are pregnant women admitted to hospital with a positive PCR test maximum 7 days prior to admission or within 2 days postpartum. The study will determine the incidence of hospitalization, the influence of medical treatment for covid-19 and maternal and neonatal outcomes in women treated or not treated with covid-19 medication such as antiviral therapies. Analyses will be performed using a 2 step individual patient data meta analysis, with primary analyses on a national level and subsequent meta analyses on the merged dataset.

Study status

Ongoing
Research institution and networks

Institutions

Networks

International Obstetric Survey Systems

Contact details

Kitty Bloemenkamp

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Data collection

Planned:
Actual:

Date of interim report, if expected

Planned:
Actual:

Date of final study report

Planned:
Sources of funding
Other

More details on funding

K. W. M. Bloemenkamp
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

Not applicable