Status: Ongoing First registered on: 29/04/2021
Last updated on: 29/04/2021
1. Study identification
EU PAS Register NumberEUPAS40489
Official titleCOVID-19 infections and medicines in pregnancy- the INOSS collaboration
Study title acronymINOSS CONSIGN
Study typeObservational study
Brief description of the studyFew 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.
Was this study requested by a regulator?Yes: EMA
Is the study required by a Risk Management Plan (RMP)? Not applicable
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsUMCU
Department/Research groupDepartment of Obstetrics
Organisation/affiliationUniversity Medical Center Utrecht
Website/Homepagewww.umcutrecht.nl
Details of (Primary) lead investigator
Title Professor
Last name Bloemenkamp
First name Kitty
Is this study being carried out with the collaboration of a research network?
Yes
International Obstetric Survey Systems
Other centres where this study is being conducted
Not applicable (single centre)

Countries in which this study is being conducted
International study

Belgium
Denmark
Finland
France
Iceland
Italy
Norway
Slovakia
Spain
Sweden
United Kingdom
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed17/07/202017/07/2020
Start date of data collection01/02/202001/03/2020
Start date of data analysis
Date of interim report, if expected29/01/202129/01/2021
Date of final study report15/07/2021
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companies
Charities
Government body
Research councils
EU funding scheme
OtherK. W. M. Bloemenkamp100
5. Contact details for enquiries
Scientific Enquiries
Title Professor
Last name Bloemenkamp
First name Kitty
Address line 1University Medical Center
Address line 2Utrecht 
Address line 3 
CityUTRECHT 
Postcode3508 AB 
CountryNetherlands
Phone number (incl. country code)31650124509 
Alternative phone number 
Fax number (incl. country code) 
Public Enquiries
Title Professor 
Last name Bloemenkamp 
First name Kitty 
Address line 1University Medical Center 
Address line 2Utrecht 
Address line 3 
CityUTRECHT 
Postcode3508 AB 
CountryNetherlands 
Phone number (incl. country code)31650124509 
Alternative phone number 
Fax number (incl. country code) 
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