SARS-CoV-2 infection in pregnancy: a prospective study by the Italian Obstetric Surveillance System (ItOSS)
On 25 March 2020, in collaboration with Italy’s Regions and Autonomous Provinces, the Istituto Superiore di Sanità (ISS) launched an observational cohort study, entitled “SARS-CoV-2 infection in pregnancy and the puerperium: a study by the Italian Obstetric Surveillance System”, to identify and analyze cases of SARS-CoV-2 infection in pregnant women visiting healthcare facilities, with the purpose of providing useful information for clinical practice.
In the Autonomous Province of Trento and in Regions Piedmont, Lombardy, Emilia-Romagna, Tuscany, Umbria and Campania, this project also involves taking biological samples from mothers, foetuses and the adnexal region to test for the virus and study possible routes of mother-to-child transmission of the infection.
The initiative is part of the public health research activities coordinated by the Italian Obstetric Surveillance System (ItOSS) in collaboration with the network of healthcare facilities and professionals taking part in the surveillance system.
Pregnant or postpartum women with a definite diagnosis of SARS-CoV-2 infection are recruited after the appropriate informed consent is obtained.
In these uncertain times, this project can hopefully provide timely information to help the clinical, organizational and logistical management of COVID-19 in pregnancy both in Italy and other countries that will be facing the epidemic over the next few months.
For more information, please read the relevant documents
- SARS-CoV-2 infection in pregnancy and the puerperium: a study by the Italian Obstetric Surveillance System (ItOSS) - basic protocol (pdf 622 kb, in Italian)
- SARS-CoV-2 infection in pregnancy and the puerperium: a study by the Italian Obstetric Surveillance System (ItOSS) - expanded protocol (pdf 636 kb, in Italian)
- Guidelines on the collection, storage and transfer of biological samples (pdf 448 kb, in Italian)
- Data entry guide (pdf 896 kb, in Italian)
- Information note on the study and participant consent form - expanded protocol (pdf 609 kb, in Italian)
- Information note and participant consent form - basic protocol (pdf 601 kb, in Italian)
- Conditional favourable opinion of the ISS Ethics Committee (pdf 618 kb, in Italian)
- Final favourable opinion of the ISS Ethics Committee (pdf 1,7 Mb, in Italian)
- Operating procedures of the ItOSS study on SARS-CoV-2 infection in pregnancy and the puerperium (pdf 547 kb, in Italian)
For more information on the Italian Obstetric Surveillance System (ItOSS), please visit the dedicated website.