Status: Ongoing First registered on: 20/10/2020
Last updated on: 20/10/2020
1. Study identification
EU PAS Register NumberEUPAS37675
Official titleAssessing exposure to cardiovascular therapy, anxiety depressive syndrome treatment and anti-infectives during pregnancy and breastfeeding
Study title acronymDrug exposure in pregnancy and breastfeeding
Study typeObservational study
Brief description of the studyPharmacotherapy during pregnancy and breastfeeding implies the possible risk of congenital disorders and other diseases in the offspring, so it is necessary to assess the benefit-risk balance of all drug treatments before prescribing them in pregnant or breastfeeding women. The drug use in pregnancy and breastfeeding has been assessed through different studies and, lately, through database studies, which offer advantages such as linked information mother-offspring, long-term follow-up periods for mothers and infants, information on maternal and birth outcomes, and information on confounding factors. The use of drugs during pregnancy and breastfeeding has not been assessed through electronic health records in our setting and we plan to assess it through a population based study conducted with SIDIAP data in all women with pregnancy and breastfeeding registered in this database throughout 2011-2020. We plan to analyse drug use during pregnancy and breastfeeding, focalising in cardiovascular, neurologic and psychiatric disorders; to analyse vaccines use during these periods; and to detect possible congenital disorders and other diseases during childhood which may be caused by drug exposures of the mothers during pregnancy and breastfeeding. Due to the actual pandemic situation of COVID19 we would like to explore pregnancy and perinatal outcomes of SARS-Co-V2 infections occurring during pregnancy in Catalonia (2020). Even few publications have been made, they would probably have to be updated as there is still a lot to know regarding SARS-Co-V2 infection.
Was this study requested by a regulator?No
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 belongsIDIAPJGol
Department/Research groupInstitut Universitari d'Investigació en Atenció Primària Jordi Gol
Organisation/affiliationIDIAPJGol
Website/Homepagewww.idiapjgol.org
Details of (Primary) lead investigator
Title Dr
Last name Gomez-Lumbreras
First name Ainhoa
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Not applicable (single centre)

Countries in which this study is being conducted
National study

Spain
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed02/09/201901/09/2020
Start date of data collection01/10/201920/07/2020
Start date of data analysis02/11/2020
Date of interim report, if expected
Date of final study report30/12/2022
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
OtherIDIAPJGol100
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Giner-Soriano
First name Maria
Address line 1Gran Via de les Corts Catalanes 587, àtic
Address line 2 
Address line 3 
CityBarcelona 
Postcode08007 
CountrySpain
Phone number (incl. country code)34934824110 
Alternative phone number 
Fax number (incl. country code) 
Email address mginer@idiapjgol.info
Public Enquiries
Title Dr 
Last name Giner-Soriano 
First name Maria 
Address line 1Gran Via de les Corts Catalanes 587, àtic 
Address line 2 
Address line 3 
CityBarcelona 
Postcode08007 
CountrySpain 
Phone number (incl. country code)34934824110 
Alternative phone number 
Fax number (incl. country code) 
Email address mginer@idiapjgol.info 
Top