Assessing exposure to cardiovascular therapy, anxiety depressive syndrome treatment and anti-infectives during pregnancy and breastfeeding (Drug exposure in pregnancy and breastfeeding)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/103358
• EU PAS number:
  EUPAS37675
• Study ID:
  103358
• Official title and acronym:
  Assessing exposure to cardiovascular therapy, anxiety depressive syndrome treatment and anti-infectives during pregnancy and breastfeeding (Drug exposure in pregnancy and breastfeeding)
• DARWIN EU® study:
  No
• Study countries:
  Spain
• Study description:
  Pharmacotherapy 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.
• Study status:
  Finalised

Research institutions and networks

Institutions

Fundació Institut Universitari per a la Recerca a l'Atenció Primària de Salut Jordi Gol i Gurina, IDIAPJGol

Spain

Study timelines

Date when funding contract was signed

Planned: 02/09/2019

Actual: 01/09/2020

Study start date

Planned: 01/10/2019

Actual: 20/07/2020

Data analysis start date

Planned: 02/11/2020

Actual: 01/01/2021

Date of final study report

Planned: 30/12/2022

Actual: 30/06/2022

Sources of funding

Other

More details on funding

IDIAPJGol

Study protocol

Initial protocol

ProtocolAjutsIDIAP_PREGNANCYesmena_20200709_v2-clean

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable