Study identification

PURI

https://redirect.ema.europa.eu/resource/48065

EU PAS number

EUPAS47450

Study ID

48065

Official title and acronym

Uso de fármacos en mujeres embarazadas y lactantes. Consecuencias en la salud de estas mujeres y en la de su descendencia (Drug use in pregnant and breastfeeding women. Outcomes in the health of the women and the offspring) (Drug use during pregnancy and breastfeeding)

DARWIN EU® study

No

Study countries

Spain

Study description

Drug use during pregnancy and breastfeeding is frequent to treat chronic and acute conditions. However, information on use, safety or effectiveness of drugs in these women is not routinely available due to limited access to participation of pregnant and lactating women in clinical trials for ethical concerns, making it difficult to assess benefits and risks of drug exposure of these women in their own health and in their offspring. The European Medicines Agency (EMA) Good Pharmacovigilance Practices indicate that it is necessary to conduct post-authorisation safety studies for those drugs which cannot be discontinued during gestation, those used for pregnancy or breastfeeding-related conditions or those associated with any risk for the offspring in the preclinical studies. In recent years, health care databases have made possible to conduct pharmacoepidemiological studies to assess drug exposure during pregnancy and breastfeeding and, through the mother-offspring linkage, to study health problems in the offspring which might be caused by their mother exposure. Our objective is to analyze drug use during these periods through a population-based cohort study with SIDIAP data, including women who are pregnant and breastfeeding, and to detect possible congenital anomalies and other health problems at birth and childhood which may have been caused by mothers’ drug exposure during pregnancy and breastfeeding. We also aim to explore beliefs, experiences and attitudes on drug use during pregnancy and breastfeeding from the women’s perspective and their partners and from the health professionals’ perspective through a qualitative exploratory study and an observational descriptive study by means of questionnaires, in order to detect if there are false beliefs on the risk or safety of medicines. Thus, we can add evidence to improve the evaluation of the benefit-risk balance of pharmacological treatments to support clinicians in their management and treatment practices.

Study status

Planned
Research institution and networks

Institutions

Contact details

Vedia Cristina

Primary lead investigator
ORCID number:
0000-0003-4192-3779
Study timelines

Date when funding contract was signed

Planned:

Data collection

Planned:

Start date of data analysis

Planned:

Date of final study report

Planned:
Sources of funding
Other

More details on funding

Pla estratègic de recerca i innovació en salut, PERIS 2022-2024. Generalitat de Catalunya, Departament de Salut. SLT0021/21/000068
Study protocol
Initial protocol

PROTOCOL_DefPERIS_20220204

English (864.03 KB - PDF)View document
Regulatory

Was the study required by a regulatory body?

No

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

Not applicable