Anti-thyroid Drug Use during pregnancy and risk of congenital anomalies: systematic review of observational studies and methodological considerations (Anti-thyroid drugs in pregnancy)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/30991
• EU PAS number:
  EUPAS30990
• Study ID:
  30991
• Official title and acronym:
  Anti-thyroid Drug Use during pregnancy and risk of congenital anomalies: systematic review of observational studies and methodological considerations (Anti-thyroid drugs in pregnancy)
• DARWIN EU® study:
  No
• Study countries:
  United Kingdom
• Study description:
  This study will undertake a systematic review of the literature to identify observational studies examining maternal exposure to methimazole, carbimazole or propylthiouracil during pregnancy and the risk of congenital anomolies. Effect estimates from these studies will then be meta-analysed according to their comparator groups defined.
• Study status:
  Ongoing

Research institutions and networks

Institutions

University of Dundee

United Kingdom

Study timelines

Date when funding contract was signed

Planned: 03/06/2019

Actual: 03/06/2019

Study start date

Planned: 10/06/2019

Actual: 10/06/2019

Date of final study report

Planned: 01/10/2019

Sources of funding

Other

More details on funding

University of Dundee internal resources

Regulatory

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