Safety of the second generation antipsychotics during pregnancy (Second generation antipsychotics and pregnancy)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/42972
• EU PAS number:
  EUPAS4799
• Study ID:
  42972
• Official title and acronym:
  Safety of the second generation antipsychotics during pregnancy (Second generation antipsychotics and pregnancy)
• DARWIN EU® study:
  No
• Study countries:
  Finland
• Study description:
  Second generation antipsychotics have largely replaced first generation antipsychotics but little is known about their safety during pregnancy. This is a population based study based on national register data in Finland. Data from the National Birth Register, the Register of Congenital Malformations, and the Drug Prescription Register have been linked through years 1996-2012 in the Drugs and Pregnancy project, and data in this study are extracted from the Drugs and Pregnancy project database. The data include all births (live and still births), pregnancy terminations due to major congenital anomaly, and information on drug purchases during pregnancy and 3 months before pregnancy. There are appr. 55,000-60,000 births per year in Finland, and we expect to have a baseline study population with appr. 1 mil. pregnancies. Appr. 0.2-0.6% of pregnant women during the study period used antipsychotics and we expect to include appr.2,000 pregnancies exposed to second generation antipsychotics. The primary aims of the study are i.) to assess the risk of major congenital anomalies after first trimester exposure to second generation antipsychotics and ii.) to investigate the prevalence of other perinatal outcomes, including large for gestational age, preterm birth, low birth weight, and perinatal mortality after continuous exposure. The exposed group is compared i) to women and their offspring exposed to first generation antipsychotics during the period of theree months prior to pregnancy until the end of pregnancy (to control for maternal illness), and ii) to unexposed women. Logistic regression is used to evaluate associations between exposure and outcome, and covariates to be considered include year of birth, mother's age, parity, tobacco use, prepregnancy diabetes, use of other psychiatric drugs and use of drugs classified as potentially harmful. The results will provide important information on the safety of second generation antipsychotics during pregnancy.
• Study status:
  Finalised

Research institution and networks

Institutions

Finnish Institute for Health and Welfare (THL)

Finland

Study timelines

Date when funding contract was signed

Planned: 01/01/2012

Actual: 01/01/2012

Study start date

Planned: 15/05/2014

Actual: 15/05/2014

Data analysis start date

Planned: 15/09/2014

Actual: 01/09/2016

Date of interim report, if expected

Planned: 31/10/2018

Date of final study report

Planned: 01/09/2019

Actual: 03/11/2019

Sources of funding

Other

More details on funding

Finnish Medicines Agency

Study protocol

Initial protocol

NEW_antipsychotics_HM

Updated protocol

NEW_antipsychotics_HM__09052014

Regulatory

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