Consequences for life of children with in utero exposure to metformin in Finland (CLUE) – a register-based cohort study

Study identification

• EU PAS number:
  EUPAS19686
• Study ID:
  47386
• Official title and acronym:
  Consequences for life of children with in utero exposure to metformin in Finland (CLUE) – a register-based cohort study
• DARWIN EU® study:
  No
• Study countries:
  Finland
• Study description:
  Metformin is used during pregnancy to treat hyperglycaemia in gestational diabetes mellitus (GDM) and pre-gestational diabetes (PGDM), and to treat the polycystic ovary syndrome (PCOS). Despite the use of metformin during pregnancy in these three conditions, the long-term effects of metformin exposure in utero have not been widely studied in the children beyond two years of age. Evidence on these effects is of major interest, as metformin crosses the placenta and might therefore have long-term effect on the children. Using population-level data from Finland, this study will provide information on these long-term effects among children of women who used metformin during pregnancy. The aim of this study is to investigate the long-term and immediate effects of exposure to metformin in utero among the children of all pregnant women treated with metformin, regardless of the purpose of use. The long-term effects include e.g. diagnoses of obesity, hypo- and hyperglycaemia, diabetes mellitus, diagnoses related to challenges in motor-social development, and growth-related outcomes. In addition, immediate effects of exposure to metformin in utero will be investigated, including growth outcomes at birth, preterm birth, perinatal mortality, hypo- and hyperglycaemia at birth, and major congenital anomalies. The long-term effects described above in the children of women pregnant from 1996 onwards and treated during their pregnancy with metformin only, or with a combination of insulin and metformin, will be compared to the children of pregnant women treated during their pregnancy with insulin only. Additionally, and making use of the availability of GDM diagnosis data from 2004 onwards, a cohort of children born to mothers with GDM and naïve to in utero exposure to pharmacological antidiabetic treatment will be added for comparison.
• Study status:
  Finalised

Research institutions and networks

Institutions

IQVIA

United Kingdom

Study timelines

Date when funding contract was signed

Actual:08/02/2017

Study start date

Planned:05/11/2018

Actual:30/11/2018

Data analysis start date

Planned:31/12/2018

Actual:30/11/2018

Date of final study report

Planned:31/12/2020

Actual:04/08/2020

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Merck KGaA

Regulatory

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