Me-D-Links Version 1
Research type
Research Study
Full title
Me-D-Links: Metformin for diabetes in pregnancy – an analysis of health and educational outcomes using linked administrative data
IRAS ID
192882
Contact name
Joanne Given
Contact email
Sponsor organisation
Ulster University
Duration of Study in the UK
2 years, 7 months, 28 days
Research summary
BACKGROUND
Gestational diabetes (GDM), diabetes which develops during pregnancy, and type 2 diabetes are increasingly common during pregnancy. Traditionally insulin has been considered the ‘gold standard’ for the treatment of diabetes in pregnancy. However, the recently published National Institute of Health and Care Excellence Diabetes in Pregnancy Guideline (2015) recommends metformin, an oral blood glucose lowering drug, for those with GDM. In those with type 2 diabetes the guideline states that metformin may be used when the likely benefits outweigh the potential for harm.
The routine use of metformin in GDM is controversial outside the UK. Metformin has been shown to cross the placenta and we do not know if it affects the growth or long term development of children who were exposed in the womb. With increasing numbers of women in the UK taking metformin during their pregnancy more research is needed to determine the potential harms or benefits.AIM
To use data routinely collected by the NHS and government departments to explore the effect of metformin on maternal and infant health and early childhood educational achievements.METHODS
Prescribing records, mother and child health records and educational records, from the 4 regions of the UK, will be accessed through the Administrative Data Research Network (ADRN). The Honest Broker Service (HBS) may be used in Northern Ireland, for access to health data, if there are delays in accessing this data through the ADRN.ANALYSIS
Pregnant women, or their infants, who were exposed to metformin will be compared to those who were not. In particular comparisons will be made between those treated with metformin for type 2 diabetes and GDM and those who received other treatments for these diseases.IMPACT
This research will benefit both health care practitioners and pregnant women by aiding them in making informed decisions about their care.REC name
London - Fulham Research Ethics Committee
REC reference
16/LO/0768
Date of REC Opinion
20 Apr 2016
REC opinion
Favourable Opinion