Treatment of mild GDM
Research type
Research Study
Full title
Metformin treatment vs a diabetes model of antenatal care in women with mild fasting hyperglycaemia diagnosed in pregnancy: a pilot study
IRAS ID
137098
Contact name
Jenny Myers
Contact email
Sponsor organisation
Central Manchester University Hospitals NHS Foundation Trust
Eudract number
2013-004065-13
Research summary
Recent international guidelines have suggested that the threshold used to diagnose gestational diabetes (GDM) in pregnancy should be lowered. The most common complication which arises as a result of GDM is a large baby which can be associated with birth complications and long term health problems for the infant. As a result, most women with GDM are monitored very intensively and often delivered before their due date. Two previous trials have confirmed that treatment of GDM (diagnosed using higher blood glucose values) can reduce the size of the baby. However, the benefit and potential harm, which includes increased interventions associated with a diagnosis of GDM, have not been assessed in women with lower levels of blood glucose
This study aims to assess the acceptability and feasibility of using a simple treatment with tablets (metformin) for women with mild GDM. Metformin is safe in pregnancy and has the advantage that frequent blood glucose monitoring is not necessary. We hope this treatment will be effective in reducing the number of babies which gain excessive weight in pregnancy, without the need for frequent hospital visits and high intervention rates which are associated with the intensive antenatal care routinely offered to women with GDM.
This research will generate very important information regarding the management of women with mild changes in blood glucose levels in pregnancy; to date pregnancy care has not been studied in this group of women. We will assess how effective this treatment is at reducing blood glucose levels. Anxiety levels and differences in attitudes between different ethnic groups will also be studied. The recruitment rates and the assessment of the effectiveness of metformin in this study will allow us to plan a larger randomised study which will be able to determine whether metformin treatment is cost effective for the treatment of mild GDM.REC name
North West - Liverpool Central Research Ethics Committee
REC reference
13/NW/0755
Date of REC Opinion
22 Nov 2013
REC opinion
Further Information Favourable Opinion