Gestational Diabetes Mellitus Clinical Trial
Official title:
Metformin vs Control to Prevent Gestational Diabetes Mellitus (GDM) in Women With a High Risk for GDM, an Open Label Randomized Controlled Trial, The Medico-GDM Trial
Metformin vs Control to prevent gestational diabetes mellitus (GDM) in women with a high risk for GDM, an open label randomized controlled trial' The Medico-GDM trial
Rationale: GDM is a frequent pregnancy complication1 and associated with complications for
mother and child.2 At present, the drug of choice for treatment of GDM is Insulin.3 In the
last years several studies documented the use of oral blood glucose lowering medication in
GDM. Metformin is an accepted alternative for insulin, with comparable glycemic control and
neonatal outcomes.4 In studies with women with polycystic ovarian syndrome (PCOS) who
received Metformin during pregnancy, the incidence of GDM is less compared to pregnant women
with PCOS without Metformin. These studies were however small and there was no adequate
control group.5 Our aim is to study the effect of Metformin on the incidence of GDM in women
with a high risk for GDM.
Objective: the primary objective is to compare metformin versus no intervention for
incidence of GDM in women with a high risk for GDM. The main secondary objective is
pregnancy outcome with Metformin, neonatal outcomes and neonatal complications.
Study design: 2 years open label randomized controlled trial, comparing metformin versus
control group.
Study population: pregnant women with a high risk of GDM between 18 and 40 years old in the
first trimester of pregnancy.
Intervention: the first group receives Metformin twice daily 500 mg for the first week,
after that twice daily 1000 mg. The second group receives no intervention. All the subjects
are receiving a diet which contains a 2000 calories/day diet, with an adequate distribution
of carbohydrates during the day.
Main study parameters/endpoints: the main study parameter is the difference in incidence of
GDM between the two groups.
Nature and extent of the burden and risks associated with participation, benefit and group
relatedness: the subjects will visit our centre for the first time between 12 and 14 weeks
of pregnancy, then blood samples will be collected. Further on they will visit our centre at
24 weeks to perform an oral glucose tolerance test (OGTT). Women with GDM in history will
perform an OGTT at 16 weeks for the first time. If the OGTT is borderline normal, it will
repeated every 4 weeks. This is according to current Dutch guidelines3, without any extra
discomfort for study participants. The subjects will visit their own gynaecologist or
obstretican for their regular pregnancy controls. Metformin is not officially registered for
use in pregnancy. Long term effects for the unborn child are not known. However, previous
studies did not found neonatal and pregnancy related complications.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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