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.
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
- Maternal complications of pregnancy
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is the difference in incidence of GDM between the two
groups.
Secondary outcome
Pregnancy outcome, neonatal outcome and neonatal complications
Background summary
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 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.
Study 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.
Intervention
All subjects will be instructed in a 2000 calories/day diet, with an adequate
distribution of carbohydrates during the day. They receive a standard list of a
diet they have to follow. It includes the quantity and the quality of the
nutrition they have to take every day.
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.
Study burden and risks
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 and 30 weeks to perform an 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.
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.
Maasstadweg 21
Rotterdam 3079 DZ
NL
Maasstadweg 21
Rotterdam 3079 DZ
NL
Listed location countries
Age
Inclusion criteria
Women with a high risk for gestational diabetes mellitus
'High risk' is defined if one or more of the risk factors below is present, according to the Dutch national criteria for screening
- Gestational diabetes in history
- Body mass index > 30 (kg/m2) at the first prenatal screening
- Birth weight previous child > P95 or > 4500 gram
- First degree relative with diabetes mellitus
- Certain ethnic groups with a high prevalence of diabetes mellitus
(South Asians, like Hindustani, Afro-Caribbean people, women from the
Middle East, Morocco and Egypt)
- History of unexplained intra-uterine foetal death/stillbirth
- Polycystic ovary syndrome (PCOS);And aged between 18 and 40 years, gestational age between 8 and 12 weeks, able to communicate and read in Dutch
Exclusion criteria
No singleton pregnancy judged by ultrasonography, high fasting glucose
at first trimester, cardiac insufficiency, renal insufficiency (MDRD < 60), liver disease, use of medication other than Paracetamol or vitamins and incompetent women.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2014-000446-30-NL |
| CCMO | NL48005.101.14 |