Fetal Macrosomia, Impaired Glucose Tolerance
Conditions
Keywords
Gestational diabetes mellitus, Impaired glucose Tolerance, Pregnancy, Fetal macrosomia, Treatment, Perinatal morbidity
Brief summary
The purpose of this study is to evaluate if treatment (insulin or diet) of pregnant women with impaired glucose tolerance (75-g OGTT with a fasting P-gluc \<7.0 mmol/l and 2 h P-gluc \>10.0 and \<12.2 mmol/l) close to normoglycemia reduces children´s birth weight and neonatal morbidity. There will be a focus on treatment according to specific goals and separate follow-up regimes for the children and women post partum.
Interventions
DRUGInsulin aspart and Insulin human (isophane)
Insulin treatment if fasting p-glucose \>5.0 mmol/l or post meal value \>6.5 mmol/l according to study protocol.
Sponsors
Uppsala-Örebro Regional Research Council
Region Örebro County
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Women with 75g OGTT result : fasting capillary plasma \<=7.0 mmol/l and/or 2 h value \>= 12.2 mmol/l
Exclusion criteria
* Multiple pregnancy * Pregestational Diabetes
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Perinatal morbidity and intrauterine growth | 1 year post partum |
Secondary
| Measure | Time frame |
|---|---|
| Children´s future health | 5 years |
Countries
Sweden
Outcome results
None listed