Gestational Diabetes Mellitus
Conditions
Interventions
Intervention group: 200 pregnant women who will be randomized to 20 weeks of gestation, will be subjected to treatment with use of metformin hydrochloride 500 mg orally after breakfast and dinner dail
Drug
Sponsors
Universidade da Região de Joinville - Univille
Hospital Regional Hans Dieter Schmidt Secretaria do Estado de Saúde de Santa Catarina
Eligibility
Sex/Gender
Female
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: Pregnant women will be diagnosed with GDM selected according to the criteria of the World Health Organization; aged over 18 years; singleton pregnancy; with screening for gestational diabetes mellitus (GDM) in early positive pregnancy; gestational age between 11 and 33 weeks; no pathology that interferes with glucose metabolism; no hypersensitivity to metformin hydrochloride or important drug allergy; history or presence of liver disease; renal or gastrointestinal or other conditions that interfere with absorption; distribution; excretion or metabolism of the drug.
Exclusion criteria
Exclusion criteria: They will be excluded from follow-up losses; intolerance to drugs; desire of the mother and presence of risk to the fetus.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction of cases of Gestational Diabetes Mellitus in pregnant women who have made the use of metformin hydrochloride, 2 times a day (breakfast and dinner), the realization of the reduction will be performed by biochemical analysis through oral test of glucose tolerance (OGTT) to be held during the gestational trimesters. It expects a 50% effectiveness in reducing cases of Gestational Diabetes Mellitus which will be proven through statistical tests and comparing the concentrations in the OGTT test and control groups. | — |
Secondary
| Measure | Time frame |
|---|---|
| Decreased neonatal hypoglycemia in infants whose mothers had made the use of metformin hydrochloride during pregnancy. For evaluation of this variable will be held plasma glucose dosage of newborns according to protocol guidelines of the Brazilian Society of Pediatrics. For realization of the expected outcomes will be performed statistical tests and comparing the concentrations of plasma glucose in babies of mothers of test and control groups. | — |
Countries
Brazil
Contacts
Public ContactJean Silva
Universidade da Região de Joinville - Univille
Outcome results
None listed