Diabetes mellitus arising in pregnancy
Conditions
Interventions
This is a randomized clinical controlled trial, with two arms, open label. 310 pregnant women diagnosed with diabetes that require drug treatment and fulfill all inclusion criteria will be randomizes
E02.491
Sponsors
Hospital da Mulher Prof. Dr. José Aristodemo Pinotti - CAISM
Hospital da Mulher Prof. Dr. José Aristodemo Pinotti - CAISM
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Pregnant women diagnosed with diabetes type two or gestational diabetes; pregnant women that require medication for glycemic control; pregnant women that agree to participate of the study; pregnant women over 18 years old; pregnant women following in the prenatal care unit of our service
Exclusion criteria
Exclusion criteria: Pregnant women diagnosed with diabetes that do not require medication for glycemic control, pregnant women that cannot use any of the medication (insulin or metformin); pregnant women that refuse to participate of the study; pregnant women under 18 years old
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| We expect that the glycemic control in the metformin group will be superior to the insulin group, which will be evalueted with fasting and post prandial glucose measurements | — |
Secondary
| Measure | Time frame |
|---|---|
| We expect that gestational outcomes are better in the metformin group than in the insulin group, which will be evalueted by lower weight gain in pregnancy ;We expect that perinatal outcomes are better in the metformin group than the insulin group will be evalueted by less macrossomic newborns in the metformin group | — |
Countries
Brazil
Contacts
Public ContactCarolina Moreira
Hospital da Mulher Prof. Dr. José Aristodemo Pinotti - CAISM
Outcome results
None listed