diabetes mellitus, diabetes mellitus Type 1 diabetes, diabetes mellitus type 2, gestational diabetes, loss of glycemic control, macrosomia, cesarean delivery, inadequate weight gain, dietary intake, congenital malformations, maternal complications (Preeclampsia, eclampsia, gestational hypertension, urinary tract infection) and neonatal complications (neonatal (hypoglycemia, jaundice), dietary intake
Conditions
Interventions
Study conducted at a public hospital in Rio de Janeiro, Brazil, that provides prenatal care of pregnant women with diabetes mellitus.
For the study will be recruited pregnant women diagnosed with diab
Other
J01.576.423.500.300
Sponsors
Universidade Federal do Rio de Janeiro - UFRJ
Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq)
Eligibility
Sex/Gender
Female
Age
20 Years to 49 Years
Inclusion criteria
Inclusion criteria: adult women ( aged 20 to 49 years), diagnosed with diabetes mellitus prior to pregnancy or during pregnancy with gestational age below 28 weeks and, of singleton pregnancy.
Exclusion criteria
Exclusion criteria: diabetic pregnant women with chronic diseases or diabetes mellitus complications.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome of the study is to increase the adequacy of the total gestational weight gain. The main outcome will be the adequacy of the total gestational weight gain in childbirth among the study groups. For the analysis will be used statistical tools to observe the change in outcome between the groups G1, G2 and G3; and G4 and G5 groups, with an expected 15% difference between the groups, at a significance level of 5 %, with a power of 90%;The adequacy of gestational weight gain will be classified as total weight gain (kg) during pregnancy, calculated as the difference between the pre-birth weight (kg) and prepregnancy weight (kg). The assessment of the weight gain will be made according to the recommendation of the Institute of Medicine (2009), ranking appropriate gain, gain insufficient and excessive gain, according to the prepregnancy body mass index. | — |
Secondary
| Measure | Time frame |
|---|---|
| The study's secondary outcomes will be: glycemic control, dietary intake, comorbidities during pregnancy, the cesarean delivery, fetal macrosomia, complications of newborns and congenital malformations. For realization of the outcomes will evaluate the efficiency of nutritional intervention in the proportion of outcomes described between the study groups. For the analysis will be used statistical tools to observe the change (increase or decrease) in outcomes between the groups G1, G2 and G3; and G4 and G5 groups, with an expected 15% difference between the groups, at a significance level of 5 %, with a power of 90%.;Glycemic control will be investigated during all trimesters, according to maternal fasting glucose and postprandial glucose (1 hour). The loss of glycemic control will be identified when the fasting plasma glucose is greater than or equal to 95mg / dL and a postprandial 2 hours after start of the meal is greater than or equal to 140mg / dl.;Dietary energy consumption (kilocalories), protein (% and grams), lipids (% and grams), carbohydrates (% and grams) - will be compared to the consumption before the intervention and after the intervention in each trimester and compared with intake recommendations for pregnant women. Consumption will be ranked right, below or above the recommendation.;The intercurrences during pregnancy, childbirth or the postpartum period, which will be analyzed are anemia (when the hemoglobin concentration is less than 11g / dL), gestational hypertension (blood pressure greater than or equal to 140 x 90 mmHg), preeclampsia (higher blood pressure or equal to 140 x 90 mmHg over proteinuria greater than or equal to 300 mg in the 24 hour urine), eclampsia (high blood pressure greater than or equal to 140 x 90 mmHg over proteinuria greater than or equal to 300mg in urine 24 hours and convulsions) are identified in medical records in order.;Fetal macrosomia will be identified by the higher birth weight or equal to 4000g.;The evaluated ne | — |
Countries
Brazil
Contacts
Public ContactClaudia;Patricia Saunders;Padilha
Universidade Federal do Rio de Janeiro - UFRJ;Universidade Federal do Rio de Janeiro - UFRJ
Outcome results
None listed