Gestational diabetes, adverse perinatal outcomes (preeclampsia, preterm birth, fetal growth impairment), alterations in newborn and infant nutritional status, excessive adiposity and neurodevelopmental disorders.
Conditions
Interventions
Group 1 (intervention group): Women in this group will receive medical prenatal care by an assigned attending obstetrician who will follow institutional guidelines and intensive medical nutrition th
a goal setting approach and problem-solving strategies will be implemented in each visit. MNT will be delivered in the context of intensive counseling, with a strong education component. Breastfeeding
Sponsors
Instituto Nacional de Perinatologia
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Adult women without previous diseases, pregnancies with only one fetus (no congenital malformations), and pregestational BMI (pBMI) equal or more than 30 (using pregestational weight self reported and height measured with a digital stadiometer).
Exclusion criteria
Exclusion criteria: Women will be excluded if they have pregestational diabetes mellitus, chronic hypertension, heart, kidney, liver or autoimmune disease, uncontrolled hypothyroidism, history of bariatric surgery, or if take medications influencing the metabolism of the endocrine system (insulin, metformin, and/or corticosteroids). All women will have an oral glucose tolerance test (OGTT) at the first prenatal care visit, according to Institutional GDM screening procedures. Women with 2 or more altered values or those classified with pregestational diabetes mellitus will be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Gestational diabetes mellitus (GDM). The primary outcome is to compare GDM incidence in both groups. For this, a 75g 2h oral glucose tolerance test (OGTT) will be performed at 24 to 28 weeks of gestation. GDM will be stablished if at least one glucose value is altered: fasting equal or more than 92 mg/dL, 1h equal or more than 180 mg/dL and 2h equal or more than 153 mg/dL, according to the International Association of Diabetes and Pregnancy Study Groups criteria. All women (in both groups) who develop GDM will be referred to the Institutional Diabetes in Pregnancy Program for multidisciplinary care, including endocrinology treatment and intensive MNT. | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse perinatal outcomes: - Preeclampsia - Preterm birth - Fetal and neonatal death - Mode of delivery - Fetal growth alterations (intrauterine growth restriction(IUGR), small for gestational age(SGA), large for gestational age(LGA)) Maternal nutrition and metabolic variables: - Gestational weight and postpartum weight retention - Metabolic markers and inflammation (lipid profile, glucose, insulin, HOMA-IR, leptin, adiponectin, resistin, high sensitive C-reactive protein, lipopolysacharide) Neonatal and infant outcomes: - Newborn and infant nutritional status (low birth weight, macrosomia, SGA, LGA, weight/age, lenght/age, weight/lenght, body mass index(BMI)/age, head circumference/age) - Infant body composition (body density, fat mass (in kg)) - Neurodevelopment outcomes (Brazelton Neonatal Behavioral Assessment Scale (NBAS), Bayley Scales of Infant Development, third edition (BSID III)) Control variables: - Dietary intake - Adherence to the intervention - Adherence to supplementation - Pharmacological treatment - Physical activity (International Physical Activity Questionnaire-Short version) - Sleep quality (Pittsburgh Sleep Quality Index scale) | — |
Countries
North America
Contacts
Public ContactOtilia Perichart Perera
Instituto Nacional de Perinatologia (National Institute of Perinatology) Coordinacion de Nutricion y Bioprogramacion (Nutrition and Bioprogramming Coordination)
Outcome results
None listed