• Composite neonatal morbidity (hypoglycemia, hyperinsulinemia, hyperbilirubinemia, birth trauma, neonatal mortality; death or stillbirth
• death or stillbirth

• - Composite neonatal morbidity (hypoglycemia, hyperinsulinemia, hyperbilirubinemia, birth trauma)
• - death or stillbirth

• large for gestational age
• macrosomia (birth weight > 4000 gm)
• delivery route
• neonatal fat mass
• neonatal mortality and morbidity

• - large for gestational age
• - macrosomia (birth weight > 4000 gm)
• - delivery route
• - neonatal fat mass
• - neonatal mortality and morbidity

Gestational diabetes mellitus (GDM) is a type of diabetes (high blood sugar) that occurs in pregnant women. This study will determine whether treating pregnant women who have mild GDM improves the health of their babies.

Gestational diabetes mellitus is defined as glucose intolerance of variable severity with onset or first recognition during pregnancy. The definition applies regardless of insulin use for treatment or the persistence of the condition after pregnancy, and does not exclude the possibility that unrecognized glucose intolerance or overt diabetes may have preceded the pregnancy. Pre-existing diabetes substantially contributes to perinatal morbidity and mortality. The association of milder forms of gestational diabetes with adverse pregnancy outcomes, including morbidities such as macrosomia, birth trauma, and neonatal hypoglycemia, remains questionable. While it is likely that maternal glucose intolerances reflect a continuum of risk for adverse outcomes, it is not known whether there is a benefit to identification and subsequent treatment of mild glucose intolerance during pregnancy. This study will determine whether dietary treatment (and insulin as required) for mild GDM will reduce the frequency of neonatal morbidity associated with mild glucose intolerance.

Participants in this study will receive a 50-gram glucose loading test (GLT) between 24 and 30 weeks' gestation. Those with a positive GLT will receive a subsequent 3-hour oral glucose tolerance test (OGTT). Based upon these test results, women will be assigned to 4 groups. Women with a positive GLT and abnormal OGTT will be randomly assigned to receive either nutritional counseling and diet therapy (Group 1) or no specific treatment (Group 2a). Women with a positive GLT but normal OGTT will be enrolled in Group 2b for observation. Women with a negative GLT will be enrolled in Group 3 and will serve as a control group.

Women in Group 1 will receive formal nutritional counseling and will be instructed on the techniques of self blood glucose monitoring. Patients will take daily blood glucose measurements and will be seen at weekly study visits. The study will evaluate birth outcomes, including stillbirth, neonatal hypoglycemia, neonatal hyperinsulinemia, neonatal hyperbilirubinemia, and birth trauma.

• Behavioral: nutritional counseling
• Behavioral: self blood glucose monitoring

• Landon MB, Thom E, Spong CY, Gabbe SG, Leindecker S, Johnson F, Lain K, Miodovnik M, Carpenter M. A planned randomized clinical trial of treatment for mild gestational diabetes mellitus. J Matern Fetal Neonatal Med. 2002 Apr;11(4):226-31.
• Landon MB, Spong CY, Thom E, Carpenter MW, Ramin SM, Casey B, Wapner RJ, Varner MW, Rouse DJ, Thorp JM Jr, Sciscione A, Catalano P, Harper M, Saade G, Lain KY, Sorokin Y, Peaceman AM, Tolosa JE, Anderson GB; Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. A multicenter, randomized trial of treatment for mild gestational diabetes. N Engl J Med. 2009 Oct 1;361(14):1339-48.

Inclusion Criteria

• Pregnant
• Gestational age at enrollment 24 - 31 weeks

Exclusion Criteria

• Diabetes diagnosed prior to pregnancy
• Abnormal gestational diabetes (>= 135 mg/dl) testing prior to 24 weeks' gestation
• Gestational diabetes in a previous pregnancy
• History of stillbirth or fetal death
• Pregnancy with more than one fetus
• Known major fetal anomaly
• Current or planned corticosteroid therapy
• Asthma requiring medication
• Current or planned beta adrenergic therapy
• Chronic hypertension requiring medication within 6 months of or during pregnancy
• Chronic medical conditions such as HIV/AIDS, kidney disease, or congenital heart disease
• Hematologic or autoimmune disease such as sickle cell disease, other hemoglobinopathies, lupus, or antiphospholipid syndrome
• Maternal or fetal conditions likely to require preterm delivery, such as pre-eclampsia, preterm labor, or intrauterine growth retardation
• Previous or planned tocolytic therapy to induce labor or increase contraction strength