A Randomized Clinical Trial of Treatment for Mild Gestational Diabetes Mellitus
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Diabetes, Gestational
- Sponsor
- The George Washington University Biostatistics Center
- Enrollment
- 7381
- Locations
- 16
- Primary Endpoint
- Number of Participants With Composite Neonatal Morbidity
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
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. The follow-up study will examine whether factors during the previous pregnancy (such as blood sugar during pregnancy) are associated with the woman and her child's health 4-9 years later.
Detailed Description
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. The follow-up study will examine if blood sugar levels and treatments during pregnancy influence the health of the mother and child several years later. The study will also examine whether there is a genetic link to the health of the mother and child. The study visit will include blood pressure, body size measurements, blood draw and saliva collection, and questions related to the mother and child's health and environment.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Outcomes
Primary Outcomes
Number of Participants With Composite Neonatal Morbidity
Time Frame: Delivery through discharge of infant from hospital up to 120 days
The composite perinatal outcome included stillbirth, neonatal death, hypoglycemia, hyperbilirubinemia, elevated cordblood C-peptide level, and birth trauma.
Number of Children at the 5-10 Year Followup With BMI ≥ 95th Percentile for Age and Sex
Time Frame: Age 5-10 years
Number of children with BMI ≥ 95th percentile for age and sex. BMI is measured as kg / m\^2. Standards based on the 2000 Centers for Disease Control growth charts.
Secondary Outcomes
- Mean Neonatal Birth Weight(Assessed at delivery)
- Number of Neonates With Macrosomia (Birth Weight > 4000 gm)(Assessed at Delivery)
- Mean Neonatal Fat Mass at Delivery(Assessed at delivery)
- Number of Neonates Who Received Intravenous Glucose Treatment(Delivery through hospital discharge up to 120 days)
- Number of Neonates Who Experienced Respiratory Distress Syndrome(Delivery through hospital discharge up to 120 days)
- Number of Infants Admitted to NICU(Delivery through hospital discharge up to 120 days)
- Number of Neonates Who Were Large for Gestational Age at Delivery(From time of randomization through delivery (up to 17 weeks))
- Number Participants Who Delivered Preterm(Delivery before 37 weeks gestation)
- Number of Neonates Who Were Small for Gestational Age(From time of randomization through delivery (up to 17 weeks))
- Number of Participants Who Underwent Labor Induction(From time of randomization through induction (up to 17 weeks))
- Number of Participants Who Underwent Cesarean Delivery(Delivery)
- Number of Participants Who Experienced Preeclampsia(From time of randomization through delivery (up to 17 weeks))
- Number of Neonates Who Experienced Shoulder Dystocia(During the process of labor through delivery)
- Number of Participants Who Had Preeclampsia or Gestational Hypertension(From time of randomization through delivery (up to 17 weeks))
- Mean Maternal Body-mass Index at Delivery(Delivery)
- Number of Children at 5-10 Year Follow up With Waist Circumference >90th Percentile for Age, Sex and Race/Ethnicity(Age 5-10 years)
- Number of Children at 5-10 Year Follow up With Hypertension ≥ 95th Percentile for Age, Sex and Height(Age 5 - 10 years)
- Mean Maternal Weight Gain(From time of randomization through delivery (up to 17 weeks))
- Number of Children With BMI ≥ 85th Percentile for Age and Sex(Age 5-10 years)
- Number of Children at 5-10 Year Follow-up With Impaired Fasting Glucose ≥100 mg/dL(Age 5-10 years)