Gestational Diabetes Mellitus Trial (GDM)
- Conditions
- Diabetes, Gestational
- Interventions
- Behavioral: nutritional counselingBehavioral: self blood glucose monitoring
- Registration Number
- NCT00069576
- Lead Sponsor
- The George Washington University Biostatistics Center
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 7381
- Pregnant
- Gestational age at enrollment 24 - 31 weeks
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Nutritional counseling & self blood glucose monitoring nutritional counseling Within one week of enrollment, women in the treatment group receive formal nutritional counseling and will be instructed on the technique of self blood glucose monitoring using a memory-based reflectance meter. Nutritional counseling & self blood glucose monitoring self blood glucose monitoring Within one week of enrollment, women in the treatment group receive formal nutritional counseling and will be instructed on the technique of self blood glucose monitoring using a memory-based reflectance meter.
- Primary Outcome Measures
Name Time Method Number of Participants With Composite Neonatal Morbidity 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 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 Outcome Measures
Name Time Method Number of Neonates Who Received Intravenous Glucose Treatment Delivery through hospital discharge up to 120 days Number of neonates who received intravenous glucose treatment at any time from delivery through hospital discharge.
Number of Neonates Who Experienced Respiratory Distress Syndrome Delivery through hospital discharge up to 120 days Number of neonates who experienced Respiratory Distress Syndrome at any time from delivery through hospital discharge
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 Were Large for Gestational Age at Delivery From time of randomization through delivery (up to 17 weeks) Mean Neonatal Birth Weight Assessed at delivery Birth weight in grams
Number of Infants Admitted to NICU Delivery through hospital discharge up to 120 days Admission to the Neonatal Intensive Care Unit
Number Participants Who Delivered Preterm Delivery before 37 weeks gestation Number of preterm deliveries before 37 weeks gestation
Number of Neonates Who Were Small for Gestational Age From time of randomization through delivery (up to 17 weeks) Birth weight below the 10th percentile
Number of Participants Who Underwent Labor Induction From time of randomization through induction (up to 17 weeks) Number of participants who underwent labor induction
Number of Participants Who Underwent Cesarean Delivery Delivery Delivery by cesarean section
Number of Neonates Who Experienced Shoulder Dystocia During the process of labor through delivery Number of neonates who experienced shoulder dystocia during labor and delivery
Number of Participants Who Had Preeclampsia or Gestational Hypertension From time of randomization through delivery (up to 17 weeks) Number of participants who had Preeclampsia or gestational hypertension
Mean Maternal Body-mass Index at Delivery Delivery Mean maternal body-mass index at the time of 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 Child waist circumference \>90th percentile for age, sex and race/ethnicity based on a study examining cross-sectional data from the Third National Health and Nutrition Examination Survey (NHANES III)
Number of Participants Who Experienced Preeclampsia From time of randomization through delivery (up to 17 weeks) Number of participants who experienced preeclampsia
Number of Children at 5-10 Year Follow up With Hypertension ≥ 95th Percentile for Age, Sex and Height Age 5 - 10 years Hypertension ≥ 95th percentile for age, sex and height based on the National Heart, Lung and Blood Institute Expert Panel on Integrated Guidelines for Children and Adolescents.
Mean Maternal Weight Gain From time of randomization through delivery (up to 17 weeks) Mean Maternal weight gain from enrollment in the trial until delivery
Number of Children With BMI ≥ 85th Percentile for Age and Sex Age 5-10 years Number of children with BMI ≥ 85th percentile for age and sex at the 5-10 year follow-up. BMI is measured as kg/m\^2. Standards base on the 2000 Centers for Disease Control growth charts.
Number of Children at 5-10 Year Follow-up With Impaired Fasting Glucose ≥100 mg/dL Age 5-10 years Number of children at 5-10 year follow-up with impaired fasting glucose ≥100 mg/dL
Trial Locations
- Locations (16)
Drexel University
🇺🇸Philadelphia, Pennsylvania, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Wayne State University - Hutzel Hospital
🇺🇸Detroit, Michigan, United States
Ohio State University Hospital
🇺🇸Columbus, Ohio, United States
Columbia University-St. Luke's Hospital
🇺🇸New York, New York, United States
University of Pittsburgh-Magee Womens Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
Brown University
🇺🇸Providence, Rhode Island, United States
University of North Carolina-Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
Oregon Health and Science University
🇺🇸Portland, Oregon, United States
University of Texas-Houston
🇺🇸Houston, Texas, United States
Case Western Reserve University
🇺🇸Cleveland, Ohio, United States
University of Texas Medical Branch
🇺🇸Galveston, Texas, United States
University of Utah
🇺🇸Salt Lake City, Utah, United States
Wake Forest University School of Medicine
🇺🇸Winston-Salem, North Carolina, United States
University of Texas Southwestern Medical Center
🇺🇸Dallas, Texas, United States