Gestational Diabetes Mellitus Trial (GDM) (GDM)
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|ClinicalTrials.gov Identifier: NCT00069576|
Recruitment Status : Completed
First Posted : September 30, 2003
Results First Posted : May 31, 2019
Last Update Posted : July 15, 2019
|Condition or disease||Intervention/treatment||Phase|
|Diabetes, Gestational||Behavioral: nutritional counseling Behavioral: self blood glucose monitoring||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||7381 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Clinical Trial of Treatment for Mild Gestational Diabetes Mellitus|
|Study Start Date :||October 2002|
|Actual Primary Completion Date :||November 2007|
|Actual Study Completion Date :||October 2013|
Active Comparator: Nutritional counseling & 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.
Behavioral: nutritional counseling
Behavioral: self blood glucose monitoring
No Intervention: No treatment
This group will not receive any specific dietary therapy except for written information concerning general nutritional recommendations for normal pregnancy.
- 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.
- Number of Neonates Who Were Large for Gestational Age at Delivery [ Time Frame: From time of randomization through delivery (up to 17 weeks) ]
- Number of Neonates With Macrosomia (Birth Weight > 4000 gm) [ Time Frame: Assessed at Delivery ]
- Number Participants Who Delivered Preterm [ Time Frame: Delivery before 37 weeks gestation ]Number of preterm deliveries before 37 weeks gestation
- Mean Neonatal Fat Mass at Delivery [ Time Frame: Assessed at delivery ]
- Number of Neonates Who Were Small for Gestational Age [ Time Frame: From time of randomization through delivery (up to 17 weeks) ]Birth weight below the 10th percentile
- Mean Neonatal Birth Weight [ Time Frame: Assessed at delivery ]Birth weight in grams
- Number of Infants Admitted to NICU [ Time Frame: Delivery through hospital discharge up to 120 days ]Admission to the Neonatal Intensive Care Unit
- Number of Neonates Who Received Intravenous Glucose Treatment [ Time Frame: 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 [ Time Frame: 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 Participants Who Underwent Labor Induction [ Time Frame: From time of randomization through induction (up to 17 weeks) ]Number of participants who underwent labor induction
- Number of Participants Who Underwent Cesarean Delivery [ Time Frame: Delivery ]Delivery by cesarean section
- Number of Neonates Who Experienced Shoulder Dystocia [ Time Frame: During the process of labor through delivery ]Number of neonates who experienced shoulder dystocia during labor and delivery
- Number of Participants Who Experienced Preeclampsia [ Time Frame: From time of randomization through delivery (up to 17 weeks) ]Number of participants who experienced preeclampsia
- Number of Participants Who Had Preeclampsia or Gestational Hypertension [ Time Frame: 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 [ Time Frame: Delivery ]Mean maternal body-mass index at the time of delivery
- Mean Maternal Weight Gain [ Time Frame: 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 [ Time Frame: 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 Waist Circumference >90th Percentile for Age, Sex and Race/Ethnicity [ Time Frame: 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 Children at 5-10 Year Follow up With Hypertension ≥ 95th Percentile for Age, Sex and Height [ Time Frame: 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.
- Number of Children at 5-10 Year Follow-up With Impaired Fasting Glucose ≥100 mg/dL [ Time Frame: Age 5-10 years ]Number of children at 5-10 year follow-up with impaired fasting glucose ≥100 mg/dL
- Mean Gestational Age at Birth [ Time Frame: Delivery ]Mean Gestational age at the time of delivery
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00069576
|United States, Alabama|
|University of Alabama at Birmingham|
|Birmingham, Alabama, United States, 35233|
|United States, Illinois|
|Chicago, Illinois, United States, 60611|
|United States, Michigan|
|Wayne State University - Hutzel Hospital|
|Detroit, Michigan, United States, 48201|
|United States, New York|
|Columbia University-St. Luke's Hospital|
|New York, New York, United States, 10032|
|United States, North Carolina|
|University of North Carolina-Chapel Hill|
|Chapel Hill, North Carolina, United States, 17599|
|Wake Forest University School of Medicine|
|Winston-Salem, North Carolina, United States, 27157|
|United States, Ohio|
|Case Western Reserve University|
|Cleveland, Ohio, United States, 44109|
|Ohio State University Hospital|
|Columbus, Ohio, United States, 43210|
|United States, Oregon|
|Oregon Health and Science University|
|Portland, Oregon, United States, 97239|
|United States, Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19107|
|University of Pittsburgh-Magee Womens Hospital|
|Pittsburgh, Pennsylvania, United States, 15213|
|United States, Rhode Island|
|Providence, Rhode Island, United States, 02905|
|United States, Texas|
|University of Texas Southwestern Medical Center|
|Dallas, Texas, United States, 75235|
|University of Texas Medical Branch|
|Galveston, Texas, United States, 77555|
|University of Texas-Houston|
|Houston, Texas, United States, 77030|
|United States, Utah|
|University of Utah|
|Salt Lake City, Utah, United States, 84132|
|Study Chair:||Mark B. Landon, MD||Ohio State University|
|Study Director:||Uma Reddy, MD, MPH||Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)|
|Principal Investigator:||Elizabeth A Thom, Ph.D.||George Washington University Biostatistics Center|