- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01864564
Early Gestational Diabetes Screening in the Gravid Obese Woman (EGGO)
Specific Aim 1: To test the hypothesis that early GDM screening between 14-18 weeks in obese women (body mass index ≥30.0) will result in improved perinatal outcomes.
Specific Aim 2: To test the hypothesis that a lower diagnostic threshold for GDM at 14-18 weeks will result in improved detection of GDM and reduce the need for third-trimester testing.
Specific Aim 3: To test the hypothesis that 1,5-anhydroglucitol, a sensitive marker of hyperglycemia, can be used as a simple and sensitive serum test for GDM in the obese population.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Over 1/3 of reproductive age women are obese. Obese women have higher rates of adverse pregnancy outcomes, including stillbirth, fetal growth disorders, diabetes, hypertensive diseases and maternal death. Although weight loss prior to pregnancy is the ideal, a significant proportion of obese women do not present to care until after conception. Consequently, developing a comprehensive plan for managing the obese gravida is imperative. One component of such a plan must include screening and treating for gestational diabetes (GDM), which is associated with macrosomia, cesarean delivery, preeclampsia, shoulder dystocia, and neonatal hypoglycemia. Obesity substantially increases the risk of GDM (odds ratio 2-5). GDM treatment has been shown to improve pregnancy outcomes,but obese women with GDM continue to have worsened outcomes compared to normal weight women with GDM, with more cesarean delivery, preeclampsia, macrosomia and stillbirths occurring in obese women. This is perhaps due to pre-existing insulin resistance in obese women that, when coupled with the normal insulin resistance of pregnancy, leads to earlier onset of GDM in obese women compared to normal weight women, with consequently longer fetal exposure to hyperglycemic episodes prior to diagnosis and treatment.
The American College of Obstetricians and Gynecologists recommends screening obese women for gestational diabetes (GDM) in the first trimester or upon presentation. However, due to lack of supporting data, this recommendation is not widely followed and the majority of obese women do not undergo GDM screening until 24-28 weeks gestation. Postponing testing may delay the diagnosis and treatment of GDM by 10 weeks or more, resulting in fetal hyperglycemia during critical periods of fetal growth and development. Early screening, between 14-18 weeks gestation, in this high-risk population will allow for earlier recognition and treatment of GDM, thereby improving perinatal outcomes.
Additionally, little is known about screening and diagnostic standards for GDM early in pregnancy. Currently, when GDM testing is performed early in pregnancy, the criteria used to diagnose GDM at 24-28 weeks are applied. However, these thresholds were developed for a test performed at 24-28 weeks; applying these same thresholds at 14-18 weeks may not be appropriate. As insulin resistance increases throughout pregnancy, lowering the criteria for glucose tolerance testing earlier in gestation may improve GDM detection and avoid the need for re-testing later in pregnancy. Alternatively, as GDM is the new-onset of insulin resistance with resulting hyperglycemia, biomarkers that reflect metabolic markers of recent hyperglycemic episodes may perform well in screening for GDM and may decrease the patient burden of, while increasing compliance with, glucose tolerance testing. One such marker that has been evaluated in Type 2 diabetes is 1,5-anhydroglucitol (AG), an unmetabolized monosaccharide. AG has a fairly stable steady-state concentration in the blood that is unaffected by fasting, dietary changes and pregnancy; it is reabsorbed in the renal tubules by the same transporter that reabsorbs glucose. During a hyperglycemic episode, the presence of glucose in the urine competitively inhibits the reabsorption of AG, resulting in a precipitous decline in AG levels. AG levels recover slowly in the presence of continued hyperglycemia. The rapid fall of AG with the onset of hyperglycemia and its slow recovery in situations of on-going hyperglycemia suggest it as both a sensitive and specific marker for new-onset glucose intolerance requiring treatment. As perinatal outcomes are closely linked to hyperglycemic excursions, (18) AG may be the most sensitive and specific marker for determining the GDM patient who will benefit most from treatment.
This study is potentially practice changing and could greatly reduce the disparities in perinatal outcomes seen in obese women. Early GDM screening of obese women may reduce the risk of cesarean delivery, macrosomia, stillbirth, preterm birth, and preeclampsia in this population. This study has 3 specific aims:
Specific Aim 1: To test the hypothesis that early GDM screening between 14-18 weeks in obese women (body mass index ≥30.0) will result in improved composite perinatal outcomes.
Specific Aim 2: To test the hypothesis that a lower diagnostic threshold for GDM at 14-18 weeks will result in improved detection of GDM and reduce the need for third-trimester testing.
Specific Aim 3: To test the hypothesis that 1,5-anhydroglucitol, a sensitive marker of recent hyperglycemic excursions, can be used as a simple and sensitive serum test for GDM in the obese population.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Alabama
-
Birmingham, Alabama, United States, 35233
- University of Alabama at Birmingham
-
-
Louisiana
-
New Orleans, Louisiana, United States, 70121
- Ochsner Health System
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Pregnant
- 18 years and older
- Body mass index >=30.0
- <20 weeks gestation at presentation for care
Exclusion Criteria:
- Prior cesarean
- History of bariatric surgery
- Major maternal medical illness (cardiac disease, HIV, hemoglobinopathy, oxygen requirement)
- Chronic prednisone use
- Known fetal anomalies
- Multifetal gestation
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Routine Screening
Obese women will be screened at 24-28 weeks of gestation for gestational diabetes using the standard U.S. screening method of a 1-hour, 50-g glucose challenge test followed by a 3-hour, 100-g glucose tolerance test if abnormal. Women identified as having diabetes will be treated according to standards of care. All women will have a hemoglobin A1c and 1,5-anhydroglucitol checked at 14-18 weeks and 24-28 weeks gestation. |
|
Experimental: Early Screening
Obese women will be randomized to be screened at 14-19.9 weeks of gestation for gestational diabetes using the standard U.S. screening method of a 1-hour, 50-g glucose challenge test followed by a 3-hour, 100-g glucose tolerance test if abnormal. Women identified as having diabetes will be treated according to standards of care. Women who do not have diabetes at 14-19.9 weeks will be re-screened at 24-28 weeks per the standard of care. All women will have a hemoglobin A1c and 1,5-anhydroglucitol checked at 14-18 weeks and 24-28 weeks gestation. |
Women will be randomized to be screened for gestational diabetes at 14-19.9 weeks gestation (early=intervention) versus routine screening at 24-28 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With a Composite Perinatal Outcome
Time Frame: Baseline to within 6 weeks of delivery
|
Any one of the following: Macrosomia (birth weight > 4000 g), primary cesarean, gestational hypertension, preeclampsia, shoulder dystocia, neonatal hyperbilirubinemia, neonatal hypoglycemia (<40 mg/dL)
|
Baseline to within 6 weeks of delivery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Macrosomia
Time Frame: Within 6 weeks of delivery
|
Number of infants with Birth weight >4000 g
|
Within 6 weeks of delivery
|
Primary Cesarean Delivery
Time Frame: Delivery
|
Primary cesarean : delivery via cesarean, first cesarean (does not include repeat cesarean deliveries)
|
Delivery
|
Pregnancy Induced Hypertension
Time Frame: Within 6 weeks of delivery
|
Includes gestational hypertension and preeclampsia
|
Within 6 weeks of delivery
|
Shoulder Dystocia
Time Frame: At birth
|
Shoulder dystocia as identified by delivering physician
|
At birth
|
Neonatal Hyperbilirubinemia
Time Frame: Within 6 weeks of delivery
|
serum bilirubin level above the 95th percentile for gestational age
|
Within 6 weeks of delivery
|
Neonatal Hypoglycemia
Time Frame: Within 6 weeks of delivery
|
Blood sugar level <40 mg/dL
|
Within 6 weeks of delivery
|
Gestational Age at Delivery
Time Frame: at delivery
|
Gestational age in weeks as calculated by ACOG criteria
|
at delivery
|
Any Diabetic Medication
Time Frame: baseline to delivery
|
includes the use of any diabetic medication
|
baseline to delivery
|
Insulin Medication
Time Frame: baseline to delivery
|
Includes the use of Insulin
|
baseline to delivery
|
Large for Gestational Age
Time Frame: at delivery
|
defined as >= the 90th percentile by Duryea et al
|
at delivery
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Lorie M Harper, MD, MSCI, University of Alabama at Birmingham
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- F121008004
- K12HD001258 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Obesity
-
Central Hospital, Nancy, FranceNot yet recruiting
-
University of MinnesotaNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Active, not recruitingAdolescent ObesityUnited States
-
Helsinki University Central HospitalKarolinska Institutet; Folkhälsan Researech CenterEnrolling by invitation
-
Istanbul Medipol University HospitalMedipol UniversityCompletedObesity, Morbid | Obesity, Adolescent | Obesity, Abdominal | Weight, Body | Obesity, VisceralTurkey
-
Queen Fabiola Children's University HospitalNot yet recruitingMorbid Obesity | Adolescent Obesity | Bariatric SurgeryBelgium
-
Washington University School of MedicinePatient-Centered Outcomes Research Institute; Pennington Biomedical Research... and other collaboratorsActive, not recruitingOvernutrition | Nutrition Disorders | Overweight | Body Weight | Pediatric Obesity | Body Weight Changes | Childhood Obesity | Weight Gain | Adolescent Obesity | Obesity, Childhood | Overweight and Obesity | Overweight or Obesity | Overweight AdolescentsUnited States
-
The Hospital for Sick ChildrenCompleted
-
Ihuoma EneliCompletedObesity, ChildhoodUnited States
-
Azienda Ospedaliero-Universitaria Consorziale Policlinico...Institute of Biomembranes, Bioenergetics and Molecular Biotechnologies; Istituti... and other collaboratorsCompletedMorbid Obesity | Metabolically Healthy ObesityItaly
-
Fundació Sant Joan de DéuNot yet recruitingObesity, Childhood | Obesity, AdolescentSpain
Clinical Trials on Early Screen
-
University of South FloridaActive, not recruiting
-
Mayo ClinicAgency for Healthcare Research and Quality (AHRQ)Completed
-
Chinese University of Hong KongUnknownColorectal Neoplasms | Colon Adenoma | Colon PolypHong Kong
-
Theodore MacnowCompleted
-
Allen A. Greiner, MD, MPHNational Institutes of Health (NIH)CompletedColorectal CancerUnited States
-
Alaska Blind Child DiscoveryCompletedStrabismus | Strabismic Amblyopia | Refractive AmblyopiaUnited States
-
University of Southern DenmarkEuropean Research CouncilCompleted
-
Georgetown UniversityAmerican Lung AssociationCompleted
-
Assiut UniversityNot yet recruitingSubstance Use Disorders
-
Karolinska InstitutetTerminated