EGGO: Early Gestational Diabetes Screening in the Gravid Obese Woman
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| 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. |
Other: Early Screen
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.
|
Outcome Measures
Primary Outcome Measures
- Number of Participants With a Composite Perinatal Outcome [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)
Secondary Outcome Measures
- Number of Participants With Macrosomia [Within 6 weeks of delivery]
Number of infants with Birth weight >4000 g
- Primary Cesarean Delivery [Delivery]
Primary cesarean : delivery via cesarean, first cesarean (does not include repeat cesarean deliveries)
- Pregnancy Induced Hypertension [Within 6 weeks of delivery]
Includes gestational hypertension and preeclampsia
- Shoulder Dystocia [At birth]
Shoulder dystocia as identified by delivering physician
- Neonatal Hyperbilirubinemia [Within 6 weeks of delivery]
serum bilirubin level above the 95th percentile for gestational age
- Neonatal Hypoglycemia [Within 6 weeks of delivery]
Blood sugar level <40 mg/dL
- Gestational Age at Delivery [at delivery]
Gestational age in weeks as calculated by ACOG criteria
- Any Diabetic Medication [baseline to delivery]
includes the use of any diabetic medication
- Insulin Medication [baseline to delivery]
Includes the use of Insulin
- Large for Gestational Age [at delivery]
defined as >= the 90th percentile by Duryea et al
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Alabama at Birmingham | Birmingham | Alabama | United States | 35233 |
| 2 | Ochsner Health System | New Orleans | Louisiana | United States | 70121 |
Sponsors and Collaborators
- University of Alabama at Birmingham
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Ochsner Health System
Investigators
- Principal Investigator: Lorie M Harper, MD, MSCI, University of Alabama at Birmingham
Study Documents (Full-Text)
More Information
Publications
None provided.- F121008004
- K12HD001258
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Routine Screening | Early Screening |
|---|---|---|
| Arm/Group Description | 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. | 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. Early Screen: 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. |
| Period Title: Overall Study | ||
| STARTED | 480 | 482 |
| COMPLETED | 443 | 387 |
| NOT COMPLETED | 37 | 95 |
Baseline Characteristics
| Arm/Group Title | Routine Screening | Early Screening | Total |
|---|---|---|---|
| Arm/Group Description | 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. | 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. Early Screen: 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. | Total of all reporting groups |
| Overall Participants | 463 | 459 | 922 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
26.8
(5.9)
|
27.2
(5.9)
|
27
(5.9)
|
| Sex/Gender, Customized (Count of Participants) | |||
| female |
463
100%
|
459
100%
|
922
100%
|
| Race/Ethnicity, Customized (Count of Participants) | |||
| White, Non-Hispanic |
35
7.6%
|
52
11.3%
|
87
9.4%
|
| Black, Non-Hispanic |
299
64.6%
|
280
61%
|
579
62.8%
|
| Native American |
3
0.6%
|
2
0.4%
|
5
0.5%
|
| Asian |
2
0.4%
|
1
0.2%
|
3
0.3%
|
| Hispanic |
123
26.6%
|
122
26.6%
|
245
26.6%
|
| Other |
1
0.2%
|
2
0.4%
|
3
0.3%
|
| Region of Enrollment (participants) [Number] | |||
| United States |
463
100%
|
459
100%
|
922
100%
|
| Region of Enrollment (participants) [Number] | |||
| United States |
463
100%
|
459
100%
|
922
100%
|
| Body Mass index at randomization (kg/m^2) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [kg/m^2] |
37.0
(6.5)
|
37.2
(6.6)
|
37
(0.6)
|
| Medicaid/no insurance (Count of Participants) | |||
| Count of Participants [Participants] |
441
95.2%
|
434
94.6%
|
875
94.9%
|
| Married (Count of Participants) | |||
| Count of Participants [Participants] |
96
20.7%
|
98
21.4%
|
194
21%
|
| High School education or greater (Count of Participants) | |||
| Count of Participants [Participants] |
305
65.9%
|
309
67.3%
|
614
66.6%
|
| Parous (Count of Participants) | |||
| Count of Participants [Participants] |
338
73%
|
329
71.7%
|
667
72.3%
|
| Any Smoking (Count of Participants) | |||
| Count of Participants [Participants] |
98
21.2%
|
83
18.1%
|
181
19.6%
|
| Any alcohol use (Count of Participants) | |||
| Count of Participants [Participants] |
61
13.2%
|
76
16.6%
|
137
14.9%
|
| Any drug use (Count of Participants) | |||
| Count of Participants [Participants] |
49
10.6%
|
41
8.9%
|
90
9.8%
|
| Hypertension (Count of Participants) | |||
| Count of Participants [Participants] |
50
10.8%
|
61
13.3%
|
111
12%
|
| Asthma (Count of Participants) | |||
| Count of Participants [Participants] |
53
11.4%
|
61
13.3%
|
114
12.4%
|
| Depression (Count of Participants) | |||
| Count of Participants [Participants] |
50
10.8%
|
55
12%
|
105
11.4%
|
| Hemoglobin A1c at 14-20 weeks (% A1c) [Mean (Full Range) ] | |||
| Mean (Full Range) [% A1c] |
5.3
|
5.3
|
5.3
|
| Gestational age at Randomization (weeks) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [weeks] |
13.6
(3.7)
|
13.8
(3.8)
|
13.7
(3.7)
|
Outcome Measures
| Title | Number of Participants With a Composite Perinatal Outcome |
|---|---|
| Description | Any one of the following: Macrosomia (birth weight > 4000 g), primary cesarean, gestational hypertension, preeclampsia, shoulder dystocia, neonatal hyperbilirubinemia, neonatal hypoglycemia (<40 mg/dL) |
| Time Frame | Baseline to within 6 weeks of delivery |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Routine Screening | Early Screening |
|---|---|---|
| Arm/Group Description | 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. | 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. Early Screen: 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. |
| Measure Participants | 463 | 459 |
| Count of Participants [Participants] |
235
50.8%
|
261
56.9%
|
| Title | Number of Participants With Macrosomia |
|---|---|
| Description | Number of infants with Birth weight >4000 g |
| Time Frame | Within 6 weeks of delivery |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Routine Screening | Early Screening |
|---|---|---|
| Arm/Group Description | 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. | 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. Early Screen: 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. |
| Measure Participants | 463 | 459 |
| Count of Participants [Participants] |
21
4.5%
|
25
5.4%
|
| Title | Primary Cesarean Delivery |
|---|---|
| Description | Primary cesarean : delivery via cesarean, first cesarean (does not include repeat cesarean deliveries) |
| Time Frame | Delivery |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Routine Screening | Early Screening |
|---|---|---|
| Arm/Group Description | 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. | 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. Early Screen: 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. |
| Measure Participants | 463 | 459 |
| Count of Participants [Participants] |
93
20.1%
|
79
17.2%
|
| Title | Pregnancy Induced Hypertension |
|---|---|
| Description | Includes gestational hypertension and preeclampsia |
| Time Frame | Within 6 weeks of delivery |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Routine Screening | Early Screening |
|---|---|---|
| Arm/Group Description | 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. | 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. Early Screen: 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. |
| Measure Participants | 463 | 459 |
| Count of Participants [Participants] |
102
22%
|
136
29.6%
|
| Title | Shoulder Dystocia |
|---|---|
| Description | Shoulder dystocia as identified by delivering physician |
| Time Frame | At birth |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Routine Screening | Early Screening |
|---|---|---|
| Arm/Group Description | 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. | 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. Early Screen: 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. |
| Measure Participants | 463 | 459 |
| Count of Participants [Participants] |
32
6.9%
|
30
6.5%
|
| Title | Neonatal Hyperbilirubinemia |
|---|---|
| Description | serum bilirubin level above the 95th percentile for gestational age |
| Time Frame | Within 6 weeks of delivery |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Routine Screening | Early Screening |
|---|---|---|
| Arm/Group Description | 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. | 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. Early Screen: 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. |
| Measure Participants | 463 | 459 |
| Count of Participants [Participants] |
72
15.6%
|
90
19.6%
|
| Title | Neonatal Hypoglycemia |
|---|---|
| Description | Blood sugar level <40 mg/dL |
| Time Frame | Within 6 weeks of delivery |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Routine Screening | Early Screening |
|---|---|---|
| Arm/Group Description | 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. | 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. Early Screen: 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. |
| Measure Participants | 463 | 459 |
| Count of Participants [Participants] |
19
4.1%
|
22
4.8%
|
| Title | Gestational Age at Delivery |
|---|---|
| Description | Gestational age in weeks as calculated by ACOG criteria |
| Time Frame | at delivery |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Routine Screening | Early Screening |
|---|---|---|
| Arm/Group Description | 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. | 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. Early Screen: 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. |
| Measure Participants | 463 | 459 |
| Mean (Standard Deviation) [weeks] |
38.5
(3.4)
|
38.2
(4.4)
|
| Title | Any Diabetic Medication |
|---|---|
| Description | includes the use of any diabetic medication |
| Time Frame | baseline to delivery |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Routine Screening | Early Screening |
|---|---|---|
| Arm/Group Description | 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. | 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. Early Screen: 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. |
| Measure Participants | 463 | 459 |
| Count of Participants [Participants] |
20
4.3%
|
31
6.8%
|
| Title | Insulin Medication |
|---|---|
| Description | Includes the use of Insulin |
| Time Frame | baseline to delivery |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Routine Screening | Early Screening |
|---|---|---|
| Arm/Group Description | 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. | 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. Early Screen: 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. |
| Measure Participants | 463 | 459 |
| Count of Participants [Participants] |
3
0.6%
|
11
2.4%
|
| Title | Large for Gestational Age |
|---|---|
| Description | defined as >= the 90th percentile by Duryea et al |
| Time Frame | at delivery |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Routine Screening | Early Screening |
|---|---|---|
| Arm/Group Description | 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. | 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. Early Screen: 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. |
| Measure Participants | 463 | 459 |
| Count of Participants [Participants] |
26
5.6%
|
27
5.9%
|
Adverse Events
| Time Frame | Baseline through 8 months | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Routine Screening | Early Screening | ||
| Arm/Group Description | 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. | 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. Early Screen: 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. | ||
All Cause Mortality |
||||
| Routine Screening | Early Screening | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 10/463 (2.2%) | 22/459 (4.8%) | ||
Serious Adverse Events |
||||
| Routine Screening | Early Screening | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 10/463 (2.2%) | 22/459 (4.8%) | ||
| Pregnancy, puerperium and perinatal conditions | ||||
| Fetal or Neonatal death | 10/463 (2.2%) | 10 | 22/459 (4.8%) | 22 |
Other (Not Including Serious) Adverse Events |
||||
| Routine Screening | Early Screening | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/463 (0.2%) | 0/459 (0%) | ||
| Pregnancy, puerperium and perinatal conditions | ||||
| Other - Preterm Delivery | 1/463 (0.2%) | 1 | 0/459 (0%) | 0 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Lorie M. Harper, MD, MSCI |
|---|---|
| Organization | University of Texas at Austin |
| Phone | 512-324-7036 |
| lorie.harper@austin.utexas.edu |
- F121008004
- K12HD001258