Gestational Diabetes Mellitus Trial (GDM) | NCT00069576

NCT00069576

Secondary IDs

ID	Type	Link
U10HD021410	U.S. NIH Grant/Contract	View source
U10HD027869	U.S. NIH Grant/Contract	View source
U10HD027917	U.S. NIH Grant/Contract	View source
U10HD027915	U.S. NIH Grant/Contract	View source
U10HD034116	U.S. NIH Grant/Contract	View source
U10HD034208	U.S. NIH Grant/Contract	View source
U10HD040500	U.S. NIH Grant/Contract	View source
U10HD040485	U.S. NIH Grant/Contract	View source
U10HD040544	U.S. NIH Grant/Contract	View source
U10HD040545	U.S. NIH Grant/Contract	View source
U10HD040560	U.S. NIH Grant/Contract	View source
U10HD040512	U.S. NIH Grant/Contract	View source
U10HD036801	U.S. NIH Grant/Contract	View source
U10HD053118	U.S. NIH Grant/Contract	View source
U10HD053097	U.S. NIH Grant/Contract	View source
U10HD027860	U.S. NIH Grant/Contract	View source
U10HD034136	U.S. NIH Grant/Contract	View source

Status Module

Sponsor/Collaborators Module

Name	Class
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	NIH

Oversight Module

Description Module

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.

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Nutritional counseling & self blood glucose monitoring	Active Comparator	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 treatment	No Intervention	This group will not receive any specific dietary therapy except for written information concerning general nutritional recommendations for normal pregnancy.

Name	Type	Description	Arm Group Labels	Other Names
nutritional counseling	Behavioral		Nutritional counseling & self blood glucose monitoring
self blood glucose monitoring

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants With Composite Neonatal Morbidity	The composite perinatal outcome included stillbirth, neonatal death, hypoglycemia, hyperbilirubinemia, elevated cordblood C-peptide level, and birth trauma.	Delivery through discharge of infant from hospital up to 120 days
Number of Children at the 5-10 Year Followup With BMI ≥ 95th Percentile for Age and Sex	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.	Age 5-10 years

Secondary Outcomes

Measure	Description	Time Frame
Number of Neonates Who Were Large for Gestational Age at Delivery		From time of randomization through delivery (up to 17 weeks)
Number of Neonates With Macrosomia (Birth Weight > 4000 gm)		Assessed at Delivery

Measure	Description	Time Frame
Mean Gestational Age at Birth	Mean Gestational age at the time of delivery	Delivery

Eligibility Module

Contacts/Locations Module

Overall Officials

Name	Affiliation	Role
Mark B. Landon, MD	Ohio State University	Study Chair
Uma Reddy, MD, MPH	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Study Director
Elizabeth A Thom, Ph.D.	George Washington University Biostatistics Center	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
University of Alabama at Birmingham		Birmingham	Alabama	35233	United States
Northwestern University

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
12375675	Background	Landon MB, Thom E, Spong CY, Gabbe SG, Leindecker S, Johnson F, Lain K, Miodovnik M, Carpenter M. A planned randomized clinical trial of treatment for mild gestational diabetes mellitus. J Matern Fetal Neonatal Med. 2002 Apr;11(4):226-31. doi: 10.1080/jmf.11.4.226.231.
21309194	Background	Landon MB, Mele L, Spong CY, Carpenter MW, Ramin SM, Casey B, Wapner RJ, Varner MW, Rouse DJ, Thorp JM Jr, Sciscione A, Catalano P, Harper M, Saade G, Caritis SN, Sorokin Y, Peaceman AM, Tolosa JE, Anderson GD; Eunice Kennedy Shriver National Institute of Child Health, and Human Development (NICHD) Maternal-Fetal Medicine Units (MFMU) Network. The relationship between maternal glycemia and perinatal outcome. Obstet Gynecol. 2011 Feb;117(2 Pt 1):218-224. doi: 10.1097/AOG.0b013e318203ebe0.

Label	URL
NICHD Maternal Fetal Medicine Units Network website	View source

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	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. nutritional counseling self blood glucose monitoring
FG001

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	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. nutritional counseling self blood glucose monitoring
BG001	No Treatment	This group will not receive any specific dietary therapy except for written information concerning general nutritional recommendations for normal pregnancy.
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00029.2± 5.7 BG00128.9± 5.6 BG00229.1± 5.7

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000485 BG001473 BG002

Race/Ethnicity, Customized

Count of Participants

Participants

Title

Denominators

Categories

Ethnic Groups

Title	Measurements
Black	BG00056 BG00154 BG002

Primigravida

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
	BG000104 BG001123 BG002

Smoking

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
	BG00038 BG00131 BG002

Alcohol Use

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
	BG00023 BG00111 BG002

Body-mass Index at Entry

Mean

Standard Deviation

kg/m^2

Title

Denominators

Categories

Title	Measurements
	BG00030.1± 5.0 BG00130.2± 5.1 BG002

Glucose level after 50-g glucose-loading test - mg/dL

Mean

Standard Deviation

mg/dL

Title

Denominators

Categories

Title	Measurements
	BG000159.0± 15.3 BG001159.7± 15.5 BG002

Duration of gestation randomization

Mean

Standard Deviation

weeks

Title

Denominators

Categories

Title	Measurements
	BG00028.8± 1.6 BG00128.9± 1.5 BG002

Glucose levels in 3-hr Oral Glucose Tolerance Test (OGTT) -mg/dL

Mean

Standard Deviation

mg/Dl

Title

Denominators

Categories

Fasting

Title	Measurements
	BG00086.6± 5.7 BG00186.3± 5.7 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Participants With Composite Neonatal Morbidity

The composite perinatal outcome included stillbirth, neonatal death, hypoglycemia, hyperbilirubinemia, elevated cordblood C-peptide level, and birth trauma.

The results of some blood tests were not available either because samples were not obtained or were not obtained according to protocol or because they could not be assayed owing to a laboratory processing error. Data were not available in some cases because some women delivered at outside institutions.

Posted

Count of Participants

Participants

Delivery through discharge of infant from hospital up to 120 days

ID	Title	Description
OG000	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. nutritional counseling self blood glucose monitoring
OG001	No Treatment	This group will not receive any specific dietary therapy except for written information concerning general nutritional recommendations for normal pregnancy.

Units	Counts
Participants	OG000485 OG001473

Title

Denominators

Categories

Composite End Point Total

- ParticipantsOG000460
- ParticipantsOG001440

Title	Measurements
	OG000149

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	For Total Composite End Point	Chi-squared		0.14		Risk Ratio (RR)	0.87			2-Sided	97	0.72	1.07					Superiority or Other
OG000 OG001	Analysis for Hypoglycemia	Chi-squared

Primary

Number of Children at the 5-10 Year Followup With BMI ≥ 95th Percentile for Age and Sex

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.

Posted

Count of Participants

Participants

Age 5-10 years

ID	Title	Description
OG000	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. nutritional counseling self blood glucose monitoring
OG001	No Treatment	This group will not receive any specific dietary therapy except for written information concerning general nutritional recommendations for normal pregnancy.

Units	Counts
Participants	OG000

Secondary

Number of Neonates Who Were Large for Gestational Age at Delivery

There were 8 women in the treatment group and 19 women in the control group for whom at least some delivery data were missing

Posted

Count of Participants

Participants

From time of randomization through delivery (up to 17 weeks)

ID	Title	Description
OG000	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. nutritional counseling self blood glucose monitoring
OG001	No Treatment	This group will not receive any specific dietary therapy except for written information concerning general nutritional recommendations for normal pregnancy.

Units	Counts
Participants	OG000

Secondary

Number of Neonates With Macrosomia (Birth Weight > 4000 gm)

There were 8 women in the treatment group and 19 women in the control group for whom at least some delivery data were missing

Posted

Count of Participants

Participants

Assessed at Delivery

ID	Title	Description
OG000	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. nutritional counseling self blood glucose monitoring
OG001	No Treatment	This group will not receive any specific dietary therapy except for written information concerning general nutritional recommendations for normal pregnancy.

Units	Counts
Participants	OG000

Secondary

Number Participants Who Delivered Preterm

Number of preterm deliveries before 37 weeks gestation

Posted

Count of Participants

Participants

Delivery before 37 weeks gestation

ID	Title	Description
OG000	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. nutritional counseling self blood glucose monitoring
OG001	No Treatment	This group will not receive any specific dietary therapy except for written information concerning general nutritional recommendations for normal pregnancy.

Units	Counts
Participants	OG000

Secondary

Mean Neonatal Fat Mass at Delivery

Posted

Mean

Standard Deviation

grams

Assessed at delivery

ID	Title	Description
OG000	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. nutritional counseling self blood glucose monitoring
OG001	No Treatment	This group will not receive any specific dietary therapy except for written information concerning general nutritional recommendations for normal pregnancy.

Units	Counts
Participants	OG000

Secondary

Number of Neonates Who Were Small for Gestational Age

Birth weight below the 10th percentile

There were 8 women in the treatment group and 19 women in the control group for whom at least some delivery data were missing

Posted

Count of Participants

Participants

From time of randomization through delivery (up to 17 weeks)

ID	Title	Description
OG000	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. nutritional counseling self blood glucose monitoring
OG001	No Treatment	This group will not receive any specific dietary therapy except for written information concerning general nutritional recommendations for normal pregnancy.

Units	Counts
Participants	OG000

Secondary

Mean Neonatal Birth Weight

Birth weight in grams

Posted

Mean

Standard Deviation

grams

Assessed at delivery

ID	Title	Description
OG000	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. nutritional counseling self blood glucose monitoring
OG001	No Treatment	This group will not receive any specific dietary therapy except for written information concerning general nutritional recommendations for normal pregnancy.

Units	Counts
Participants	OG000

Secondary

Number of Infants Admitted to NICU

Admission to the Neonatal Intensive Care Unit

Posted

Count of Participants

Participants

Delivery through hospital discharge up to 120 days

ID	Title	Description
OG000	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. nutritional counseling self blood glucose monitoring
OG001	No Treatment	This group will not receive any specific dietary therapy except for written information concerning general nutritional recommendations for normal pregnancy.

Units	Counts
Participants	OG000

Secondary

Number of Neonates Who Received Intravenous Glucose Treatment

Number of neonates who received intravenous glucose treatment at any time from delivery through hospital discharge.

Data was missing for 10 infants in the treatment group and 18 infants in the control group.

Posted

Count of Participants

Participants

Delivery through hospital discharge up to 120 days

ID	Title	Description
OG000	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. nutritional counseling self blood glucose monitoring
OG001	No Treatment	This group will not receive any specific dietary therapy except for written information concerning general nutritional recommendations for normal pregnancy.

Units	Counts
Participants

Secondary

Number of Neonates Who Experienced Respiratory Distress Syndrome

Number of neonates who experienced Respiratory Distress Syndrome at any time from delivery through hospital discharge

Data was missing for 8 infants in the treatment group and 18 infants in the control group.

Posted

Count of Participants

Participants

Delivery through hospital discharge up to 120 days

ID	Title	Description
OG000	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. nutritional counseling self blood glucose monitoring
OG001	No Treatment	This group will not receive any specific dietary therapy except for written information concerning general nutritional recommendations for normal pregnancy.

Units	Counts
Participants

Secondary

Number of Participants Who Underwent Labor Induction

Number of participants who underwent labor induction

Data was missing for 9 women in the treatment group and 18 women in the control group.

Posted

Count of Participants

Participants

From time of randomization through induction (up to 17 weeks)

ID	Title	Description
OG000	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. nutritional counseling self blood glucose monitoring
OG001	No Treatment	This group will not receive any specific dietary therapy except for written information concerning general nutritional recommendations for normal pregnancy.

Units	Counts
Participants	OG000

Secondary

Number of Participants Who Underwent Cesarean Delivery

Delivery by cesarean section

Data was missing for 9 women in the treatment group and 18 women in the control group.

Posted

Count of Participants

Participants

Delivery

ID	Title	Description
OG000	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. nutritional counseling self blood glucose monitoring
OG001	No Treatment	This group will not receive any specific dietary therapy except for written information concerning general nutritional recommendations for normal pregnancy.

Units	Counts
Participants	OG000

Secondary

Number of Neonates Who Experienced Shoulder Dystocia

Number of neonates who experienced shoulder dystocia during labor and delivery

Data was missing for 9 women in the treatment group and 18 women in the control group.

Posted

Count of Participants

Participants

During the process of labor through delivery

ID	Title	Description
OG000	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. nutritional counseling self blood glucose monitoring
OG001	No Treatment	This group will not receive any specific dietary therapy except for written information concerning general nutritional recommendations for normal pregnancy.

Units	Counts
Participants	OG000

Secondary

Number of Participants Who Experienced Preeclampsia

Number of participants who experienced preeclampsia

Data was missing for 9 women in the treatment group and 18 women in the control group.

Posted

Count of Participants

Participants

From time of randomization through delivery (up to 17 weeks)

ID	Title	Description
OG000	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. nutritional counseling self blood glucose monitoring
OG001	No Treatment	This group will not receive any specific dietary therapy except for written information concerning general nutritional recommendations for normal pregnancy.

Units	Counts
Participants	OG000

Secondary

Number of Participants Who Had Preeclampsia or Gestational Hypertension

Number of participants who had Preeclampsia or gestational hypertension

Data was missing for 9 women in the treatment group and 18 women in the control group.

Posted

Count of Participants

Participants

From time of randomization through delivery (up to 17 weeks)

ID	Title	Description
OG000	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. nutritional counseling self blood glucose monitoring
OG001	No Treatment	This group will not receive any specific dietary therapy except for written information concerning general nutritional recommendations for normal pregnancy.

Units	Counts
Participants	OG000

Secondary

Mean Maternal Body-mass Index at Delivery

Mean maternal body-mass index at the time of delivery

Data was missing for 9 women in the treatment group and 18 women in the control group.

Posted

Mean

Standard Deviation

kg/m^2

Delivery

ID	Title	Description
OG000	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. nutritional counseling self blood glucose monitoring
OG001	No Treatment	This group will not receive any specific dietary therapy except for written information concerning general nutritional recommendations for normal pregnancy.

Units	Counts
Participants	OG000

Secondary

Mean Maternal Weight Gain

Mean Maternal weight gain from enrollment in the trial until delivery

Data was missing for 9 women in the treatment group and 18 women in the control group.

Posted

Mean

Standard Deviation

kilograms

From time of randomization through delivery (up to 17 weeks)

ID	Title	Description
OG000	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. nutritional counseling self blood glucose monitoring
OG001	No Treatment	This group will not receive any specific dietary therapy except for written information concerning general nutritional recommendations for normal pregnancy.

Units	Counts
Participants	OG000

Secondary

Number of Children With BMI ≥ 85th Percentile for Age and Sex

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.

Posted

Count of Participants

Participants

Age 5-10 years

ID	Title	Description
OG000	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. nutritional counseling self blood glucose monitoring
OG001	No Treatment	This group will not receive any specific dietary therapy except for written information concerning general nutritional recommendations for normal pregnancy.

Units	Counts
Participants	OG000

Secondary

Number of Children at 5-10 Year Follow up With Waist Circumference >90th Percentile for Age, Sex and Race/Ethnicity

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)

Posted

Count of Participants

Participants

Age 5-10 years

ID	Title	Description
OG000	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. nutritional counseling self blood glucose monitoring
OG001	No Treatment	This group will not receive any specific dietary therapy except for written information concerning general nutritional recommendations for normal pregnancy.

Units	Counts
Participants	OG000

Secondary

Number of Children at 5-10 Year Follow up With Hypertension ≥ 95th Percentile for Age, Sex and Height

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.

Posted

Count of Participants

Participants

Age 5 - 10 years

ID	Title	Description
OG000	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. nutritional counseling self blood glucose monitoring
OG001	No Treatment	This group will not receive any specific dietary therapy except for written information concerning general nutritional recommendations for normal pregnancy.

Units	Counts
Participants	OG000

Secondary

Number of Children at 5-10 Year Follow-up With Impaired Fasting Glucose ≥100 mg/dL

Number of children at 5-10 year follow-up with impaired fasting glucose ≥100 mg/dL

The number of children for whom glucose data is available is 390, lower than the larger follow-up sample.

Posted

Count of Participants

Participants

Age 5-10 years

ID	Title	Description
OG000	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. nutritional counseling self blood glucose monitoring
OG001	No Treatment	This group will not receive any specific dietary therapy except for written information concerning general nutritional recommendations for normal pregnancy.

Units	Counts
Participants	OG000

Other Pre-specified

Mean Gestational Age at Birth

Mean Gestational age at the time of delivery

Posted

Mean

Standard Deviation

weeks

Delivery

ID	Title	Description
OG000	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. nutritional counseling self blood glucose monitoring
OG001	No Treatment	This group will not receive any specific dietary therapy except for written information concerning general nutritional recommendations for normal pregnancy.

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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. nutritional counseling self blood glucose monitoring			0	485	0	485
EG001	No Treatment	This group will not receive any specific dietary therapy except for written information concerning general nutritional recommendations for normal pregnancy.			0	473	0	473

ID	Term
D016640	Diabetes, Gestational

Ancestor Terms

ID	Term
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

ID	Term
D015596	Nutrition Assessment
D015190	Blood Glucose Self-Monitoring

Ancestor Terms

ID	Term
D003625	Data Collection
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D017531	Health Care Evaluation Mechanisms
D011787	Quality of Health Care
D017530	Health Care Quality, Access, and Evaluation
D015991	Epidemiologic Measurements
D011634	Public Health
D004778	Environment and Public Health
D001774	Blood Chemical Analysis
D019963	Clinical Chemistry Tests
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis
D003940	Diagnostic Techniques, Endocrine
D008991	Monitoring, Physiologic
D000085263	Self-Testing
D012648	Self Care
D013812	Therapeutics