Diabetes, Gestational
Conditions
Keywords
Mild gestational diabetes mellitus, Maternal Fetal Medicine Units Network
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.
Interventions
BEHAVIORALnutritional counseling
BEHAVIORALself blood glucose monitoring
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
The George Washington University Biostatistics Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* Pregnant * Gestational age at enrollment 24 - 31 weeks
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Number Participants Who Delivered Preterm | Delivery before 37 weeks gestation | Number of preterm deliveries before 37 weeks gestation |
| Mean Neonatal Fat Mass at Delivery | Assessed at delivery | — |
| 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 Infants Admitted to NICU | Delivery through hospital discharge up to 120 days | Admission to the Neonatal Intensive Care Unit |
| 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 Participants Who Underwent Labor Induction | From time of randomization through induction (up to 17 weeks) | Number of participants who underwent labor induction |
| 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 Experienced Preeclampsia | 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 | 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 |
| 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 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 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. |
| 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 |
| Number of Participants Who Underwent Cesarean Delivery | Delivery | Delivery by cesarean section |
| Mean Neonatal Birth Weight | Assessed at delivery | Birth weight in grams |
Other
| Measure | Time frame | Description |
|---|---|---|
| Mean Gestational Age at Birth | Delivery | Mean Gestational age at the time of delivery |
Countries
United States
Participant flow
Recruitment details
19,665 pregnant women between 24 weeks 0 days and 30 weeks 6 days gestation with glucose levels greater than or equal to 135mg/dl and less than 200 mg/dl after a 1-hour 50-g glucose loading test were assessed for eligibility in the trial. 500 of the eligible patients consented for teh follow-up study.
Pre-assignment details
Of the women screened, 7,381 consented to participate but 83 did not complete an oral glucose tolerance test. Of the 7,298 women who completed an oral glucose tolerance test, 54 were ineligible, 1,938 were referred for treatment and 4,348 had normal tolerance tests. Thus 958 with abnormal tolerance tests had mild GDM and were randomized.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 485 |
| No Treatment This group will not receive any specific dietary therapy except for written information concerning general nutritional recommendations for normal pregnancy. | 473 |
| Total | 958 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Follow-up Study at 5-10 Years | Not eligible or did not consent | 196 | 204 |
| Original Trial | Lost to Follow-up | 25 | 33 |
Baseline characteristics
| Characteristic | Nutritional Counseling & Self Blood Glucose Monitoring | Total | No Treatment |
|---|---|---|---|
| Age, Continuous | 29.2 years STANDARD_DEVIATION 5.7 | 29.1 years STANDARD_DEVIATION 5.7 | 28.9 years STANDARD_DEVIATION 5.6 |
| Alcohol Use | 23 Participants | 34 Participants | 11 Participants |
| Body-mass Index at Entry | 30.1 kg/m^2 STANDARD_DEVIATION 5 | 30.1 kg/m^2 STANDARD_DEVIATION 5 | 30.2 kg/m^2 STANDARD_DEVIATION 5.1 |
| Duration of gestation randomization | 28.8 weeks STANDARD_DEVIATION 1.6 | 28.8 weeks STANDARD_DEVIATION 1.6 | 28.9 weeks STANDARD_DEVIATION 1.5 |
| Glucose level after 50-g glucose-loading test - mg/dL | 159.0 mg/dL STANDARD_DEVIATION 15.3 | 159.3 mg/dL STANDARD_DEVIATION 15.4 | 159.7 mg/dL STANDARD_DEVIATION 15.5 |
| Glucose levels in 3-hr Oral Glucose Tolerance Test (OGTT) -mg/dL 1-hour | 191.8 mg/Dl STANDARD_DEVIATION 21.9 | 192.6 mg/Dl STANDARD_DEVIATION 20.6 | 193.4 mg/Dl STANDARD_DEVIATION 19.3 |
| Glucose levels in 3-hr Oral Glucose Tolerance Test (OGTT) -mg/dL 2-hour | 173.7 mg/Dl STANDARD_DEVIATION 21.8 | 173.5 mg/Dl STANDARD_DEVIATION 20.7 | 173.3 mg/Dl STANDARD_DEVIATION 19.6 |
| Glucose levels in 3-hr Oral Glucose Tolerance Test (OGTT) -mg/dL 3-hour | 137.3 mg/Dl STANDARD_DEVIATION 29 | 135.7 mg/Dl STANDARD_DEVIATION 30.2 | 134.1 mg/Dl STANDARD_DEVIATION 31.5 |
| Glucose levels in 3-hr Oral Glucose Tolerance Test (OGTT) -mg/dL Fasting | 86.6 mg/Dl STANDARD_DEVIATION 5.7 | 86.5 mg/Dl STANDARD_DEVIATION 5.7 | 86.3 mg/Dl STANDARD_DEVIATION 5.7 |
| Primigravida | 104 Participants | 227 Participants | 123 Participants |
| Race/Ethnicity, Customized Ethnic Groups Asian | 22 Participants | 50 Participants | 28 Participants |
| Race/Ethnicity, Customized Ethnic Groups Black | 56 Participants | 110 Participants | 54 Participants |
| Race/Ethnicity, Customized Ethnic Groups Hispanic | 281 Participants | 546 Participants | 265 Participants |
| Race/Ethnicity, Customized Ethnic Groups Other | 3 Participants | 10 Participants | 7 Participants |
| Race/Ethnicity, Customized Ethnic Groups White | 123 Participants | 242 Participants | 119 Participants |
| Sex: Female, Male Female | 485 Participants | 958 Participants | 473 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Smoking | 38 Participants | 69 Participants | 31 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 485 | 0 / 473 |
| serious Total, serious adverse events | 0 / 485 | 0 / 473 |
Outcome results
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.
Time frame: Age 5-10 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nutritional Counseling & Self Blood Glucose Monitoring | Number of Children at the 5-10 Year Followup With BMI ≥ 95th Percentile for Age and Sex | 55 Participants |
| No Treatment | Number of Children at the 5-10 Year Followup With BMI ≥ 95th Percentile for Age and Sex | 54 Participants |
95% CI: [0.68, 1.28]
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.
Time frame: Delivery through discharge of infant from hospital up to 120 days
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nutritional Counseling & Self Blood Glucose Monitoring | Number of Participants With Composite Neonatal Morbidity | Composite End Point Total | 149 Participants |
| Nutritional Counseling & Self Blood Glucose Monitoring | Number of Participants With Composite Neonatal Morbidity | Hypoglycemia | 62 Participants |
| Nutritional Counseling & Self Blood Glucose Monitoring | Number of Participants With Composite Neonatal Morbidity | Hyperbilirubinemia | 43 Participants |
| Nutritional Counseling & Self Blood Glucose Monitoring | Number of Participants With Composite Neonatal Morbidity | Elevated cord-blood C-peptide level | 75 Participants |
| Nutritional Counseling & Self Blood Glucose Monitoring | Number of Participants With Composite Neonatal Morbidity | Stillbirth or Neonatal Death | 0 Participants |
| Nutritional Counseling & Self Blood Glucose Monitoring | Number of Participants With Composite Neonatal Morbidity | Birth Trauma | 3 Participants |
| No Treatment | Number of Participants With Composite Neonatal Morbidity | Stillbirth or Neonatal Death | 0 Participants |
| No Treatment | Number of Participants With Composite Neonatal Morbidity | Composite End Point Total | 163 Participants |
| No Treatment | Number of Participants With Composite Neonatal Morbidity | Elevated cord-blood C-peptide level | 92 Participants |
| No Treatment | Number of Participants With Composite Neonatal Morbidity | Hypoglycemia | 55 Participants |
| No Treatment | Number of Participants With Composite Neonatal Morbidity | Birth Trauma | 6 Participants |
| No Treatment | Number of Participants With Composite Neonatal Morbidity | Hyperbilirubinemia | 54 Participants |
Comparison: For Total Composite End Pointp-value: 0.1497% CI: [0.72, 1.07]Chi-squared
Comparison: Analysis for Hypoglycemiap-value: 0.7597% CI: [0.73, 1.53]Chi-squared
Comparison: Analysis for hyperbilirubinemiap-value: 0.1297% CI: [0.49, 1.12]Chi-squared
Comparison: Analysis for elevated cord-blood C-peptide levelp-value: 0.0797% CI: [0.57, 1.05]Chi-squared
Comparison: Analysis for birth traumap-value: 0.3397% CI: [0.1, 2.2]Chi-squared
Secondary
Mean Maternal Body-mass Index at Delivery
Mean maternal body-mass index at the time of delivery
Time frame: Delivery
Population: Data was missing for 9 women in the treatment group and 18 women in the control group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nutritional Counseling & Self Blood Glucose Monitoring | Mean Maternal Body-mass Index at Delivery | 31.3 kg/m^2 | Standard Deviation 5.2 |
| No Treatment | Mean Maternal Body-mass Index at Delivery | 32.3 kg/m^2 | Standard Deviation 5.2 |
p-value: <0.001Wilcoxon (Mann-Whitney)
Secondary
Mean Maternal Weight Gain
Mean Maternal weight gain from enrollment in the trial until delivery
Time frame: From time of randomization through delivery (up to 17 weeks)
Population: Data was missing for 9 women in the treatment group and 18 women in the control group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nutritional Counseling & Self Blood Glucose Monitoring | Mean Maternal Weight Gain | 2.8 kilograms | Standard Deviation 4.5 |
| No Treatment | Mean Maternal Weight Gain | 5.0 kilograms | Standard Deviation 3.3 |
p-value: <0.001Wilcoxon (Mann-Whitney)
Secondary
Mean Neonatal Birth Weight
Birth weight in grams
Time frame: Assessed at delivery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nutritional Counseling & Self Blood Glucose Monitoring | Mean Neonatal Birth Weight | 3302 grams | Standard Deviation 502.4 |
| No Treatment | Mean Neonatal Birth Weight | 3408 grams | Standard Deviation 589.4 |
p-value: <0.001Wilcoxon (Mann-Whitney)
Secondary
Mean Neonatal Fat Mass at Delivery
Time frame: Assessed at delivery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nutritional Counseling & Self Blood Glucose Monitoring | Mean Neonatal Fat Mass at Delivery | 427.0 grams | Standard Deviation 197.9 |
| No Treatment | Mean Neonatal Fat Mass at Delivery | 464.3 grams | Standard Deviation 222.3 |
p-value: 0.003Wilcoxon (Mann-Whitney)
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.
Time frame: Age 5 - 10 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nutritional Counseling & Self Blood Glucose Monitoring | Number of Children at 5-10 Year Follow up With Hypertension ≥ 95th Percentile for Age, Sex and Height | 30 Participants |
| No Treatment | Number of Children at 5-10 Year Follow up With Hypertension ≥ 95th Percentile for Age, Sex and Height | 23 Participants |
95% CI: [0.74, 2.05]
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
Time frame: Age 5-10 years
Population: The number of children for whom glucose data is available is 390, lower than the larger follow-up sample.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nutritional Counseling & Self Blood Glucose Monitoring | Number of Children at 5-10 Year Follow-up With Impaired Fasting Glucose ≥100 mg/dL | 12 Participants |
| No Treatment | Number of Children at 5-10 Year Follow-up With Impaired Fasting Glucose ≥100 mg/dL | 13 Participants |
95% CI: [0.36, 1.62]
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)
Time frame: Age 5-10 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nutritional Counseling & Self Blood Glucose Monitoring | Number of Children at 5-10 Year Follow up With Waist Circumference >90th Percentile for Age, Sex and Race/Ethnicity | 31 Participants |
| No Treatment | Number of Children at 5-10 Year Follow up With Waist Circumference >90th Percentile for Age, Sex and Race/Ethnicity | 27 Participants |
95% CI: [0.65, 1.69]
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.
Time frame: Age 5-10 years
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nutritional Counseling & Self Blood Glucose Monitoring | Number of Children With BMI ≥ 85th Percentile for Age and Sex | 86 Participants |
| No Treatment | Number of Children With BMI ≥ 85th Percentile for Age and Sex | 91 Participants |
95% CI: [0.71, 1.1]
Secondary
Number of Infants Admitted to NICU
Admission to the Neonatal Intensive Care Unit
Time frame: Delivery through hospital discharge up to 120 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nutritional Counseling & Self Blood Glucose Monitoring | Number of Infants Admitted to NICU | 43 Participants |
| No Treatment | Number of Infants Admitted to NICU | 53 Participants |
p-value: 0.1997% CI: [0.51, 1.18]Chi-squared
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
Time frame: Delivery through hospital discharge up to 120 days
Population: Data was missing for 8 infants in the treatment group and 18 infants in the control group.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nutritional Counseling & Self Blood Glucose Monitoring | Number of Neonates Who Experienced Respiratory Distress Syndrome | 9 Participants |
| No Treatment | Number of Neonates Who Experienced Respiratory Distress Syndrome | 13 Participants |
p-value: 0.3397% CI: [0.26, 1.67]Chi-squared
Secondary
Number of Neonates Who Experienced Shoulder Dystocia
Number of neonates who experienced shoulder dystocia during labor and delivery
Time frame: During the process of labor through delivery
Population: Data was missing for 9 women in the treatment group and 18 women in the control group.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nutritional Counseling & Self Blood Glucose Monitoring | Number of Neonates Who Experienced Shoulder Dystocia | 7 Participants |
| No Treatment | Number of Neonates Who Experienced Shoulder Dystocia | 18 Participants |
p-value: 0.0297% CI: [0.14, 0.97]Chi-squared
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.
Time frame: Delivery through hospital discharge up to 120 days
Population: Data was missing for 10 infants in the treatment group and 18 infants in the control group.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nutritional Counseling & Self Blood Glucose Monitoring | Number of Neonates Who Received Intravenous Glucose Treatment | 25 Participants |
| No Treatment | Number of Neonates Who Received Intravenous Glucose Treatment | 31 Participants |
p-value: 0.3297% CI: [0.44, 1.36]Chi-squared
Secondary
Number of Neonates Who Were Large for Gestational Age at Delivery
Time frame: From time of randomization through delivery (up to 17 weeks)
Population: There were 8 women in the treatment group and 19 women in the control group for whom at least some delivery data were missing
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nutritional Counseling & Self Blood Glucose Monitoring | Number of Neonates Who Were Large for Gestational Age at Delivery | 34 Participants |
| No Treatment | Number of Neonates Who Were Large for Gestational Age at Delivery | 66 Participants |
p-value: <0.00197% CI: [0.32, 0.76]Chi-squared
Secondary
Number of Neonates Who Were Small for Gestational Age
Birth weight below the 10th percentile
Time frame: From time of randomization through delivery (up to 17 weeks)
Population: There were 8 women in the treatment group and 19 women in the control group for whom at least some delivery data were missing
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nutritional Counseling & Self Blood Glucose Monitoring | Number of Neonates Who Were Small for Gestational Age | 36 Participants |
| No Treatment | Number of Neonates Who Were Small for Gestational Age | 29 Participants |
p-value: 0.4997% CI: [0.7, 1.99]Chi-squared
Secondary
Number of Neonates With Macrosomia (Birth Weight > 4000 gm)
Time frame: Assessed at Delivery
Population: There were 8 women in the treatment group and 19 women in the control group for whom at least some delivery data were missing
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nutritional Counseling & Self Blood Glucose Monitoring | Number of Neonates With Macrosomia (Birth Weight > 4000 gm) | 28 Participants |
| No Treatment | Number of Neonates With Macrosomia (Birth Weight > 4000 gm) | 65 Participants |
p-value: <0.00197% CI: [0.26, 0.66]Chi-squared
Secondary
Number of Participants Who Experienced Preeclampsia
Number of participants who experienced preeclampsia
Time frame: From time of randomization through delivery (up to 17 weeks)
Population: Data was missing for 9 women in the treatment group and 18 women in the control group.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nutritional Counseling & Self Blood Glucose Monitoring | Number of Participants Who Experienced Preeclampsia | 12 Participants |
| No Treatment | Number of Participants Who Experienced Preeclampsia | 25 Participants |
p-value: 0.0297% CI: [0.22, 0.97]Chi-squared
Secondary
Number of Participants Who Had Preeclampsia or Gestational Hypertension
Number of participants who had Preeclampsia or gestational hypertension
Time frame: From time of randomization through delivery (up to 17 weeks)
Population: Data was missing for 9 women in the treatment group and 18 women in the control group.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nutritional Counseling & Self Blood Glucose Monitoring | Number of Participants Who Had Preeclampsia or Gestational Hypertension | 41 Participants |
| No Treatment | Number of Participants Who Had Preeclampsia or Gestational Hypertension | 62 Participants |
p-value: 0.0197% CI: [0.42, 0.96]Chi-squared
Secondary
Number of Participants Who Underwent Cesarean Delivery
Delivery by cesarean section
Time frame: Delivery
Population: Data was missing for 9 women in the treatment group and 18 women in the control group.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nutritional Counseling & Self Blood Glucose Monitoring | Number of Participants Who Underwent Cesarean Delivery | 128 Participants |
| No Treatment | Number of Participants Who Underwent Cesarean Delivery | 154 Participants |
p-value: 0.0297% CI: [0.64, 0.99]Chi-squared
Secondary
Number of Participants Who Underwent Labor Induction
Number of participants who underwent labor induction
Time frame: From time of randomization through induction (up to 17 weeks)
Population: Data was missing for 9 women in the treatment group and 18 women in the control group.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nutritional Counseling & Self Blood Glucose Monitoring | Number of Participants Who Underwent Labor Induction | 130 Participants |
| No Treatment | Number of Participants Who Underwent Labor Induction | 122 Participants |
p-value: 0.8697% CI: [0.81, 1.29]Chi-squared
Secondary
Number Participants Who Delivered Preterm
Number of preterm deliveries before 37 weeks gestation
Time frame: Delivery before 37 weeks gestation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Nutritional Counseling & Self Blood Glucose Monitoring | Number Participants Who Delivered Preterm | 45 Participants |
| No Treatment | Number Participants Who Delivered Preterm | 53 Participants |
p-value: 0.2797% CI: [0.53, 1.23]Chi-squared
Other Pre-specified
Mean Gestational Age at Birth
Mean Gestational age at the time of delivery
Time frame: Delivery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nutritional Counseling & Self Blood Glucose Monitoring | Mean Gestational Age at Birth | 39.0 weeks | Standard Deviation 1.8 |
| No Treatment | Mean Gestational Age at Birth | 38.9 weeks | Standard Deviation 1.8 |
p-value: 0.87Wilcoxon (Mann-Whitney)