Trial Outcomes & Findings for Early Screening and Treatment of Women With Prediabetes in Pregnancy (NCT NCT01552213)
NCT ID: NCT01552213
Last Updated: 2019-01-16
Results Overview
Diagnosis based on criteria recommended by the ADA (Oral GTT with one abnormal value, fasting greater than or equal to 92, on hour greater than or equal to 180, two hour greater than or equal to 153)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
95 participants
Primary outcome timeframe
26 weeks of gestation
Results posted on
2019-01-16
Participant Flow
Participant milestones
| Measure |
Treatment for Glucose Intolerance
Regular visit with dietician, exercise, self blood glucose monitoring, Insulin therapy if determined necessary.
Treatment for glucose intolerance: Diet, exercise glucose monitoring, insulin if necessary
|
Minimum Intervention Control Group
Single visit with dietician or health educator followed by routine care per provider.
Minimum intervention control group: A single visit with a dietician or health educator to discuss general health risks, good eating habits, and appropriate weight gain. This will be followed by routine prenatal care per provider.
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
45
|
|
Overall Study
Analyzed
|
42
|
41
|
|
Overall Study
COMPLETED
|
37
|
37
|
|
Overall Study
NOT COMPLETED
|
13
|
8
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Early Screening and Treatment of Women With Prediabetes in Pregnancy
Baseline characteristics by cohort
| Measure |
Treatment for Glucose Intolerance
n=42 Participants
Regular visit with dietician, exercise, self blood glucose monitoring, Insulin therapy if determined necessary.
Treatment for glucose intolerance: Diet, exercise glucose monitoring, insulin if necessary
|
Minimum Intervention Control Group
n=41 Participants
Single visit with dietician or health educator followed by routine care per provider.
Minimum intervention control group: A single visit with a dietician or health educator to discuss general health risks, good eating habits, and appropriate weight gain. This will be followed by routine prenatal care per provider.
|
Total
n=83 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
32.4 years
STANDARD_DEVIATION 5.1 • n=99 Participants
|
34.3 years
STANDARD_DEVIATION 5.2 • n=107 Participants
|
33.4 years
STANDARD_DEVIATION 5.3 • n=206 Participants
|
|
Sex: Female, Male
Female
|
42 Participants
n=99 Participants
|
41 Participants
n=107 Participants
|
83 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 26 weeks of gestationDiagnosis based on criteria recommended by the ADA (Oral GTT with one abnormal value, fasting greater than or equal to 92, on hour greater than or equal to 180, two hour greater than or equal to 153)
Outcome measures
| Measure |
Treatment for Glucose Intolerance
n=42 Participants
Regular visit with dietician, exercise, self blood glucose monitoring, Insulin therapy if determined necessary.
Treatment for glucose intolerance: Diet, exercise glucose monitoring, insulin if necessary
|
Minimum Intervention Control Group
n=41 Participants
Single visit with dietician or health educator followed by routine care per provider.
Minimum intervention control group: A single visit with a dietician or health educator to discuss general health risks, good eating habits, and appropriate weight gain. This will be followed by routine prenatal care per provider.
|
|---|---|---|
|
Number of Patients With a Diagnosis of Gestational Diabetes at 26 Weeks Gestation.
|
19 Participants
|
23 Participants
|
SECONDARY outcome
Timeframe: Duration of pregnancy. Pregnancy expected to last up to 40 weeks gestationPopulation: Participants with available data included in the analysis.
Modes of delivery investigated were: cesarean delivery, vaginal delivery, assisted vaginal delivery, spontaneous delivery and termination of pregnancy.
Outcome measures
| Measure |
Treatment for Glucose Intolerance
n=40 Participants
Regular visit with dietician, exercise, self blood glucose monitoring, Insulin therapy if determined necessary.
Treatment for glucose intolerance: Diet, exercise glucose monitoring, insulin if necessary
|
Minimum Intervention Control Group
n=38 Participants
Single visit with dietician or health educator followed by routine care per provider.
Minimum intervention control group: A single visit with a dietician or health educator to discuss general health risks, good eating habits, and appropriate weight gain. This will be followed by routine prenatal care per provider.
|
|---|---|---|
|
Number of Participants With Different Modes of Delivery
Cesarian delivery
|
11 Participants
|
17 Participants
|
|
Number of Participants With Different Modes of Delivery
Vaginal delivery
|
26 Participants
|
19 Participants
|
|
Number of Participants With Different Modes of Delivery
Assisted vaginal
|
0 Participants
|
1 Participants
|
|
Number of Participants With Different Modes of Delivery
Spontaneous abortion
|
2 Participants
|
1 Participants
|
|
Number of Participants With Different Modes of Delivery
Termination
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Duration of pregnancy. Pregnancy expected to last up to 40 weeks gestationPopulation: Participants with available data included in the analysis.
Excessive weight gain greater than the Institute of Medicine guidelines
Outcome measures
| Measure |
Treatment for Glucose Intolerance
n=35 Participants
Regular visit with dietician, exercise, self blood glucose monitoring, Insulin therapy if determined necessary.
Treatment for glucose intolerance: Diet, exercise glucose monitoring, insulin if necessary
|
Minimum Intervention Control Group
n=36 Participants
Single visit with dietician or health educator followed by routine care per provider.
Minimum intervention control group: A single visit with a dietician or health educator to discuss general health risks, good eating habits, and appropriate weight gain. This will be followed by routine prenatal care per provider.
|
|---|---|---|
|
Number of Participants With Excessive Gestational Weight Gain
|
6 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Duration of pregnancy. Pregnancy expected to last up to 40 weeks gestationPopulation: Participants with available data included in the analysis.
Outcome measures
| Measure |
Treatment for Glucose Intolerance
n=28 Participants
Regular visit with dietician, exercise, self blood glucose monitoring, Insulin therapy if determined necessary.
Treatment for glucose intolerance: Diet, exercise glucose monitoring, insulin if necessary
|
Minimum Intervention Control Group
n=28 Participants
Single visit with dietician or health educator followed by routine care per provider.
Minimum intervention control group: A single visit with a dietician or health educator to discuss general health risks, good eating habits, and appropriate weight gain. This will be followed by routine prenatal care per provider.
|
|---|---|---|
|
Mean Hemoglobin A1C Value at Delivery
|
5.5 percent
Standard Deviation 0.3
|
5.8 percent
Standard Deviation 0.4
|
SECONDARY outcome
Timeframe: Duration of pregnancy. Pregnancy expected to last up to 40 weeks gestationPopulation: Participants with available data included in the analysis.
Outcome measures
| Measure |
Treatment for Glucose Intolerance
n=40 Participants
Regular visit with dietician, exercise, self blood glucose monitoring, Insulin therapy if determined necessary.
Treatment for glucose intolerance: Diet, exercise glucose monitoring, insulin if necessary
|
Minimum Intervention Control Group
n=38 Participants
Single visit with dietician or health educator followed by routine care per provider.
Minimum intervention control group: A single visit with a dietician or health educator to discuss general health risks, good eating habits, and appropriate weight gain. This will be followed by routine prenatal care per provider.
|
|---|---|---|
|
Mean Fasting Triglyceride Level
|
181 mg/dL
Standard Deviation 66.0
|
177.5 mg/dL
Standard Deviation 51.5
|
SECONDARY outcome
Timeframe: Duration of pregnancy. Pregnancy expected to last up to 40 weeks gestationPopulation: Participants with available data included in the analysis.
Hypertensive disorder in pregnancy with blood pressure greater than or equal to 140/90 after 20 weeks gestation
Outcome measures
| Measure |
Treatment for Glucose Intolerance
n=38 Participants
Regular visit with dietician, exercise, self blood glucose monitoring, Insulin therapy if determined necessary.
Treatment for glucose intolerance: Diet, exercise glucose monitoring, insulin if necessary
|
Minimum Intervention Control Group
n=36 Participants
Single visit with dietician or health educator followed by routine care per provider.
Minimum intervention control group: A single visit with a dietician or health educator to discuss general health risks, good eating habits, and appropriate weight gain. This will be followed by routine prenatal care per provider.
|
|---|---|---|
|
Number of Patients With Gestational Hypertension
|
3 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Up to 6 weeks after deliveryPopulation: Participants with available data included in the analysis.
Blood pressure greater than or equal to 140/90 with 300 mg of protein on a 24-hour urine collection.
Outcome measures
| Measure |
Treatment for Glucose Intolerance
n=50 Participants
Regular visit with dietician, exercise, self blood glucose monitoring, Insulin therapy if determined necessary.
Treatment for glucose intolerance: Diet, exercise glucose monitoring, insulin if necessary
|
Minimum Intervention Control Group
n=45 Participants
Single visit with dietician or health educator followed by routine care per provider.
Minimum intervention control group: A single visit with a dietician or health educator to discuss general health risks, good eating habits, and appropriate weight gain. This will be followed by routine prenatal care per provider.
|
|---|---|---|
|
Number of Patients With Pre-eclampsia
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 6 weeks after deliveryPopulation: Participants with available data included in the analysis.
Outcome measures
| Measure |
Treatment for Glucose Intolerance
n=23 Participants
Regular visit with dietician, exercise, self blood glucose monitoring, Insulin therapy if determined necessary.
Treatment for glucose intolerance: Diet, exercise glucose monitoring, insulin if necessary
|
Minimum Intervention Control Group
n=28 Participants
Single visit with dietician or health educator followed by routine care per provider.
Minimum intervention control group: A single visit with a dietician or health educator to discuss general health risks, good eating habits, and appropriate weight gain. This will be followed by routine prenatal care per provider.
|
|---|---|---|
|
Mean Level of Postpartum Oral Glucose-tolerance-test at 6 Weeks Postpartum
|
115.8 mg/dL
Standard Deviation 46.5
|
108.9 mg/dL
Standard Deviation 41.1
|
SECONDARY outcome
Timeframe: Duration of pregnancy. Pregnancy expected to last up to 40 weeks gestationPopulation: Participants with available data included in the analysis.
Insulin required during pregnancy
Outcome measures
| Measure |
Treatment for Glucose Intolerance
n=39 Participants
Regular visit with dietician, exercise, self blood glucose monitoring, Insulin therapy if determined necessary.
Treatment for glucose intolerance: Diet, exercise glucose monitoring, insulin if necessary
|
Minimum Intervention Control Group
n=38 Participants
Single visit with dietician or health educator followed by routine care per provider.
Minimum intervention control group: A single visit with a dietician or health educator to discuss general health risks, good eating habits, and appropriate weight gain. This will be followed by routine prenatal care per provider.
|
|---|---|---|
|
Number of Participants With Need for Insulin Therapy
|
14 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: Duration of pregnancy. Pregnancy expected to last up to 40 weeks gestationPopulation: Participants with available data included in the analysis.
Outcome measures
| Measure |
Treatment for Glucose Intolerance
n=42 Participants
Regular visit with dietician, exercise, self blood glucose monitoring, Insulin therapy if determined necessary.
Treatment for glucose intolerance: Diet, exercise glucose monitoring, insulin if necessary
|
Minimum Intervention Control Group
n=41 Participants
Single visit with dietician or health educator followed by routine care per provider.
Minimum intervention control group: A single visit with a dietician or health educator to discuss general health risks, good eating habits, and appropriate weight gain. This will be followed by routine prenatal care per provider.
|
|---|---|---|
|
Mean Neonatal Birth Weight
|
3218 grams
Standard Deviation 611
|
3322 grams
Standard Deviation 473
|
SECONDARY outcome
Timeframe: Duration of pregnancy. Pregnancy expected to last up to 40 weeks gestationPopulation: Participants with available data included in the analysis.
The Corpulence Index (CI) or Ponderal Index (PI) is a measure of leanness (corpulence) of a person calculated as a relationship between mass and height.
Outcome measures
| Measure |
Treatment for Glucose Intolerance
n=36 Participants
Regular visit with dietician, exercise, self blood glucose monitoring, Insulin therapy if determined necessary.
Treatment for glucose intolerance: Diet, exercise glucose monitoring, insulin if necessary
|
Minimum Intervention Control Group
n=36 Participants
Single visit with dietician or health educator followed by routine care per provider.
Minimum intervention control group: A single visit with a dietician or health educator to discuss general health risks, good eating habits, and appropriate weight gain. This will be followed by routine prenatal care per provider.
|
|---|---|---|
|
Mean Ponderal Index
|
2.5 kg/m3
Standard Deviation 0.3
|
2.5 kg/m3
Standard Deviation 0.3
|
SECONDARY outcome
Timeframe: Duration of pregnancy. Pregnancy expected to last up to 40 weeks gestationPopulation: Participants with available data included in the analysis.
C-peptide test is a tool for monitoring and treating diabetes.
Outcome measures
| Measure |
Treatment for Glucose Intolerance
n=23 Participants
Regular visit with dietician, exercise, self blood glucose monitoring, Insulin therapy if determined necessary.
Treatment for glucose intolerance: Diet, exercise glucose monitoring, insulin if necessary
|
Minimum Intervention Control Group
n=17 Participants
Single visit with dietician or health educator followed by routine care per provider.
Minimum intervention control group: A single visit with a dietician or health educator to discuss general health risks, good eating habits, and appropriate weight gain. This will be followed by routine prenatal care per provider.
|
|---|---|---|
|
Mean Level of Umbilical Cord C-peptide >=90th Percentile in the Whole Cohort
|
3 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 1 week after deliveryPopulation: Participants with available data included in the analysis.
Infants treated for neonatal hypoglycemia-- Glucose of \<36 mg/dl; \<2 millimoles (mM)
Outcome measures
| Measure |
Treatment for Glucose Intolerance
n=35 Participants
Regular visit with dietician, exercise, self blood glucose monitoring, Insulin therapy if determined necessary.
Treatment for glucose intolerance: Diet, exercise glucose monitoring, insulin if necessary
|
Minimum Intervention Control Group
n=36 Participants
Single visit with dietician or health educator followed by routine care per provider.
Minimum intervention control group: A single visit with a dietician or health educator to discuss general health risks, good eating habits, and appropriate weight gain. This will be followed by routine prenatal care per provider.
|
|---|---|---|
|
Number of Participants With Neonatal Hypoglycemia
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 1 week after deliveryPopulation: Participants with available data included in the analysis.
Neonates treated for hyperbilirubinemia
Outcome measures
| Measure |
Treatment for Glucose Intolerance
n=36 Participants
Regular visit with dietician, exercise, self blood glucose monitoring, Insulin therapy if determined necessary.
Treatment for glucose intolerance: Diet, exercise glucose monitoring, insulin if necessary
|
Minimum Intervention Control Group
n=36 Participants
Single visit with dietician or health educator followed by routine care per provider.
Minimum intervention control group: A single visit with a dietician or health educator to discuss general health risks, good eating habits, and appropriate weight gain. This will be followed by routine prenatal care per provider.
|
|---|---|---|
|
Number of Participants With Neonatal Hyperbilirubinemia
|
9 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Duration of pregnancy and up to 28 days after deliveryOutcome measures
| Measure |
Treatment for Glucose Intolerance
n=37 Participants
Regular visit with dietician, exercise, self blood glucose monitoring, Insulin therapy if determined necessary.
Treatment for glucose intolerance: Diet, exercise glucose monitoring, insulin if necessary
|
Minimum Intervention Control Group
n=37 Participants
Single visit with dietician or health educator followed by routine care per provider.
Minimum intervention control group: A single visit with a dietician or health educator to discuss general health risks, good eating habits, and appropriate weight gain. This will be followed by routine prenatal care per provider.
|
|---|---|---|
|
Number of Participants With Intrauterine Fetal Demise
|
0 Participants
|
1 Participants
|
Adverse Events
Treatment for Glucose Intolerance
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Minimum Intervention Control Group
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment for Glucose Intolerance
n=50 participants at risk
Regular visit with dietician, exercise, self blood glucose monitoring, Insulin therapy if determined necessary.
Treatment for glucose intolerance: Diet, exercise glucose monitoring, insulin if necessary
|
Minimum Intervention Control Group
n=45 participants at risk
Single visit with dietician or health educator followed by routine care per provider.
Minimum intervention control group: A single visit with a dietician or health educator to discuss general health risks, good eating habits, and appropriate weight gain. This will be followed by routine prenatal care per provider.
|
|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Intrauterine Fetal Demise
|
0.00%
0/50
|
2.2%
1/45
|
Other adverse events
Adverse event data not reported
Additional Information
Anna Girsen, Research Operations Manager
Stanford University, School of Medicine
Phone: (650) 725-5720
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place