GDM: Monitoring (2008)
The purpose of this study was to determine if the neurological and psychological status of children born to women with diabetes differs from children of non-diabetic mothers.
- Pregnancies resulting in single, live-born babies who had been given the Bayley mental and motor examination at 8 months or the Stanford-Binet IQ test at 4 years of age.
- Diagnosis of diabetes (Somogyi-Nelson) or known diabetic on >20 units insulin/d
- Diabetes classified as A (gestational), B, C, D, E, or F
- Babies of both diabetic and nondiabetic mothers weighing less than 2.0 kg were excluded from the data analysis.
Recruitment
Cases were drawn from the Perinatal Study of the National Institute of Neurological Diseases and Blindness.
Design
Case-Control Study.
Blinding used (if applicable): none
Intervention (if applicable):
Diabetic cases were matched to non-diabetic, acetonuria-negative "control " cases. Each diabetic case was matched for hospital of birth, race, and sex with a single nondiabetic case.
Statistical Analysis: Means of dependent variables was compared by use of paired sample t tests.
Timing of Meaurements:
Measurements were evaluated at 8 months, 12 months, and 4 years of age
Dependent Variables:
- duration of pregnancy (wks)
- birth weight
- Bayley mental scores
- Bayley motor scores
- Binet IQ score
- Rating scale for postural control observed at 1 yr of age
Independent Variables
- Mother with diabetes
Control Variables
Initial N: 241 diabetic cases
Attrition (Final N): 237 cases. 5 excluded: 1 Oriental that could not be matched, 3 babies weighing less than 2.0 kg, 1 child with Down's syndrome.
Age: Not mentioned
Ethnicity: Not mentioned
Other Relevant Demographics: None described
Anthropometrics: Cases matched with nondiabetic controls for hospital of birth, race, sex, socioecomic index, birth order and maternal age.
Location: Several locations nationwide participated.
Other Findings:
Diabetic mothers with acetonuria (n=62) had offspring with lower IQ (mean score of 93) than controls (mean score of 102), p < 0.001.
However, the offspring of diabetic patients without acetonuria (n=44) had IQ equal to controls (mean score of 101).
The association between maternal diabetes complicated by acetonuria and IQ of the children was present in mild (including gestational) as well as in severe diabetes.
No significant effect of insulin reactions in the mother on IQ of the offspring was demonstrated.
All diabetic patients had infants with a shorter duration of pregnancy, lower mental and motor scales, higher posturing rating scales, and lower IQ scores than controls.
Women with acetonuria had infants with lower mental and motor scales, higher posturing rating scales and lower IQ scores than controls.
Infants of women with diabetes without acteonuria had mental, motor, posturing and IQ scores equal to controls.
The association of diabetes with acetonuria in respect to IQ of offspring was independent of duration of pregnancy.
Maternal diabetes mellitus when accompanied by acetonuria during gestation was found to have an adverse effect on the neuropsychological attributes of children.
In clinical practice, closer attention should be paid to ketonuria as an indicator of a suboptimum fetal environment in pregnant women with diabetes.
Although this study was done ~30 years ago, the data is convincing regarding the negative effect of ketones on IQ. Characteristics of cases not well described.
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Quality Criteria Checklist: Primary Research
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| Relevance Questions | |||
| 1. | Would implementing the studied intervention or procedure (if found successful) result in improved outcomes for the patients/clients/population group? (Not Applicable for some epidemiological studies) | Yes | |
| 2. | Did the authors study an outcome (dependent variable) or topic that the patients/clients/population group would care about? | Yes | |
| 3. | Is the focus of the intervention or procedure (independent variable) or topic of study a common issue of concern to dieteticspractice? | Yes | |
| 4. | Is the intervention or procedure feasible? (NA for some epidemiological studies) | Yes | |
| Validity Questions | |||
| 1. | Was the research question clearly stated? | Yes | |
| 1.1. | Was (were) the specific intervention(s) or procedure(s) [independent variable(s)] identified? | Yes | |
| 1.2. | Was (were) the outcome(s) [dependent variable(s)] clearly indicated? | Yes | |
| 1.3. | Were the target population and setting specified? | No | |
| 2. | Was the selection of study subjects/patients free from bias? | No | |
| 2.1. | Were inclusion/exclusion criteria specified (e.g., risk, point in disease progression, diagnostic or prognosis criteria), and with sufficient detail and without omitting criteria critical to the study? | Yes | |
| 2.2. | Were criteria applied equally to all study groups? | Yes | |
| 2.3. | Were health, demographics, and other characteristics of subjects described? | No | |
| 2.4. | Were the subjects/patients a representative sample of the relevant population? | No | |
| 3. | Were study groups comparable? | ??? | |
| 3.1. | Was the method of assigning subjects/patients to groups described and unbiased? (Method of randomization identified if RCT) | Yes | |
| 3.2. | Were distribution of disease status, prognostic factors, and other factors (e.g., demographics) similar across study groups at baseline? | No | |
| 3.3. | Were concurrent controls or comparisons used? (Concurrent preferred over historical control or comparison groups.) | N/A | |
| 3.4. | If cohort study or cross-sectional study, were groups comparable on important confounding factors and/or were preexisting differences accounted for by using appropriate adjustments in statistical analysis? | N/A | |
| 3.5. | If case control study, were potential confounding factors comparable for cases and controls? (If case series or trial with subjects serving as own control, this criterion is not applicable.) | No | |
| 3.6. | If diagnostic test, was there an independent blind comparison with an appropriate reference standard (e.g., "gold standard")? | N/A | |
| 4. | Was method of handling withdrawals described? | Yes | |
| 4.1. | Were follow-up methods described and the same for all groups? | Yes | |
| 4.2. | Was the number, characteristics of withdrawals (i.e., dropouts, lost to follow up, attrition rate) and/or response rate (cross-sectional studies) described for each group? (Follow up goal for a strong study is 80%.) | Yes | |
| 4.3. | Were all enrolled subjects/patients (in the original sample) accounted for? | Yes | |
| 4.4. | Were reasons for withdrawals similar across groups? | Yes | |
| 4.5. | If diagnostic test, was decision to perform reference test not dependent on results of test under study? | N/A | |
| 5. | Was blinding used to prevent introduction of bias? | No | |
| 5.1. | In intervention study, were subjects, clinicians/practitioners, and investigators blinded to treatment group, as appropriate? | N/A | |
| 5.2. | Were data collectors blinded for outcomes assessment? (If outcome is measured using an objective test, such as a lab value, this criterion is assumed to be met.) | N/A | |
| 5.3. | In cohort study or cross-sectional study, were measurements of outcomes and risk factors blinded? | N/A | |
| 5.4. | In case control study, was case definition explicit and case ascertainment not influenced by exposure status? | ??? | |
| 5.5. | In diagnostic study, were test results blinded to patient history and other test results? | N/A | |
| 6. | Were intervention/therapeutic regimens/exposure factor or procedure and any comparison(s) described in detail? Were interveningfactors described? | No | |
| 6.1. | In RCT or other intervention trial, were protocols described for all regimens studied? | N/A | |
| 6.2. | In observational study, were interventions, study settings, and clinicians/provider described? | No | |
| 6.3. | Was the intensity and duration of the intervention or exposure factor sufficient to produce a meaningful effect? | Yes | |
| 6.4. | Was the amount of exposure and, if relevant, subject/patient compliance measured? | Yes | |
| 6.5. | Were co-interventions (e.g., ancillary treatments, other therapies) described? | No | |
| 6.6. | Were extra or unplanned treatments described? | No | |
| 6.7. | Was the information for 6.4, 6.5, and 6.6 assessed the same way for all groups? | ??? | |
| 6.8. | In diagnostic study, were details of test administration and replication sufficient? | N/A | |
| 7. | Were outcomes clearly defined and the measurements valid and reliable? | Yes | |
| 7.1. | Were primary and secondary endpoints described and relevant to the question? | Yes | |
| 7.2. | Were nutrition measures appropriate to question and outcomes of concern? | Yes | |
| 7.3. | Was the period of follow-up long enough for important outcome(s) to occur? | Yes | |
| 7.4. | Were the observations and measurements based on standard, valid, and reliable data collection instruments/tests/procedures? | Yes | |
| 7.5. | Was the measurement of effect at an appropriate level of precision? | Yes | |
| 7.6. | Were other factors accounted for (measured) that could affect outcomes? | Yes | |
| 7.7. | Were the measurements conducted consistently across groups? | Yes | |
| 8. | Was the statistical analysis appropriate for the study design and type of outcome indicators? | Yes | |
| 8.1. | Were statistical analyses adequately described and the results reported appropriately? | Yes | |
| 8.2. | Were correct statistical tests used and assumptions of test not violated? | Yes | |
| 8.3. | Were statistics reported with levels of significance and/or confidence intervals? | Yes | |
| 8.4. | Was "intent to treat" analysis of outcomes done (and as appropriate, was there an analysis of outcomes for those maximally exposed or a dose-response analysis)? | ??? | |
| 8.5. | Were adequate adjustments made for effects of confounding factors that might have affected the outcomes (e.g., multivariate analyses)? | ??? | |
| 8.6. | Was clinical significance as well as statistical significance reported? | Yes | |
| 8.7. | If negative findings, was a power calculation reported to address type 2 error? | N/A | |
| 9. | Are conclusions supported by results with biases and limitations taken into consideration? | Yes | |
| 9.1. | Is there a discussion of findings? | Yes | |
| 9.2. | Are biases and study limitations identified and discussed? | ??? | |
| 10. | Is bias due to study's funding or sponsorship unlikely? | Yes | |
| 10.1. | Were sources of funding and investigators' affiliations described? | No | |
| 10.2. | Was the study free from apparent conflict of interest? | Yes | |