GDM: Postpartum Care (2008)
- To determine the rate of GDM recurrence in a Japanese population
- Report risk factors associated with GDM recurrence
- Pregnant women diagnosed with GDM or one abnormal value (OAV) on the 75 g OGTT
- At least one subsequent pregnancy
- Women with pregestational diabetes
Recruitment
Women delivering at term from January 1, 1993 - December 21, 2003 at two health clinics in Japan.
Design
Maternal outcome after delivery of index pregnancy (6 months - 7 years) was followed carefully regarding the recurrence of GDM or the development of DM. Study included 69 women having diagnosis of GDM (n=32) or OAV (n=37) during their index pregnancy and then had a subsequent pregnancy.
Blinding used (if applicable): Not applicable
Intervention (if applicable): Not applicable
Statistical Analysis
T-test and logistic regression. p-value <0.05 indicated statistical significance
Timing of Measurements
- Women diagnosed with GDM or OAV seen in Japanese clinics over 10 year period were followed through next pregnancy. Postpartum 75g OGTT performed 1-3 months after delivery and Japan Diabetes Society criteria were used
Dependent Variables
- Screening for GDM/OAV : Blood glucose measured at random at 7-10 weeks and 24-30 weeks and if glucose >100mg/dL, 75 g OGTT was performed. GDM and OAV made according to Japanese criteria
Independent Variables
- maternal age, family history of DM, BMI before pregnancy and at delivery, gestational weight gain, and interval between pregnancies
- sum of blood glucose at 0, 30, 60, 120 minutes
- sum of insulin levels (IRI) at 30, 60, 120 minutes
- insulinogenic index : blood glucose at 30 min-blood glucose at 0 min/ (insulin at 30min - insulin at 0 min )
- HbA1c
Control Variables
Initial N: 69 (32 GDM, 37 OAV)
Attrition (final N): 2 developed DM in the interval between the index and subsequent pregnancy (67)
Age: Women having GDM during index pregnancy were more likely to have recurrent GDM if they were older (28.8 vs 24.5 years, P=0.03).
Ethnicity: Japanese
Other relevant demographics:
Anthropometrics
Location:
Hachioji Medical Center of Tokyo Medical University and Yoneyama Obsetric Hospital, Japan
Maternal demographics in the index pregnancy and their relationship to recurrence of GDM
Recurrent GDM | Nonrecurrent GDM | OR | P-Value | |
---|---|---|---|---|
n | 21 | 9 | ||
Age (year) | 28.8 ± 5.1 | 24.5 ± 2.3 | 1.25 | 0.0254 |
Parity >1 (%) | 76.2 | 44.4 | 4 | 0.0062 |
Family history (%) | 57.1 | 55.6 | 0.72 | NS |
BMI before pregnancy (kg/m2) | 20.0 ± 1.9 | 22.4 ± 1.9 | 0.24 | NS |
Gestational age at delivery (weeks) | 38.2 ± 2.8 | 38.9 ± 2.1 | 1 | NS |
HbA1c (%) | 6.6 ± 0.7 | 5.8 ± 0.6 | 2.41 | 0.014 |
Birth weight of infant (g) | 3244.6 ± 656.2 | 3086.9 ± 520.3 | 0.14 | NS |
Other Findings
- The recurrence rate from index GDM and index OAV were 65.6% and 40.5%, respectively
- The development to GDM from the index OAV was more common in women with low ∑IRI (179.0 ± 43.5 versus 244.8 ± 66.6, p = 0.0273; OR 0.14; 95% CI 0.021–0.983).
University/Hospital: | Hachioji Medical Center, Tokyo Medical University, yoneyama Obstetrics & Gynecology Hospital |
Percent of eligible women participating was unclear.
Study period over 10 years - secular trends may have contributed to differences between recurrent and non-recurrent GDM.
Only present unadjusted odds ratios rather than using multivariate analyses to examine independent effects of age, bmi, etc
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? | Yes | |
2. | Was the selection of study subjects/patients free from bias? | Yes | |
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? | Yes | |
2.4. | Were the subjects/patients a representative sample of the relevant population? | ??? | |
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.) | ??? | |
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? | No | |
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? | No | |
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? | Yes | |
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.) | Yes | |
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? | Yes | |
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? | Yes | |
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? | Yes | |
6.3. | Was the intensity and duration of the intervention or exposure factor sufficient to produce a meaningful effect? | N/A | |
6.4. | Was the amount of exposure and, if relevant, subject/patient compliance measured? | N/A | |
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? | Yes | |
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? | N/A | |
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)? | N/A | |
8.5. | Were adequate adjustments made for effects of confounding factors that might have affected the outcomes (e.g., multivariate analyses)? | Yes | |
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? | Yes | |
10. | Is bias due to study's funding or sponsorship unlikely? | Yes | |
10.1. | Were sources of funding and investigators' affiliations described? | Yes | |
10.2. | Was the study free from apparent conflict of interest? | Yes | |