The impact of an educational DVD on pregnant women with gestational diabetes mellitus: a randomised controlled trial

Background The diagnosis of gestational diabetes (GDM) during pregnancy can lead to anxiety. Little research has focused on the education these women receive and how this is best delivered in a busy clinic. Aim This study evaluated the impact of an innovative patient-centred educational DVD on anxiety and glycaemic control and in newly diagnosed women with GDM. Method 150 multi-ethnic women, aged 19-44 years, from three UK hospitals were randomised to either standard care plus DVD (DVD group, n=77) or standard care alone (control group, n=73) at GDM diagnosis. Women were followed up at their next clinic visit at a mean ± SD of 2.5 ± 1.6 weeks later. Primary outcomes were anxiety (State-Trait Anxiety Inventory) and mean 1-hour postprandial capillary self-monitored blood glucose for all meals, on day prior to follow-up. Secondary outcomes included pregnancy specific stress (Pregnancy Distress Questionnaire), emotional adjustment to diabetes (Appraisal of Diabetes Scale), self-efficacy (Diabetes Empowerment Scale) and GDM knowledge (non-validated questionnaire). Other outcomes included mean fasting and 1-hour postprandial blood glucose at each meal, on day prior to follow-up. Women in the DVD group completed a feedback questionnaire on the resource. Results No significant difference between the DVD and control group were reported, for anxiety (37.7 ± 11.7 vs 36.2 ± 10.9; mean difference after adjustment for covariates (95%CI) 2.5 (-0.8, 5.9) or for mean 1-hour postprandial glucose (6.9 ± 0.9 vs 7.0 ± 1.2 mmol/L; -0.2 (-0.5, 0.2). Similarly, no significant differences in the other psychosocial variables were identified between the groups. However, the DVD group had significantly lower postprandial breakfast glucose compared to the control group (6.8 ± 1.2 vs 7.4 ± 1.9 mmol/L; -0.5 (-1.1, -<0.1; p=0.04). Using a scale of 0-10, 84% rated the DVD 7 or above for usefulness (10 being very useful), and 88% rated it 7 or above when asked if they would recommend to a friend (10 being very strongly recommend). Women described the DVD as ‘reassuring’, ‘a fantastic tool’, that ‘provided a lot of information in a quick and easy way’ and ‘helped reinforce all the information from clinic’. Discussion While no significant change was observed in anxiety or mean postprandial glucose, the DVD was rated highly by women with GDM and may be a useful resource to assist with educating newly diagnosed women. This project is supported by BRIDGES, an IDF programme supported by an educational grant from Lilly Diabetes.

Exploring the needs, concerns and knowledge of women diagnosed with gestational diabetes: A qualitative study

Objective
To explore the concerns, needs and knowledge of women diagnosed with Gestational Diabetes Mellitus (GDM).
Design
A qualitative study of women with GDM or a history of GDM.
Methods
Nineteen women who were both pregnant and recently diagnosed with GDM or post- natal with a recent history of GDM were recruited from outpatient diabetes care clinics. This qualitative study utilised focus groups. Participants were asked a series of open-ended questions to explore 1) current knowledge of GDM; 2) anxiety when diagnosed with GDM, and whether this changed overtime; 3) understanding and managing GDM and 4) the future impact of GDM. The data were analysed using a conventional content analysis approach.
Findings
Women experience a steep learning curve when initially diagnosed and eventually become skilled at managing their disease effectively. The use of insulin is associated with fear and guilt. Diet advice was sometimes complex and not culturally appropriate. Women appear not to be fully aware of the short or long-term consequences of a diagnosis of GDM.
Conclusions
Midwives and other Health Care Professionals need to be cognisant of the impact of a diagnosis of GDM and give individual and culturally appropriate advice (especially with regards to diet). High quality, evidence based information resources need to be made available to this group of women. Future health risks and lifestyle changes need to be discussed at diagnosis to ensure women have the opportunity to improve their health.

The association between spastic Cerebral Palsy, intellectual impairment, and gestational age: results from the Northern Ireland Cerebral Palsy Register

Background
Studies suggest a complex relationship between Cerebral Palsy sub-types, severity of impairment, and risk factors such as gestational age. To investigate these relationships, we conducted analyses on over 1,100 children included in the Northern Ireland Cerebral Palsy Register (NICPR) whose clinical CP subtype was Bilateral Spastic or Spastic Hemiplegia, and for whom information was available on the relevant variables.
Methods
We tested for the association between Bilateral and Hemiplegia subtypes, severe intellectual impairment, and gestational age (term; moderately preterm; very or extremely preterm) while controlling for gender, socio-economic deprivation, year of birth, and birth weight (using a standardized birth-weight score based on deviance from the birth weight average within each gestational age band). Severity of intellectual impairment was dichotomised (severe intellectual delay vs. moderate or no delay).
Results
Logistic regressions indicated a good fit of the model, and the predictors included explained approximately 19% of variability in the outcome. The results indicated a strong association between the Bilateral subtype and severe intellectual impairment: compared to children with the Hemiplegia subtype, those with Bilateral Spastic CP displayed a 10-fold increase in the odds of severe intellectual impairment. The results revealed a significant interaction between CP subtype and gestational age: for the Bilateral CP subtype, being born at term was associated with increased probability of severe intellectual impairment.
Discussion
Results are consistent with other studies (Hemming et al., 2008) in indicating that the likelihood of cognitive impairments increases with increasing gestational age at delivery of Bilateral Spastic CP children. The results are discussed in light of hypotheses that suggest the brain might be able to reorganise and compensate the effects of lesions and injuries when it is still less developed.

A Multicenter, Randomised Open Study of Early Corticosteroid Treatment (OSECT) in Preterm Infants With Respiratory Illness: Comparison of Early and Late Treatment and of Dexamethasone and Inhaled Budesonide

AIM: To compare early (15 days) steroid therapy and dexamethasone with inhaled budesonide in very preterm infants at risk of developing chronic lung disease. METHODS: Five hundred seventy infants from 47 neonatal intensive care units were enrolled. Criteria for enrollment included gestational age 30%. Infants were randomly allocated to 1 of 4 treatment groups in a factorial design: early (15 days) dexamethasone, and delayed selective budesonide. Dexamethasone was given in a tapering course beginning with 0.50 mg/kg/day in 2 divided doses for 3 days reducing by half until 12 days of therapy had elapsed. Budesonide was administered by metered dose inhaler and a spacing chamber in a dose of 400 microg/kg twice daily for 12 days. Delayed selective treatment was started if infants needed mechanical ventilation and >30% oxygen for >15 days. The factorial design allowed 2 major comparisons: early versus late treatment and systemic dexamethasone versus inhaled budesonide. The primary outcome was death or oxygen dependency at 36 weeks and analysis was on an intention-to-treat basis. Secondary outcome measures included death or major cerebral abnormality, duration of oxygen treatment, and complications of prematurity. Adverse effects were also monitored daily. RESULTS: There were no significant differences among the groups for the primary outcome. Early steroid treatment was associated with a lower primary outcome rate (odds ratio [OR]: 0.85; 95% confidence interval [CI]: 0.61,1.18) but even after adjustment for confounding variables the difference remained nonsignificant. Dexamethasone-treated infants also had a lower primary outcome rate (OR: 0.86; 95% CI: 0.62,1.20) but again this difference remained not significant after adjustment. For death before discharge, dexamethasone and early treatment had worse outcomes than budesonide and delayed selective treatment (OR: 1.42; 95% CI: 0.93,2.16; OR: 1.51; 95% CI: 0.99,2.30 after adjustment, respectively) with the results not quite reaching significance. Duration of supplementary oxygen was shorter in the early dexamethasone group (median: 31 days vs 40-44 days). Early dexamethasone was also associated with increased weight loss during the first 12 days of treatment (52 g vs 3 g) compared with early budesonide, but over 30 days there was no difference. In the early dexamethasone group, there was a reduced incidence of persistent ductus arteriosus (34% vs 52%-59%) and an increased risk of hyperglycemia (55% vs 29%-34%) compared with the other 3 groups. Dexamethasone was associated with an increased risk of hypertension and gastrointestinal problems compared with budesonide but only the former attained significance. CONCLUSIONS: Infants given early treatment and dexamethasone therapy had improved survival without chronic lung disease at 36 weeks compared with those given delayed selective treatment and inhaled budesonide, respectively, but results for survival to discharge were in the opposite direction; however, none of these findings attained statistical significance. Early dexamethasone treatment reduced the risk of persistent ductus arteriosus. Inhaled budesonide may be safer than dexamethasone, but there is no clear evidence that it is more or less effective

Birthweight and the risk of childhood-onset type 1 diabetes: a meta-analysis of observational studies using individual patient data

Aims/hypothesis: We investigated whether children who are heavier at birth have an increased risk of type 1 diabetes. Methods: Relevant studies published before February 2009 were identified from literature searches using MEDLINE, Web of Science and EMBASE. Authors of all studies containing relevant data were contacted and asked to provide individual patient data or conduct pre-specified analyses. Risk estimates of type 1 diabetes by category of birthweight were calculated for each study, before and after adjustment for potential confounders. Meta-analysis techniques were then used to derive combined ORs and investigate heterogeneity between studies. Results: Data were available for 29 predominantly European studies (five cohort, 24 case-control studies), including 12,807 cases of type 1 diabetes. Overall, studies consistently demonstrated that children with birthweight from 3.5 to 4 kg had an increased risk of diabetes of 6% (OR 1.06 [95% CI 1.01-1.11]; p=0.02) and children with birthweight over 4 kg had an increased risk of 10% (OR 1.10 [95% CI 1.04-1.19]; p=0.003), compared with children weighing 3.0 to 3.5 kg at birth. This corresponded to a linear increase in diabetes risk of 3% per 500 g increase in birthweight (OR 1.03 [95% CI 1.00-1.06]; p=0.03). Adjustments for potential confounders such as gestational age, maternal age, birth order, Caesarean section, breastfeeding and maternal diabetes had little effect on these findings. Conclusions/interpretation: Children who are heavier at birth have a significant and consistent, but relatively small increase in risk of type 1 diabetes. © 2010 Springer-Verlag.


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Vitamins C and E for prevention of pre-eclampsia in women with type 1 diabetes (DAPIT): a randomised placebo-controlled trial.

Background
Results of several trials of antioxidant use during pregnancy have not shown a reduction in pre-eclampsia, but the eff ect in women with diabetes is unknown. We aimed to assess whether supplementation with vitamins C and E reduced incidence of pre-eclampsia in women with type 1 diabetes.

Methods
We enrolled women from 25 UK antenatal metabolic clinics in a multicentre randomised placebo-controlled trial. Eligibility criteria were type 1 diabetes preceding pregnancy, presentation between 8 weeks’ and 22 weeks’ gestation, singleton pregnancy, and age 16 years or older. Women were randomly allocated in a 1:1 ratio to receive1000 mg vitamin C and 400 IU vitamin E (a-tocopherol) or matched placebo daily until delivery. The randomisation sequence was stratifi ed by centre with balanced blocks of eight patients. All trial personnel and participants were masked to treatment allocation. The primary endpoint was pre-eclampsia, which we defi ned as gestational hypertension with proteinuria. Analysis was by modifi ed intention to treat. This study is registered, ISRCTN27214045.

Findings
Between April, 2003, and June, 2008, 762 women were randomly allocated to treatment groups (379 vitamin supplementation, 383 placebo). The primary endpoint was assessed for 375 women allocated to receive vitamins, and 374 allocated to placebo. Rates of pre-eclampsia did not differ between vitamin (15%, n=57) and placebo (19%, 70)groups (risk ratio 0·81, 95% CI 0·59–1·12). No adverse maternal or neonatal outcomes were reported.

Interpretation
Supplementation with vitamins C and E did not reduce risk of pre-eclampsia in women with type 1 diabetes. However, the possibility that vitamin supplementation might be benefi cial in women with a low antioxidant status at baseline needs further testing.

An exploration of knowledge and attitudes related to pre-pregnancy care in women with diabetes

Aims: Pre-pregnancy care optimizes pregnancy outcome in women with pre-gestational diabetes, yet most women enter pregnancy unprepared. We sought to determine knowledge and attitudes of women with Type 1 and Type 2 diabetes of childbearing age towards pre-pregnancy care.

Methods: Twenty-four women (18 with Type 1 diabetes and six with Type 2 diabetes) aged 17–40 years took part in one of four focus group sessions: young nulliparous women with Type 1 diabetes (Group A), older nulliparous women with Type 1 diabetes (Group B), parous women with Type 1 diabetes (Group C) and women with Type 2 diabetes of mixed parity (Group D).

Results: Content analysis of transcribed focus groups revealed that, while women were well informed about the need to plan pregnancy, awareness of the rationale for planning was only evident in parous women or those who had actively sought pre-pregnancy advice. Within each group, there was uncertainty about what pre-pregnancy advice entailed. Despite many women reporting positive healthcare experiences, frequently cited barriers to discussing issues around family planning included unsupportive staff, busy clinics and perceived social stereotypes held by health professionals.

Conclusions: Knowledge and attitudes reported in this study highlight the need for women with diabetes, regardless of age, marital status or type of diabetes, to receive guidance about planning pregnancy in a motivating, positive and supportive manner. The important patient viewpoints expressed in this study may help health professionals determine how best to encourage women to avail of pre-pregnancy care

Caesarean section is associated with an increased risk of childhood-onset type 1 diabetes: A meta-analysis of observational studies

Aims/hypothesis: The aim of this study was to investigate the evidence of an increased risk of childhood-onset type 1 diabetes in children born by Caesarean section by systematically reviewing the published literature and performing a meta-analysis with adjustment for recognised confounders.
Methods: After MEDLINE, Web of Science and EMBASE searches, crude ORs and 95% CIs for type 1 diabetes in children born by Caesarean section were calculated from the data reported in each study. Authors were contacted to facilitate adjustments for potential confounders, either by supplying raw data or calculating adjusted estimates. Meta-analysis techniques were then used to derive combined ORs and to investigate heterogeneity between studies.
Results: Twenty studies were identified. Overall, there was a significant increase in the risk of type 1 diabetes in children born by Caesarean section (OR 1.23, 95% CI 1.15-1.32, p<0.001). There was little evidence of heterogeneity between studies (p=0.54). Seventeen authors provided raw data or adjusted estimates to facilitate adjustments for potential confounders. In these studies, there was evidence of an increase in diabetes risk with greater birthweight, shorter gestation and greater maternal age. The increased risk of type 1 diabetes after Caesarean section was little altered after adjustment for gestational age, birth weight, maternal age, birth order, breast-feeding and maternal diabetes (adjusted OR 1.19, 95% CI 1.04-1.36, p=0.01).
Conclusions/interpretation: This analysis demonstrates a 20% increase in the risk of childhood-onset type 1 diabetes after Caesarean section delivery that cannot be explained by known confounders.

Early Childhood Development of Late-Preterm Infants: A Systematic Review

CONTEXT: Late-preterm infants (LPIs) born at 34 to 36 weeks' gestation are increasingly regarded as being at risk for adverse developmental outcomes. To date, the early childhood development of LPIs has not been systematically considered.

OBJECTIVE: To undertake a broad examination of literature relating to early childhood development at the ages of 1 to 7 years of LPIs born at 34 to 36 weeks' gestation.

METHODS: We conducted a systematic review of early childhood outcomes in LPIs by using 9 electronic databases (January 1980 to March 2010). Bibliographies were reviewed. After examination of abstracts, ineligible studies were excluded. A specifically designed data-extraction form was used. The methodologic quality of included studies was assessed by using well-documented quality-appraisal guidelines.

RESULTS: Of 4581 studies, 10 (3 prospective and 7 retrospective cohort) were included. Studies were heterogeneous, and poorer outcomes were reported among LPIs in relation to neurodevelopmental disabilities, educational ability, early-intervention requirements, medical disabilities, and physical growth in comparison to term-born children. No identified study used healthy nonadmitted LPIs as a comparison group for admitted LPIs.

CONCLUSIONS: Evidence suggests that LPIs are at increased risk of adverse developmental outcomes and academic difficulties up to 7 years of age in comparison to term infants. An infant control group matched for gestational age has not been used; thus, for LPIs, the effect of neonatal admission on longer-term outcomes has not been fully explored. Systematic measurement of early childhood outcomes is lacking, and focused long-term follow-up studies are needed to investigate early childhood development after late-preterm birth. Pediatrics 2011;127:1111-1124

Levels of Neonatal Thyroid Hormone in Preterm Infants and Neurodevelopmental Outcome at 51/2 Years: Millennium Cohort Study

Context: Transient hypothyroxinemia is the commonest thyroid dysfunction of premature infants, and recent studies have found adverse associations with neurodevelopment. The validity of these associations is unclear because the studies adjusted for a differing range of factors likely to influence neurodevelopment. Objective: The aim was to describe the association of transient hypothyroxinemia with neurodevelopment at 5.5 yr corrected age. Design: We conducted a follow-up study of a cohort of infants born in Scotland from 1999 to 2001 =34 wk gestation. Main Outcome Measures: We measured scores on the McCarthy scale adjusted for 26 influences of neurodevelopment including parental intellect, home environment, breast or formula fed, growth retardation, and use of postnatal drugs. Results: A total of 442 infants =34 wk gestation who had serum T4 measurements on postnatal d 7, 14, or 28 and 100 term infants who had serum T4 measured in cord blood were followed up at 5.5 yr. Infants with hypothyroxinemia (T4 level = 10th percentile on d 7, 14, or 28 corrected for gestational age) scored significantly lower than euthyroid infants (T4 level greater than the 10th percentile and less than the 90th percentile on all days) on all McCarthy scales, except the quantitative. After adjustment for confounders of neurodevelopment, hypothyroxinemic infants scored significantly lower than euthyroid infants on the general cognitive and verbal scales. Conclusions: Our findings do not support the view that the hypothyroxinemic state, in the context of this analysis, is harmless in preterm infants. Many factors contribute both to the etiology of hypothyroxinemia and neurodevelopment; strategies for correction of hypothyroxinemia should acknowledge its complex etiology and not rely solely on one approach.

PREDICTION OF NETILMICIN DISPOSITION IN NEONATES

Multiple regression analyses of data from 33 neonates who received netilmicin therapy showed that concurrent treatment with other drugs (Drg), creatinine clearance (CL(cr)), gestational age (GA), and an apgar score of less than 6 at 1 min (Agl') were significant determinants of netilmicin clearance. Apparent volume of distribution was significantly affected by postnatal age (PNA), gender, the presence of ascites and/or oedema (A/O), and whether or not the neonate was small for gestational age (SGA). The following formulae were obtained: CL (ml min-1 kg-1) = -0.108 - 0.210 (Drg) + 0.152(CL(cr)) + 0.019(GA) -0.128(Agl') (multiple R = 0.725, p