Obstetric outcomes and effects on babies born to women treated for epilepsy during pregnancy in a resource limited setting: a comparative cohort study.

BACKGROUND: Management of epilepsy during pregnancy in a resource-limited setting (RLS) is challenging. This study aimed to assess obstetric outcomes and effects on babies of women with epilepsy (WWE) exposed to Anti-epileptic drugs (AEDs) compared to non-exposed controls in a RLS. METHODS: Pregnant WWE were recruited from antenatal and neurology clinics of a tertiary care hospitals in Sri Lanka. Patients were reviewed in each trimester and post-partum. Medication adherence, adverse effects, seizure control and carbamazepine blood levels were monitored. Post-partum, measurements for anthropometric and dysmorphic features of the babies and congenital abnormalities were recorded. Age and sex matched babies not exposed to AED recruited as controls were also examined. RESULTS: Ninety-six pregnant WWE were recruited (mean period of gestation 22.9 weeks). Mean age was 28 years and 48(50%) were primigravidae. Fifty percent (48) were on monotherapy, while 23.8, 15.9 and 4.1% were on two, three and four AEDs respectively. AEDs in first trimester (TM1) were carbamazepine (71%), valproate (25.8%) clobazam (29.5%), lamotrigine (7%) topiramate (5%) and others (3.4%). Sodium valproate use reduced significantly from T1 to T2(p < 0.05). Sub-therapeutic carbamazepine levels correlated positively (r = 0.547) with poor medication adherence (p = 0.009) and negatively (r = 0.306) with adverse effects (p = 0.002). Seventy-six WWE completed follow-up reporting w 75 (98.6%) live births and one T1 miscarriage (1.3%). Three (4.3%) were preterm. Majority (73.33%) were normal vaginal deliveries. Cesarean sections were not increased in WWE. Fifty-nine (61.45%) babies were examined. For those examined during infancy, 53 age and sex matched controls were recruited and examined.. Congenital abnormalities occurred in 5 (9.43%) babies of WWE [atrio-ventricular septal defect (2), renal hypoplasia (1), cryptorchidism (1), microcephaly (1)] compared to 2 (3.77%) in controls (2 microcephaly; p = 0.24). Fetal exposure to AEDs increased a risk of low birth weight (RR 2.8; p = 0.049). Anthropometric parameters of AED exposed babies were lower at birth but not statistically significant between the two groups (weight p = 0.263, length p = 0.363, occipito-frontal circumference (OFC) p = 0.307). However, weight (p = 0.009), length (p = 0.016) and OFC (p = 0.002) were significantly lower compared to controls at an average of 3.52 months. CONCLUSION: Most pregnancies are unplanned in the RLS studied, and AEDs were altered during pregnancy. Congenital anomalies occurred at rates comparable to previous reports. Fetal exposure to AED had growth retardation in infancy compared to non-exposed babies.

Is walking barefoot a risk factor for diabetic foot disease in developing countries?

INTRODUCTION: Walking barefoot is common in poorer developing countries which have large rural populations. Although high rates of foot injury could be expected among those who walk barefoot, walking barefoot as a risk factor for diabetic foot disease is rarely documented in the literature. METHODS: Two preliminary clinical studies were undertaken to investigate whether there is a causal link between walking barefoot and diabetic foot ulcers. The first study investigated whether being barefoot was a factor in initiating foot ulceration. In the second study, 204 consecutive diabetic outpatients were studied to further investigate the association between diabetic foot disease and walking barefoot. RESULTS: In the first study, of the 75 consecutive diabetics admitted for foot ulceration of less than 4 weeks, 32 (42.4%) had foot ulcers resulting from injuries by sharp or hard objects. Of those injured, 27 (84%) were barefoot at the time of the injury. This suggested that walking barefoot is a risk factor for foot ulcers, and that using footwear has the potential to prevent foot ulcers. In the second study, the relative risk of foot ulcers among barefoot diabetics was 2.21 (95% CI 1.55 to 3.14) compared with those using some form of footwear. A history of foot ulcers was more frequent in the group who wore footwear less than 10 hours per day, compared with those who used footwear more than 10 hours. The prevalence of web space and nail infections was also higher in the group who wore footwear less than 10 hours per day, compared with those who used footwear for more than 10 hours. CONCLUSION: The data suggest that walking barefoot is a risk factor for diabetic foot disease. Thus, public health messages in developing countries with large rural populations who walk barefoot should strongly advise diabetics to use footwear for a greater part of the day. This may be overlook in literature originating from affluent countries where footwear use is the norm. Further studies are indicated to investigate potential associations between walking barefoot, rurality and cultural factors.