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Major Birth Defects (major + birth_defects)
Selected AbstractsValidation study of the Victorian Birth Defects RegisterJOURNAL OF PAEDIATRICS AND CHILD HEALTH, Issue 9-10 2004M Riley Objective: To determine whether there has been an improvement in ascertainment of birth defects cases (,case validity') by the Victorian Birth Defects Register (BDR) since an earlier study (conducted in 1993), to ascertain the accuracy of registered data (,item validity') and to investigate another possible source of notification. Methods: The medical records were reviewed of 500 children born after 1 January 1993 who were consecutively admitted after 1 January 1999 to two paediatric teaching hospitals in Victoria. In addition, records of 200 children referred to a clinical genetics service were reviewed for children born after 1 January 1993 and who were seen in two periods: 2 months after 1 January 2001 and 2 months after 1 January 2002. The records from the hospitals and clinical genetics service were reviewed separately to determine whether children recorded as having a birth defect had previously been notified to the BDR. Results: Twenty percent of the hospital records related to a child with a birth defect, as did 70% of the clinical genetics service records. Overall case validity for birth defect cases from the hospitals was 88%. There was 100% ascertainment for three of five categories. Sixty per cent of birth defects cases from the clinical genetics service had been notified to the BDR. When all diagnoses in matched cases were considered, item validity was 54%, however, if only primary diagnoses were included then 92% of cases had the same diagnosis. Conclusions: Overall case validity from the two paediatric teaching hospitals has significantly improved since our previous study. The addition of an extra data source from a clinical genetics service would identify new cases, particularly genetic disorders and developmental delay, as well as adding new diagnoses to existing ones. This study has highlighted the need to improve item validity, perhaps through routine education for all coders and notifiers on the inclusion and exclusion of specific associated conditions when notifying major birth defects. [source] Clinical review procedures for the Antiretroviral Pregnancy Registry,PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, Issue 8 2004Angela Scheuerle MD Abstract The Antiretroviral Pregnancy Registry (APR) is an international pregnancy exposure registry designed to monitor prenatal antiretroviral medication exposures and detect any potential increase in the risk of major birth defects. The APR process imitates that of the Metropolitan Atlanta Congenital Defects Program (MACDP) modified to account for the differences in surveillance systems. The APR case definition attempts to separate prenatal and postnatal medication exposure, includes cases with multiple conditional defects only and collects cases diagnosed at later ages. Possible temporal association between defect pathogenesis and antiretroviral medication exposure includes a way to identify cases with known etiology,such as familial genetic conditions,and those with currently ambiguous pathogenesis,like hemangiomata and club feet. The APR also accounts for confounding factors like maternal alcohol use. Some defect reports automatically generate questions back to the reporter asking for more information. The APR incorporates procedures for managing and recording some of the more inconsistently reported malformations, such as microcephaly. Copyright © 2004 John Wiley & Sons, Ltd. [source] Vitamin supplements and the risk for congenital anomalies other than neural tube defects,AMERICAN JOURNAL OF MEDICAL GENETICS, Issue 1 2004Lorenzo D. Botto Abstract Randomized trials, supported by many observational studies, have shown that periconceptional use of folic acid, alone or in multivitamin supplements, is effective for the primary prevention of neural tube defects (NTDs). Whether this is true also for other congenital anomalies is a complex issue and the focus of this review. It is useful to consider the evidence not only for specific birth defects separately but, importantly, also for all birth defects combined. For the latter, the Hungarian randomized clinical trial indicated, for periconceptional multivitamin use, a reduction in the risk for all birth defects (odds ratio (OR),=,0.53, 95% confidence interval (CI),=,0.35,0.70), even after excluding NTDs (OR,=,0.53, 95% CI,=,0.38,0.75). The Atlanta population-based case-control study, the only large observational study to date on all major birth defects, also found a significant risk reduction for all birth defects (OR,=,0.80, 95% CI,=,0.69,0.93) even after excluding NTDs (OR,=,0.84, 95% CI,=,0.72,0.97). These and other studies also evaluated specific anomalies, including those of the heart, limb, and urinary tract, as well as orofacial clefts, omphalocele, and imperforate anus. For cardiovascular anomalies, two studies were negative, whereas three, including the randomized clinical trial, suggest a possible 25,50% overall risk reduction, more marked for some conotruncal and septal defects. For orofacial clefts, six of seven case-control studies suggest an apparent reduced risk, which could vary by cleft type and perhaps, according to some investigators, by pill dosage. For limb deficiencies, three case-control studies and the randomized trial estimated approximately a 50% reduced risk. For urinary tract defects, three case-control studies and the randomized trial reported reduced risks, as did one study of nonsyndromic omphalocele. All these studies examined multivitamin supplement use. With respect to folic acid alone, a reduced rate of imperforate anus was observed among folic acid users in China. We discuss key gaps in knowledge, possible avenues for future research, and counseling issues for families concerned about occurrence or recurrence of these birth defects. © 2004 Wiley-Liss, Inc. [source] Latest news and product developmentsPRESCRIBER, Issue 14 2007Article first published online: 19 OCT 200 Studies suggest risk of bone loss with SSRIs Two cross-sectional studies have suggested the SSRI antidepressants may be associated with an increased risk of bone loss (Arch Intern Med 2007;167:1240,5 &1246,51). In 2722 older women (mean age 79) living in the community who were participating in the Study of Osteoporotic Fractures cohort study, use of SSRIs was associated with a significant increase in the rate of loss of hip bone density compared with nonusers(0.82 vs 0.47 per cent per year). The rate of loss among women taking a tricyclic antidepressant was also 0.47 per cent per year. Excluding women with more severe depression did not alter the findings. In 5995 men aged 65 or older taking an SSRI in another study, mean bone density was 3.9 per cent lower at the hip and 5.9 per cent lower in the lumbar spine compared with no use of antidepressants. Use of a tricyclic antidepressant or trazodone was not associated with increased bone loss. The authors comment that the degree of bone loss is comparable with that associated with corticosteroids. Serotonin transporters have been identified in osteoblasts and osteocytes. Risk of rare birth defects with SSRIs Two US case-control studies have found qualified evidence that use of SSRIs during the first trimester may be associated with a small increase in the risk of rare neonatal defects (N Engl J Med 2007;356:2675,83 & 2684,92). The Slone Epidemiology Center Birth Defects Study identified 9849 infants with birth defects and 5860 without and found no significant association between SSRI use overall and defects previously attributed to SSRIs (craniosynostosis, omphalocele or heart defects). There was some evidence that sertraline and paroxetine may cause specific defects, but this was based on few cases and the absolute risk remained low. The National Birth Defects Prevention Study identified 9622 infants with major birth defects and 4092 controls. There was no significant association with heart defects but the odds of anencephaly, craniosynostosis and omphalocele were each significantly increased by a factor of 2,3. The authors say the absolute risk remains small and their findings require confirmation. UK data do not support MI link with rosiglitazone An interim analysis of a UK clinical trial of rosiglitazone (Avandia) has found no evidence that it is associated with an increased risk of myocardial infarction (N Eng J Med 2007;357:28,38). A US meta-analysis (N Engl J Med 2007;356:2457,71) recently suggested that the odds of an MI or cardiovascular (CV) death in patients taking rosiglitazone were increased by 40,60 per cent compared with controls. The UK analysis of an ongoing nonblinded trial comparing rosiglitazone plus a sulphonylurea or metformin with sulphonylurea/metformin found no significant differences in the risk of MI or CV death. The risk of heart failure was doubled in patients taking rosiglitazone. The authors comment that, with a mean follow-up of 3.75 years, they had too few data to reach a conclusive finding. Switch piroxicam users to another NSAID The European Medicines Agency has advised prescribers to switch patients who are taking oral piroxicam to another NSAID. The advice follows a reappraisal of the safety of piroxicam when the 2006 review of all nonselective NSAIDs suggested it may be associated with increased risks of GI adverse effects and serious skin reactions. The advice does not apply to topical formulations. Piroxicam should not be prescribed for acute conditions and should not be first-choice for osteoarthritis, rheumatoid arthritis and ankylosing spondylitis. The maximum dose should be 20mg per day and treatment should be reviewed after 14 days. The MHRA states there is no need for urgent action; long-term treatment should be reviewed at the next routine appointment. OTC azithromycin? The MHRA is consulting on a request by a pharmaceutical company to reschedule azithromycin to pharmacy-only status for the treatment of known or suspected Chlamydia trachomatis infection in individuals aged 16 years or older. The applicant envisages supplies being made only when a nucleic acid amplification test (NAAT) is positive. Responses should be submitted to the MHRA (www.mhra.gov.uk) by 2 August. Computers can reduce prescribing errors Computerised prescribing reduces by two-thirds the rate of medication errors associated with handwritten prescriptions, a new review has found (Health Services Research 2007; online doi:10.1111/j.1475,6773. 2007.00751.x). There was some evidence that the risk of all errors, dose errors and adverse effects were reduced by computerisation. The greatest impact was seen in settings with very high error rates (>12 per cent) associated with handwritten prescriptions. However, the studies included produced heterogeneous results and the reduction in errors in prescribing for children was not statistically significant. Furthermore, computerisation did not reduce the rate of prescribing the wrong drug. Echinacea works for colds, new study finds The herbal remedy Echinacea does reduce the risk of catching a cold, according to a new metaanalysis (Lancet Infect Dis 2007;7:473,80). In 2006, a Cochrane review found insufficient evidence to support the benefits claimed for Echinacea. The new study, which additionally included experimentally-induced infections among the 14 trials analysed, found that Echinacea reduced the odds of catching a cold by about half and reduced the average duration of a cold by 1.4 days. Though inconclusive, the possibility of publication bias and heterogeneity between the trials could not be excluded. HRT may reduce cardiovascular risk after all A subgroup analysis of the Women's Health Initiative (WHI) suggests that HRT may reduce the risk of coronary heart disease if started soon after the menopause (N Engl J Med 2007;356:2591,602). The main analysis of WHI showed no cardiovascular benefit for HRT, a finding attributed to the relatively old mean age of participants (59). In the new analysis of 1064 women aged 50,59, HRT use was associated with a significant reduction in coronary artery calcification compared with nonuse, with greater effect associated with greater adherence. Reducing BP key to avoiding heart failure An angiotensin,II receptor blocker (ARB) is no better than other antihypertensives at avoiding the development of heart failure in individuals with hypertension, say US investigators (Lancet 2007;369:2079,87). Drugs that affect the renin-angiotensin system can reduce ventricular hypertrophy and may therefore prevent the development of heart failure in patients with hypertension. This study found similar improvements in diastolic function in 384 patients with hypertension and left ventricular dysfunction randomised to valsartan (Diovan) or placebo in addition to standard antihypertensive treatment for 38 weeks. The authors conclude that blood pressure reduction, not choice of drug, is the most important factor. Copyright © 2007 Wiley Interface Ltd [source] Folate intake and the primary prevention of non-neural birth defectsAUSTRALIAN AND NEW ZEALAND JOURNAL OF PUBLIC HEALTH, Issue 3 2006Carol Bower Objectives: To investigate whether maternal periconceptional folate intake is associated with a reduction in selected non-neural birth defects in Western Australia (WA). Methods: Case-control study of folate intake in women whose infants had orofacial clefts (62); congenital heart defects (151); urinary tract defects (117); limb reduction defects (26); or other major birth defects (119); and 578 control women. Results: Neither folic acid supplements nor dietary folate intake in women not using supplements was significantly associated with a reduction in risk in any of the case groups. In contrast to neural tube defects, WA population data for orofacial clefts, heart defects, limb reduction defects and urinary tract defects showed no fall in prevalence since the introduction of folate promotion and voluntary food fortification. Conclusions: This study provides no evidence of folate being an important factor in the prevention of birth defects other than neural tube defects. [source] Maternal smoking and the risk for clubfoot in infants,BIRTH DEFECTS RESEARCH, Issue 2 2008Kathryn C. Dickinson Abstract BACKGROUND: Clubfoot is one of the most common major birth defects, with a prevalence of approximately 1 per 1,000 live births. The etiology of clubfoot is complex and not well understood, and yet, few epidemiologic studies of risk factors have been conducted. Maternal smoking has been suggested as a possible risk factor. The purpose of this population-based, case-control study was to examine the association between maternal smoking and clubfoot. METHODS: Data from the North Carolina Birth Defects Monitoring Program matched to North Carolina birth certificates and health services data were used in the analysis of 443 cases of clubfoot and 4,492 randomly sampled controls for the years 1999,2003. Smoking data were ascertained from the birth certificates, and the reliability of the data was assessed by comparing them with reported smoking from the North Carolina Pregnancy Risk Assessment Monitoring System. Multiple logistic regression was used to calculate crude and adjusted ORs and 95% CIs for smoking and clubfoot. RESULTS: The crude OR for maternal smoking during pregnancy and clubfoot was 1.49 (95% CI: 1.15, 1.92). Controlling for maternal age, race/ethnicity, infant's sex, and timing of prenatal care initiation did not appreciably change the results (adjusted OR 1.40; 95% CI: 1.07, 1.83). CONCLUSIONS: This study is consistent with the hypothesis that smoking during pregnancy is associated with a slightly increased risk of an infant being born with clubfoot. Further research is needed to confirm this association, and to identify potential genetic factors that may modify the magnitude of the risk. Birth Defects Research (Part A) 2008. © 2007 Wiley-Liss, Inc. [source] Sex differences in the prevalence of human birth defects: A population-based study,BIRTH DEFECTS RESEARCH, Issue 5 2001Joseph M. Lary Background Sex differences in the prevalence of several human birth defects have often been reported in the literature, but the extent of sex differences for most birth defects is unknown. To determine the full extent of sex differences in birth defects in a population, we examined population-based data from the Metropolitan Atlanta Congenital Defects Program (MACDP). Methods MACDP records were analyzed for 1968 through 1995. We determined the sex-specific prevalence of all major birth defects, using the total number of live births by sex during these years as the denominator. For each specific defect, we calculated a relative risk with regard to sex on the basis of the ratio of prevalence among males to prevalence among females. Male,female relative risks were also determined for total major birth defects and for several broad categories of defects. Results The overall prevalence of major defects at birth was 3.9% among males and 2.8% among females. All but two of the major categories of birth defects (nervous system defects and endocrine system defects) had a higher prevalence among males. Defects of the sex organs were eight and one-half times more prevalent among males and accounted for about half of the increased risk of birth defects among males relative to females. Urinary tract defects were 62% more prevalent among males, and gastrointestinal tract defects were 55% more prevalent among males. Among specific defect types, twofold or greater differences in prevalence by sex were common. Conclusions Our data indicate that sex differences in the prevalence of specific human birth defects are common, and male infants are at greater risk for birth defects than female infants. Several mechanisms have been proposed to account for these differences. Teratology 64:237,251, 2001. Published 2001 Wiley-Liss, Inc. [source] Continued occurrence of Accutane® -exposed pregnancies ,BIRTH DEFECTS RESEARCH, Issue 3 2001M.A. Honein Background Accutane® a teratogenic prescription drug licensed to treat severe, recalcitrant nodular acne. First-trimester pregnancy exposure can cause major birth defects. The manufacturer began a Pregnancy Prevention Program (PPP) in 1988; however, exposed pregnancies continue to occur. In 1996, the manufacturer began a direct-to-consumer advertising campaign, raising concerns of more exposed pregnancies. Methods We examined trends in Accutane use by reproductive-aged women. We also interviewed a series of 14 women in California who had recent Accutane-exposed pregnancies to identify opportunities for prevention. Results The estimated number of Accutane prescriptions for reproductive-aged women has more than doubled in the past 10 years; it is the most widely used teratogenic drug in the United States, with approximately 2.5 per 1,000 reproductive-aged women exposed to Accutane in 1999. One-half of the women interviewed reported seeing an advertisement for prescription acne treatment before taking Accutane. Eight of the 14 women used no contraception at the time of the exposed pregnancy; 13 of the 14 women did not use two forms of contraception. Four of the 14 women did not have pregnancy tests before starting Accutane. None reported seeing all PPP components, and four saw only the information on the pill packet. These 14 pregnancies resulted in four live infants who had no apparent birth defects, one live-born infant with multiple defects, four spontaneous abortions, and five induced abortions. Conclusions The increase in Accutane use observed among females may be exacerbated by advertising. Physicians and patients must use more caution with teratogenic prescription drugs. Teratology 64:142,147, 2001. Published 2001 Wiley-Liss, Inc. [source] | |||||||||||||