Risk of malformations and other outcomes in children exposed to fluconazole in utero

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Abstract

Fluconazole is an active drug systematically used in the oral treatment of vaginal candidiasis and other fungal diseases. We examined the risk of malformations and other birth outcomes following pregnancy related exposures.

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Most cited references 11

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The risk of a diagnosis of cancer after primary deep venous thrombosis or pulmonary embolism.

H Sørensen, L. Mellemkjaer, F Steffensen … (1998)

Several small studies have indicated an association between deep venous thrombosis or pulmonary embolism and a subsequent diagnosis of cancer, but the subject is controversial. We conducted a nationwide study of a cohort of patients with deep venous thrombosis or pulmonary embolism that was drawn from the Danish National Registry of Patients for the years 1977 through 1992. The occurrence of cancer in the cohort was determined by linkage to the Danish Cancer Registry. The expected number of cancer cases was estimated on the basis of national age-, sex-, and site-specific incidence rates. A total of 15,348 patients with deep venous thrombosis and 11,305 patients with pulmonary embolism were identified. We observed 1737 cases of cancer in the cohort with deep venous thrombosis, as compared with 1372 expected cases (standardized incidence ratio, 1.3; 95 percent confidence interval, 1.21 to 1.33). Among the patients with pulmonary embolism, the standardized incidence ratio was 1.3, with a 95 percent confidence interval of 1.22 to 1.41. The risk was substantially elevated only during the first six months of follow-up and declined rapidly thereafter to a constant level slightly above 1.0 one year after the thrombotic event. Forty percent of the patients given a diagnosis of cancer within one year after hospitalization for thromboembolism had distant metastases at the time of the diagnosis of cancer. There were strong associations with several cancers, most pronounced for those of the pancreas, ovary, liver (primary hepatic cancer), and brain. An aggressive search for a hidden cancer in a patient with a primary deep venous thrombosis or pulmonary embolism is not warranted.

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Validation of the Danish Birth Registration.

Jens Kristensen, Jens Langhoff-Roos, Lene Skovgaard … (1996)

We assessed validity and reliability of data on four serious pregnancy complications and gestational age in two national registers, the Medical Birth Register (MBR) and the National Register of Hospital Discharges (NRHD). From a cohort of all women in Denmark who gave birth to their first and second singleton infant in 1982-1987, a review was made of a selected sample of 1662 medical records. Regarding registration of pregnancy complications, there was good agreement (kappa above 0.6) between medical records and the registers, and between the registers. However, there was a tendency toward understatement evidenced by low sensitivity of three of four pregnancy complications. The level of agreement (43%) for length of gestation was disappointing. The number of systematic and nonsystematic errors indicate that there was about 52% more singleton preterm deliveries in Denmark in 1982 than previously reported (6.9% instead of 4.5%). It is concluded that the validity of the Danish birth registers should be improved by explicit definitions, increased use of raw data, and data collection by motivated professionals at birth.

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Birth weight and cognitive function in young adult life: historical cohort study.

S Sabroe, J. Olsen, M Gillman … (1997)

To examine the relation between birth weight and cognitive function in young adult life. Retrospective cohort study based on birth registry data and cognitive function measured during evaluation for military service. 4300 Danish conscripts born between 1973 and 1975. Mean score in the Boerge Prien test of cognitive function; score is the number of correct answers to 78 questions and correlates with full scale intelligence quotient (IQ). Mean score in the Boerge Prien test increased from 39.9 at a birth weight of < or = 2500 g to 44.6 at a birth weight of 4200 g even after adjustment for gestational age and length at birth, maternal age and parity, and other variables. Above a birth weight of 4200 g the test score decreased slightly. Birth weight is associated with cognitive performance in young adult life. Interference with fetal growth may influence adult cognitive performance.