The outcomes of pregnancy in women exposed to the new macrolides in the first trimester: a prospective, multicentre, observational study.

BACKGROUND: Macrolides are a group of commonly prescribed antibiotics. There is some doubt surrounding the use of the newer macrolides in pregnancy. OBJECTIVE: The present study aimed to compare outcomes of pregnancies exposed to the new macrolides clarithromycin, azithromycin and roxithromycin with non-teratogenic preparations. METHODS: In this prospective, multinational, multicentre, controlled, observational study, information was obtained either from pregnant women or their healthcare professionals who contacted their local teratogen information services in Italy, Israel, the Czech Republic, the Netherlands and Germany seeking information after exposure to macrolides. The comparison group included women or their healthcare professional who contacted these centres with questions regarding known non-teratogenic preparations. Information on obstetric and other background parameters was collected at enrollment; after delivery, subjects or their healthcare professionals were contacted to ascertain pregnancy outcome parameters and other exposures through the remainder of the pregnancy. RESULTS: A total of 608 women exposed to macrolides during pregnancy were enrolled; 511 of the exposures occurred during the first trimester. The comparison group comprised 773 women exposed to non-teratogenic preparations during the first trimester of pregnancy. No significant difference in the rate of major congenital malformations was found between the study group and the comparison group (3.4% vs 2.4%; p = 0.36; odds ratio (OR) 1.42; 95% CI 0.70, 2.88) or in the rate of cardiovascular malformations (1.6% vs 0.9%; p = 0.265; OR 1.91; 95% CI 0.63, 5.62). No significant differences were found between subgroups of macrolides in the rates of major congenital malformations or cardiac malformations, although for azithromycin this was of borderline significance. CONCLUSIONS: This study, in agreement with earlier smaller studies, suggests that the new macrolides do not pose a significantly increased risk of major congenital malformations or cardiac malformations.

heterogeneity of dna ploidy in endometrial carcinoma: comparison of different tissue samples obtained during diagnosis and treatment.

AIM: Comparison of DNA ploidy status of different tumour tissue samples (fresh/frozen vs. paraffin-embedded; curettage vs. hysterectomy samples) obtained during diagnosis and treatment of patients with endometrial carcinoma. PATIENTS AND METHODS: DNA ploidy status and conventional prognostic parameters were recorded for 74 patients with endometrial carcinoma prospectively. RESULTS: In 59 (79.7%) patients the DNA status was described as diploid in all analyzed tissue samples. The remaining 15 (20.3%) cases were described as DNA aneuploid in at least one of the corresponding tissue samples. The concordance between DNA ploidy status in fresh vs. paraffin-embedded hysterectomy samples as well as curettage vs. hysterectomy paraffin-embedded samples was high (kappa coefficient κ=0.6348, 95% confidence interval CI=0.3673-0.9023, and p=0.6408, 95% CI=0.3977-0.8838), however, the methods are not interchangeable. CONCLUSION: The DNA ploidy discordance observed in our study group seems to document intratumoral heterogeneity that should be expected when applying DNA ploidy status in the clinical management of endometrial carcinoma.

Appetite suppressants in pregnancy.

OBJECTIVES: Both, obesity as well as anorexia may be associated with infertility and other complications of pregnancy. Weight loss during pregnancy is therefore considered a risk factor. Weight loss and appetite suppressant are contraindicated during pregnancy, but the unintended exposure is probably not associated with higher risk. Our work was focused on trends in the appetite suppressants use in the Czech Republic and their embryotoxicity. METHODS: The pregnancies exposed to various appetite suppressants were followed prospectively in the years 1997-2012. The study group was compared to the comparison group which enrolled pregnant women exposed to non-teratogenic drugs. Drugs used as appetite suppressants were sibutramine and phentermine. RESULTS: Number of calls for this type of exposure was rare till 2005. Their number started to increase until 2009. Later, number of calls decreased because both drugs were withdrawn from the market. This finding reflects increasing tendency for the weight control in the group of fertile women in the Czech Republic. In our study, we did not reveal differences in pregnancy outcomes between study and comparison groups. CONCLUSIONS: However, we should be aware of the increasing food supplements exposure, that could be used as alternative to the appetite suppressants. Their potential risk results from the limited or completely absent control of their origin. Some of them have probably only placebo effect, but some of them could represent the risk.

Drugs during lactation accenting boron exposure.

OBJECTIVES: The benefits of breastfeeding are generally accepted. Risk of drug usage for baby due to lactation is well assessed minimally in certain cases. However, information given about drugs are often insufficient, frustrating, and not recommending lactation. In Czech Teratology Information Service (CZTIS) counselling we use these information. RESULTS: We have given advice in 58 cases inquiring the CZTIS about the risk of drug exposure during lactation. The most frequent queries were on chronic disease treatment following the drug exposure during pregnancy. Remaining cases were associated with acute infections. Mothers suffered from idiopathic bowel disease and psychiatric patients want to be informed before delivery about possibility to breastfeed their babies. Treatment of epilepsy, another frequent disease, is associated with better level of knowledge of both, neurologists and patients. Breastfeeding is recommended according to management in care of epileptic women. CONCLUSION: In our counselling we consider the factors which are involved in drug transfer in the milk and mechanisms and steps of transfer as well. We follow the classification of drugs during lactation by their effect on infants: absolutely contraindicated, temporary cessation of breastfeeding, drugs of special concern and drugs compatible with breastfeeding.

Czech Teratology Information Service: comparison of treatments by psychotropic and antiepileptic drugs.

OBJECTIVES: Care, treatment and follow-up in psychiatric and epileptic pregnant women were compared with women inquiring Czech Teratology Information Service (CZTIS) due to other exposure to drugs during pregnancy. METHODS: Data were collected by CZTIS, member of European Network of Teratology Information Services from 1996. Exposed groups were compared with pregnant women exposed to drugs which were not classified as major teratogens or hyperthermia. Groups do not vary in age, reproductive history and other parameters. RESULTS: We observed higher frequency of miscarriage and voluntary termination of pregnancy in the group of psychiatric patients. The number of malformation in prospective follow-up cases was lower than in control group. CONCLUSIONS: Chronic diseases as epilepsy or psychiatric disorders have to be treated during pregnancy. Women should obtain accurate information about possible risk before pregnancy. Co-operation is needed in these cases. Physicians should keep in mind that appropriate information is to be given to the patient according to her disease, education and comprehension of the problem. If there is any doubt they should organize help for their patients.