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1. Failure of Metronidazole to Prevent Preterm Delivery among Pregnant Women with AsymptomaticTrichomonas vaginalisInfection

Author

Mark A. Klebanoff, A. Meier, S. J. Yaffe, T. A. Siddiqi, C. Alfonso, Robert P. Nugent, Sharon L. Hillier, John C. Hauth, Donald J. Dudley, Jay D. Iams, A. Northen, M. L. Fischer, Brian M. Mercer, M. L. Sherman, S. Nicholson, Cora MacPherson, Gary R. Thurnau, S. Leindecker, Mark B. Landon, F. Johnson, L. Reynolds, M. DiVito, Elizabeth Thom, Nancy C. Elder, E. Mueller-Heubach, S. Beydoun, Marshall D. Lindheimer, Paul J. Meis, G. S. Norman, Kenneth J. Leveno, T. Camon, R. P. Heine, R. B. Newman, Atef H. Moawad, F. LeBoeuf, Steve N. Caritis, S. F. Bottoms, Phyllis L. Jones, Steven L. Bloom, J. M. Ernest, Ronald J. Wapner, W. Trout, R. D. Ramsey, Jorge E. Tolosa, B. A. Collins, J. C. Carey, Michael D. Berkus, R. L. Copper, Charlotte Catz, M. Swain, Margaret Cotroneo, F. Doyle, and William W. Andrews

Subjects
Adult, medicine.medical_specialty, Antitrichomonal Agents, Placebo, medicine.disease_cause, Asymptomatic, Obstetric Labor, Premature, Vaginal disease, Pregnancy, Metronidazole, Trichomonas vaginalis, medicine, Animals, Humans, Treatment Failure, Gynecology, Trichomoniasis, Obstetrics, business.industry, Infant, Newborn, General Medicine, medicine.disease, Pregnancy Complications, Pregnancy Complications, Parasitic, Vagina, Gestation, Female, medicine.symptom, Trichomonas Vaginitis, business, Infant, Premature, Follow-Up Studies, medicine.drug
Abstract

Infection with Trichomonas vaginalis during pregnancy has been associated with preterm delivery. It is uncertain whether treatment of asymptomatic trichomoniasis in pregnant women reduces the occurrence of preterm delivery.We screened pregnant women for trichomoniasis by culture of vaginal secretions. We randomly assigned 617 women with asymptomatic trichomoniasis who were 16 to 23 weeks pregnant to receive two 2-g doses of metronidazole (320 women) or placebo (297 women) 48 hours apart. We treated women again with the same two-dose regimen at 24 to 29 weeks of gestation. The primary outcome was delivery before 37 weeks of gestation.Between randomization and follow-up, trichomoniasis resolved in 249 of 269 women for whom follow-up cultures were available in the metronidazole group (92.6 percent) and 92 of 260 women with follow-up cultures in the placebo group (35.4 percent). Data on the time and characteristics of delivery were available for 315 women in the metronidazole group and 289 women in the placebo group. Delivery occurred before 37 weeks of gestation in 60 women in the metronidazole group (19.0 percent) and 31 women in the placebo group (10.7 percent) (relative risk, 1.8; 95 percent confidence interval, 1.2 to 2.7; P=0.004). The difference was attributable primarily to an increase in preterm delivery resulting from spontaneous preterm labor (10.2 percent vs. 3.5 percent; relative risk, 3.0; 95 percent confidence interval, 1.5 to 5.9).Treatment of pregnant women with asymptomatic trichomoniasis does not prevent preterm delivery. Routine screening and treatment of asymptomatic pregnant women for this condition cannot be recommended.

Published
2001
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2. Risk-based approach to developing a national residue sampling plan for testing under European Union regulation for veterinary medicinal products and coccidiostat feed additives in domestic animal production.

Author

Danaher M, Shanahan C, Butler F, Evans R, O'Sullivan D, Glynn D, Camon T, Lawlor P, and O'Keeffe M

Subjects
Animal Feed analysis, Animals, Anthelmintics analysis, Anti-Bacterial Agents analysis, Antifungal Agents analysis, Antiprotozoal Agents analysis, Cattle, Chickens, Coccidiostats analysis, European Union, Food Safety, Goats, Risk Assessment, Sheep, Swine, Dietary Supplements analysis, Drug Residues analysis, Meat analysis, No-Observed-Adverse-Effect Level, Veterinary Drugs analysis
Abstract

A ranking system for veterinary medicinal products and coccidiostat feed additives has been developed as a tool to be applied in a risk-based approach to the residue testing programme for foods of animal origin in the Irish National Residue Control Plan (NRCP). Three characteristics of substances that may occur as residues in food are included in the developed risk ranking system: Potency, as measured by the acceptable daily intake assigned by the European Medicines Agency Committee for Medicinal Products for Veterinary Use, to each substance; Usage, as measured by the three factors of Number of Doses, use on Individual animals or for Group treatment, and Withdrawal Period; and Residue Occurrence, as measured by the number of Non-Compliant Samples in the NRCP. For both Number of Doses and Non-Compliant Samples, data for the 5-year period 2008-12 have been used. The risk ranking system for substances was developed for beef cattle, sheep and goats, pigs, chickens and dairy cattle using a scoring system applied to the various parameters described above to give an overall score based on the following equation: Potency × Usage (Number of Doses + Individual/Group Use + Withdrawal Period) × Residue Occurrence. Applying this risk ranking system, the following substances are ranked very highly: antimicrobials such as amoxicillin (for all species except pigs), marbofloxacillin (for beef cattle), oxytetracycline (for all species except chickens), sulfadiazine with trimethoprim (for pigs and chickens) and tilmicosin (for chickens); antiparasitic drugs, such as the benzimidazoles triclabendazole (for beef and dairy cattle), fenbendazole/oxfendazole (for sheep/goats and dairy cattle) and albendazole (for dairy cattle), the avermectin ivermectin (for beef cattle), and anti-fluke drugs closantel and rafoxanide (for sheep/goats); the anticoccidials monensin, narasin, nicarbazin and toltrazuril (for chickens). The risk ranking system described is a relatively simple system designed to provide a reliable basis for selecting the veterinary medicinal products and coccidiostat feed additives that might be prioritised for residue testing.

Published
2016
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