The fetal safety of hydrocortisone-pramoxine (Proctofoam-HC) for the treatment of hemorrhoids in late pregnancy.

OBJECTIVE: Fetal safety has never been studied for any drug used in the treatment of hemorrhoids. Proctofoam-HC is a combination of a corticosteroid and a local anaesthetic that is proven effective for the treatment of hemorrhoids. The objective of this study was to assess prospectively the fetal safety of third trimester exposure to Proctofoam-HC. METHODS: In a multicentre study, 204 [corrected] women exposed to Proctofoam-HC in the third trimester and a similar number of control pregnant women were followed up postnatally. RESULTS: When compared to controls exposure to Proctofoam-HC was not associated with any adverse fetal effects on birth weight, gestational age, rates of prematurity, or pre- or postnatal complications. CONCLUSION: Proctofoam-HC is safe to use in the treatment of hemorrhoids in late pregnancy.

A simple and rapid HPLC method for the detection of glyburide in plasma original research communication (analytical).

INTRODUCTION: Although a variety of HPLC methods have been previously described for the quantification of glyburide, attempts to implement them clinically have been unsuccessful. Some are time consuming, expensive, or not directly applicable to human plasma. Others are outdated, as the necessary materials are no longer available. OBJECTIVE: To describe a simple, rapid, and sensitive HPLC method for the analysis of human plasma and perfusate. DESIGN AND METHOD: Samples were extracted by liquid-liquid extraction with chloroform at neutral pH. Glyburide was detected at 254 nm, with a total run time of 7 min per sample. RESULTS: Standard curves of 50 to 400 ng/mL of glyburide were linear (r(2)=0.998). Inter-day and intra-day sample coefficient of variations were 8% and 4%, respectively. Recoveries ranged from 71 to 75% in human plasma samples for the 20-400 ng/mL concentration range. CONCLUSION: Clinically, this method can be applied in the therapeutic drug monitoring of glyburide.

Ethical issues in pharmacologic research in women undergoing pregnancy termination: a systemic review and survey of researchers.

Objective. To evaluate the ethics of performing research in the field of maternal-fetal medicine involving women undergoing pregnancy termination. Methods. We identified published pharmacological studies performed during elective pregnancy termination. In addition, a questionnaire was administered to investigate whether this research would be acceptable to professionals performing research in the field of maternal-fetal pharmacology. Results. The majority of participants believe that this form of research is necessary to furthering our understanding of drug use in pregnancy. Twenty studies were identified in women undergoing a pregnancy termination where exogenous drug was administered and drug measurement conducted during an abortion. The majority of studies were completed by international groups and not in North America or Western Europe. Conclusions. While a majority of respondents to the survey felt that, although research in women undergoing a pregnancy termination is ethically acceptable, 40% stated that it is not likely to be approved by institutional review boards of most North American medical institutions.