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Prospective, controlled, multicentre study of loperamide in pregnancy: PATIENTS AND METHODS

The Motherisk Program is a counselling service for pregnant and lactating mothers, and their health professionals. Infor­mation about the safety or risk of drugs, chemicals, radiation and infectious diseases is given to approximately 35,000 call­ers per year. The other centres in Italy, Israel and Finland have similar services. The authors attempted to follow all the women who had called enquiring about the safety of this drug in pregnancy. All women who had used the drug during preg­nancy and agreed to participate were included in the study, with no exclusions. Upon contacting these women, history of exposure and pregnancy outcome were obtained, as well as other end points of interest, with the aid of a structured ques­tionnaire. Exposure history included medical indication for drug used, dosage, frequency of administration and timing of exposure. Outcomes were confirmed whenever possible by the child’s primary care physician. The primary outcome of interest was the presence or absence of a major malformation. Major malformation was defined as the presence of an anom­aly that has an adverse effect on either the function or social acceptability of the individual. Secondary outcomes of interest were spontaneous or therapeutic abortions, still­births, and presence or absence of a minor abnormality. Ex­posure was said to be during organogenesis if it occurred between the fourth and 14th week of gestation, when rates of 1% to 3% for major malformations, 10% to 15% for minor malformations and up to 15% for spontaneous abortions are expected. In addition to comparing mean birth weights be­tween the study and control groups, birth weights were com­pared between the babies whose mothers took the drug for only a few days for an acute case of diarrhea and those who took the drug throughout the pregnancy for chronic bowel disease.

Each woman was matched to a subsequent woman who had either called the authors about loperamide but had not needed to use it, or a woman who had been exposed to cisapride (a nonteratogenic drug for gastrointestinal motility problems). They were also matched for age, smoking and alcohol use. To assess the possibility of selection bias, women lost to follow-up were compared with those participating for age, parity, smoking and alcohol use. Outcome end points of interest were compared between the study and control groups with the Student’s t test, % or the Fisher’s exact test, whenever appropriate. These follow-up procedures were ap­proved by The Hospital for Sick Children’s Research Ethics Committees.
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Category: Health

Tags: Diarrhea, Loperamid, pregnancy

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