Iron supplementation during pregnancy--experiences of a randomized trial relying on health service personnel.
This article reports the design and feasibility of a randomized controlled trial of the benefits of routine iron prophylaxis during pregnancy. The multicenter trial, supported by a small budget, relied on health service personnel in Finnish maternity centers. Iron prophylaxis has had an established position in Finnish maternity care, and iron is freely available. This contributed to our decision to ask for informed consent after randomization. During a year, 2960 mothers were recruited by midwives in 27 maternity health centers and randomized into two groups: selective and routine iron supplementation. Mothers were followed until the postpartum checkup, and data were collected by five different questionnaires and abstracted from the infant's patient record. Adherence of the midwives to the study protocol was satisfactory, as was mothers' compliance with recommended treatments. However, because the study was designed to compare two treatment policies, problems of nonmasking hamper of the biologic effects of iron. This trial encourages the use of existing health services and their personnel in evaluation of medical technology.
Hemminki
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Department of Public Health, University of Helsinki, Finland.
Uski
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Koponen
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Rimpelä
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D002985:Clinical Protocols; D005260:Female; D005387:Finland; D006280:Health Workforce; D006454:Hemoglobins / Q000032:analysis; D006801:Humans; D007231:Infant, Newborn; D007501:Iron / Q000627:therapeutic use*; D008499:Medical Records; D008880:Midwifery; D011247:Pregnancy; D011256:Pregnancy Outcome; D011295:Prenatal Care; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D011795:Surveys and Questionnaires
D006454:Hemoglobins; D007501:Iron