Trial of Calcium for Preeclampsia Prevention (CPEP): rationale, design, and methods
| Autor: | Joy R. Esterlitz, L. Ben Curet, Sig Linda Jacobson, Steven A. Friedman, Alice Stollenwerk Petrulis, Cynthia D. Morris, Robert L. Goldenberg, Jose G. Rigau-Perez, Mark A. Klebanoff, Gary M. Joffe, Patrick M. Catalano, John D. Clemens, Marian G. Ewell, John C. Hauth, Elizabeth G. Raymond, Bahaeddine M Sibai, Rebecca DerSimonian, Richard J. Levine |
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| Rok vydání: | 1996 |
| Předmět: |
Quality Control
medicine.medical_specialty Randomization Pregnancy Complications Cardiovascular Statistics as Topic chemistry.chemical_element Calcium Placebo Severity of Illness Index Preeclampsia Management Information Systems Placebos Random Allocation Double-Blind Method Pre-Eclampsia Pregnancy Internal medicine medicine Clinical endpoint Humans Multicenter Studies as Topic Randomized Controlled Trials as Topic Pharmacology business.industry Patient Selection medicine.disease United States Surgery Clinical trial Nutrition Assessment chemistry Research Design Sample Size Hypertension Gestation Patient Compliance Female Urinary Calculi business |
| Zdroj: | Controlled clinical trials. 17(5) |
| ISSN: | 0197-2456 |
| Popis: | The results of ten clinical trials suggest that supplemental calcium may prevent preeclampsia. However, methodologic problems and differences in study design limit the acceptance of the results and their relevance to other patient populations. Many of the trials were conducted in countries where, unlike the United States, the usual daily diet contained little calcium. Moreover, none of the trials has reported the outcome of systematic surveillance for urolithiasis, a potential complication of calcium supplementation. In response to the need for a thorough evaluation of the effects of calcium supplementation for the prevention of preeclampsia in the United States, the trial of Calcium for Preeclampsia Prevention (CPEP) was undertaken at five university medical centers. Healthy nulliparous patients were randomly assigned to receive either 2 g supplemental calcium daily ( n = 2295) or placebo ( n = 2294) in a double-blind study. Study tablets were administered beginning from 13 to 21 completed weeks of gestation and continued until the termination of pregnancy. CPEP employed detailed diagnostic criteria, standardized techniques of measurement, and systematic surveillance for the major study endpoints and for urolithiasis. The nutrient intake of each patient was assessed at randomization and at 32–33 weeks gestation. This report describes the study rationale, design, and methods. |
| Databáze: | OpenAIRE |
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