drugset / Trial / NCT00000534
Calcium for Pre-Eclampsia Prevention (CPEP)
Phase 3
Completed
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Double-blindPrevention
Summary
To evaluate the efficacy of 2 grams per day of oral calcium supplementation in reducing the combined incidence of hypertensive disorders of pregnancy: pre-eclampsia, eclampsia, and the HELLP Syndrome (hypertension, thrombocytopenia, hemolysis, and abnormal liver function). The National Institute of Child Health and Human Development (NICHD) initiated the trial in 1991, with joint funding provided by the National Heart, Lung, and Blood Institute in fiscal years 1992, 1993, and 1995.
Timeline
- Start
- 1991-03
- Primary completion
- —
- Completion
- 2000-06
Publications
- Background Levine RJ, Esterlitz JR, Raymond EG, DerSimonian R, Hauth JC, Ben Curet L, Sibai BM, Catalano PM, Morris CD, Clemens JD, Ewell MG, Friedman SA, Goldenberg RL, Jacobson SL, Joffe GM, Klebanoff MA, Petrulis AS, Rigau-Perez JG. Trial of Calcium for Preeclampsia Prevention (CPEP): rationale, design, and methods. Control Clin Trials. 1996 Oct;17(5):442-69. doi: 10.1016/s0197-2456(96)00106-7.
- Background Sibai BM, Ewell M, Levine RJ, Klebanoff MA, Esterlitz J, Catalano PM, Goldenberg RL, Joffe G. Risk factors associated with preeclampsia in healthy nulliparous women. The Calcium for Preeclampsia Prevention (CPEP) Study Group. Am J Obstet Gynecol. 1997 Nov;177(5):1003-10. doi: 10.1016/s0002-9378(97)70004-8.
- Background Mills JL, DerSimonian R, Raymond E, Morrow JD, Roberts LJ 2nd, Clemens JD, Hauth JC, Catalano P, Sibai B, Curet LB, Levine RJ. Prostacyclin and thromboxane changes predating clinical onset of preeclampsia: a multicenter prospective study. JAMA. 1999 Jul 28;282(4):356-62. doi: 10.1001/jama.282.4.356.
- Background Joffe GM, Esterlitz JR, Levine RJ, Clemens JD, Ewell MG, Sibai BM, Catalano PM. The relationship between abnormal glucose tolerance and hypertensive disorders of pregnancy in healthy nulliparous women. Calcium for Preeclampsia Prevention (CPEP) Study Group. Am J Obstet Gynecol. 1998 Oct;179(4):1032-7. doi: 10.1016/s0002-9378(98)70210-8.
- Background Levine RJ, Hauth JC, Curet LB, Sibai BM, Catalano PM, Morris CD, DerSimonian R, Esterlitz JR, Raymond EG, Bild DE, Clemens JD, Cutler JA. Trial of calcium to prevent preeclampsia. N Engl J Med. 1997 Jul 10;337(2):69-76. doi: 10.1056/NEJM199707103370201.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Calcium carbonate | Other / unclassified | 2 g | Oral |