Calcium for Pre-Eclampsia Prevention (CPEP)

NCT00000534 | Completed Phase 3

• 1 other identifier: 77
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Cardiovascular Diseases; Eclampsia; Heart Diseases; HELLP Syndrome; Hypertension; Pre-Eclampsia; Pregnancy Toxemias; Vascular Diseases

Interventions

calcium DRUG

dietary supplements BEHAVIORAL

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

Nulliparous, normotensive, pregnant women.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): lead

Related Publications (5)

• 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.

  PMID: 8932976 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.

  PMID: 9396883 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.

  PMID: 10432033 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.

  PMID: 9790393 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.

  PMID: 9211675 BACKGROUND

MeSH Terms

Conditions

Cardiovascular Diseases; Eclampsia; Heart Diseases; HELLP Syndrome; Hypertension; Pre-Eclampsia; Vascular Diseases

Interventions

Calcium; Dietary Supplements

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Metals, Alkaline Earth; Elements; Inorganic Chemicals; Metals; Blood Coagulation Factors; Biological Factors; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Patrick Catalano

  Case Western Reserve University

• Luis Curet

  University of New Mexico

• John Hauth

  University of Alabama at Birmingham

• Cynthia Morris

  Oregon Health and Science University

• Baha Sibai

  University of Tennessee

Study Design

• Study Type: interventional
• Phase: phase 3
• Masking: DOUBLE
• Purpose: PREVENTION
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 1999
• First Posted: October 28, 1999
• Study Start: March 1, 1991
• Study Completion: June 1, 2000
• Last Updated: March 13, 2017

Record last verified: 2017-03