Calcium for Pre-Eclampsia Prevention (CPEP)

March 9, 2017 updated by: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

BACKGROUND:

A considerable body of data has associated lower blood pressures with higher levels of dietary calcium. Epidemiologic studies, laboratory evaluations, and clinical trials have also indicated that the incidence of hypertensive disorders of pregnancy is affected similarly by calcium intake. A meta-analysis of five controlled clinical trials of calcium supplementation in pregnancy suggested a significant reduction in proteinuric pre-eclampsia of 46 percent. Several of the trials, however, suffered from 'pitfalls' in the diagnosis of pre-eclampsia, including lack of blinding, uncertain definition of endpoints, and unknown techniques of measurement. Most trials have not assessed the role of dietary nutrients or the possibility that a subgroup with low baseline urinary calcium may benefit most from calcium supplementation. In no trial has the potential for increased risk of kidney stones in the treatment group been examined systematically. Moreover, the daily schedule for administration of calcium, has generally not been reported. There was a great need, therefore, to evaluate the efficacy of calcium supplementation for the prevention of pre-eclampsia in a large multicenter controlled clinical trial. The trial considered the role of dietary nutrients, establish whether treatment is beneficial only for those with low baseline urinary calcium, conduct systematic surveillance for urolithiasis, and employ standardized terminology, techniques of measurement, and diagnostic criteria. The NHLBI provided funding to NICHD for three years by means of an Intraagency Agreement (Y01HC20154).

DESIGN NARRATIVE:

Randomized, double-blind, multicenter. Healthy nulliparous patients were randomly assigned to receive either 2 grams of supplemental calcium daily ((n = 2,295) or placebo (n = 2,294) 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. Eligible patients entered a run-in period of 6 to 14 days to exclude highly noncompliant subjects. During the run-in, obstetrical ultrasound was performed if it had not been obtained previously, and blood was drawn for serum calcium and creatinine. Follow-up visits were scheduled every four weeks through the 29th week of gestation, then every two weeks through the 35th week, and weekly thereafter. Blood pressure and urine-protein were obtained at each clinic visit, during labor and delivery, and during the first 24 hours postpartum. Primary endpoints included pregnancy-associated hypertension, pregnancy-associated proteinuria, pre-eclampsia, eclampsia, or hypertension. Other endpoints included placental abruption, cerebral hemorrhage or thrombosis, elevated liver enzymes, acute renal failure, and disseminated intravascular coagulation. Surveillance was conducted for renal calculi. Recruitment began in May 1992 and ended in March 1995. Follow-up was completed in October of 1995. Data analysis continued through March 2000 under the NICHD contract N01HD13121.

Study Type

Interventional

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Nulliparous, normotensive, pregnant women.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Masking: DOUBLE

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Investigators

  • 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

Publications and helpful links

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General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 1991

Study Completion

June 1, 2000

Study Registration Dates

First Submitted

October 27, 1999

First Submitted That Met QC Criteria

October 27, 1999

First Posted (ESTIMATE)

October 28, 1999

Study Record Updates

Last Update Posted (ACTUAL)

March 13, 2017

Last Update Submitted That Met QC Criteria

March 9, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 77

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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