LABORATORY TESTS OF BLOOD AND URINE SAMPLES FROM THE CPEP CLINICALTRIAL



NIH GUIDE, Volume 24, Number 8, March 3, 1995



RFP AVAILABLE:  NICHD-DESPR-95-14



P.T. 34



Keywords:

  Clinical Trial 

  Biological Resources 



National Institute of Child Health and Human Development



As a part of the Trial of Calcium for Preeclampsia Prevention (CPEP),

the National Institute of Child Health and Human Development (NICHD)

is planning to (1) compare urinary excretion of calcium and related

nutrients in preeclamptic women before and after the diagnosis of

preeclampsia to that in normal pregnant women at comparable

gestational ages, and determine the effect of oral calcium

supplementation on the excretion of these substances; (2) determine

the presence or absence of proteinuria not previously ascertained in

up to 125 urine specimens obtained from normal women and from women

with gestational hypertension within seven days of documented

hypertension; and (3) measure the quantity of elemental calcium in

each of up to 100 study medication tablets for purposes of quality

control.  The comparison of urinary excretion of calcium and related

nutrients will be a nested case control study using stored urine

specimens collected at specified times during pregnancy and at the

diagnosis of preeclampsia from pregnant women participating in CPEP.

CPEP is a randomized clinical trial designed to determine whether

oral calcium supplementation will prevent preeclampsia.  The

Contractor will be expected to measure calcium, sodium, potassium,

chloride, magnesium, zinc, phosphorus, urea nitrogen, and creatinine

in approximately 5912 urine specimens selected by the Project Officer

over the course of one year.  Measurements of protein and creatinine

in up to 125 additional urine specimens and calcium content of up to

100 study medication tablets must also be completed within the same

year.



INQUIRIES



This announcement is a new solicitation.  The issuance of this

Request for Proposals (RFP) will be on or about March 6, 1995, and

proposals are due by 4:00 p.m. (local time), May 2, 1995.  The

short-form version of the RFP will be provided first, which includes

only the Statement of Work, Technical Reporting Requirements,

Background Information, and the Evaluation Criteria to be used for

selection of the awardee.  After examining this, a full-text version

of the RFP must be requested, in writing, for those organizations

interested in responding.  FAX requests are acceptable.  All requests

must cite the RFP number and include two self-addressed mailing

labels.  All sources who consider themselves qualified are encouraged

to submit a proposal.  This advertisement does not commit the

Government to make an award.  Organizations desiring a copy of the

short-form RFP may send a written request to:



Mrs. Lynn Salo

Office of Grants and Contracts

National Institute of Child Health and Human Development

Executive Building, Room 7A07

6100 Executive Boulevard MSC 7510

Bethesda, MD  20892-7510

Telephone:  (301) 496-4611

FAX:  (301) 402-3676



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