SOLICITATION NOTICE
A -- The Effects of Aspirin in Gestation and Reproduction (EAGR) Trial: Clinical Sites
- Notice Date
- 3/20/2006
- Notice Type
- Solicitation Notice
- NAICS
- 541710
— Research and Development in the Physical, Engineering, and Life Sciences
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Institute of Child Health and Human Development, Contracts Management Branch 6100 Executive Blvd., Suite 7A07, MSC7510, Bethesda, MD, 20892-7510
- ZIP Code
- 20892-7510
- Solicitation Number
- NIH-NICHD-2006-05
- Archive Date
- 5/31/2006
- Description
- The Division of Epidemiology, Statistics and Prevention Research, National Institute of Child Health and Human Development, National Institutes of Health, plans to solicit proposals for a multi-site (up to three sites) clinical trial to evaluate the effect of daily low-dose aspirin on all phases of reproduction beginning at preconception and continuing throughout pregnancy, including implantation and live births. The objectives of this study are to: (1) determine the effect of low-dose aspirin in combination with folic acid on the incidence of live births among those with HCG detected pregnancy relative to folic acid alone; (2) determine the effect of low-dose aspirin in combination with folic acid treatment on incidence of HCG detected pregnancy relative to folic acid alone; (3) determine the effect of low-dose aspirin in combination with folic acid treatment on early loss of pregnancy (ELP) relative to folic acid alone; (4) determine the effect of low-dose aspirin in combination with folic acid treatment on pregnancy outcomes relative to folic acid alone; (5) determine the effect of low-dose aspirin in combination with folic acid treatment on intermediate outcomes including endometrial thickness and cord arterial blood flow; (6) create a repository of urine and serum samples for future evaluation; and (7) investigate the validity of self-reported aspirin use by comparison with laboratory measured aspirin metabolites. In addition to the primary study noted above, offerors may also propose to provide central laboratory services for all of the clinical sites participating in the study. Only one of the clinical sites will be selected to provide the central laboratory services. It is anticipated that three five-year, cost-reimbursement type contracts will be awarded, with awards made on or about September 30, 2006. The solicitation will be issued on or about April 5, 2006, and will be posted on this Web site. Offerors are responsible for routinely checking this Web site for any amendments to the solicitation. Proposals will be due forty-five days after the date of issuance of the solicitation. All responsible sources may submit a proposal, which will be considered by the Government. See Numbered Note 26.
- Record
- SN01010473-W 20060322/060320213500 (fbodaily.com)
- Source
-
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