National Institute of Child Health and Human Development, Contracts Management Branch, 6100 Bldg., Suite 7A07, 6100- Executive Blvd MSC 7510, Bethesda, MD 20892-7510

A -- RANDOMIZED CLINICAL TRIAL OF EARLY PREGNANCY FAILURE: DATA COORDINATING CENTER SOL RFP-NICHD-2000-07 DUE 052500 POC Charles Newman, 301-435-6960, Fax: 301-402-3676 WEB: Click here to visit the NICHD, CMB home page and download, http://www.nichd.nih.gov/oam_cmb/. E-MAIL: Click here to contact the NICHD Contract Specialist, cn43m@nih.gov. 100% Small Business Set-aside. Early pregnancy failure, including spontaneous abortion, anembryonic gestation and first trimester fetal death, occurs in more than 15% of clinically recognized pregnancies. About one in four women experiences such a condition during her life. For more than half a century, dilatation and curettage (D&C) has been a standard of care for early pregnancy failure. Recently, D&C as the standard care for uncomplicated early intrauterine pregnancy failure has been challenged. Previous small studies have suggested that vaginal misoprostol appears to be an effective and safe treatment for early pregnancy failure. The National Institute of Child Health and Human Development (NICHD) is planning to conduct a multi-center randomized clinical trial. The purposes of this trial are: (1) to examine the efficacy of different management strategies for early pregnancy failure; (2) to examine the safety of the management strategies; and (3) to examine patients' anxiety, acceptability for the new managements and cost-effectiveness. Approximately 800 patients with early pregnancy failure under 13 weeks of gestation, will be recruited and randomized into either D&C or vaginal misoprostol treatment. Women who insist to be managed expectantly may be followed as an observational group. It is estimated that up to four clinical centers will participate in this clinical trial. The resultant contractor will coordinate data collection from the clinical centers as well as perform data management, quality control, data entry, cleaning, preliminary and interim analyses, and deliver the data and documents to NICHD. The tasks under this contract will be divided into three phases. Phase 1 (9 months): preparation and pilot study; Phase 2 (24 months): recruitment and follow-up; and Phase 3 (6 months): data editing, cleaning and analysis. Small Businesses that believe they have the capabilities necessary to serve as the Data Coordinating Center for this study, may access the Request for Proposal(s), RFP-NICHD-2000-07, electronically at the NICHD Contracts Management Branch's (CMB) home page at http://www.nichd.nih.gov/oam_cmb/ The NICHD does not intend to release hard copies of the RFP. The closing date for receipt of proposals will be May 25, 2000. Any questions concerning the RFP should be sent to Charles Newman, Contract Specialist, CMB, NICHD, 6100 Executive Building, Suite 7A07-MSC 7510, Bethesda, MD 20892-7510. Please note, the government reserves the right to cancel the requirement at any time prior to contract award. SEE Note 1. Posted 03/17/00 (W-SN435500). (0077)

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