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 ON MANAGEMENT OF EARLY PREGNANCY FAILURE: CLINICAL CENTER(S) SOL RFP-NICHD-2000-06 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. 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 clinical 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 managementsand cost-effectiveness. The goal of the study is to enroll and randomize 800 patients with an early pregnancy failure (including incomplete spontaneous abortion, inevitable abortion, anembryonic gestation and fetal death) under 13 weeks of gestation, across all sites, in no more than 24 months. It is estimated that up to four clinical centers will participate in this clinical trial. Offerors are not required to have the ability to recruit a stated minimum number of patients to be considered for award. However, the NICHD seeks clinical sites with a high potential for successful performance and one key element of a successful clinical site proposal will be demonstrated evidence of recruitment ability. Subjects will be interviewed for baseline information. All patients will be interviewed regarding their anxiety and acceptability of the treatment. We will also compare the cost-effectiveness between these two treatments. Patients who insist to be managed expectantly may be followed as an observational group. Organization's that believe they have the capabilities and recruitment ability necessary to participate in this research study, may access the Request for Proposal(s), RFP-NICHD-2000-06, 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 is 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. Posted 03/17/00 (W-SN435493). (0077)

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