RANDOMIZED CLINICAL TRIAL ON MANAGEMENT OF EARLY PREGNANCY FAILURE: CLINICAL CENTER(S) Release Date: April 3, 2000 NOTICE: HD-00-004 RFP AVAILABLE: RFP-NICHD-2000-06 National Institute of Child Health and Human Development Early pregnancy failure, including spontaneous abortion, anembryonic gestation and first trimester fetal death, occurs in more than 15 percent 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 in order to examine: (1) the efficacy of different management strategies for early pregnancy failure, (2) the safety of the management strategies, and (3) patient anxiety, acceptability of the new management approaches, and 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, 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. Cost- effectiveness of treatments will be compared. Patients who insist upon expectant management may be followed as an observational group. Organizations that believe they have the capabilities and recruitment ability necessary to participate in this research study may access the Request for Proposals (RFP), RFP-NICHD-2000-06, at http://www.nichd.nih.gov/about/org/od/oam/. The NICHD does not intend to distribute hard copies of the RFP. The closing date for receipt of proposals is June 4, 2000. Please note, the government reserves the right to cancel the requirement at any time prior to contract award. INQUIRIES Charles Newman Contract Specialist Contracts Management Branch National Institute of Child Health and Human Development 6100 Executive Blvd., Suite 7A07, MSC 7510 Bethesda, MD 20892-7510 Telephone: 301-435-6960 Fax: 301-402-3676 E-mail: cn43m@nih.gov

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