RANDOMIZED CLINICAL TRIAL ON MANAGEMENT OF EARLY PREGNANCY FAILURE: DATA COORDINATING CENTER Release Date: April 3, 2000 NOTICE: HD-00-005 RFP AVAILABLE: RFP-NICHD-2000-07 National Institute of Child Health and Human Development ONE HUNDRED PERCENT SMALL BUSINESS SET-ASIDE 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 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. 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. 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; perform data management, quality control, data entry, cleaning, and 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 (nine months): preparation and pilot study; Phase 2 (24 months): recruitment and follow-up; and Phase 3 (six 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 Proposals (RFP), RFP-NICHD-2000-07, 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. 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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