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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