NOT-HD-00-004: RANDOMIZED CLINICAL TRIAL ON MANAGEMENT OF EARLY PREGNANCY FAILURE: CLINICAL CENTER(S)

Department of Health
and Human Services (HHS)
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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:  [email protected]
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