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