AMENDMENT TO RFA-HD-02-025, RESEARCH ON THE SCOPE AND CAUSES OF STILLBIRTH
IN THE UNITED STATES 

RELEASE DATE:  January 29, 2003 

NOTICE: NOT-HD-03-008

National Institute of Child Health and Human Development (NICHD)
 (http://www.nichd.nih.gov/)

The National Institute of Child Health and Human Development (NICHD) is 
publishing this notice to clarify several requirements for applications 
responding to NICHD Request for Applications RFA-HD-02-025, RESEARCH ON 
THE SCOPE AND CAUSES OF STILLBIRTH IN THE UNITED STATES 
(http://grants.nih.gov/grants/guide/rfa-files/RFA-HD-02-025.html).  The 
following information reiterates and expands on the RFA language 
regarding the objectives and requirements for a geographic population-
based study of stillbirth. 

(1) As stated in the RFA, the second research objective is to:  

"obtain a geographic population-based determination of the incidence of 
fetal deaths at 20 weeks gestation or greater, their causes, and risk 
factors.  This will involve a geographic population-based study of 
stillbirths enrolled at the time of demise, and a sub-cohort case-
control study." 

(2) In order to achieve this objective, the project organization will 
be developed post-award as stated in the RFA as follows: 

"The grantees will form a cooperative network in scientific partnership 
with NICHD to conduct a geographic population-based study of 
stillbirths, which will require a highly effective surveillance system, 
and at least 90 percent ascertainment."

Thus, a "geographic population-based study of stillbirths enrolled at 
the time of demise" means that within a geographic area, the 
investigative team should have the capability to have at least 90 
percent case ascertainment in real time of women living in the 
geographic area, and to capture information on at least 90 percent of 
all the pregnancies (ending in live- or stillbirth) occurring to the 
women living in the geographic area.  The boundaries of the geographic 
catchment must be able to be drawn on a map.    

(3) As a starting point, the applicant is required to define the 
minimum geographic catchment as described in the RFA as follows:

"Minimum Catchment Populations:  Clinical Sites with urban populations 
should have a catchment population with at least 8,000 deliveries per 
year, and those with rural populations at least 3,000 deliveries per 
year in order to apply.  Applicants may propose urban only, rural only, 
or urban and rural geographic areas for case ascertainment. The 
applicant must demonstrate that a large majority of the population 
receives prenatal care within the catchment."
 
(4) Thus, the applicant must provide the following information in the 
application as delineated under Supplemental Instructions in the RFA:

"(1) Patient population

o Geographic definition of the catchment area proposed for a 
population-based assessment of stillbirths by the applicant 
organization.

o Documentation of number of deliveries at or later than 20 weeks 
within the catchment geographic population from 1995-1999 to include: 
(a) each pregnancy outcome (fetal death, live birth,) stratified by 
race/ethnicity; (b) each pregnancy outcome stratified by gestational 
age (20-23 weeks, 24-27 weeks, 28-31 weeks, 32-36 weeks, 37 plus 
weeks); (c) proportion receiving prenatal care within the catchment 
stratified by trimester.

o Estimated rates of fetal deaths at or later than 20 weeks per 1000 
live births plus stillbirths, and rates of fetal autopsy and placental 
pathology from 1995-1999.

o Distribution of causes of fetal deaths at or later than 20 weeks from 
1995-1999."    
 
It is recognized that interested potential applicants may not have a 
geographically-based system of prenatal care delivery or stillbirth 
surveillance in place, and that collaborations will have to be 
developed to respond to the RFA.  This is delineated under Supplemental 
Instructions in the RFA as follows:

"(2) Staffing and Procedures

o Descriptions of the staff and programs in place for surveillance of 
deliveries in the catchment area to identify all eligible fetal deaths 
at or later than 20 weeks, and proposals for expansion of services if 
needed.  This includes creative proposals for partnering with 
community-based organizations including health departments."

INQUIRIES

For further information, contact:

Marian Willinger
Special Assistant for SIDS
National Institute of Child Health and Human Development
6100 Executive Boulevard, Room 4B03, MSC 7510
Bethesda, MD  20892-7510
Telephone:  (301) 435-6896
Fax:  (301) 496-3790
Email:  willingm@mail.nih.gov 


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