Awardee OrganizationLOS ANGELES REG FAMILY PLANNING COUNCIL
Description
Abstract Text
This contract provides support for a clinical trial whose overall
objectives are: (1) to measure the ability of prophylactic antibiotics to
reduce the risk of PID and other events requiring premature removal of the
IUD, (2) to estimate incidence rates for PID and other events requiring IUD
removal, and (3) to determine the side effects of the antibiotic used in
the treatment. The investigation will be conducted in two parts: a
preliminary study in which the protocol will be validated and the initial
choice of antibiotic will be confirmed by microbiological studies of
endometrial tissue for women requiring premature removal of their IUD, and
a larger study in which the benefit of prophylactic antibiotics will be
evaluated in a multi-center, randomized, double-blind study of 2000 women
receiving an IUD as their choice for contraception. Study subjects will be
obtained from the following sources for this study: Kaiser-Permanente Los
Angeles, Kaiser-Permanente Woodland Hills, Planned Parenthood-World
Population (Clinics at El Monte, Midtown Los Angeles, Santa Monica, and
Sherman Oaks), and Los Angeles County Women's Hospital. The Contractor
shall obtain information about the diagnosis and management of women who
develop problems associated with IUD use that require removal of the device
(subacute salpingitis, endometritis, endoparametritis, bleeding, or pelvic
pain) and acquire information about participants who require treatment for
acute pelvic inflammatory disease ()ID). The data collected shall be
sufficient to determine whether the use of prophylactic antibiotics will be
a valuable adjunct to the IUD-insertion procedure.
Eunice Kennedy Shriver National Institute of Child Health and Human Development
CFDA Code
DUNS Number
UEI
Project Start Date
01-February-1991
Project End Date
31-January-1995
Budget Start Date
28-May-1992
Budget End Date
31-January-1993
Project Funding Information for 1992
Total Funding
$596,886
Direct Costs
Indirect Costs
$82,329
Year
Funding IC
FY Total Cost by IC
1992
Eunice Kennedy Shriver National Institute of Child Health and Human Development
$596,886
Year
Funding IC
FY Total Cost by IC
Sub Projects
No Sub Projects information available for N01HD013112-001
Publications
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No Publications available for N01HD013112-001
Patents
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Outcomes
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No Outcomes available for N01HD013112-001
Clinical Studies
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News and More
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History
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Similar Projects
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