Pelvic inflammatory disease (PID) affects over one million American women every year. Yet, the diagnosis of this common and frequently morbid condition remains unstandardized and the approach to treatment uncertain. This study is designed to address two of the outstanding issues confronting clinicians who care for women with PID: the accuracy of available diagnostic techniques, and the efficacy and effectiveness of inpatient versus outpatient treatment.
The first aim of this study is to conduct a multicenter randomized clinical trial (RCT) of 1300 women with suspected PID in order to evaluate the efficacy and effectiveness of inpatient treatment with at least 48 hours of parenteral Cefoxitin and fourteen days of Doxycycline compared with outpatient treatment with a single dose of parenteral Ceftriaxone plus fourteen days of oral Doxycycline. The primary long-term outcomes in this study will be: 1) Time to fertility i.e., time to the first pregnancy after the index episode of PID among non-contracepting women. 2) Infertility. Involuntary infertility will be defined using a standard definition: any sexual activity without contraception for a period of at least one year in total without resultant pregnancy.

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
3M01RR000040-37S4
Application #
2757477
Study Section
Project Start
Project End
Budget Start
1997-10-01
Budget End
1998-09-30
Support Year
37
Fiscal Year
1998
Total Cost
Indirect Cost
Name
University of Pennsylvania
Department
Type
DUNS #
042250712
City
Philadelphia
State
PA
Country
United States
Zip Code
19104
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