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PID Evaluation and Clinical Health (PEACH) Study

PID Evaluation and Clinical Health (PEACH) Study. PEACH. Multi-center randomized clinical trial of 831 women followed 2-5 yrs through 10/00. Inpatient 2gr Cefoxitin IV every 6 hours 100grs Doxiciclyne IV Every 12 hours. Outpatient 2gr Cefoxitin 1gr Probenecid

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PID Evaluation and Clinical Health (PEACH) Study

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  1. PID Evaluation and Clinical Health (PEACH) Study

  2. PEACH Multi-center randomized clinical trial of 831 women followed 2-5 yrs through 10/00

  3. Inpatient 2gr Cefoxitin IV every 6 hours 100grs Doxiciclyne IV Every 12 hours Outpatient 2gr Cefoxitin 1gr Probenecid 100 mg Doxiciclyne oral twice a day Study treatment 1 shot

  4. Eligibility of patients into the study Inclusion (Must meet all of the following criteria) • 37 years of age or younger • Willing to participate • Presenting with a history of pelvic discomfort for <30 days (this does not need to be the chief complain) • Experiencing pelvic organ tenderness (uterine or adnexal tenderness) on bilateral examination • Leukorrhea and/or Mucopurulent Cervicitis and/or untreated known + GC or CT

  5. Eligibility of patients into the study • Exclusion • (Must not meet any of the following criteria) • Currently pregnant by urine testing. • Tubo-ovarian abscess. • Appendicitis, hemorrhagic ovarian cyst or other condition requiring surgery by ultrasound or laparoscopy. • Nausea or vomiting after a trial of metocopramide • Antimicrobial therapy within the past 7 days

  6. Eligibility of patients into the study Exclusion 6. Delivery, abortion or gynecology surgery with the past 30 days. 7. Prior hysterectomy or bilateral salipingectomy. 8. Allergy to penicillins, cephalosporins or tetracyclines. 9. Homeless.

  7. Outcomes Primary Involuntary infertility

  8. Others Outcomes Short term: • Time to clinical improvement • Microbiologic cure on repeat cervical culture and endometrial biopsy • Patient satisfaction with medical care • Treatment adherence

  9. Others Outcomes • Long term: • Tubal occlusion in women with involuntary infertility • Repeat episodes of PID • Ectopic pregnancy • Functional decline due to pelvic pain • Quality of life • Frequency of health service use and indirect PID-related cost, cost-utility analysis

  10. PID Evaluation and Clinical Health (PEACH) Study Adjusted OR (95% CI) Inpatient Outpatient p-value Pregnancy Infertility Salpingo Hysterectomy Ectopic pregnancy Tubal obstruction Chronic pelvic pain (CPP) 172 71 41 7(1.7) 4 7 12 172 67 1.0 0.5 .11 1. 0.37 0.72 0.1 1.0 1.32 0 1.4 3 0.61 1.24

  11. Risk of Reproductive Outcomes Following Endometriosis and/or Upper Genital Tract Infection (UGTI) or No Endometritis/No UGTI Among Women with Clinical PID No Endometriosis/ No UGTI (n=258) No Endometriosis and/or UGTI (n=156) Adjusted OR 95%CI Crude OR 95%CI Outpatient N % N % Pregnancy Infertile Recurrent PID Chronic pelvic pain 103 50 50 112 40.2 17.87 19.5 44.48 142 53 46 98 40.8 16.4 13.2 29.5 1.0(0.7,1.4) 0.9(0.6,1.4) 0.6(0.4,1.0) 0.5(0.4.,0.7) 0.8(0.6,1.2) 1.0.(0.6,1.6) 0.6(0.4,0.9) 0.6(0.4.,0.9)

  12. Pregnancy rates-197 US and 1st Year Follow-up, PEACH StudyWhite Women

  13. Pregnancy rates-197 US and 1st Year Follow-up, PEACH StudyBlack Women

  14. PEACH 2 Specific Aims: • To continue the follow-up of women in the PEACH study go as to better describe the rates of inability to achieve pregnancy, chronic pelvic pain, and recurrence after mild-to-moderate PID • To develop and validate a clinical prediction rule(s) that identifies women after diagnosis of PID who are at high risk for: inability to achieve pregnancy, having chronic pelvic pain, or having recurrent disease • To identify whether inpatient treatment is more effective than outpatient treatment in reducing the risk of sequelae among prognostic subset of women

  15. DAISY Project

  16. Women Not Counseled by Physician on Selected Health Behaviors in Past Year, 1991

  17. Recurrent Infection with C. Trachomatis by Age

  18. Chlamydial Infection Baseline testing Home screening Every 6 mo * 2 yr Return visits Every 6 mo * 2 yr Number of screens completed Number infected Proportion of infection treated

  19. Hormonal Contraception and the Recognition of Pelvic Inflammatory Disease • RB Ness, LM Keder, • DE Soper, AJ Amertegul, • J Glack, H Wiesenfeld, • PA Rice, JF Pelpert, • A Karmbour-Shakir, • SP Donegan

  20. Epidemiologic Data • Oral Contraceptive use associated with 2* Increase prevalence of C. trachomatis. • Oral contraceptive associated with protection against symptomatic PID. • Salpingitis more mild among women using oral contraceptives.

  21. Subjects Cases Controls Endometritis Unrecognized PID Recognized PID Proportion of Hormonal Contraceptive Use

  22. Odds Ratios (95% CI) for Hormone Use vs. No Contraception or Barrier Contraception

  23. Independent Risk Factors for UGTI/Endometritis*

  24. Gyn Infections Follow-Through (GIFT) Study

  25. Douching Prevalence

  26. Bacterial Vaginosis (BV): What is it? • A replacement of the normal vaginal flora (Lactobacillus) with a mixed flora of Gardnerella vaginalis, anaerobes, and Mycoplasma hominis

  27. Prospective Observational Study 1200 women enrolled from 5 clinical sites over 18 months

  28. Primary Objective To compare the time to PID between women who are douching (at least once / month on average) vs. women who are not.

  29. Prevention, prevention and prevention • Douching cessation programs • Self-testing for STDs • Predictors of infertility among women with PID • Will treating BV prevent PID?

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