PID Evaluation and Clinical Health (PEACH) Study

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PID Evaluation and Clinical Health (PEACH) Study
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PEACH

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

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Study treatment

• 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

1 shot
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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 lt30 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

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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

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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.
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(No Transcript)
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Outcomes

• Primary
• Involuntary infertility

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Others Outcomes

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

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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

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PID Evaluation and Clinical Health (PEACH) Study
Adjusted OR (95 CI)
Inpatient Outpatient p-value
Pregnancy Infertility Salpingo Hysterectomy Ectopi
c pregnancy Tubal obstruction Chronic pelvic pain
(CPP)
172 71 41 7(1.7) 4 7 12
1.0 0.5 .11 1. 0.37 0.72 0.1
1.0 1.32 0 1.4 3 0.61 1.24
172 67
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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 (n258)
No Endometriosis and/or UGTI (n156)
Adjusted OR 95CI
Crude OR 95CI
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)
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Pregnancy rates-197 US and 1st Year Follow-up,
PEACH StudyWhite Women
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Pregnancy rates-197 US and 1st Year Follow-up,
PEACH StudyBlack Women
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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

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DAISY Project
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Women Not Counseled by Physician on Selected
Health Behaviors in Past Year, 1991
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Recurrent Infection with C. Trachomatis by Age
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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
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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

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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.

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Subjects
Cases
Controls
Endometritis
Unrecognized PID
Recognized PID
Proportion of Hormonal Contraceptive Use
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Odds Ratios (95 CI) for Hormone Use vs. No
Contraception or Barrier Contraception
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Independent Risk Factors for UGTI/Endometritis
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Gyn Infections Follow-Through (GIFT) Study
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Douching Prevalence
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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

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Prospective Observational Study

• 1200 women enrolled from 5 clinical sites over 18
  months

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Primary Objective

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

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Prevention, prevention and prevention

• Douching cessation programs
• Self-testing for STDs
• Predictors of infertility among women with PID
• Will treating BV prevent PID?