PID Evaluation and PID Evaluation and Clinical Health Clinical Health (PEACH) Study(PEACH) Study

PEACH

Multi-center randomized clinical trial of 831 women followed 2-5

yrs through 10/00

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

Eligibility of patients into the studyInclusion(Must meet all of the following criteria)1. 37 years of age or younger2. Willing to participate3. Presenting with a history of pelvic discomfort for <30

days (this does not need to be the chief complain)4. Experiencing pelvic organ tenderness (uterine or adnexal

tenderness) on bilateral examination5. Leukorrhea and/or Mucopurulent Cervicitis and/or

untreated known + GC or CT

Eligibility of patients into the study

Exclusion(Must not meet any of the following criteria)1. Currently pregnant by urine testing.2. Tubo-ovarian abscess. 3. Appendicitis, hemorrhagic ovarian cyst or

other condition requiring surgery by ultrasound or laparoscopy.

4. Nausea or vomiting after a trial of metocopramide

5. Antimicrobial therapy within the past 7 days

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.

Outcomes

Primary

Involuntary infertility

Others Outcomes

Short term:

• Time to clinical improvement

• Microbiologic cure on repeat cervical culture and endometrial biopsy

• Patient satisfaction with medical care

• Treatment adherence

Others OutcomesLong 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

PID Evaluation and Clinical Health (PEACH) Study

Inpatient Outpatient p-value

Pregnancy

Infertility

Salpingo

Hysterectomy

Ectopic pregnancy

Tubal obstruction

Chronic pelvic pain (CPP)

Adjusted OR (95% CI)

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

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)

Crude OR 95%CI

Adjusted 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)

Pregnancy rates-197 US and 1st Year Follow-up, PEACH Study

White Women

0

10

20

30

40

50

<= 19 20-24 25-39

US

PEACHEndometrisis and/orGTNOEndometrisis/UGTI

Pregnancy rates-197 US and 1st Year Follow-up, PEACH Study

Black Women

0

10

20

30

40

50

<=19 20-24 25-39

US

PEACHEndometriosisand/or GTNoEndometriosis/UGTI

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

DAISY Project

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

5460 61

65

8083

0

10

20

30

40

50

60

70

80

90

Smoking Diet Eating PhysicalActivity

Alcohol Use Drug Use STDPrevention

Health Behavior

Pe

rce

nt

of

Wo

me

n A

ge

18

or

Old

er

Recurrent Infection with C. Trachomatis by Age41.9

25.3

12.3

7

0

5

10

15

20

25

30

35

40

45

10-14 15-19 20-29 30-44

Age(Years)

Inci

den

ce o

f R

ecu

rren

t In

fect

ion

Chlamydial Infection

Baseline testing

Home screeningEvery 6 mo * 2 yr

Return visitsEvery 6 mo * 2 yr

Number of screens completedNumber infectedProportion of infection treated

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

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.

Subjects

Cases Controls

UnrecognizedPID

Endometritis RecognizedPID

Proportion of Hormonal Contraceptive Use

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

Hormone vs. No Contraception

Hormone vs. Barrier

Any endometritis

5.0 (1.9,13.4)

(N=98)

2.6 (0.9,7.1)

(N=69)

A+C 4.7 (1.4,16.1)

(N=72)

3.1 (0.7,13.8)

(N=33)

Independent Risk Factors for UGTI/Endometritis*

Endometritis without UGTI (OR(95% CI))

UGTI

(OR(95% CI))

Tenderness score >12

(OR(95% CI))

Oral Contraceptives+ 0.7(0.3-1.8) 2.2(0.9-5.0) 0.7(0.4-1.4)

progesterone* 1.7(0.8-3.8) 0.6(0.2-1.7) 0.9(0.4-1.8)

Other Barrier* 0.9(0.3-3.1) 2.6(0.8-8.2) 1.1(0.4-2.8)

Condom use+

<5/10 times 0.5(0.2-1.2) 2.5(0.9-7.1) 0.8(0.4-1.8)

6-9/10 times 1.6(0.3-1.6) 3.1(1.0-9.6) 1.1(0.5-2.4)

10/10 times 0.4(0.2-1.2) 1.2(0.3-4.2) 0.6(0/3-1.4)

Gyn Infections

Follow-Through (GIFT) Study

Douching Prevalence

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

Prospective Observational Study

1200 women enrolled from 5 clinical sites over 18 months

Primary Objective

To compare the time to PID between women who are douching (at least

once / month on average) vs. women who are not.

Prevention, prevention and prevention

• Douching cessation programs

• Self-testing for STDs

• Predictors of infertility among women with PID

• Will treating BV prevent PID?