Hugh Randall

Douching and endometritis: results from the PID evaluation and clinical health (PEACH) study.

Background Douching has been related to risk of pelvic inflammatory disease (PID). Goal To examine the association between douching and PID in a large, multicenter, clinical trial of PID after adjustment for race/ethnicity. Study Design Interviews were conducted with 654 women who had signs and symptoms of PID. Vaginal Gram stains and upper genital tract pathology/cultures were obtained from all the women. Women with evidence of plasma cell endometritis and/or gonococcal or chlamydial upper genital tract infections were compared with women who had neither endometritis nor upper genital tract infection. Results Women with endometritis or upper genital tract infection were more likely to have douched more than once a month or within 6 days of enrollment than women who never douched. These associations remained after adjustment for confounding factors, after analysis of black women only; and among women with normal or intermediate vaginal flora but not bacterial vaginosis. Conclusion Among a predominantly black group of women with clinical PID, frequent and recent douching was associated with endometritis and upper genital tract infection.

Effectiveness of treatment strategies of some women with pelvic inflammatory disease: a randomized trial.

Objective: Among all women with pelvic inflammatory disease (PID), prevention of adverse reproductive consequences appears to be similarly achieved by outpatient treatment and inpatient treatment. We assessed whether outpatient is as effective as inpatient treatment in relevant age, race, and clinical subgroups of women with PID. Methods: Women with clinical signs and symptoms of mild-to-moderate pelvic inflammatory disease (n = 831) were randomized into a multicenter trial of inpatient treatment, initially employing intravenous cefoxitin and doxycycline compared with outpatient treatment consisting of a single intramuscular injection of cefoxitin and oral doxycycline. Comparisons between treatment groups during a mean of 84 months of follow-up were made for pregnancies, live births, time to pregnancy, infertility, PID recurrence, chronic pelvic pain, and ectopic pregnancy. Results: Outpatient treatment assignment did not adversely impact the proportion of women having one or more pregnancies, live births, or ectopic pregnancies during follow-up; time to pregnancy; infertility; PID recurrence; or chronic pelvic pain among women of various races; with or without previous PID; with or without baseline Neisseria gonorrhoeae and/or Chlamydia trachomatis infection; and with or without high temperature/white blood cell count/pelvic tenderness score. This was true even in teenagers and women without a previous live birth. Ectopic pregnancies were more common in the outpatient than the inpatient treatment group, but because these were so rare, the difference did not reach statistical significance (5 versus 1, odds ratio 4.91, 95% confidence interval 0.57–42.25). Conclusion: Among all women and subgroups of women with mild-to-moderate PID, there were no differences in reproductive outcomes after randomization to inpatient or outpatient treatment. Level of Evidence: I

Chlamydia antibodies, chlamydia heat shock protein, and adverse sequelae after pelvic inflammatory disease: the PID Evaluation and Clinical Health (PEACH) Study.

Background: Among women with pelvic inflammatory disease (PID), we assessed the associations among antibodies to Chlamydia trachomatis elementary bodies (EB), antibodies to chlamydia heat shock protein (Chsp60), rates of pregnancy, and PID recurrence. Methods: Four hundred forty-three women with clinical signs and symptoms of mild to moderate PID enrolled in the PID Evaluation and Clinical Health Study were followed for a mean of 84 months for outcomes of time-to-pregnancy and time-to-PID recurrence. Antibodies to EB and Chsp60 were assessed in relation to these long-term sequelae of PID. Results: Rates of pregnancy were significantly lower (adj. hazard ratio 0.47, 95% confidence interval 0.28–0.79) and PID recurrence higher (adj. hazard ratio 2.48, 95% confidence interval 1.00–6.27) after adjusting for confounding factors among women whose antibody titers to chlamydia EB measured in the final year of follow-up were in the highest tertile. Conclusion: Among women with mild to moderate PID, antibodies to C. trachomatis were independently associated with reduced rates of pregnancy and elevated rates of recurrent PID.

Condom Use and the Risk of Recurrent Pelvic Inflammatory Disease, Chronic Pelvic Pain, or Infertility Following an Episode of Pelvic Inflammatory Disease

Among 684 sexually active women with pelvic inflammatory disease (PID) followed up for a mean of 35 months, we related contraceptive use to self-reported PID recurrence, chronic pelvic pain, and infertility. Persistent use of condoms during the study reduced the risk of recurrent PID, chronic pelvic pain, and infertility. Consistent condom use (about 60% of encounters) at baseline also reduced these risks, after adjustment for confounders, by 30% to 60%. Self-reported persistent and consistent condom use was associated with lower rates of PID sequelae.

Design of the PID Evaluation and Clinical Health (PEACH) Study

This paper describes the PID Evaluation and Clinical Health Study (PEACH), a multicenter, randomized clinical trial designed to compare treatment with outpatient and inpatient antimicrobial regimens among women with pelvic inflammatory disease (PID). PEACH is the first trial to evaluate the effectiveness and cost-effectiveness of currently recommended antibiotic combinations in preventing infertility, ectopic pregnancy, chronic pelvic pain, recurrent PID, and other health outcomes. It is also the largest prospective study of PID ever conducted in North America. We describe the PEACH studys specific aims, study organization, patient selection criteria, conditions for exclusion, data collected upon entry, randomization and treatment, adherence measures, follow-up activities, quality-of-life measures, outcomes, and statistical analyses. In the first 11 months of enrollment (March 1996-January 1997), 312 women were randomized. Of eligible women, 59% consented to enroll. Participating women are primarily black (72%) and young (mean age 24 years). After a median of 5.5 months of follow-up, we were in contact with 95% of study participants. The PEACH study will provide a rationale for selecting between inpatient and outpatient antibiotic treatment, the two most common treatment strategies, for PID.

Predictors of chronic pelvic pain in an urban population of women with symptoms and signs of pelvic inflammatory disease.

Objective: The objective of this study was to assess the risk profile for chronic pelvic pain (CPP) after pelvic inflammatory disease (PID). Study: Multivariate logistic regression was used to assess risk factors for CPP in a longitudinal study of 780 predominately black, urban women with clinically suspected PID: complaints of acute pain (<30 days); a clinical finding of pelvic tenderness; and leukorrhea, mucopurulent cervicitis, or untreated gonococcal or chlamydial cervicitis. CPP was defined as pain reported at ≥2 consecutive interviews conducted every 3 to 4 months for 2 to 5 years. Results: Nonblack race (odds ratio [OR], 2.17; 95% confidence interval [CI], 1.31–3.58), being married (OR, 2.06; 95% CI, 1.02–4.18), a low SF-36 mental health composite score (OR, 2.71; 95% CI, 1.69–4.34), ≥2 prior PID episodes (OR, 2.84; 95% CI, 1.07–7.54), and smoking (OR, 1.65; 95% CI, 1.01–2.71) independently predicted CPP. Histologic endometritis or evidence of endometrial Neisseria gonorrhoeae or Chlamydia trachomatis infection was negatively associated with CPP (OR, 0.69; 95% CI, 0.44–1.10). Conclusions: A range of demographic, clinical, historical, and behavioral factors predict CPP after PID.

The ambulatory surgical management of bartholin duct cysts

Marsupialization of Bartholin duct cysts was performed in the emergency department (ED) under pudendal anesthesia. Nineteen symptomatic cysts were treated surgically using techniques suitable for outpatient facilities. Pudendal anesthesia was adequate in all but two patients in whom supplemental local infiltration was used. One-third of the patients experienced unilateral lower extremity numbness following the pudendal block. Symptoms had completely subsided approximately 20 minutes after the procedure, and there were no sequelae. The average length of time of the procedure was 25 minutes. All patients were discharged from the ED within 30 minutes of completion of the procedure. In all patients examined one week postoperatively, the residual pouch had shrunk to less than half its original size and the apertures were patent. There have been no problems with bleeding, infection, pain or dyspareunia. In a follow-up survey, no recurrent cysts were reported. This problem can be treated safely in the ED with good results.

Inhibition of Progenitor Dendritic Cell Maturation by Plasma from Patients with Peripartum Cardiomyopathy: Role in Pregnancy-associated Heart Disease

Dendritic cells (DCs) play dual roles in innate and adaptive immunity based on their functional maturity, and both innate and adaptive immune responses have been implicated in myocardial tissue remodeling associated with cardiomyopathies. Peripartum cardiomyopathy (PPCM) is a rare disorder which affects women within one month antepartum to five months postpartum. A high occurrence of PPCM in central Haiti (1 in 300 live births) provided the unique opportunity to study the relationship of immune activation and DC maturation to the etiology of this disorder. Plasma samples from two groups (n = 12) of age- and parity-matched Haitian women with or without evidence of PPCM were tested for levels of biomarkers of cardiac tissue remodeling and immune activation. Significantly elevated levels of GM-CSF, endothelin-1, proBNP and CRP and decreased levels of TGF- were measured in PPCM subjects relative to controls. Yet despite these findings, in vitro maturation of normal human cord blood derived progenitor dendritic cells (CBDCs) was significantly reduced (p < 0.001) in the presence of plasma from PPCM patients relative to plasma from post-partum control subjects as determined by expression of CD80, CD86, CD83, CCR7, MHC class II and the ability of these matured CBDCs to induce allo-responses in PBMCs. These results represent the first findings linking inhibition of DC maturation to the dysregulation of normal physiologic cardiac tissue remodeling during pregnancy and the pathogenesis of PPCM.

Clinical Predictors of Endometritis in Women With Symptoms and Signs of Pelvic Inflammatory Disease

OBJECTIVE Careful detection and treatment of pelvic inflammatory disease are essential for the prevention of adverse sequelae. The purpose of this study was to evaluate the diagnostic test characteristics of clinical criteria for the diagnosis of pelvic inflammatory disease. STUDY DESIGN We performed a cross-sectional analysis of the baseline characteristics of 651 patients enrolled in a multicenter randomized treatment trial for pelvic inflammatory disease. Clinical and laboratory findings were recorded for all patients, and endometrial sampling was performed. We calculated sensitivity and specificity and performed receiver operating characteristic curve analysis and multivariate logistic regression, using histologic endometritis as the criterion standard. RESULTS The minimal criteria for pelvic inflammatory disease, as recommended by the Centers for Disease Control and Prevention, had a sensitivity of 83%, in comparison with a 95% sensitivity for adnexal tenderness (P =.001). Of the supportive clinical criteria, the finding most highly associated with endometritis was a positive test result for Chlamydia trachomatis or Neisseria gonorrhoeae (adjusted odds ratio, 4.3; 95% confidence interval, 2.89--6.63). A multivariate logistic regression model indicated that combinations of criteria significantly improve the prediction of endometritis. CONCLUSION Sensitivity can be maximized by using the presence of adnexal tenderness as a minimal criterion for the diagnosis of pelvic inflammatory disease, and supportive criteria are helpful in estimating the probability of endometritis.