Chorioamnionitis, not epidural analgesia, is associated with maternal fever during labour.

PURPOSE: Maternal fever is associated with chorioamnionitis and has been linked to labour epidural analgesia (LEA). The purpose of this study was to determine possible associations between LEA and chorioamnionitis, maternal fever, operative delivery rate, and neonatal outcome. METHODS: Data from 14,073 patients were entered into a database over a two-year period. From this database, 62 nulliparous parturients with clinical chorioamnionitis (amnionitis), but without LEA were identified (Group I). Two other groups who received LEA were matched for parity and gestation: Group II - LEA with concomitant amnionitis (n=50) and, Group III - LEA without concomitant amnionitis (n=201). The diagnosis of chorioamnionitis was confirmed by histologic examination. Results are expressed as mean +/- SD and analyzed at P <0.05 using ANOVA or Chi-square. RESULTS: No differences were noted among the groups in the operative delivery rate or Apgar scores at five minutes. The percentage of patients with maternal fever during labour (38.0 degrees C) with amnionitis was significantly less in Group III compared to the other groups (100% in both Groups I and II vs 1.0% in Group III; P=0.000). Likewise, Group III had a lower percentage of neonates with Apgar scores <7 at one minute (35.5% in Group I, 20.0% in Group II, 17.4% in Group III; P=0.010). The percentage of histologic chorioamnionitis was significantly higher in both amnionitis groups compared to Group III (67.7% in Group I, 56.0% in Group II, 4.0% in Group III; P=0.000). CONCLUSION: LEA without chorioamnionitis is not associated with maternal fever (38.0 degrees C), increased operative delivery rates or low Apgar scores.

Hormonal and barrier contraception and risk of upper genital tract disease in the PID Evaluation and Clinical Health (PEACH) study.

OBJECTIVE: Among women diagnosed with pelvic inflammatory disease, we examined the associations between hormonal or barrier methods of contraception and upper genital tract infection or inflammation. METHODS: Participants were 563 patients from a treatment trial for pelvic inflammatory disease. All had pelvic pain; pelvic organ tenderness; and leukorrhea, mucopurulent cervicitis, or untreated cervicitis. Contraceptive use within the prior 4 weeks was compared among women with baseline upper genital tract gonorrhea or chlamydia, women with endometritis without upper genital tract gonorrhea or chlamydia, and women with neither upper genital tract gonorrhea or chlamydia nor endometritis. RESULTS: Inconsistent condom use was significantly and independently associated with a 2 to 3 times elevated risk for upper genital tract infection. Upper genital tract gonorrhea or chlamydia was not significantly associated with use of oral contraceptives, use of medroxyprogesterone, condoms used consistently, nor other barrier methods. CONCLUSION: No hormonal or barrier contraceptive method was related to a reduction in upper genital tract disease among women with clinical pelvic inflammatory diseases.

Self-collection of vaginal swabs for the detection of Chlamydia, gonorrhea, and trichomoniasis: opportunity to encourage sexually transmitted disease testing among adolescents.

BACKGROUND: Many sexually transmitted diseases (STDs) are prevalent among adolescents, yet compliance to undergo STD testing by this population is suboptimal. Efforts to enhance compliance with testing among at-risk youth are needed. GOAL: To determine the feasibility and acceptability of self-collection of vaginal swabs for the detection of Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis among high-school students attending a school health clinic. STUDY DESIGN: Enrolled in the study were 228 female students between the ages of 15 and 19 years. Each student self-collected a single vaginal swab that was tested for C trachomatis, N gonorrhoeae, and T vaginalis by polymerase chain reaction amplification. Acceptability of self-collection of vaginal swabs was assessed. RESULTS: The prevalence of any STD was 18%. Trichomoniasis, chlamydia, and gonorrhea were diagnosed in 10%, 8%, and 2% of students, respectively. Nearly 13% of females who had never previously had a gynecologic examination tested positive for an STD, and 51% of infected students would not have pursued testing by traditional gynecologic examination if self-collection was not offered. Self-collection of vaginal swabs was almost uniformly reported as easy to perform (99%) and preferable to a gynecologic examination (84%). Nearly all (97%) stated that they would undergo testing at frequent intervals if self-testing were available. CONCLUSIONS: Self-collected vaginal swabs for STD testing can be easily implemented in a high-school setting with high acceptability among students, enabling the detection of many STDs that would otherwise remain undetected and untreated.

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.

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.

Gynecologic conditions and bacterial vaginosis: implications for the non-pregnant patient.

Bacterial vaginosis is characterized by a shift from the predominant lactobacillus vaginal flora to an overgrowth of anaerobic bacteria. Bacterial vaginosis is associated with an increased risk of gynecologic complications, including pelvic inflammatory disease, postoperative infection, cervicitis, human immunodeficiency virus (HIV), and possibly cervical intraepithelial neoplasia (CIN). The obstetrical risks associated with bacterial vaginosis include premature rupture of membranes, preterm labor and delivery, chorioamnionitis and postpartum endometritis. Despite the health risks associated with bacterial vaginosis and its high prevalence in women of childbearing age, bacterial vaginosis continues to be largely ignored by clinicians, particularly in asymptomatic women.

Effect of a screening-based prevention policy on prevalence of early-onset group B streptococcal sepsis.

OBJECTIVE: To assess the effectiveness and feasibility of implementing the Centers for Disease Control and Prevention (CDC) screening-based guidelines for preventing early-onset group B streptococcal sepsis. METHODS: We compared prevalence of early-onset group B streptococcal sepsis after institution of the CDC screening-based protocol (October 1, 1995 through August 31, 1999) with that of historical controls (January 1, 1992 through June 30, 1995). We reviewed medical records for a cohort of deliveries of at least 23 weeks' gestation (January 1, 1996 through December 31, 1996) for group B streptococcal colonization status, risk factors, and intrapartum antibiotic prophylaxis. RESULTS: The prevalence of early-onset group B streptococcal sepsis was 1.16 per 1000 (36 of 31, 133) live births before and 0.14 per 1000 (four of 28,733) live births after institution of the CDC protocol (P <.001). Maternal colonization was known for 95.3% of the 7168 women who delivered (January 1, 1996 through December 31, 1996) at or after 37 weeks' gestation. Of 2174 women who qualified for intrapartum antibiotic prophylaxis, 1871 (86.1%) received it before delivery. There was 93. 8% compliance with intrapartum antibiotic prophylaxis for women who delivered vaginally and 53.2% compliance for women who delivered by cesarean. CONCLUSION: Institution of the CDC screening-based protocol was accomplished at a specialty women's hospital, staffed by full-time faculty and community physicians, with 93.8% compliance for vaginal deliveries, and was associated with an 88% reduction in early-onset group B streptococcal sepsis.

Evaluation of ofloxacin in the treatment of laparoscopically documented acute pelvic inflammatory disease (salpingitis).

OBJECTIVE: To evaluate the safety and efficacy of intravenous and oral ofloxacin monotherapy in the treatment of laparoscopically documented acute pelvic inflammatory disease (PID). METHODS: This study was conducted as an open-label, phase-III, uncontrolled, multicenter study. Patients identified with laparoscopic findings of salpingitis were treated with 400 mg of intravenous ofloxacin every 12 hours followed by 400 mg of oral ofloxacin every 12 hours for 10 to 14 days. Patients were evaluated five times for clinical and microbial efficacy. Since laparoscopy was performed only at admission, pathogens identified laparoscopically were presumed eradicated if they were present on the laparoscopic culture and the patient was clinically cured or improved at final evaluation. RESULTS: Of the 70 patients evaluable for safety (intent-to-treat population), the mean age was 25.6 years. Sixty-one of 70 patients (87%) were cured, one improved, one did not improve, and seven were unevaluable because they discontinued study participation. Fifty-one were evaluable for clinical efficacy: 50 (98%) were cured and one did not improve. Sixteen were evaluable for expanded microbiological efficacy: three had documented Neisseria gonorrhoeae; 12, Chlamydia trachomatis; and one, a mixed infection of both organisms. All cervical, laparoscopic, and endometrial cultured pathogens, including N. gonorrhoeae and C. trachomatis, were eradicated or presumed eradicated at the posttherapy visit. No serious or unexpected adverse events occurred. CONCLUSIONS: Ofloxacin monotherapy was effective and well tolerated in the treatment of laparoscopically proven PID in a geographically diverse population. Future studies are necessary to evaluate long-term outcomes and sequelae of PID treatment with single agent therapy.

Comparison of once-daily and twice-daily dosing of 0.75% metronidazole gel in the treatment of bacterial vaginosis.

BACKGROUND AND OBJECTIVES: Bacterial vaginosis is the most common cause of vaginal symptoms in women and has potential complications. Efforts to improve treatment of this disease process are warranted. GOAL OF THIS STUDY: The goal of this study was to compare the safety and efficacy of once-daily intravaginal administration of 0.75% metronidazole gel for 5 days to the established twice-daily regimen in the treatment of bacterial vaginosis. STUDY DESIGN: Nonpregnant women with bacterial vaginosis diagnosed by accepted clinical criteria at 14 geographically diverse general gynecology clinics were enrolled in this prospective, randomized, investigator-blind, parallel study. They were treated with either once-daily or twice-daily 0.75% metronidazole gel 5 g intravaginally for 5 days and were reevaluated at 7 to 12 days and 28 to 35 days after completing treatment. Efficacy was determined by clinical criteria. Adverse drug reactions were monitored. RESULTS: Of the 514 evaluable women enrolled, bacterial vaginosis was cured at the first return visit among evaluable patients in 153 of 199 (77%) of those who received the once-daily and in 157 of 196 (80%) of those who received the twice-daily administration. Bacterial vaginosis was cured among evaluable patients at the final visit in 104 of 180 (58%) of those who received once-daily and 109 of 178 (61%) of those who received the twice-daily regimen. Intent-to-treat analysis showed cure at 1 month in 118 of 207 (57%) of those treated once daily and 129 of 209 (62%) of those treated twice daily. Side effects were mild, and none caused treatment discontinuation. CONCLUSIONS: Once-daily dosing of 0.75% metronidazole gel 5 g for 5 days yields efficacy, safety, and tolerance equivalent to the currently used twice-daily dosing in the treatment of bacterial vaginosis, adding another competitive choice to the available therapeutic options for this condition.

Anaerobes in pelvic inflammatory disease: implications for the Centers for Disease Control and Prevention's guidelines for treatment of sexually transmitted diseases.

In preparing the 1998 sexually transmitted disease treatment guidelines of the Centers for Disease Control and Prevention, we reviewed evidence regarding the need to eradicate anaerobes when treating pelvic inflammatory disease (PID). Anaerobes are present in the upper genital tract during an episode of acute PID, with the prevalence dependent on the population under study. Vaginal anaerobes can facilitate acquisition of PID and cause tissue damage to the fallopian tube, either directly or indirectly through the host inflammatory response. Use of several broad-spectrum regimens appears to result in excellent clinical cure rates, despite the fact that some combinations fall short of providing comprehensive coverage of anaerobes. There are limited data on the long-term effects of failing to eradicate anaerobes from the upper genital tract. Concern that tissue damage may continue when anaerobes are suboptimally treated has prompted many experts to caution that therapeutic regimens should include comprehensive anaerobic coverage for optimal treatment of women with PID.

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 study's 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.

The enigmatic cervix.

Because of the serious complications associated with cervicitis, detection of the clinical signs of cervicitis is paramount importance to the reproductive health of young women. This article discusses causes of infectious and noninfectious cervicitis, as well as, the interactions of cervicitis with well-known diseases.

Polymerase chain reaction analysis of distal vaginal specimens: a less invasive strategy for detection of Trichomonas vaginalis.

We compared polymerase chain reaction (PCR) analysis of specimens obtained from the distal vagina with wet mount microscopy and culture of specimens from the posterior vaginal fornix. One or all three techniques revealed that 61 (20.3%) of 300 women tested were positive for Trichomonas vaginalis. PCR analysis of distal vaginal specimens detected 56 (91.8%) of 61 infections, while wet mount microscopy and culture detected 49 (80.3%) of 61 infections. Results of this study may impact the approach to testing for T. vaginalis by eliminating the requirement of a vaginal speculum examination. The distal vagina is an appropriate testing site for T. vaginalis by PCR analysis.

Oral contraception and the recognition of endometritis.

OBJECTIVE: Oral contraceptive use has been associated with a lower risk of symptomatic pelvic inflammatory disease but a higher risk of chlamydial cervicitis. To explain these seemingly contradictory findings, we asked whether oral contraceptive use was more common among women with unrecognized endometritis than among women with recognized endometritis. STUDY DESIGN: A multicenter case-control study was performed. Women without signs of pelvic inflammatory disease were ascertained through contact tracing of partners with sexually transmitted diseases or through presentation with cervicitis. Women with symptomatic pelvic inflammatory disease met a set of standard clinical criteria. We compared the 43 cases without signs of pelvic inflammatory disease but with endometritis ("unrecognized endometritis") with the 111 controls with recognized pelvic inflammatory disease and endometritis ("recognized endometritis"). RESULTS: Women with unrecognized endometritis were 4.3 times (95% confidence interval 1.6 to 11.7) more likely than women with recognized endometritis to use oral contraceptives. CONCLUSION: Future studies need to fully characterize the risks and benefits of oral contraceptives in relation to sexually transmitted diseases.

Validity of the vaginal gram stain for the diagnosis of bacterial vaginosis.

OBJECTIVE: To determine the sensitivity and specificity of vaginal Gram stain as interpreted by the Nugent criteria for the diagnosis of bacterial vaginosis, and to consider the use of Gram stain as the criterion standard for the diagnosis of bacterial vaginosis. METHODS: A multicenter study was conducted of women attending gynecology or sexually transmitted disease clinics. Clinical data consisting of vaginal pH, "whiff test," clue cells, and appearance of the vaginal discharge (Amsel criteria) were compared with the vaginal fluid Gram stain (Nugent criteria) for the diagnosis of bacterial vaginosis. RESULTS: The sensitivity and specificity of the Gram stain compared with the Amsel criteria were 89 and 83%, respectively. There was significant variation in the specificity values by geographic site. If the Gram stain was considered the criterion standard for the diagnosis of bacterial vaginosis, the sensitivity and specificity of the Amsel criteria were 70 and 94%, respectively. CONCLUSION: The vaginal Gram stain (Nugent criteria) is a sensitive method for the diagnosis of bacterial vaginosis. The 83% specificity suggests that the currently used Amsel criteria may lead to the underdiagnosis of bacterial vaginosis.

Risk factors for pelvic inflammatory disease. A case control study.

BACKGROUND AND OBJECTIVES: Pelvic inflammatory disease (PID) is associated with major medical and economic consequences for women of reproductive age. Identification of the risk factors associated with PID is crucial to efforts for prevention of these consequences. GOAL: To identify risk factors and markers for symptomatic PID. STUDY DESIGN: A case-control study of 234 women with PID treated at San Francisco General Hospital between October 1986 and August 1989 and 122 controls attending the Women's Clinic at the same institution. The two groups were comparable in sociodemographic, reproductive, sexual, and medical history. RESULTS: Risk factors and markers identified by univariate analysis were < 12 years education, gravidity > 0, parity > 0, spontaneous abortion > 0, lack of a birth control method, > 1 male sexual partner in the previous 30 days, younger than 18 years at age of first sex, history of gonorrhea, sex during the previous menses, douching, exposure to nongonococcal urethritis in the previous 30 days, and history of crack cocaine use. With multivariate analysis to control for confounders the risks still identified were parity > 0, (odds ratio [OR] 4.44; 95% confidence interval [CI] 2.34 to 8.42), > 1 sexual partner in the previous 30 days (OR 11.08; 95% CI 4.31 to 28.5), sex during the previous menses (OR 5.22; 95% CI 1.88 to 14.48), and a lack of contraception (OR 7.6; 95% CI 4.10 to 14.09). CONCLUSIONS: Findings indicated that certain reproductive behaviors could be targeted for public health attention and risk reduction interventions to reduce the incidence of PID. These include limiting numbers of sexual partners and encouraging the use of barrier methods of contraception for sexually transmitted disease prevention. Another finding was that it is probably best to avoid sexual intercourse during the menses. The question of douching as a risk factor for PID could not be answered by this study.

The vaginal introitus: a novel site for Chlamydia trachomatis testing in women.

OBJECTIVE: We evaluated the vaginal introitus as a noninvasive sampling site for testing for Chlamydia trachomatis. STUDY DESIGN: Swabs from the vaginal introitus were obtained from 300 women attending a sexually transmitted diseases clinic and tested for the presence of Chlamydia trachomatis by polymerase chain reaction. Additionally, 200 of these women self-collected an additional introitus swab and submitted a urine sample for polymerase chain reaction testing. These samples were compared with polymerase chain reaction, culture, and enzyme immunoassay for Chlamydia trachomatis from endocervical samples and polymerase chain reaction and culture on urethral swabs. Patients were determined to be infected with Chlamydia trachomatis by a positive culture result from any site or a confirmed positive result by polymerase chain reaction with an alternate primer. RESULTS: The sensitivity of vaginal introitus swabs obtained by health care providers for the detection of urogenital Chlamydia trachomatis was 92% (95% confidence interval 83 to 100), greater than polymerase chain reaction, culture, or enzyme immunoassay of the cervix or urethra. The sensitivity by polymerase chain reaction of patient self-collected swabs was 81%. Sampling of the vaginal introitus, by both health care workers and the patient herself, performed as well as commonly used diagnostic tests that require vaginal speculum examination. The sensitivity of polymerase chain reaction testing of urine samples was 73%. CONCLUSION: The vaginal introitus represents a highly effective noninvasive specimen collection site for Chlamydia trachomatis testing by polymerase chain reaction. Self-collection of introitus specimens may revolutionize sexually transmitted disease testing by eliminating the need for a speculum examination by skilled health care personnel.