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BACKGROUND: Fallopian tube prolapse is reported to most commonly occur after vaginal hysterectomy. Both diagnosis and management have varied, resulting in differing efficacies of treatment. METHODS: We reviewed the presentation, diagnosis, management, and outcomes of 18 cases of tubal prolapse in 17 women. RESULTS: Most cases (65%) occurred after abdominal hysterectomy. The post-hysterectomy course was complicated by cuff cellulitis in three women, an infected cuff hematoma in one, and post-extubation pulmonary edema in one; four were observed for elevated temperature only. At presentation, 44% complained of dyspareunia, 39% vaginal bleeding, 33% vaginal discharge, 28% abdominal pain, and 28% were asymptomatic. Seven women had vaginal excision (one requiring an additional abdominal procedure), three had laparotomy with salpingectomy, and seven (41%) had spontaneous disappearance of prolapsed fallopian tube without treatment. CONCLUSIONS: In our series, tubal prolapse most commonly occurred after abdominal hysterectomy. Moreover, women with tubal prolapse may be asymptomatic, and observation alone may lead to resolution.

Background: Trovafloxacin is a new fourth-generation fluoroquinolone whose pharmacokinetics and in vitro activity suggest that it is well suited for antibiotic prophylaxis in elective hysterectomy. Methods: In a randomized, double-blind, multicenter study, parallel groups of women 18 years of age or older received either 200 mg trovafloxacin by mouth and intravenous (IV) placebo or 2 g cefoxitin by IV infusion and placebo by mouth before elective vaginal or abdominal hysterectomy for nonmalignant disease. Results: In the 103 and 97 patients in the trovafloxacin and cefoxitin groups, respectively, who were evaluable for efficacy, the prophylactic success rates at hospital discharge (96% in both groups) and 30 ± 6 days after hysterectomy (88% and 91% in the trovafloxacin and cefoxitin groups, respectively) were statistically equivalent. Both antibiotics were well tolerated. Conclusion: A single oral 200 mg dose of trovafloxacin is as effective and safe as a standard cefoxitin parenteral regimen in the prevention of primary bacterial infection after elective vaginal or abdominal hysterectomy for nonmalignant disease.

Antibiotic prophylaxis and advances in technology have reduced operative site infections after hysterectomy to a minimum. Pelvic infections are the most common infection type and respond promptly to a variety of parenteral single-agent and combination antibiotic regimens. Oral antibiotic regimens following parenteral therapy are unnecessary. Abdominal incision infections are less common than pelvic infections, less common than seromas or hematomas, and usually do not require antimicrobial therapy. Abscesses or infected hematomas require parenteral antimicrobial therapy, and drainage of those located above the cuff will predictably shorten therapy time. With early discharge from the hospital, many infections will not become evident until after the patient is home. For that reason, it is important that the patient's discharge instructions outline symptoms and signs associated with these infections so she can present for care at the earliest possible time.

Background:We report a case of symptomatic actinomycosis associated with vaginal suture erosion and granulation tissue refractory to conservative management, in an outpatient setting.Case:Three months after total vaginal hysterectomy and uterosacral ligament vaginal vault suspension, a woman complained of painless, intermittent vaginal discharge and spotting. Despite cauterization of granulation tissue, vaginal spotting persisted for another month. On re-examination, braided polyester suture that was found underlying the granulation tissue was removed. Recurrent symptoms, together with a biopsy revealing actinomycetes, prompted a trial of oral penicillin VK. With persistent symptoms and discomfort during attempts in the outpatient clinic, the woman eventually required suture removal in the operating room. Her symptoms subsequently resolved without recurrence, and no further antibiotic treatment was required.Conclusions:Actinomyces may be associated with persistent granulation tissue and vault suspension suture material. In rare circumstances, when tissue debridement and suture removal in the clinic is unsatisfactory, surgical intervention in the operating room may be necessary. Ten days of antibiotic therapy alone did not eradicate the granulation tissue, and symptoms resolved only after complete removal of the underlying permanent suture.

The purpose of this prospective, randomized, double-blind clinical trial was to compare the efficacy of 1-g doses of intravenous cefazolin with that of 1-g doses of intravenous cefotetan in preventing major operative site infections after elective abdominal hysterectomy. A major operative site infection requiring parenteral antimicrobial therapy developed in 46 (9%) of 511 evaluable women: 30 (11.6%) of 258 women given cefazolin prophylaxis and 16 (6.3%) of 253 women given cefotetan prophylaxis (relative risk, 1.84; 95% confidence interval, 1.03 to 3.29; P < .05). Risk factors for major operative site infection were younger age, lower postoperative hemoglobin concentration, and a proliferative endometrium. Ten (3.9%) of 258 women given cefazolin prophylaxis had a postoperative pelvic abscess; two of these women required additional surgical procedures, compared with two (0.8%) of 253 women given cefotetan prophylaxis who had an abscess but did not require surgery (relative risk, 4.9; 95% confidence interval, 1.09 to 22.16; P = .04). A greater number of infections and more serious infections occurred following cefazolin prophylaxis; this treatment resulted in 234 additional hospital days for administration of parenteral antimicrobial therapy.

The purpose of this study was to evaluate the relationship between postoperative abdominal incision problems and opening subcutaneous tissues with electrocautery or scalpel. Women scheduled for elective abdominal hysterectomy who gave informed consent were randomly assigned to subcutaneous abdominal wall tissue incision by electrocautery or scalpel. Postoperative abdominal wound problem diagnoses included seroma, hematoma, infection, or dehiscence without identifiable etiology. Fifteen of 380 women (3.9%) developed a wound problem; six had scalpel and nine had electrosurgical subcutaneous incisions (P = 0.4). Thicker subcutaneous tissues (P = 0.04) and concurrent pelvic infection (P < 0.001) were significant risk factors for postoperative wound problems. Only two women (0.5%) developed an infection. We conclude that the method of subcutaneous tissue incision was unrelated to the development of postoperative abdominal incision problems in 380 women undergoing elective abdominal hysterectomy.

Objective:Ampicillin plus sulbactam, an irreversible β-lactamase inhibitor, was compared to cefoxitin in the treatment of women with acute pelvic inflammatory disease (PID) with and without inflammatory mass(es).Methods:Participation in an open, prospective, randomized clinical trial was offered to all women given the clinical diagnosis of acute PID who required inpatient therapy.Neisseria gonorrhoeaeandChlamydia trachomatiswere sought in cervical and endometrial samples and aerobic and anaerobic species were sought in endometrial samples prior to treatment initiation. Treatment was given on at least 4 days and until women were afebrile for at least 48 h. Daily examinations were performed to assess response to therapy and safety. Only women in whomC. trachomatiswas identified were discharged from the hospital on oral doxycycline to be taken for 10–14 days.Results:One hundred twenty-four women were evaluated for safety; 117 (94%) were evaluated for efficacy. Demographic characteristics were similar for women in each treatment group.N. gonorrhoeaewas recovered from 59% andC. trachomatiswas recovered from 42% of study subjects. Inflammatory masses were identified in 35/76 (46%) women given ampicillin/sulbactam and 17/41 (41%) women given cefoxitin. Ampicillin/sulbactam cured 75 ,of 76 women (98.7%) [95% confidence interval (CI) 92.9–100.0%] and cefoxitin cured 37 of,41,omen (90.2%) (95% CI 76.9–97.3%) in that treatment regimen.Conclusions:Overall ampicillin/sulbactam was more effective (P= 0.05) than cefoxitin, due to superior efficacy in infection complicated by inflammatory mass(es).35/35 vs. 12/17 cured;P= 0.007).

These guidelines deal with the evaluation of anti-infective drugs for the treatment of intraabdominal infections. The clinical entities consist of infections arising from any part of the gastrointestinal tract, from the distal esophagus to the colon. These include surgical infections of the bowel, biliary tree, liver, spleen, and pancreas. Virtually all intraabdominal infections are due to multiple microorganisms resident in the gastrointestinal tract; these include aerobes and facultative and obligate anaerobes. Infections are classified as complicated (requiring an operative procedure), uncomplicated (managed medically), and postoperative wound (the operative procedure should be curative, but anti-infective drugs are used to prevent further infection at the site). Clinical criteria are paramount for entry into a study and for evaluation of efficacy. For complicated infections an adequate operation is an important determinant of outcome and needs assessment. Cultures of purulent intraabdominal fluid or abscess material are the only valid microbiologic indicators of infection. The acute physiology and chronic health evaluation score is useful in defining the severity of acute illness. The control regimen should consist of effective, established drugs and surgical procedures for the condition. Duration of therapy for complicated infections is usually 5-14 days; for uncomplicated infections, 3-7 days; and for postoperative wound infection, 2-5 days. Periodic assessment of safety and efficacy must be conducted during therapy. The outcome at final assessment is cure, failure, or indeterminate.

Pelvic inflammatory disease (PID) is a syndrome unrelated to pregnancy or surgery and characterized by lower abdominal pain and tenderness, cervical motion tenderness, and adnexal tenderness. Fever, leukocytosis, and the results of laboratory tests are used to support the diagnosis. Participants in clinical trials should be stratified into two groups: those with and those without tubo-ovarian abscess--i.e., those with complicated and those with uncomplicated PID. Diagnostic studies and treatment should be directed at four major groups of pathogens: Neisseria gonorrhoeae, Chlamydia trachomatis, anaerobic bacteria, and facultative bacteria such as Escherichia coli. Women requiring hospitalization should generally be treated as inpatients for at least 4-7 days; outpatient therapy should then be instituted to complete a 14- to 21-day course. Clinical and laboratory evaluations should be conducted daily during hospitalization and both 2-4 days and 2-4 weeks after the completion of therapy.

This set of guidelines deals with evaluation of anti-infective drugs for treatment of acute pelvic infections in hospitalized women. The clinical entities include infectious complications of cesarean section; elective hysterectomy; and septic, incomplete abortion. Conditions including endomyometritis, cuff cellulitis, pelvic cellulitis, parametritis, phlegmon, and pelvic abscesses may arise due to a variety of bacterial species, both aerobic and anaerobic, that comprise the endogenous flora of the lower reproductive tract. Anaerobic bacteria have assumed particular importance, and therapy should be directed against such organisms. The roles of enterococci, chlamydiae, and mycoplasmas remain uncertain. Culture samples must be obtained under conditions assuring minimal vaginal contamination. Before a new drug may be used for treatment of human pelvic infections, considerable information is necessary about its antimicrobial spectrum as well as its safety and efficacy. Placebo-controlled trials are considered unethical. Historical controls may be used, but concurrent active control comparative trials are preferred. Parenteral administration is recommended for at least the initial 4 days of therapy, but orally administered drugs may be evaluated for completion of longer courses. The expected cure rate is approximately 90%. Uncomplicated infections should be treated for at least 4 days; more complicated infections may require prolonged therapy. Although clinical cure is paramount, microbiologic response must also be taken into account. In the final assessment, outcome will be classified as cure, failure, or indeterminate.

Preventing infections at operative sites has long been a goal of gynecologic and obstetric surgeons. These infections constitute the leading cause of morbidity after both elective and emergent surgical procedures. Serious sequelae such as bacteremia, septic shock, phlegmon, pelvic abscess, septic pelvic thrombophlebitis, wound abscess, and fascial dehiscence may complicate primary infections, with devastating results. Early attempts to prevent postoperative infections concentrated on aseptic techniques and the modification of surgical skills. Soon after the introduction of antibiotics into clinical medicine, surgeons began to administer these drugs to clinically uninfected women to prevent operative-site infection; that practice has been documented and assessed in a large volume of literature. This article reviews the chronologic development of prospective data in the areas of benign gynecology, obstetrics, gynecologic oncology, and infertility and makes recommendations regarding antibiotic prophylaxis of infections associated with surgical procedures.

Objective: To determine the bacteriology of lower genital tract cancers to direct potential treatment modalities and to determine the impact of treatment on quality of life. Methods: Gram stain, saline preparations, tumor pH determinations, and anaerobic and aerobic tumor cultures were obtained from 13 consecutive patients with malodorous gynecologic cancers and 13 patients (controls) with nonmalodorous tumors. All patients with odor were treated with topical metronidazole for 7 days. Odor assessment questionnaires were administered daily in the treatment group. Quality-of-life evaluation was assessed using the Functional Assessment of Cancer Therapy questionnaire before and after treatment. Results: Cancer of the cervix (n 5 5 21) was the most common primary site and accounted for 81% (95% confidence interval 61%, 93%) of malodorous gynecologic cancers. Eight of 13 (62%) patients with malodorous tumors had bacterial vaginosis compared with four of 13 (31%) of those without odor (P 5 5 .11). Aerobic and anaerobic bacteria were isolated with equal frequency from malodorous gynecologic cancers. Results of odor assessment questionnaires showed a graded improvement with topical antibiotic therapy (P < < .001). The Functional Assessment of Cancer Therapy questionnaire indicated improved quality of life after therapy (P 5 .02). Conclusion: Most patients with odor had bacterial vaginosis and had an improvement in odor with topical metronidazole. Therefore, this treatment might be useful for patients with malodorous pelvic tumors. (Obstet Gynecol 2000; 96:23‐7. © 2000 by The American College of Obstetricians and Gynecologists.)

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.

We conducted a multicenter trial to compare the efficacy and safety of meropenem with the efficacy and safety of clindamycin plus gentamicin in the treatment of 515 hospitalized patients with acute gynecologic and obstetric pelvic infections. At the end of treatment, the rates of satisfactory clinical and bacteriologic response were high (88%) in both treatment groups: the rates of response were 90% for the meropenem group and 86% for the clindamycin/gentamicin group. No serious adverse events occurred. The most frequently reported drug-related adverse clinical events in the meropenem group were nausea and injection-site reactions (> 1% of patients), and the most common drug-related laboratory abnormality was thrombocythemia. Similar patterns of adverse events occurred in the clindamycin/gentamicin group; however, the incidence of diarrhea and eosinophilia was higher in this group. In summary, this trial demonstrated that meropenem is an effective and safe alternative to the combination of clindamycin plus gentamicin for the treatment of women with acute gynecologic and obstetric pelvic infections.

Meropenem, a new carbapenem with improved stability in the presence of human dehydropeptidase-I [1], was evaluated in three prospective, multicenter, randomized, controlled clinical trials in North America. We compared the in vitro activity of meropenem and conventional antimicrobial agents for the treatment of intraabdominal, obstetric/gynecologic, and skin or soft tissue infections as well as the responses of pathogens to all of these agents. The trials of the drug for intraabdominal infection were double blind, and those for the obstetric/gynecologic and soft tissue infections were open labeled. Overall, MICs of meropenem for pathogens were lower, and the pathogen response rates were at least comparable to those for the following comparative agents : clindamycin plus tobramycin (for intraabdominal infections) ; clindamycin plus gentamicin (for obstetric/gynecologic infections) ; and imipenem and cilastatin (for skin or soft tissue infections). Meropenem has high in vitro potency and covers a broad spectrum of anaerobic and aerobic pathogens.

Obstetricians and gynecologists frequently face a multitude of gynecologic dermatoses, including lesions caused by infectious diseases and neoplasias/cancers. Human papillomavirus (HPV), for example, is one of the most frequently reported sexually transmitted diseases in the United States, with approximately 5.5 million new cases per year reported and 20million ormore people currently infected.1 Furthermore, the number of visits by patients older than 15 years to physicians or clinicians for molluscum contagiosum (Molluscipoxvirus) has increased significantly in recent decades.2 In addition to conditions caused by infectious diseases, obstetricians and gynecologists are also challenged with accurately diagnosing dermatologic conditions such as vulvar squamous cell carcinoma, extramammary Paget’s disease, and vulvodynia, in which there may be no visible lesions. This special issue of American Journal of Obstetrics and Gynecology provides readers with current strategies for the diagnosis and treatment of several important dermatologic conditions that may present in the clinic. Articles were contributed by leading US experts in the diagnosis and management of gynecologic dermatoses. These clinicians/researchers have a special interest in the topics they cover in this supplement. In addition, this special issue provides a thorough review of physicianand patientadministered therapies for these conditions. Although treatment is often considered elective because many lesions or conditions may spontaneously resolve, effective treatment can have a significant effect on patient quality of life (eg, psychological improvements), suggesting that patients should be treated if safe treatment options are available. The supplement begins with an overview by Jennifer Gunter of the diagnosis and current standards of care for genital and perianal warts. When appropriate, patients generally prefer patient-administered therapies to reduce

This six-center, prospective, open-label clinical trial compared the efficacy and safety of three regimens recommended by the Centers for Disease Control and Prevention (CDC) for the treatment of women hospitalized for acute pelvic inflammatory disease (PID). The study focused on the response to inpatient therapy, not on long-term prevention of sequelae. A severity score was used for objective comparison of the degree of illness before and after therapy. Women were randomly assigned (in a 1:1:1 ratio) to treatment with cefoxitin plus doxycycline, clindamycin plus gentamicin, or cefotetan plus doxycycline. Two hundred seventy-five (94.2%) of 292 evaluable women required no alteration in therapeutic regimen. The three regimens produced almost identical cure rates. No serious adverse clinical or laboratory events were observed. In short, the three regimens recommended by the CDC for inpatient therapy of acute PID were similarly effective and safe.

Objective: The purpose of this study was to investigate the efficacy of 200 mg of prophylactic doxycycline in preventing pelvic infection after curettage for spontaneous (incomplete) abortion.Methods: A randomized, prospective, double-blinded study was carried out involving 300 women with an incomplete abortion who were given either placebo or 200 mg of doxycycline orally 30–60 min prior to curettage. A hematocrit, WBC count, pregnancy test, syphilis serology, Neisseria gonorrhoeae culture, and Micro Trak (monoclonal antibody test, Syba, San Jose, CA) for Chlamydia trachomatis were performed. The patients were scheduled for follow-up 2 weeks later. Antibiotic administration for any reason as well as the postoperative infection rate in these women was assessed.Results: Eleven women were excluded from analysis, leaving 289 evaluable. N. gonorrhoeae was isolated from 6 (2%) women and C. trachomatis from 8 (3%) women, and the syphilis serology was serofast in 4 (1%) women. Endometritis complicated the procedure in 4 women who received placebo and in 1 woman who received doxycycline (P = 0.22).Conclusion: Prophylactic doxycycline is not effective in preventing pelvic infection after curettage for spontaneous (incomplete) abortion.

Patients with presumed acute gynaecological infections were randomized (2:1) to receive cefepime 2 g every 12 h (n = 159) or cefotaxime 2 g every 8 h (n = 72), both im or by a 30-min i.v. infusion. For evaluation of efficacy, patients were required to have a bacteriologically documented infection, with at least one pathogen isolated susceptible to both drugs. Duration of treatment was 2-8 days in the 95 cefepime-treated patients and 3-10 days in the 36 cefotaxime-treated patients with evaluable infections; approximately three-quarters of the patients in each group were treated for 4-5 days. Clinical response was satisfactory in 81/95 (85%) of the evaluable cefepime recipients and 30/36 (83%) of the evaluable cefotaxime recipients (P = 0.802). In total, 211 (85%) of the 247 pathogens isolated from evaluable cefepime recipients were eradicated, compared with 98 (90%) of 109 pathogens isolated from evaluable cefotaxime recipients. All pathogens were eradicated in 77 (81%) cefepime-treated patients and in 31 (86%) cefotaxime-treated patients (P = 0.379). Overall response to treatment, calculated by combining clinical response and individual patient bacteriological response, was considered effective, partially effective or ineffective in 77%, 13% and 11% of cefepime-treated patients respectively and in 75%, 19% and 6% of cefotaxime-treated patients respectively (P = 0.932 for effective response). Adverse clinical events were reported by 68 (43%) of 159 cefepime recipients and by 26 (36%) of 72 cefotaxime recipients (P = 0.342); adverse events were deemed drug-related in 6% of cefepime recipients (diarrhoea, rash and headache) and in 1% of cefotaxime recipients (diarrhoea, pruritus and rash). Treatment was discontinued prematurely due to adverse events in five cefepime-treated patients and in one cefotaxime-treated patient (P = 0.476). Local intolerance was reported by 33 (21%) of the 159 cefepime-treated patients and by 14 (19%) of the 72 cefotaxime-treated patients receiving drug via the iv route alone; none of the patients discontinued treatment because of local intolerance. Laboratory test abnormalities were observed in a small number of patients in each group (1-8%), but none warranted discontinuation of treatment. Cefepime 2 g bd appears to have efficacy and safety comparable to that of cefotaxime 2 g tid in the treatment of acute obstetric and gynaecological infections.

The advent of the AIDS epidemic coupled with enhanced recognition of the morbidity and mortality associated with occupationally acquired hepatitis B virus infection has resulted in a great interest in the epidemiologic characteristics of contact of surgical personnel with patient's blood and other bodily fluids in assessing and identifying risks of such contact, and in developing preventive interventions. The Centers for Disease control have made recommendations designed to decrease the transmission of blood-borne pathogens and have been given the force of law by the Occupational Safety and Health Administration. Despite prospective data documenting contamination rates and effect preventive measures, for unknown reasons many physicians and other health care workers continue to ignore preventive practices.

Little is known about the acute effects of sexual assault on pregnant victims and the outcome of their gestations. A retrospective review of sexual assault victims in Dallas County from 1983-1988 revealed that 114 of 5734 (2%) were pregnant. There were 0.55 and 0.75 gravid sexual assault victims per 1000 deliveries for Dallas County and Parkland Memorial Hospital, respectively. The purposes of this study were to examine patient demographics, forensic evidence and patterns of injury in pregnant victims compared with 114 matched nonpregnant sexual assault victims, and to compare pregnancy outcome with that of the Parkland Memorial Hospital obstetric population. The typical victim was a black, parous gravida in her twenties at a mean gestational age of 15 weeks, without previous prenatal care. Vulvar (95%), oral (27%), and anal (6%) penetration were reported with similar frequency in both groups. The detection of whole and motile sperm from the vaginal specimens was similar in pregnant and nonpregnant women. Physical trauma was more common in nonpregnant victims (63 versus 43%; P less than .004), especially genital trauma (21 versus 5%; P less than .001). Injury was more common to the head and neck or extremities than to the abdomen, chest, or back in both groups. There was no difference in the pattern of trauma by gestational age, but there were no truncal injuries in women at 20 weeks' gestation or greater. There were no spontaneous abortions or deliveries within 4 weeks of the assault, but low birth weight delivery (24%) and preterm delivery (16%) were common.(ABSTRACT TRUNCATED AT 250 WORDS)

Infections in the upper genital tract continue to be one of the leading causes of serious morbidity for obstetric and gynecologic patients. The polymicrobial, mixed aerobic and anaerobic isolates recovered from women with such infections demand broad-spectrum antimicrobial activity. In the past, combination therapy has been given in order to attain this coverage. In a multicenter open study, cefotaxime was used for treatment of endomyometritis after cesarean section, pelvic cellulitis after hysterectomy, and acute pelvic inflammatory disease. The drug effected a clinical cure in 93% of 104 women. In a randomized comparative study conducted at one center, cefotaxime cured 97% of 36 cases of post-cesarean section endomyometritis; clindamyclin plus gentamicin cured 94% of 18 cases of the same infection. There was no evidence of significant alteration in hematopoietic, hepatic, or renal function with either regimen. Cefotaxime appears to be a safe, extremely effective antimicrobial drug that is ideally suited for single-agent treatment of serious soft-tissue pelvic infections in obstetric or gynecologic patients. Obstetric and gynecologic infections are usually caused by mixed anaerobic and aerobic organisms, with anaerobes predominant [1-10]. The importance of the anaerobic component is becoming more obvious with improvements in technology. Although numerous combinations of antibiotics have been used with varying success for treatment of such infections in hospitalized women, these soft-tissue pelvic infections continue to be one of the leading causes of morbidity.

Moxalactam (LY 127935), a "third-generation" β-lactam antimicrobial, has been shown to have promising in vitro activity against a wide spectrum of pathogens similar to those isolated from women with pelvic infections. Pharmacodynamic studies have shown that its serum half life is longer than 2 hours, which permits less frequent dosing. The current investigation was carried out in two parts: In the first phase, the minimal inhibitory concentration of moxalactam against 519 clinical isolates was determined and compared to antimicrobials used in infections caused by these microbes. In vitro activity of moxalactam comparable to that of clindamycin was demonstrated against B. fragilis and other Bacteroides species. There was similar activity to penicillin G and clindamycin against anaerobic gram-positive cocci and activity superior to amikacin was demonstrated against Enterobacteriaceae . The second part of this investigation was a clinical one and 100 women with pelvic infections were given treatment with moxalactam. With an initial dose of 3 gm/day, women with posthysterectomy cellulitis and pelvic inflammatory disease did well. Women with pelvic infections following cesarean section responded less readily to this dose; however, when the initial dose was increased to 6 gm/day, a 91% cure rate was effected. The results of these investigations indicate that moxalactam is useful as a single-agent antimicrobial for treatment of polymicrobial female pelvic infection.

A retrospective chart analysis of women undergoing elective abdominal hysterectomy in Parkland Memorial Hospital indicated significant postoperative antibiotic administration. For that reason, we conducted a prospective, double-blind, placebo-controlled study to determine the incidence of infection and febrile morbidity in this patient population and to evaluate the efficacy of perioperative cefoxitin in modifying the incidence of these conditions. Three 2 gm intramuscular doses of cefoxitin over 12 hours significantly reduced the incidence of major infection to 12% from 32% observed in the placebo group. The mean hospital stay for women given cefoxitin (5.6 days) was also significantly reduced when compared to that for women given placebo (6.4 days). The incidence of febrile morbidity not requiring therapy was significant and was not altered by perioperative cefoxitin. Febrile morbidity was observed in 42% of women given cefoxitin and in 34% of women given placebo. Administration of perioperative antimicrobial agents is necessary for women undergoing elective abdominal hysterectomy in our hospital, but we believe that individual determination is required.

Infections observed after gynecologic surgical procedures are polymicrobial and require parenteral broad-spectrum antimicrobial therapy until the patient has been afebrile 24 to 72 hours. Therapy should be tailored to the specific infection and patient response thereto. When the infections are complicated by abscess or infected hematoma, combination therapy appears to be effective in a shorter period of time, and surgical drainage is infrequently necessary other than drainage of those in the supravaginal, extraperitoneal space. Administration of antibiotics immediately before surgery to women at high risk for postoperative infection has essentially eliminated pelvic infections. These infections range from cuff cellulitis through pelvic abscess and include pelvic thrombophlebitis. Pelvic infections and those in an abdominal, perineal, or vaginal incision can occur during the immediate postoperative period or after discharge from the hospital. As many as 50 per cent of these infections may occur after the patient is discharged from the hospital. Without question, the most appropriate means of objectively identifying infection rates, appropriate and inappropriate use of antimicrobials, and trends in morbidity is with an infection control program, usually consisting of an epidemiologist or specially trained nurses. Their contribution to appropriate patient care is significant. Information uncovered may put some clinicians on the defensive. This need not happen if gynecologic surgeons participate in and define criteria to be used for various infection diagnoses and similar situations. These diagnoses must be based on physical examination evidence, not "presumptive evidence." Antimicrobial administration and selection has an emotional component; objective evaluation avoids this bias. Optimal and efficient patient care is the goal and these programs should be established with that as their only goal. Several synergistic polymicrobial infections involve skin, subcutaneous tissue, and perhaps fascia; these are infrequently observed but require prompt recognition and antimicrobial therapy as well as wide surgical excision to healthy tissue to effect a cure. Clinical presentation extends to both ends of the spectrum with respect to degree of illness. These infections also occur spontaneously in gynecologic sites, and do so only in patients at high risk, such as those with diabetes, delibitating disease, advanced age, or evidence of arteriosclerotic disease. Another infection that was diagnosed and managed only surgically (that is, septic pelvic thrombophlebitis) can now be accurately diagnosed without surgery and can be adequately treated medically.(ABSTRACT TRUNCATED AT 400 WORDS)

Moxalactam is a newer beta-lactam antibiotic with increased activity and an extended antimicrobial spectrum. Three 1 gm doses were given to women scheduled for elective vaginal hysterectomy. This perioperative regimen was prospectively compared to identical doses of cefazolin, a first-generation cephalosporin of proved efficacy. The overall incidence of major postoperative infection in 193 women was less than 5% and there were no significant interregimen differences. The incidence of major infection was directly related to the type of procedure performed.

A family with incomplete male pseudohermaphroditism inherited as an apparent X-linked recessive trait was investigated. The phenotype in 11 affected family members ranged from a minimal de...

The specific activity of NAD+-dependent 15-hydroxyprostaglandin dehydrogenase was measured in human endometrial tissue obtained from ovulatory and anovulatory women. Employing PGE2 as substrate, the specific activity of this enzyme was found to be highest in endometrial tissue during the secretory phase of the cycle (ovarian cycle days 15–25) and lowest in menstrual (days 1–5) and premenstrual (days 26–28) endometrium. The specific activity of prostaglandin dehydrogenase in endometrium of anovulatory women was low, being similar to that found in proliferative endometrium (days 6–14) of ovulatory women. Prostaglandin dehydrogenase activity was found in the cytosolic fraction prepared from endometrial tissue, and was found principally in the glandular epithelium following separation of endometrial glands and stromal cells.

The purpose of the present study was to ascertain the relationship between aging and the extent of conversion of plasma androstenedione to estrone. Studies were carried out in 23 women and 26 men who weighed 130–180 pounds and 150–190 pounds, respectively, in which 3H estrone and 14C-androstenedione were administered intravenously and the transfer constant of plasma androstenedione to estrone as measured in urine, [ρ]AE1/BU, was determined. The results of these studies in both women and men demonstrate that with advancing age, there is a progressive and highly statistically significant increase in the efficiency with which circulating androstenedione is converted to estrone. The magnitude of the increase observed in the older subjects reached 2- to 4-fold that observed in the young adult.

Two hundred fourteen women having vaginal or abdominal hysterectomy were entered into a prospective, randomized, blind clinical trial comparing a preoperative intravenous dose of piperacillin to three perioperative intravenous doses of cefoxitin given over an eight-hour period. Interregimen clinical, surgical, and outcome variables of the 207 evaluable subjects were statistically similar, but there were significant interprocedure differences in a variety of categories; many benefits exist when vaginal hysterectomy is possible. Efficacy of a single dose of piperacillin was similar to that of three cefoxitin doses. Seven women (3.4%) had major postoperative infection requiring parenteral antimicrobial therapy, two (1.9%) after vaginal hysterectomy and five (4.8%) after abdominal hysterectomy. Three of the latter five infections (60%) occurred after discharge from the hospital. Even with prophylaxis, postoperative anemia was associated with increased frequency of infection at the operative site after both procedures, and diabetes was associated with late infection of the abdominal incision after abdominal hysterectomy.

A total of 1140 aerobic and anaerobic isolates were recovered from cultures of specimens from the reproductive tracts of 435 uninfected patients who underwent elective hysterectomy. Standard minimum inhibitory concentration susceptibility studies were performed on these isolates to 13 newer penicillins, cephalosporins, and some traditional antimicrobial agents. These data were generated to evaluate the in vitro efficacy of these antibiotics for potential use in prophylaxis or as a single agent for treatment of polymicrobial infections of the female pelvis. The minimum inhibitory concentration data for each antibiotic against 16 genera of aerobic and nine genera of anaerobic bacteria were determined and were used to compare the in vitro antimicrobial activity of newer antibiotics to that of the more traditional antibiotics. Of the antimicrobial agents tested, piperacillin had the highest in vitro activity against these isolates of any antibiotic tested.

Ceftriaxone and cefazolin concentrations were assayed by high-pressure liquid chromatography in serum and pelvic tissue. Specimens were obtained at uterine removal subsequent to a 1-g intramuscular preoperative dose given to 117 women scheduled for elective vaginal or abdominal hysterectomy. The mean serum concentration of cefazolin was 43.2 ± 13.1 and 39.8 ± 15.4 μg/ml after vaginal and abdominal hysterectomy, respectively. For ceftriaxone they were 59.2 ± 16.8 and 56.1 ± 18.3 μg/ml for vaginal and abdominal hysterectomy, respectively. Mean tissue concentrations of ceftriaxone were 22.5 ± 10.4, 17.4 ± 6.9, 27.9 ± 10.7, and 16.4 ± 6.3 μg/g for vagina, myometrium, fallopian tube, and ovary, respectively, and respective mean tissue concentrations for cefazolin were 15.8 ± 7.6, 14.4 ± 8.5, 15.6 ± 8.0, and 12.4 ± 5.8 pg/g. Pelvic tissue concentrations of cefazolin were similar, but concentrations of ceftriaxone in fallopian tube and vagina were higher than those in ovary and myometrium. Tissue to ser...

Twenty-one women who underwent radical abdominal hysterectomy and pelvic lymphadenectomy were enrolled in a prospective, comparative, randomized, placebo-controlled clinical trial of antimicrobial prophylaxis. Preoperative endocervical flora was identified and was similar in pre- and postmenopausal private and clinic service women; 46% of the 119 preoperative isolates produced beta-lactamase enzyme. Women were given three doses of either placebo or cefoperazone plus sulbactam, an irreversible beta-lactamase enzyme inhibitor. Three women (27%) given placebo developed abdominal incision infections; one women given placebo also developed a pelvic infection. None given antibiotic developed operative site infection, but one women developed a drain site infection. A major operative site infection rate of 27% observed with placebo is high enough to warrant prophylaxis. Although antimicrobial prophylaxis at radical hysterectomy and pelvic lymphadenectomy eradicted operative site infection in our patient populations, a literature review indicates that individual determination of a requirement for prophylaxis is necessary.

The practice of administering perioperative antimicrobials to uninfected patients undergoing elective surgical procedures has been subjected to careful prospective investigative scrutiny during the past two decades. A wound classification system was developed, helping to identify procedures for which prophylaxis did not provide benefit to the patient. Guidelines for prophylaxis in hysterectomy were proposed and risk factors were sought. Pharmacokinetics and spectrum of antibacterial activity, although variables of paramount importance in predicting success in the treatment of established infections, were discovered to have questionable impact on prophylactic efficacy. Duration of antimicrobial administration has gradually diminished from the total length of hospital stay to a single preoperative dose without increased risk of infection; efficacy may be related to route of administration. The wisdom of using newer agents for prophylaxis is addressed and questioned.

Antimicrobial overutilization accelerates the development of bacterial resistance. A prospective, randomized, blinded clinical trial of vaginal hysterectomy prophylaxis was designed to compare the efficacy, safety, and costs of cefazolin with those of cefoxitin and cefotaxime. Sixteen women (7.5%) developed febrile morbidity only, 10 (4.7%) developed major pelvic infection requiring parenteral antimicrobial therapy, and neither clinical nor laboratory adverse reactions of significance were observed. Anemia, diabetes, and additional surgical procedures were associated with a significantly increased incidence of postoperative infection; no regimen was more protective for women with or without these risk factors. Infections almost doubled hospital stay and the charges for health care. Diagnosis-related group reimbursement would have been more than $1,300 less than the mean hospital charge for women who developed infection. Utilizing cefazolin for prophylaxis and reserving cefoxitin and cefotaxime for therapy is cost and antimicrobial efficient.

Cefoperazone and cefoxitin concentrations were determined in serum and pelvic tissue samples obtained at various intervals after a 2-g intramuscular dose. These levels were determined in 59 women scheduled for elective abdominal hysterectomy. Concentrations were measured by a new high-pressure liquid chromatography method which correlated with the microbiological assay. The mean times (+/- standard deviation) of specimen collection were 188.5 +/- 61 and 185.5 +/- 55 min for cefoperazone and cefoxitin, respectively. The mean serum levels (+/- standard deviation) were 60.8 +/- 18.0 and 14.6 +/- 8.6 micrograms/ml, respectively. For cefoperazone, the mean pelvic tissue concentration was 19.8 micrograms/g. The mean pelvic tissue concentration for cefoxitin was 7.8 micrograms/g. The ratio of tissue concentration to serum concentration varied from 0.220 to 0.469 for cefoperazone and from 0.176 to 1.031 for cefoxitin. Although the serum and tissue concentrations of cefoperazone were much higher than those of cefoxitin, a greater portion of cefoxitin remained in the tissue. The tissue levels of both cefoperazone and cefoxitin were above the minimum inhibitory concentration of most sensitive pathogens several hours after a single prophylactic dose of either antibiotic.

Pathogens that cause acute polymicrobial female pelvic infections usually do not differ from those that compose the normal flora of the lower reproductive tract. Accurate identification of these bacteria is difficult because cultures obtained via the lower tract can easily be contaminated. Although use of a double-lumen catheter-protected brush culture cannot completely eliminate the risk of contamination, it is the least invasive method for obtaining culture material from the upper reproductive tract. Compounding the problem of accurately identifying pathogens that cause acute upper tract infections is the fact that bacteria appear to be present in the upper tracts of asymptomatic women with normal examinations. Because of these problems and because of the polymicrobial nature of these infections, empiric therapy frequently includes more than one antimicrobial agent. Newer, semisynthetic penicillins and cephalosporins have expanded spectrums of in vitro activity against most of the bacteria frequently recovered from pelvic infection sites. Comparative clinical trials have shown these agents to be as effective when used alone as is combination therapy. With few exceptions, empiric monotherapy with one of these newer antimicrobials will be curative for women with acute upper tract infection, will have less potential toxicity, will require less space, materials, and manpower to administer, and will be less expensive.

Two 46,XX true hermaphrodites with genital ambiguity since birth and gynecomastia were studied. The production rates of estradiol in these subjects, 77 and 71 microgram per 24 hours, and of estrone, 82 and 136 microgram per 24 hours, were approximately twice those of normal adult men. In one of these subjects the plasma production rates of androstenedione and testosterone were measured and found to be 389 and 1,271 microgram per 24 hours, respectively. In this subject all estrone production, 82 microgram per 24 hours, could be accounted for by extraglandular formation from plasma prehormones, whereas 71 microgram of estradiol per 24 hours could not be accounted for by extraglandular formation and presumably arose from glandular secretion. The concentration of testosterone in the testicular portion of the ovotestis of this subject was 465 ng. per gram of tissue, a value comparable to that found in testicular tissue obtained from adult men. In the other subject of this study, who had a malignant gonadal tumor, the plasma concentration of human chorionic gonadotropin was 3,000 ml.U. per milliliter. From the results of this study we conclude that both ovarian and testicular components of the gonads of these two individuals were endocrinologically active, and that their gynecomastia likely developed as a consequence of gonadal estradiol secretion.

This report describes the mechanism of origin and the quantity of estrogen produced in a prepubertal boy who developed severe feminization at 8 yr of age as the result of a heretofore undescribed metabolic abnormality. The clinical findings were gynecomastia and accelerated linear growth and bone maturation. At the time feminization developed, there were no signs of growth or development of the otherwise normal prepubertal male external genitalia or any increase of muscle mass that normally accompanies male puberty. The hyperestrogenism was found to be the consequence of massive extraglandular conversion of plasma androstenedione to estrone. During a 6-mo period of study, the plasma production rate of androstenedione ranged from 1.2 to 1.6 mg/day. More than 55% of plasma androstenedione was metabolized by aromatization to estrone which, in turn, was extensively sulfurylated in the tissue sites of aromatization before its entry into the blood. Thus, estrone sulfate was the final product in the aromatizing sites, and the plasma production rate of estrone sulfate derived from plasma androstenedione was 782 μg/24 h. The extent of extraglandular conversion of plasma androstenedione to estrone measured in this boy was 50 times that observed in two normal prepubertal boys. Moreover, 94% of the extraglandular aromatization occurred in extrahepatic sites. The metabolic clearance rate of plasma androstenedione, 2,380 liters/day per m2, was markedly increased in this boy. Approximately 1,500 liters of plasma androstenedione clearance was accounted for by extrahepatic, extraglandular aromatization. The fractional conversion of testosterone to estradiol, 0.16, was 50 times greater in this boy than that observed in normal young adult men. The total extent of aromatization of plasma prehormones was even greater in this boy inasmuch as evidence was obtained that aromatization of 16-hydroxysteroids, e.g. 16α-hydroxy androstenedione and 16α-hydroxy dehydroisoandrosterone (sulfate), resulted in estriol formation independent of estrone formation. Thus, extensive extrahepatic, extraglandular aromatization resulted in advanced feminization in this prepubertal boy by a previously undescribed metabolic abnormality.

Moxalactam was given to 136 women for treatment of uterine infections after cesarean delivery. After an intravenous loading dose of 2 g, 36 women received 3 g daily and 100 were given 6 g daily. The clinical success rates of these two regimens were 86% and 89%, respectively; however, in four of five women for whom treatment with the 3-g daily dose failed, extensive surgery was necessary for cure. A total of 395 pathogens was isolated from these women with polymicrobial infections, and almost 90% were susceptible to moxalactam at less than or equal to 32 micrograms/ml. Adverse effects of therapy were minimal. Thus, moxalactam given initially as a dosage of 6 g daily is effective for treatment of women with pelvic infections after cesarean delivery.

The purpose of this study was to ascertain if a relationship exists between the transfer constant of conversion of plasma androstenedione to estrone ([rho]AE1BU) and total body weight or excessive body weight in 50 postmenopausal women, of whom 25 had adenocarcinoma of the endometrium and 25 had no endometrial disease. The [rho]AE1BU ranged from 0.015 to 0.129 in these 50 women. The [rho]AE1BU in the women with endometrial cancer was 0.051 +/- 0.006 (mean +/- S.E.), whereas that in the women with no endometrial disease was 0.039 +/- 0.004. These values are not significantly different (p greater than 0.05). The body weights of these 50 women ranged from 104 to 430 pounds. The weight of the patients with endometrial cancer was 234 +/- 16 pounds (mean +/- S.E.), and that for the women with no endometrial disease was 194 +/- 12 pounds. A statistically significant correlation (p less than 0.001) was found between [rho]AE1BU and body weight and between [rho]AE1BU and excessive body weight in both groups of women. Moreover, obesity and aging appear to act in concert to potentiate the conversion of plasma androstenedione to estrone in extraglandular sites since the [rho]AE1BU is considerably greater among obese postmenopausal women than among comparably obese premenopausal women.

There are no current data regarding the effect of a newer, broad-spectrum penicillin on lower reproductive flora at hysterectomy. To identify any existing differential effect on species and their susceptibilities, we obtained pre- and postoperative lower reproductive tract culture material from 209 women who were given single-dose piperacillin, then placebo or triple-dose cefoxitin, intravenously for prophylaxis at vaginal and abdominal hysterectomy in a prospective, randomized, blinded clinical trial. Significantly more preoperative endocervical bacteria were susceptible to piperacillin. Piperacillin caused less alteration in the numbers of lower reproductive tract flora when preoperative species were compared with postoperative species. More resistance to cefoxitin was identified postoperatively in bacteria recovered from the vaginal cuff of women who remained uninfected.

Two hundred eighty-seven women were treated in a multicenter, randomized, comparative study to compare the safety and efficacy of cefotetan every 12 hours with that of cefoxitin every 6 or 8 hours in the treatment of acute obstetric and gynecologic pelvic infections. The most frequent primary diagnoses in both groups were endometritis and pelvic inflammatory disease; 24 of these patients were also bacteremic. The mean duration of treatment was 5.2 and 5.4 days for the cefotetan and cefoxitin groups, respectively, and the total doses administered were 18.1 and 32.1 gm, respectively. The rate of clinical failure for the cefotetan group was 8.5%, and 12.2% for the cefoxitin group. Laboratory and clinical adverse reactions were infrequent and none was serious; both antimicrobials were well tolerated. These results suggest the administration of cefotetan provided adequate clinical and bacteriologic effectiveness in the treatment of hospital- and community-acquired, polymicrobial obstetric and gynecologic pelvic infections.

The increasing number of beta-lactam antibiotic-resistant bacteria observed in many strains of aerobic and anaerobic Gram-positive and Gram-negative bacteria, including Bacteroides species, has been well documented. Semisynthetic synthesis of penicillins and cephalosporins with increased resistance to beta-lactamase enzyme hydrolysis has not solved the problem. An alternative to therapy with newer agents is combination of an irreversible, suicide-type, beta-lactamase enzyme inhibitor such as sulbactam with a beta-lactam antibiotic such as ampicillin. Women with a variety of acute polymicrobial pelvic infections have been treated with the above combination, metronidazole or clindamycin combined with aminoglycoside, or cefoxitin in prospective trials. The clinical efficacy of 92.4%, in vitro bacteriological efficacy of 96.6%, and safety of sulbactam/ampicillin were comparable to that observed in women given comparative therapy. Penetration of pelvic tissues by sulbactam and ampicillin was excellent. Sulbactam/ampicillin is a viable alternative for the treatment of women with acute pelvic infections.

Forty-one women with pelvic abscesses complicating salpingitis were treated with parenteral cefotaxime, a newer cephalosporin. Abscesses ranged in size from 4 by 4 to 13 by 15 cm, and in 10 women (24%) they were greater than or equal to 10 cm. Neisseria gonorrhoeae was recovered from the endocervix in 17 women (41%). A mean of 26.7 gm of cefotaxime was given over a mean of 6.5 days, and operation was not required during initial therapy. Only two women (5%) required the addition of another antimicrobial. Chronic pelvic pain and recurrent infection were infrequent during the 31- to 43-month follow-up period. Five women (12%) were readmitted for elective surgical therapy because of persistent or recurrent adnexal mass 1 to 33 months following study entry. Six (15%) women became pregnant and were delivered of their infants a mean of 25 months following cefotaxime therapy.