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Biomedical subjects

D E Soper

Publications and source records attributed to D E Soper.

At least 19 recordsLinked to original sources
PubMed1999

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.

Adult↗
PubMed1998

Clinical utility of CA125 levels in predicting laparoscopically confirmed salpingitis in patients with clinically diagnosed pelvic inflammatory disease.

OBJECTIVE: The purpose of this study was to determine the utility of serum CA125 determinations in diagnosing acute salpingitis. METHODS: CA125 levels were determined for 34 women with the clinical diagnosis of pelvic inflammatory disease (PID). Acute salpingitis was confirmed laparoscopically in 28 women (82.3%). RESULTS: Twenty patients (71.4%) with laparoscopically confirmed acute salpingitis had CA125 levels greater than 7.5 units, compared with no patients (0/6) with laparoscopically normal tubes (P = 0.002). The degree of elevation of CA125 levels correlated with the severity of tubal inflammation noted at laparoscopy. All patients with levels above 16 units had laparoscopically severe salpingitis. CONCLUSIONS: We conclude that while CA125 levels above 7.5 units may modestly improve the ability of the clinical diagnosis of PID to accurately reflect visually confirmed acute salpingitis, limitations of the test make its clinical utility questionable.

Adult↗
PubMed1998

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.

Adolescent↗
PubMed1998

Factors predicting upper genital tract inflammation among women with lower genital tract infection.

We sought to identify factors that discriminate between women with a lower genital tract infection and women with a lower genital tract infection and endometritis. This study enrolled women at risk for or having a lower genital tract infection with Chlamydia trachomatis or Neisseria gonorrhoeae and measured behavioral and clinical factors. Women were identified through contact tracing of male partners, presentation with cervicitis, or presentation with symptoms of pelvic inflammatory disease and classified as (1) having a lower genital tract infection without endometritis, (2) having a lower genital tract infection with endometritis, (3) having no lower genital tract infection with endometritis, and (4) having neither a lower genital tract infection nor endometritis. The primary comparison was between women having a lower genital tract infection without endometritis to women having a lower genital tract infection and endometritis. Women with a lower genital tract infection and endometritis were older and reported a history of more sexually transmitted diseases (70.0% vs. 56.7%), abdominal pain (82.2% vs. 60.0%), and use of barrier methods of contraception (28.9% vs. 8.6%) than women with a lower genital tract infection alone. The regression model found that women with a lower genital tract infection and endometritis were 7.1 times (95% CI = 2.2-23.0) more likely to report abdominal pain and 4.6 times (95% CI = 1.5-14.9) more likely to use barrier methods of contraception than women with a lower genital tract infection alone. These results suggest that behavioral factors, in addition to symptoms, can be used to identify women with and without upper genital tract involvement.

Abdominal Pain↗
PubMed1997

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.

Adult↗
PubMed1997

Sexually transmitted diseases in pregnancy.

Sexually transmitted diseases are common complications of pregnancy and may have significant maternal/fetal effects. Knowledge of the symptoms and physical examination features, methods of diagnosis, indications for screening, and appropriate treatment options are essential for obstetric/gynecologic health care providers.

Adult↗
PubMed1996

Characterization and control of intraamniotic infection in an urban teaching hospital.

OBJECTIVES: Our purpose was to determine (1) whether risk factors for intraamniotic infection were similar in women delivered of preterm infants versus term infants and (2) whether infection control techniques could decrease the incidence of intrapartum fever on a labor and delivery unit. STUDY DESIGN: A total of 5409 consecutive patients (group 1) admitted to the Medical College of Virginia's labor and delivery unit were followed up prospectively to determine the development of intraamniotic infection. Demographic and intrapartum data were collected by use of a standard data form by infection control practitioners. An additional 2549 consecutive patients (group 2) were followed up after institution of infection-control measures. RESULTS: Intraamniotic infection occurred in 416 of 5399 (7.7%) women (group 1) admitted to the labor and delivery suite. Odds ratios for term and preterm patients having intraamniotic infection with rupture of membranes > or = 12 hours compared with < 12 hours were 5.81 (95% confidence interval 512 to 6.59 and 2.49 (95% confidence interval 1.77 to 3.50), respectively. Odds ratios for term and preterm patients with internal monitors having intraamniotic infection compared with patients in whom internal monitors were not used were 2.01 (95% confidence interval 1.7 to 2.4) and 1.42 (95% confidence interval 0.99 to 2.04), respectively. Odds ratios for term and preterm patients having intraamniotic infection with more than four vaginal examinations compared with four or fewer vaginal examinations was 3.07 (95% confidence interval 2.53-3.73) and 1.59 (95% confidence interval 1.11-2.27), respectively. Intrapartum fever occurred in 475 (8.8%) women in group 1 and in 252 (9.8%) women in group 2 (not significant). CONCLUSIONS: Risk factors (duration of ruptured membranes, use of internal monitoring, number of vaginal examinations) were similar in both term and preterm women with intraamniotic infection. Infection control measures failed to decrease the incidence of intrapartum fever in our patient population.

Adult↗
PubMed1995

Wound infection after abdominal hysterectomy: effect of the depth of subcutaneous tissue.

OBJECTIVE: Our purpose was to determine the effect of the depth of the subcutaneous tissue at the operative site on abdominal wound infection after hysterectomy. STUDY DESIGN: A prospective study was performed of women undergoing abdominal hysterectomy and not receiving antibiotic prophylaxis who underwent maximum vertical measurement of their subcutaneous incisions before the abdominal cavity was surgically entered. Additional demographic and perioperative data previously associated with wound infection were collected and analyzed. Surgical technique was standardized among the three attending surgeons involved. RESULTS: Wound infection occurred in 17 of 150 (11.3%) women undergoing abdominal hysterectomy. Univariate analysis identified the following risk factors as being significantly associated with wound infection: depth of subcutaneous tissue (p = 0.0004), preoperative serum albumin (0.0015), weight (p = 0.0029), and body mass index (p = 0.0032). Logistic regression analysis confirmed the thickness of the subcutaneous tissue as the only significant risk factor for wound infection (p = 0.04) (odds ratio 1.37, 95% confidence interval 1.01 to 1.86). No patients with a maximum depth of subcutaneous tissue < 3 cm had a wound infection. CONCLUSION: We conclude that the depth of subcutaneous tissue is the most significant risk factor associated with abdominal wound infection after hysterectomy.

Abdomen↗
PubMed1994

Observations concerning the microbial etiology of acute salpingitis.

OBJECTIVES: The specific aims of this study were (1) to describe the microbiologic characteristics of patients with acute salpingitis and (2) to determine the incidence of bacterial vaginosis in patients with acute salpingitis and whether bacterial vaginosis microorganisms were common upper-genital-tract isolates in these patients. STUDY DESIGN: Women with pelvic inflammatory disease underwent laparoscopy to confirm the diagnosis of acute salpingitis and for culture of the fallopian tubes and cul-de-sac. Endometrial and minute fimbrial biopsies were performed, and specimens were evaluated for evidence of inflammation. Bacterial vaginosis was diagnosed by vaginal Gram stain. RESULTS: Eighty-four patients had visually confirmed acute salpingitis. Neisseria gonorrhoeae or Chlamydia trachomatis was isolated from 65 (77.4%) patients. Vaginal microorganisms were isolated from the endometrium in 16 (31.4%) of 51 cases and from the cul-de-sac in 12 (14.3%) of 84 cases. Bacterial vaginosis was present in 61.8% of patients with acute salpingitis, and 100% of anaerobes isolated from the upper genital tract of patients with acute salpingitis were bacterial vaginosis microorganisms. These anaerobes were isolated from the upper genital tract in the absence of a concurrent gonococcal, chlamydial, or Haemophilus influenzae infection in only two cases. CONCLUSIONS: The initiation of acute salpingitis is predominantly due to the ascending spread of sexually transmitted microorganisms. Bacterial vaginosis is a common concurrent disorder of women with acute salpingitis, and bacterial vaginosis microorganisms are commonly isolated from the upper genital tracts of patients with pelvic inflammatory disease.

Acute Disease↗
PubMed1994

Bacterial vaginosis: efficacy and safety of intravaginal metronidazole treatment.

OBJECTIVE: We evaluated the effectiveness and safety of intravaginal metronidazole in the treatment of bacterial vaginosis. Demographic data, Gram stain score, and individual clinical diagnostic criteria for bacterial vaginosis were evaluated for association with therapeutic outcome. METHODS: According to accepted diagnostic criteria and blinded Gram stain scoring for quality control, a multicenter, prospective, double-blinded trial of patients randomized to either 0.75% metronidazole gel 5 gm twice daily for 5 days or placebo was undertaken. Therapeutic response after completion of treatment was evaluated by examination at 4 to 16 days and again at 28 to 32 days for patients initially cured. RESULTS: After metronidazole treatment, 38 (78%) of 49 patients were cured initially, compared with 11 (27%) of 41 placebo recipients (p < 0.001). One month after treatment 31 (91%) of 34 in the group initially cured by metronidazole remained cured. Side effects were uncommon and mild. Significant intercenter differences were noted for vaginal discharge assessment but not for other diagnostic criteria. Among patients cured initially with metronidazole, mean Gram stain score was 0.58 among those in whom cure was maintained versus 2.33 for those in whom recurrent bacterial vaginosis developed 1 month after treatment (p = 0.03). Curative metronidazole treatment was found initially in 4 (100%) of 4 patients with sperm present on gram stain compared with 34 (76%) of 45 with sperm absent (p = 0.56) and in 6 (100%) of 6 and 25 (89%) of 28, respectively, at the final visit (p = 1.0). CONCLUSIONS: Intravaginal metronidazole is effective, safe, well-tolerated, durable therapy for bacterial vaginosis. Characterization of vaginal discharge appears to be the most variable among the diagnostic criteria for bacterial vaginosis. Gram stain score may be able to identify patients cured early after therapy who are at risk for later recurrence. Exposure to semen does not appear to affect efficacy of intravaginal metronidazole.

Administration, Intravaginal↗
PubMed1994

Pelvic inflammatory disease.

The pathophysiology of pelvic inflammatory disease (PID) involves an ascending infection of cervicovaginal microorganisms, of which the most important pathogens are Neisseria gonorrhoeae and Chlamydia trachomatis. The clinician should recognize that not all women with PID will present with abdominal pain and that associated atypical symptoms such as meteorrhagia and dyspareunia should suggest diagnosis. The documentation of lower genital tract inflammation is helpful in making the diagnosis of PID. Treatment with broad spectrum antibiotic regimens is currently recommended. Prevention of sexually transmitted diseases and ascending infection remains of utmost importance to decrease the sequelae, such as tubal factor infertility and ectopic pregnancy associated with PID.

Female↗
PubMed1993

Bacterial vaginosis and postoperative infections.

Postoperative infections are common complications of obstetric and gynecologic surgery. The pathophysiology of both postcesarean endometritis and postoperative cuff cellulitis involves the ascending spread of potentially pathogenic microorganisms found in the vagina. Bacterial vaginosis is associated with increased vaginal concentrations of certain anaerobic and facultative bacteria. Bacterial vaginosis appears to be a risk factor for the development of postoperative infections in obstetrics and gynecology.

Bacterial Infections↗
PubMed1993

Randomized comparative study of cefepime and cefotaxime in the treatment of acute obstetric and gynaecological infections.

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.

Adolescent↗