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Biomedical subjects

E R Newton

Publications and source records attributed to E R Newton.

At least 19 recordsLinked to original sources
PubMed2001

Minority women with sexually transmitted diseases: sexual abuse and risk for pelvic inflammatory disease.

Mexican American and African American women (N = 617) with a sexually transmitted disease (STD) underwent a targeted physical exam and questioning regarding sexual abuse, current genitourinary symptomatology, and pelvic inflammatory disease (PID) risk behaviors to determine the relationship between sexual abuse and risk for PID. Sexually abused women (n = 194) reported higher PID risk behaviors, including earlier coitus, more sex partners, higher STD recurrence, and a tendency toward delayed health-seeking behavior. They also reported more severe genitourinary symptomatology, confirmed by physical exam, and presumptive diagnoses of PID. These characteristics identify sexually abused women at high risk for PID. Because of its considerable impact on risk for PID, assessment for sexual abuse is essential in clinical management of women with STD and for diagnosis of PID.

Adolescent↗
PubMed2001

Is routine hemoglobin and hematocrit testing on admission to labor and delivery needed?

OBJECTIVE: Testing hemoglobin and hematocrit values in labor and delivery at term is a routine practice at many centers. This necessity was evaluated by comparing values obtained at 26-28 weeks versus those obtained at term. MATERIALS: This is a prospective, observational study. All patients at least 37 weeks presenting to labor and delivery were evaluated during the study period. Enrollment criteria included having either a hemoglobin or hematocrit between 26 and 28 weeks and again on admission with term labor. Deliveries at less than 37 weeks and pregnancies complicated by multiple gestations, hemoglobinopathies, and hypertensive disorders were excluded. The World Health Organization (WHO) definition of anemia was used as well as an operationally defined threshold, below which local practitioners would change management (hemoglobin 8 g/dL, hematocrit 25%). The compliance of patients to any form of iron therapy was evaluated by questioning patients on admission. RESULTS: One hundred and one patients met enrollment criteria. At 26-28 weeks, 20 patients were anemic by WHO criteria. On admission to labor and delivery at term, relative to 26-28-week values, hemoglobin had increased from 11.1 g/dL to 11.6 g/dL (P <.01), and hematocrit increased from 31.5-34.3% (P <.01). Eleven patients had term values that were lower than 26-28-week values. Of these, five patients met WHO criteria at 26-28 weeks. However, no value at term was below the operationally defined value. CONCLUSION: The frequency of anemia fell from 20% at 26-28 weeks to 11% at term. The mild anemia at term did not change local management in any patient. Thus, if the value obtained at 26-28 weeks is acceptable (non-anemic by WHO criteria), the routine testing of these values at term can be avoided, resulting in significant cost savings.

Adult↗
PubMed2001

Predictors of the vaginal microflora.

OBJECTIVE: Our purpose was to define influences on the patterns of the vaginal microflora. STUDY DESIGN: We enrolled 617 African American and Mexican American women in a 1-year longitudinal study of sexual behaviors and the vaginal microflora on the basis of the presence of gonorrhea, chlamydial infection, trichomoniasis, or syphilis at the initial visit. The patients were assigned randomly to a behavioral intervention or standard counseling regarding sexually transmitted disease. We reevaluated 508 (82%) and 549 (89%) women at 6 and 12 months, respectively. A comprehensive survey of lower genital tract organisms was conducted at baseline and at 6 and 12 months. Behavioral and microbiologic associations were screened by bivariate analysis. All variables associated with an organism at P < or = .15 were included in a multivariate analysis. Associations between behavior and the genital tract microflora were identified by logistic regression coefficients with P <.05. RESULTS: African American race had a consistent association with vaginal microflora, specifically, Mycoplasma hominis, Trichomonas vaginalis, bacterial vaginosis, group B streptococci, Neisseria gonorrhoeae, and Chlamydia trachomatis. Various behaviors had a less consistent effect, including multiple partners, douching, frequency of coitus >3 times a week, and cunnilingus, fellatio, and anal intercourse at the last sexual encounter. M hominis (but not Ureaplasma urealyticum ), Gardnerella vaginalis, and Lactobacillus species were associated with bacterial vaginosis. Lactobacillus species appeared to protect against bacterial vaginosis and infection with G vaginalis. Sexually transmitted diseases (caused by M hominis, N gonorrhoeae, C trachomatis, and T vaginalis ) were associated with each other. In contrast, hormonal status, vaginal blood, and foreign bodies had little effect. CONCLUSION: The presence of other microorganisms and race have a more consistent association with the presence or absence of a cervical-vaginal organism than sexual behavior, hormonal status, vaginal devices, or the presence of abnormal vaginal bleeding.

Adolescent↗
PubMed2000

Wet smear compared with gram stain diagnosis of bacterial vaginosis in asymptomatic pregnant women.

OBJECTIVE: To compare wet smear and Gram stain diagnoses of bacterial vaginosis among asymptomatic pregnant women. METHODS: Between November 1, 1996 and December 31, 1997, asymptomatic women who initiated prenatal care in our obstetric clinics were invited to participate. Exclusion criteria included antimicrobial use within 2 weeks, cervical cerclage, vaginal bleeding, placenta previa, spermicide use, douching, or intercourse within 8 hours. Clinical diagnosis that required two of three positive criteria for bacterial vaginosis (vaginal pH, whiff test, and clue cells on wet smear) was compared with Gram stain diagnosis (Bacterial vaginosis score 7-10 by Nugent criteria). RESULTS: Population characteristics (n = 69) included an average (+/- standard deviation [SD]) maternal age of 27. 3 +/- 6.6 years, 26 nulliparas (38%), 28 black women (41%), 23 white women (38%), 15 Hispanic women (22%), and three Asian women (4%). The mean (+/-SD) gestational age at entry was 15.6 +/- 7.6 weeks. Twenty-seven percent (18 of 67) of the study population was diagnosed with bacterial vaginosis by definitive Gram stain. Two slides were lost or were of poor quality and not included. Using Gram stain diagnosis of bacterial vaginosis as the standard, clinical diagnosis had sensitivity of 56% (95% confidence interval [CI] 32%, 78%), a specificity of 96% (95% CI 90%, 100%), a positive predictive value of 83%, and a negative predictive value of 85%. CONCLUSION: In asymptomatic pregnant women, bacterial vaginosis can be diagnosed reliably by Gram stain.

Adult↗
PubMed2000

Gram-stain diagnosis of bacterial vaginosis after rupture of membranes.

Correlation of the Gram stains prior to and after rupture of the membranes (ROM) and the efficacy of Gram-stain diagnosis for bacterial vaginosis (BV) after membrane rupture has not previously been evaluated. From April 1997 to May 1998, women presenting in labor or for labor induction were invited to participate. Women with ROM prior to hospital presentation or contraindications for vaginal delivery were excluded. A Gram stain of vaginal secretions was obtained prior to and approximately 2 hours after ROM. BV was diagnosed with a Nugent score of 7-10. The Gram stain prior to and after membrane rupture was evaluated using the Spearman correlation coefficient. Population characteristics (n = 91) included maternal age of 15 to 38 years, 45 (49%) nulliparas, 59 (65%) African-Americans, 23 (25%) Hispanics, 7 (8%) Caucasian, and 2 (2%) Asians. Gestational age upon study entry was 35 to 44 weeks. Twenty-one percent (19 of 91) of the study population was diagnosed with BV. Using the Gram stain prior to membrane rupture as the standard, the efficacy of the Gram stain after ROM had a sensitivity of 26%, specificity of 97%, positive predictive value of 71%, and negative predicative value of 83%. Good correlation of pre- and post-membrane rupture Gram stains was demonstrated (r = 0.69). Gram stain may be useful for ruling out BV in the presence of membrane rupture, but is not useful for diagnosing BV due to poor sensitivity.

Adolescent↗
PubMed1999

A randomized, controlled trial of a behavioral intervention to prevent sexually transmitted disease among minority women.

BACKGROUND: African-American and Hispanic women are disproportionately affected by sexually transmitted diseases, including the acquired immunodeficiency syndrome (AIDS). In the effort to reduce infection rates, it is important to create and evaluate behavioral interventions that are specific to the target populations. METHODS: We enrolled women with nonviral sexually transmitted diseases in a randomized trial of a sex- and culture-specific behavioral intervention. The intervention consisted of three small-group sessions of three to four hours each designed to help women recognize personal susceptibility, commit to changing their behavior, and acquire necessary skills. The control group received standard counseling about sexually transmitted diseases. The design of the intervention was based on the AIDS Risk Reduction Model and ethnographic data on the study populations. Participants in both groups underwent screening, counseling, and an interview before randomization and at the 6- and 12-month follow-up visits. The principal outcome variable was subsequent chlamydial or gonorrheal infection, which was evaluated on an intention-to-treat basis by logistic-regression analysis. RESULTS: A total of 424 Mexican-Americans and 193 African-American women were enrolled; 313 were assigned to the intervention group and 304 to the control group. The rate of participation in the intervention was 90 percent. The rates of retention in the sample were 82 and 89 percent at the 6- and 12-month visits, respectively. Rates of subsequent infection were significantly lower in the intervention group than in the control group during the first 6 months (11.3 vs. 17.2 percent, P=0.05), during the second 6 months (9.1 vs. 17.7 percent, P=0.008), and over the entire 12-month study period (16.8 vs. 26.9 percent, P=0.004). CONCLUSIONS: A risk-reduction intervention consisting of three small-group sessions significantly decreased the rates of chlamydial and gonorrheal infection among Mexican-American and African-American women at high risk for sexually transmitted disease.

Adolescent↗
PubMed1999

Diagnosis of perinatal TORCH infections.

Collectively, TORCH infections create more neonatal morbidity than early-onset group B streptococcal sepsis. Fortunately, the incidence of maternal infection by CMV or toxoplasmosis is low (2-10 per 1,000 births). There have been tremendous advances in direct antigen testing and in the sensitivity and specificity of IgG and IgM testing. Consistently, research laboratories show more accurate results than in the past. Unfortunately, commercial laboratories are using older, single-kit testing. The relatively poor degree of reliability can lead to unnecessary obstetric intervention or elective termination. Any positive pathogen-specific IgM on maternal serum should have additional confirmatory testing in a reputable research laboratory before any intervention. Direct antigen testing or multiple testing would seem to be appropriate for confirmation. This may include amniocentesis of fetal blood sampling. The research on the newer tests is based of the evaluation of blood from seriously immunocompromised subjects. Extrapolations of test accuracy to similar tests on healthy, pregnant women and their fetuses are likely to be in error. The application of these accurate tests to the obstetric population is a critical research need.

Cytomegalovirus Infections↗
PubMed1998

Meconium: a marker for peripartum infection.

OBJECTIVE: To test the hypothesis that the presence of meconium-stained amniotic fluid (AF) is associated with maternal and neonatal infection, both before and after delivery. METHODS: Nine hundred thirty-six laboring women were analyzed for the presence of meconium in amniotic fluid and occurrence of peripartum infection. Meconium was assessed clinically as thin, moderate, or thick. Intra-amniotic infection and endometritis were diagnosed by standard definitions. All patients were tested for vaginal group B streptococcus, bacterial vaginosis, and other aerobic organisms. RESULTS: Meconium-stained AF was present in 28% of the study participants (9% thin, 12% moderate, 7% thick). The presence of meconium was associated with increased intra-amniotic fluid (17% versus 9%, relative risk [RRI 1.98, 95% confidence interval [CI] 1.3, 3.1), endometritis (10% versus 5%, RR 2.38, 95% CI 1.3, 4.4), and total infection (25% versus 13%, RR 2.19, 95% CI 1.5, 3.2). Thick meconium had higher infection rates than clear AF (44% versus 13%, RR 5.18, 95% CI 2.9, 9.3). Meconium was associated independently with peripartum infection by multiple logistic regression (RR 1.28, 95% CI 1.1, 1.6). CONCLUSION: Meconium-stained AF is associated with increased peripartum infection, independent of other risk factors for infection. Thick meconium, in particular, is associated with a marked increase in peripartum infectious morbidity.

Adult↗
PubMed1998

Effects of prophylactic antibiotics on endometrial flora in women with postcesarean endometritis.

OBJECTIVE: To determine the effect of prophylactic antibiotics on endometrial and endocervical microflora upon diagnosis of postcesarean endometritis. METHODS: The medical records of patients enrolled in open-label comparative trials of therapeutic antibiotics for postpartum endometritis between 1989 and 1994 were reviewed (n = 682). Endometritis was diagnosed by a standard definition that included fever and localizing signs. Endometrial cultures were obtained by a sheathed injection/aspiration technique. Aerobes and anaerobes were isolated by standard microbiologic techniques. The primary outcome, endometrial and endocervical microflora, was compared in women who received intravenous ampicillin (2 g every 6 hours for 1-3 doses), cephalosporin (2 g every 6 hours for 1-3 doses), or no prophylaxis. Secondary outcomes included the cure of endometritis and the prevalence of wound infection in the three groups. RESULTS: Four hundred sixty-five of 682 patients (67%) had a cesarean delivery. One hundred fifty-one patients received ampicillin prophylaxis, 100 patients received cefazolin prophylaxis, 18 patients received extended-spectrum antibiotics, and 196 patients received no prophylaxis. Patients who received cefazolin prophylaxis had a significant increase in enterococcus (P < .05) and a significant decrease in Proteus species (P < .05) from endometrial samples. Patients who received ampicillin prophylaxis had a significant increase of Mycoplasma species (P < .05), Klebsiella pneumoniae (P < .0001), Escherichia coli (P = .04), and any aerobic gram-negative rod (P = .003) from endometrial samples. Ampicillin prophylaxis was associated with a decrease in Prevotella bivia (P < .05) and any anaerobe (P < .01). Endometritis cure rates were similar between prophylaxis groups and between prophylaxis and treatment groups. However, the cefazolin prophylaxis followed by cephalosporin treatment was associated with more wound infections (19%) than other prophylaxis and treatment groups, (6%, P < .01). CONCLUSION: Ampicillin and cefazolin prophylaxis alters endometrial and endocervical microflora of women who develop endometritis. Whereas these changes had no effect on endometritis cure rate (power > 80%), the association between cefazolin prophylaxis followed by an extended-spectrum cephalosporin and wound infection may warrant caution against the use of the combination.

Adult↗
PubMed1997

Bacterial vaginosis and intraamniotic infection.

OBJECTIVE: We sought to determine the predictors of intraamniotic infection with use of the presence or absence of vaginal microbes and clinical variables. STUDY DESIGN: Vaginal fluid was collected and analyzed on 936 of 2711 (35%) consecutive patients who were delivered over a 7-month period. Subjects were followed up prospectively for the development of intraamniotic infection. Intraamniotic infection was defined as an intrapartum fever > 37.8 degrees C plus at least two of the five following variables: maternal or fetal tachycardia, leukocytosis, tender uterus, or foul-smelling amniotic fluid. Bacterial vaginosis score and the presence or absence of aerobic vaginal organisms were independent microbial variables. Demographic, maternal, labor, and delivery characteristics were independent clinical variables. Stepwise logistic regression analysis was used to develop adjusted odds ratios for predicting intraamniotic infection (expressed as odds ratio [95% confidence interval]). Selection bias and microbiologic reliability were measured. RESULTS: A bacterial vaginosis score of 7 to 10 (odds ratio 1.7, [95% confidence interval 1.0 to 3.9]), nulliparity (2.1 [1.3 to 3.4]), each hour of internal fetal electrode (1.2 [1.0-1.3]); and, each vaginal examination (1.7 [1.0-3.9]) were predictors of intraamniotic infection. Selected aerobic vaginal organisms such as group B streptococci or gram-negative rods were not predictive. Reanalysis with a bacterial vaginosis score > or = 4 revealed similar predictors of intraamniotic infection. Bacterial vaginosis had an adjusted odds ratio of 1.85 (1.16 to 2.9). Selected higher risk populations, vaginal examinations > or = 6 (n = 365), or rupture of membranes > or = 7 hours (n = 421) did not change the risk of a bacterial vaginosis score > or = 4 (adjusted odds ratio 1.87 and 1.98, respectively). CONCLUSION: Abnormal vaginal flora combines with clinical variables to increase the risk of intraamniotic infection.

Adult↗
PubMed1996

Sexual behavior and vaginal colonization by group B streptococcus among minority women.

OBJECTIVE: To test the hypothesis that sexual behaviors predict colonization of the vagina by group B streptococcus among minority women. METHODS: We conducted a prospective, descriptive study of 192 consecutive African-American (37%) and Hispanic women (63%). Each woman underwent a detailed interview concerning sexual behavior. Separate specimens were taken from the endocervix, upper vagina, lower vagina, and anorectum and placed in selective broth media for isolation of group B streptococcus. Significant behavioral predictors of vaginal group B streptococcus colonization and heavy (3-4+) colonization were identified using stepwise logistic regression. RESULTS: The incidence of vaginal colonization was 39% and heavy colonization was 35%. Nineteen percent reported anal intercourse, 46% reported sex at least two times per week, and 21% reported more than one partner in the previous 30 days. The significant predictors of vaginal group B streptococcal infection were: African-American ethnicity, adjusted odds ratio (OR) 6.1 (95% confidence interval [CI] 2.5-15.1); presence of rectal group B streptococcus, adjusted OR 100.6 (95% CI 26.7-379.3); nulliparous, adjusted OR 3.6 (95% CI 1.4-9.5); and nonpregnant status, adjusted OR 3.9 (95% CI 1.3-12.2). The significant predictors of heavy colonization were: more than one partner in the last 30 days, adjusted OR 2.6 (95% CI 1.2-5.6); and African-American ethnicity, adjusted OR 2.3 (95% CI 1.2-4.5). Anal intercourse was associated with a reduced likelihood of vaginal group B streptococcal infection, adjusted OR 0.34 (95% CI 0.12-0.91). CONCLUSION: Sexual behavior, especially anal intercourse, does not predict vaginal colonization by group B streptococcus. African-American women are more likely to have vaginal and heavy group B streptococcus colonization. Heavy vaginal colonization is associated with multiple partners in African-American women.

Adult↗
PubMed1995

Epidural analgesia and uterine function.

OBJECTIVE: To determine whether continuous epidural analgesia with bupivacaine and fentanyl affects the rate of cervical dilation and myometrial contractility. METHODS: In a 5-week period, 62 consecutive women who received standardized epidural analgesia were matched with the next two groups of 124 consecutive women of the same parity who did not receive epidural analgesia. The outcome variables were uterine activity, rate of cervical dilation, oxytocin therapy, and operative deliveries. RESULTS: Continuous epidural analgesia with bupivacaine and fentanyl did not result in a change in myometrial contractility in the first hour after the initiation of analgesia. However, despite more oxytocin therapy, the rate of cervical dilation was significantly lower in the epidural group than in the nonepidural group (1.9 versus 5.6 cm/hour, P < .001). Operative deliveries were more common in patients with epidural analgesia than in those without it (12 of 62 versus two of 124, P < .001). CONCLUSION: After epidural analgesia, myometrial contractility is maintained with oxytocin, but the ability of the uterus to dilate the cervix is reduced significantly.

Analgesia, Epidural↗
PubMed1995

Amoxicillin or erythromycin for the treatment of antenatal chlamydial infection: a meta-analysis.

OBJECTIVE: To compare the effectiveness of amoxicillin and erythromycin for the treatment of antenatal Chlamydia trachomatis infection by meta-analysis of available trials involving random assignment of subjects. DATA SOURCES: A computer search of English-language abstracts using MEDLINE and the Cochrane Pregnancy and Childbirth Database (medical subject heading terms: pregnancy, chlamydia, erythromycin, amoxicillin, antenatal antibiotics) was supplemented with a review of the bibliographies of the relevant articles generated by the computer search. METHODS OF STUDY SELECTION: Five trials were identified, four of which met our inclusion criteria for the meta-analysis. DATA EXTRACTION AND SYNTHESIS: Trials to be included in this meta-analysis underwent trial quality evaluation and data abstraction. An estimate of the relative risk (RR) was calculated for the dichotomous outcomes using a fixed-effects model. The pooled RR for the effectiveness of amoxicillin compared with erythromycin was 1.11 (95% confidence interval [CI] 1.05-1.18), and the pooled RR for gastrointestinal side effects of amoxicillin compared with erythromycin was 0.29 (95% CI 0.20-0.42). The pooled RR for gastrointestinal side effects that resulted in discontinuation of therapy of amoxicillin compared with erythromycin was 0.14 (95% CI 0.06-0.36). CONCLUSION: The available data suggest that amoxicillin is more effective than erythromycin for the treatment of antenatal C trachomatis infection and has fewer gastrointestinal side effects, leading to better compliance.

Amoxicillin↗
PubMed1994

Human herpesvirus 6 infection of the female genital tract.

Four of the seven human herpesviruses are recognized to replicate in the female genital tract and may be transmissible to sexual partners and newborn infants. Several of these viruses have also been implicated in the etiology of various human cancers, including tumors of epithelial cell origin. Human herpesvirus 6 (HHV-6) is a newly identified herpesvirus that causes exanthem subitum. The pathogenicity of HHV-6 within the genital tract is largely unexplored. Acellular vaginal secretions from 29 women attending a sexually transmitted diseases clinic were examined for the presence of HHV-6 DNA sequences by polymerase chain reaction. Three samples (10%) were consistently positive for HHV-6 DNA. Since HHV-6 DNA is shed in the genital tract of some women, it is possible that infectious virus is transmissible through sexual contact and to newborn infants by perinatal spread.

Adult↗
PubMed1994

Platelet-activating factor antagonists and implantation in rabbits.

In an initial experiment, rabbits were injected i.v. with a platelet-activating factor (PAF) antagonist CV-3988 twice a day on days 5 and 6 of pregnancy. Some inhibition of implantation was observed. This effect could not be reproduced in subsequent experiments at the same or at larger or smaller doses. The non-metabolized analogue of PAF, N-carbamyl-PAF (C-PAF) had an inhibitory effect on implantation only when given at toxic concentrations. When CV-3988 and C-PAF were given together on days 5 and 6, there was no effect on implantation. None of the other PAF antagonists tested--BN52021, SRI63,441, WEB2086 or TCV-309--at various doses could inhibit implantation when given on the same days of pregnancy. TCV-309, at 0.1 mg kg-1 i.v. given on days 2-4 of pregnancy, was also ineffective. These results provide no clear support for a role of PAF in implantation in rabbits.

Animals↗
PubMed1993

Perinatal effects of Gardnerella vaginalis deciduitis in the rabbit.

OBJECTIVE: We determined the effects of intrauterine infection with Gardnerella vaginalis on maternal and fetal outcome in the rabbit. STUDY DESIGN: Both uterine horns of rabbits on day 20 or 21 of gestation (70% of gestation) were inoculated hysteroscopically with either 0.2 ml of 10(5) to 10(7) CFU/ml of G. vaginalis or saline solution. Animals were killed on day 4 or earlier if premature delivery occurred. The following outcome parameters were evaluated: febrile morbidity, preterm labor and delivery, maternal cultures, fetal birth weight, and fetal neuropathologic findings. RESULTS: G. vaginalis intrauterine inoculation uniformly resulted in amnionitis and deciduitis. Animals inoculated with G. vaginalis had no greater incidence of fever and preterm delivery than did saline-treated control animals. However, intrauterine infection with G. vaginalis resulted in a significant decrease in the live birth rate when compared with that of controls (80% vs 95%, p < 0.03). G. vaginalis deciduitis was associated with as 23% reduction in the birth weight of the surviving fetuses. Furthermore, animals in the G. vaginalis study group had a 60% incidence of severe brain injury compared with 0% in the saline solution group. CONCLUSION: G. vaginalis amnionitis and deciduitis produced minimal maternal morbidity but were associated with decreased birth weight and brain injury in surviving fetuses; thus it appears that G. vaginalis selectively functions as a fetal, but not maternal, pathogen in the rabbit.

Animals↗
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↗