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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

The development and testing of new instruments for operative vaginal delivery.

OBJECTIVE: Little innovation has occurred in recent years in the instruments available for operative vaginal delivery. The purpose of this study is to develop a technique to test the utility of an investigational device, the obstetric bonnet, and measure the forces it places on the fetal head. STUDY DESIGN: We constructed a model of the fetal head capable of measuring both compression and vacuum created by an applied device. A total of 18 devices were tested to a maximum traction of 60 pounds. RESULTS: A significant linear relationship exists between the traction applied and the compression (R2 = 0.42, p = 0.0004) and vacuum (R2 = 0.85, p = 0.0001) created. Compression and vacuum recorded at maximum recommended traction were 1.1 lb/sq in and 31 cm Hg, respectively. CONCLUSION: These findings explain the mechanics of this interesting device, and demonstrate forces that compare favorably with those known to occur with forceps or vacuum extraction.

Female

Predictors of antibiotic prophylactic failure in post-cesarean endometritis.

Despite the use of prophylactic antibiotics, endometritis occurs in 1-31% of patients after cesarean delivery. We sought to identify predictors of prophylactic antibiotic failure. In a retrospective review of 1800 cesarean deliveries, 766 patients had either ampicillin or cefazolin prophylaxis; 240 (31.3%) developed endometritis. Stepwise logistic regression identified the number of vaginal examinations (P less than .001), nulliparity (P = .001), low gestational age (P = .033), and cefazolin use (P = .002) as predictors of endometritis. One in two women with six or more vaginal examinations before cesarean delivery will have prophylactic failure. In preterm gestations (N = 177), the number of vaginal examinations was the single predictor of prophylactic antibiotic failure (P = .002). The number of vaginal examinations can be used to design new strategies to prevent a high rate of prophylactic failure.

Ampicillin

Combination antibiotics and indomethacin in idiopathic preterm labor: a randomized double-blind clinical trial.

Subclinical infection may play a role in the failure of magnesium sulfate tocolysis. Using a double-blind randomized study design, we administered a combination of ampicillin-sulbactam and indomethacin or corresponding placebos to patients in preterm labor who were receiving intravenous magnesium sulfate tocolysis. The mean gestational age at enrollment was 30.1 weeks, and mean cervical dilatation was 2.15 cm. No differences were noted between placebo (n = 43) and study patients (n = 43) in gestational age at delivery, term deliveries, days gained, or neonatal outcome. Preterm delivery (less than 36 weeks) occurred in 61% of the total population. The likelihood of a beta error was 0.07 to 0.23 on the basis of outcome analysis. In our population adjunctive ampicillin-sulbactam with indomethacin did not improve the success of magnesium sulfate tocolysis.

Ampicillin

The second stage of labor: factors influencing duration.

Prolonged second stage of labor is associated with increased perinatal mortality. Factors influencing second-stage duration are poorly understood. This study was undertaken to characterize those factors. A population of 473 nulliparous women and 491 multiparous women with spontaneous vaginal deliveries were analyzed extensively with history, physical examination (including clinical pelvimetry), labor and delivery data, and neonatal measurements. On the basis of stepwise multiple linear regression, epidural analgesia (p less than 0.0001), active-phase duration (p less than 0.0001), parity (p less than 0.0001), height (p less than 0.0004), birth weight (p less than 0.0003), and station at complete dilatation (p less than 0.027) predicted second-stage duration. The sum of their effect, however, accounted for less than 25% of the variability in second-stage length (total R2 = 0.233), leaving 75% of the variance unexplained.

Adult

A randomized, double-blind, placebo-controlled trial of oral antibiotic therapy following intravenous antibiotic therapy for postpartum endometritis.

One hundred thirty-six patients were enrolled in a randomized, double-blind, placebo-controlled trial of oral antibiotic therapy (amoxicillin) versus placebo following successful intravenous (IV) antibiotic therapy for postpartum endometritis. No subjects were readmitted to the hospital for recurrent endometritis and there were no wound infections or recurrent fevers. Minor side effects were seen in 10% of those taking amoxicillin and 14% of those taking placebo. Compliance was fair; only 52% of those taking amoxicillin and 65% of those taking placebo completed therapy. The lack of infectious complications in this high-risk population suggests that oral antibiotic therapy is unnecessary after successful IV antibiotic therapy for endometritis.

Administration, Oral

Surgical glove perforation in obstetrics.

Perforation of surgical gloves places the obstetrician at risk for blood-borne infectious diseases. Seven hundred fifty-four surgical gloves used in vaginal and cesarean deliveries and postpartum tubal ligations were examined for evidence of perforation by the air inflation-water submersion technique. The overall glove perforation rate was 13.3%, with 62% of the perforations remaining unrecognized during the surgical procedure. The majority of perforations occurred on the fingers of the nondominant hand. Multivariate analysis with logistic regression indicated that cesarean delivery (odds ratio 3.52), any vaginal laceration or episiotomy (odds ratio 4.95), and chief resident status (odds ratio 3.00) were the major risk factors for surgical glove perforation. Surgical technique by assistants, especially in complex cases, is as important as that of the primary surgeon in regard to glove perforations.

Equipment Failure

Does fasting interval affect the glucose challenge test?

The relationship between fasting interval and glucose screening was assessed in a prospective study of 153 non-diabetic pregnant patients undergoing a standard 50g glucose challenge test. An interval of less than 3 hours after the last meal was found to be associated with a significantly greater insulin response as opposed to a fasting interval of more than 3 hours (121.3 pmol/l vs. 83.5 pmol/l, p less than .001) and a greater insulin/glucose index (0.92 vs. 0.66, p less than .001), with no difference in plasma glucose. Overall, obese patients had a higher glucose response than non-obese, but only higher insulin levels (107 pmol/l vs. 69 pmol/l, p less than .001) and insulin/glucose index (0.79 vs. 0.59, p less than .02) when the fasting interval was greater than 3 hours. Our data suggest that the fasting interval can influence insulin response during a glucose challenge test and the aberration in insulin secretion may effect screening results, especially in the high-risk gravida with glucose abnormality.

Adult

A prospective randomized comparison of oral terbutaline and magnesium oxide for the maintenance of tocolysis.

We compared oral magnesium oxide with oral terbutaline sulfate in a prospective, randomized manner to determine efficacy and side effects. Preterm labor patients whose labor was arrested with parenteral tocolysis were randomized to oral tocolysis with either magnesium oxide, 200 mg every 3 to 4 hours (n = 23), or terbutaline, 2.5 to 5 mg every 3 to 4 hours (n = 27). The number of patients who were delivered of infants before 36 weeks' gestation was similar between groups (18.5% receiving terbutaline versus 17.4% receiving magnesium). At least one side effect occurred in 81.5% of patients in the terbutaline group and 47.8% in the magnesium group (p less than 0.01). Finally, the cost for 1 day of magnesium (20 cents) is approximately one third the cost of terbutaline (56 cents). These data suggest that oral magnesium oxide is as effective as terbutaline for the maintenance of tocolysis, with fewer side effects and at a lower cost.

Administration, Oral

A clinical and microbiologic analysis of risk factors for puerperal endometritis.

Predictors of postpartum endometritis were identified in 607 asymptomatic, laboring women. One hundred (16.5%) developed postpartum endometritis. Multivariate analysis using stepwise logistic regression identified cesarean delivery (relative risk 12.8; P less than .0001) as the dominant overall predictor. In patients with cesarean delivery (N = 124), prophylactic antibiotics (relative risk 0.54; P less than .0002) and high-virulence bacteria or Mycoplasma hominis (relative risk 1.4; P less than .01) predicted the incidence of endometritis, and in patients with vaginal delivery (N = 483), "bacterial vaginosis organisms" (relative risk 14.2; P less than .001) and aerobic gram-negative rods (relative risk 4.2; P less than .01) predicted endometritis. Despite significant associations found on univariate analysis, clinical variables such as duration of labor, rupture of membranes, and internal monitoring were not predictive of endometritis in the multivariate analysis. Our findings show that cesarean delivery and certain organisms, such as bacterial vaginosis or high-virulence organisms, predict endometritis, and that clinical variables may be facilitators rather than predictors of endometritis.

Adult

The fetus as a patient.

In the last 20 years, there has been an explosion of technology designed to diagnose fetal health. The purpose of this article is to review perinatal definitions, causes of perinatal morbidity and mortality, the efficacy of high-risk identification, and the most common and newer methods of fetal surveillance. There is a special emphasis on the predictive power and complications of the new technology.

Female

A randomized, blinded, placebo-controlled trial of antibiotics in idiopathic preterm labor.

Because subclinical genital tract infection may play a major role in preterm birth, the efficacy of adjunctive antibiotic therapy in combination with standard parenteral tocolysis was examined in a randomized, blinded study of patients with idiopathic preterm labor. Labor was documented by three contractions in 20 minutes, cervical dilation of 1 cm or more, and the need for parenteral tocolysis. Enrollment was restricted to patients with intact membranes and without known causes for preterm labor. One hundred three patients at 24-34 weeks' gestation were randomized to intravenous ampicillin plus oral erythromycin or corresponding placebos. Compared with the placebo group, the adjunctive antibiotic group had a similar frequency of preterm birth (38 versus 44%), time to delivery (34 versus 34 days), birth weight (2847 versus 2855 g), and episodes of recurrent labor requiring parenteral tocolysis (0.43 versus 0.49). In our population, we found no benefit to the adjunctive use of ampicillin plus erythromycin. Significant differences in genital microflora between our patients and those of other studies may explain our results.

Adolescent

Factors associated with hospital-specific cesarean birth rates.

The variation in hospital-specific cesarean birth rates was examined using a multiple regression analysis in a national data base of deliveries in 1977. This data base included 222,285 singleton births in 282 hospitals representing all regions of the United States. The 32 independent variables included measures of medical risk, technologic sophistication, demographic characteristics and economic incentives. The incidences of medical risk factors, nonwhite race and ratio of obstetricians to fertile women were associated positively with hospital-specific cesarean delivery rates. Participation in health maintenance organizations and numbers of deliveries were correlated negatively with those rates. Hospital-specific cesarean delivery rates were not associated with technologic sophistication, malpractice premiums or reimbursement differences between routes of delivery. Pay source stratified models explained 45-63% of the variation in the hospital-specific cesarean rates. Sensitivity analysis revealed that even a 50% change in the incidence of any independent variable would change the cesarean delivery rate by less than 2%.

Birth Rate

Logistic regression analysis of risk factors for intra-amniotic infection.

The identification of risk factors for intra-amniotic infection may allow changes in obstetric management and reduce complications. In a pilot study, stepwise logistic regression identified duration of ruptured membranes and duration of interval monitoring as significant risk factors for intra-amniotic infection. Using the preliminary regression equation, we established critical durations (risk criteria) to predict a 20% or greater probability of intra-amniotic infection. Subsequently, 2908 patients were screened prospectively for risk criteria and/or the presence of intra-amniotic infection. Seven hundred five patients of the 2908 (24%) met the risk criteria, and 107 of 124 cases of intra-amniotic infection (86%) met the risk criteria. In patients meeting the risk criteria, the relative risk of intra-amniotic infection was 19.7. In addition, 81 of 705 (12%) of mothers developed endometritis. Ten neonates of mothers with criteria developed sepsis or pneumonia. A stepwise logistic regression performed on the prospectively gathered data showed that among patients meeting risk criteria, parity, duration of internal monitoring, and duration of membrane rupture were the significant risk factors for intra-amniotic infection.

Adult

Multicenter clinical trials comparing cefotetan with moxalactam or cefoxitin as therapy for obstetric and gynecologic infections.

The clinical efficacy and safety of cefotetan was assessed in two multicenter clinical trials involving 335 evaluable patients hospitalized with obstetric and gynecologic infections. In Study I, cefotetan was compared with moxalactam and in Study II, cefotetan was compared with cefoxitin. The clinical response rate in Study I was 67 of 70 patients for cefotetan (96 percent) and 33 of 34 patients (97 percent) for moxalactam. In Study II, the clinical response rate was 138 of 147 patients in the cefotetan group (94 percent) and 76 of 84 patients in the cefoxitin group (91 percent). For the patients with bacteriologic response data, 196 of 205 cefotetan patients (96 percent), 23 of 24 moxalactam patients (96 percent), and 70 of 75 cefoxitin patients (93 percent) had a satisfactory bacteriologic response. Cefotetan was well tolerated and produced no major adverse reactions. The mean amount of cefotetan given was lower than that of moxalactam or cefoxitin.

Adult

Multicenter comparison of cefotetan and cefoxitin in the treatment of acute obstetric and gynecologic infections.

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.

Acute Disease

A randomized trial of intrapartum versus immediate postpartum treatment of women with intra-amniotic infection.

A randomized trial of intrapartum versus postpartum antibiotic treatment of women with intra-amniotic infection was conducted. Intra-amniotic infection was treated with ampicillin and gentamicin during labor (at the time of diagnosis) in 26 women and immediately after umbilical cord clamping in 19 women. Intrapartum treatment led to a lower incidence of neonatal sepsis (0 versus 21%; P = .03) and a shorter neonatal hospital stay (3.8 versus 5.7 days; P = .02) when compared with postpartum treatment. There were no significant differences in the microbiologic results, the gestational age, or the birth weight between the groups. Intrapartum-treated mothers had a shorter mean postpartum stay, a lower mean number of febrile days, and a lower mean peak postpartum temperature than did postpartum-treated mothers; these differences were all statistically significant (P = .05). The treatment of clinical intra-amniotic infection during labor results in improved outcome.

Adult