Edward R. Newton

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.

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

&NA; 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.

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.

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.

Behaviors changed by intervention are associated with reduced STD recurrence: the importance of context in measurement.

Background Evaluations of STD/HIV interventions incorporating behavioral and biologic outcomes have not reported strong correspondence. Goal The goal of the study was to demonstrate that behaviors, measured comprehensively, are associated with infection and to delineate the behaviors responsible for reduced infection rates in Project SAFE (Sexual Awareness For Everyone). Study Design Follow-up data from an intervention trial were analyzed to determine: (1) study versus control differences in complex risk behaviors and (2) the overall relationship between these behaviors and infection status (chlamydia and/or gonorrhea), with use of multiple logistic regression. Results Lower infection rates among 249 women who received intervention (compared with 228 controls) were explained by reduced-risk status in 5 modifiable behaviors. The 0 to 12–month logistic regression model (including sex with untreated partner [OR = 5.6], lack of mutual monogamy [OR = 2.4], unsafe sex [OR = 1.9], rapid partner turnover [OR = 2.7], and douching after sex [OR = 1.9]) correctly predicted infection status for 75.3% of participants (71.8% of infected, 76.2% of uninfected). Women in nonmutually monogamous unions who had sex with partners who were untreated or incompletely treated were 13 times more likely to be infected than those who were monogamous and avoided sex with an untreated/incompletely treated partner. Conclusion This intervention reduced infection rates by maintaining low-risk behaviors and changing high-risk behaviors. We elucidated the complex relationship between behavior and infection by incorporating context into variable conceptualization and considering several behaviors simultaneously.

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.

The epidemiology and clinical history of asymptomatic midtrimester placenta previa.

The current case-controlled study examines the epidemiologic factors and subsequent clinical history in 139 patients with asymptomatic low placentation and 137 patients with normal placental position diagnosed in the second and third trimesters by gray-scale ultrasonography. Increased maternal age or parity and previous endometrial or myometrial damage were significantly associated with asymptomatic midtrimester low implantation. Three percent of early low implantations persisted as instances of placenta previa at term. However, in low implantation, the antepartum course was associated with perinatal complications in 45% of patients. Statistically significant increases in third-trimester bleeding, abruptio placentae, and suspected intrauterine growth retardation were shown in the patients with low implantation, when compared to the control patients. Forty-two percent of the patients with low implantation were delivered by cesarean section. The need for cesarean delivery, loss of blood, and prolonged hospitalization were statistically increased in the patients with low implantation. Infants born to mothers with low implantation showed statistically significant increases in prematurity, low birth weight, and perinatal mortality when compared to infants born to control patients.

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 defini tions. 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 intraamniotic fluid (17% versus 9%, relative risk [RR] 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.

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.

The Effects of Hydrotherapy on Anxiety, Pain, Neuroendocrine Responses, and Contraction Dynamics During Labor

Background: Hydrotherapy (immersion or bathing) is used worldwide to promote relaxation and decrease parturient anxiety and pain in labor, but the psychophysiological effects of this intervention remain obscure. Design: A pretest—posttest design with repeated measures was used to examine the effects of hydrotherapy on maternal anxiety and pain, neuroendocrine responses, plasma volume shift (PVS), and uterine contractions (CXs) during labor. Correlations among variables were examined at three time points (preimmersion and twice during hydrotherapy). Methods: Eleven term women (mean age 24.5 years) in spontaneous labor were immersed to the xiphoid in 37 °C water for 1 hr. Blood samples and measures of anxiety and pain were obtained under dry baseline conditions and repeated at 15 and 45 min of hydrotherapy. Uterine contractions were monitored telemetrically. Results: Hydrotherapy was associated with decreases in anxiety, vasopressin (V), and oxytocin (O) levels at 15 and 45 min (all ps < .05). There were no significant differences between preimmersion and immersion pain or cortisol (C) levels. Pain decreased more for women with high baseline pain than for women with low baseline levels at 15 and 45 min. Cortisol levels decreased twice as much at 15 min of hydrotherapy for women with high baseline pain as for those with low baseline pain. β-endorphin (βE) levels increased at 15 min but did not differ between baseline and 45 min. During immersion, CX frequency decreased. A positive PVS at 15 min was correlated with contraction duration. Conclusions: Hydrotherapy during labor affects neuroendocrine responses that modify psychophysiological processes.