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Biomedical subjects

R L Goldenberg

Publications and source records attributed to R L Goldenberg.

At least 127 records · Page 7Linked to original sources
PubMed1996

Bacterial colonization of the vagina during pregnancy in four ethnic groups. Vaginal Infections and Prematurity Study Group.

OBJECTIVE: Our purpose was determine whether there are ethnic differences in vaginal colonization with organisms reputed to be associated with preterm delivery. STUDY DESIGN: In seven urban medical centers in the United States from 1984 to 1989, 13,747 predominantly low-socioeconomic-status women at 23 to 26 weeks' gestation were grouped according to ethnic origin. Each had a vaginal culture for multiple organisms and Gram's stain and pH test to diagnose bacterial vaginosis. Multivariate analyses with adjustment for maternal age, insurance status, marital status, smoking history, education level, age at first sexual intercourse, and number of male partners in the past year were also performed to determine the odds ratio for a black woman versus a white woman having a positive test result. RESULTS: For nearly every organism studied, Asian-Pacific Islander and white women had the lowest percentages of positive test results whereas black women had the highest. When black and white women are compared, black women were more likely to be colonized with Chlamydia trachomatis, 16% versus 5%; Neisseria gonorrhoeae, 2.5% versus 0.4%; Bacteroides sp., 25% versus 14%; bacterial vaginosis, 23% versus 9%; and the four other organisms evaluated. Adjustment for potential confounders including certain health behaviors did not markedly change the risk of a black woman having a positive test result, with the odds ratios for colonization with each organism ranging from 1.8 to 6.4. CONCLUSIONS: Highly significant differences exist in vaginal colonization patterns among women of different ethnic groups, with the highest rates of potentially pathogenic organisms observed in black women and the lowest in Asian-Pacific Islander women. Differences in health behaviors do not explain the variation in colonization rates.

Adult↗
PubMed1996

The preterm prediction study: risk factors in twin gestations. National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network.

OBJECTIVE: Our purpose was to determine the association between the presence of bacterial vaginosis, fetal fibronectin, and a short cervix and the risk of spontaneous preterm birth of twins. STUDY DESIGN: We prospectively screened 147 women with twins at 24 and 28 weeks' gestation for more than 50 potential risk factors for spontaneous preterm birth. We also measured cervical length with ultrasound scans and tested for the presence of bacterial vaginosis. Fetal fibronectin level was evaluated every 2 weeks from 24 to 30 weeks' gestation. Outcomes included spontaneous preterm birth at < 32 weeks, < 35 weeks, and < 37 weeks. RESULTS: Among twin as compared with singleton pregnancies, a cervical length < or = 25 mm was more common at both 24 and 28 weeks, a statistically significant difference. There were no significant differences in most other risk factors. Of the factors evaluated by means of univariate analysis at 24 weeks, only a short cervix (< or = 25 mm) was consistently associated with spontaneous preterm birth. The odds ratio and 95% confidence interval for spontaneous preterm birth at < 32 weeks, < 35 weeks, and < 37 weeks were 6.9 (2.0 to 24.2), 3.2 (1.3 to 7.9), and 2.8 (1.1 to 7.7). At 28 weeks, a cervical length < or = 25 mm was not a strong predictor of spontaneous preterm birth. At both 28 weeks (odds ratio, 9.4; confidence interval, 1.0 to 67.7) and 30 weeks (odds ratio 46.1; confidence interval, 4.2 to 1381), a positive fetal fibronectin result was significantly associated with spontaneous preterm birth at < 32 weeks. Bacterial vaginosis at 24 or 28 weeks was not associated with spontaneous preterm birth of twins. Multivariate analysis confirmed the association between cervical length < or = 25 mm at the 24-week visit and spontaneous preterm birth and also confirmed that at 24 weeks the other risk factors were less consistently and often not statistically significantly associated with spontaneous preterm birth. Of the risk factors evaluated at 28 weeks, only a positive fetal fibronectin was associated with a significantly increased risk for spontaneous preterm birth. CONCLUSIONS: Most known risk factors for spontaneous preterm birth were not significantly associated with spontaneous preterm birth of twins. At 24 weeks, cervical length < or = 25 mm was the best predictor of spontaneous preterm birth at < 32 weeks, < 35 weeks, and < 37 weeks. Of the risk factors evaluated at 28 weeks, fetal fibronectin was the only statistically significant predictor of spontaneous preterm birth at < 32 weeks.

Adolescent↗
PubMed1996

Trial of Calcium for Preeclampsia Prevention (CPEP): rationale, design, and methods.

The results of ten clinical trials suggest that supplemental calcium may prevent preeclampsia. However, methodologic problems and differences in study design limit the acceptance of the results and their relevance to other patient populations. Many of the trials were conducted in countries where, unlike the United States, the usual daily diet contained little calcium. Moreover, none of the trials has reported the outcome of systematic surveillance for urolithiasis, a potential complication of calcium supplementation. In response to the need for a thorough evaluation of the effects of calcium supplementation for the prevention of preeclampsia in the United States, the trial of Calcium for Preeclampsia Prevention (CPEP) was undertaken at five university medical centers. Healthy nulliparous patients were randomly assigned to receive either 2 g supplemental calcium daily (n = 2295) or placebo (n = 2294) in a double-blind study. Study tablets were administered beginning from 13 to 21 completed weeks of gestation and continued until the termination of pregnancy. CPEP employed detailed diagnostic criteria, standardized techniques of measurement, and systematic surveillance for the major study endpoints and for urolithiasis. The nutrient intake of each patient was assessed at randomization and at 32-33 weeks gestation. This report describes the study rationale, design, and methods.

Calcium↗
PubMed1996

The feasibility of a randomized clinical perinatal trial: maternal magnesium sulfate for the prevention of cerebral palsy.

OBJECTIVE: Because recent epidemiologic data suggest an association between maternal magnesium sulfate use and a decreased risk of cerebral palsy in infants who survive preterm birth, we investigated the feasibility of a randomized trial of intrapartum maternally administered magnesium sulfate to prevent cerebral palsy in children who were born before term. STUDY DESIGN: On the basis of a literature review, we calculated cumulative rates of delivery, neonatal survival, and cerebral palsy for progressively longer gestational age intervals beginning at 24 weeks' gestation. Sample size estimates with two-tailed chi 2 tests without Yates' correction (alpha = 0.05, beta = 0.2, 50% effect size) for a clinical trial were calculated for these rates. RESULTS: In the 4-week interval from 24 weeks 0 days to 27 weeks 6 days the minimum number of neonates required to conduct a randomized trial would be 1189. Loss to follow-up of neonates, maternal ineligibility, and failure of enrollment would substantially increase the number of necessary gravid women delivered in the 4-week interval to complete such a trial, such that 1 million pregnancies would be required to generate the necessary number of eligible gravid women. Shorter gestational age intervals (e.g., 24 weeks 0 days to 25 weeks 6 days) required fewer neonates (n = 729) but more pregnancies (n = 1.5 million). Because of the decreasing prevalence of cerebral palsy at higher gestational ages, extending the gestational age interval (e.g., to 29 weeks 6 days) markedly increased the minimum number of neonates to 1982 but only slightly decreased the necessary number of pregnancies, to 900,000. CONCLUSIONS: A randomized trial of maternally administered intrapartum magnesium sulfate to reduce the rate of cerebral palsy in surviving preterm neonates would be a formidable undertaking, requiring a concerted multicentered effort.

Cerebral Palsy↗
PubMed1996

Ethnicity and sources of prenatal care: findings from a national survey.

BACKGROUND: Improving pregnancy outcomes for minorities is a major goal of health providers and policy makers. Since most strategies involve an intervention during pregnancy, it is important to know where minority women with various characteristics receive prenatal care and why. Our purpose was to evaluate services of prenatal care for white, African-American, Mexican-American, and Puerto Rican women. METHODS: The National Maternal and Infant Health Survey (1988) was used to ascertain age, income, marital status, education level, and source of funding of the study population of 21,000 women, who were assigned to an ethnic group based on self-indentification in the survey. The sources of prenatal care were classified as private (private physician, nurse-midwife, health maintenance organization) or public (state or local health department, community health center, hospital-based clinic). RESULTS: When categorized by ethnic group alone, 78 percent of white women received private care compared with 51 percent of Mexican-American women, 44 percent of African-American women, and 37 percent of Puerto Rican women. Private health insurance was held by 78 percent of white, 50 percent of African-American, 49 percent of Mexican-American, and 47 percent of Puerto Rican women. Of those with private insurance, 86, 62, 69, and 59 percent, respectively, received private care. Of white women with Medicaid funding, 52 percent received private care as opposed to a range of 20 to 42 percent for minority women. CONCLUSIONS: Substantial differences in sources of prenatal care exist between white and minority women and between different minority groups, suggesting that policy makers and health caregivers should tailor prenatal care intervention to the needs of specific minority populations.

Adult↗
PubMed1996

Use of antenatal corticosteroids for fetal maturation.

Corticosteroids used to enhance fetal maturation are one of the best studied interventions in perinatal medicine. The treatment has been shown to reduce neonatal morbidity and mortality. The intervention is also highly cost-effective. In this article, we review the evidence supporting the benefits of corticosteroids, controversial issues concerning their use, and current practice recommendations. The review will highlight the research presented at the recent National Institutes of Health Consensus Conference concerning corticosteroids. This research led the National Institutes of Health to advocate clinical practice guidelines on the appropriate use of corticosteroids.

Adrenal Cortex Hormones↗
PubMed1996

Prediction of prematurity.

Preterm birth is the leading cause of perinatal morbidity and mortality. A poor understanding of the underlying pathophysiology of spontaneous preterm labor and preterm premature rupture of membranes has limited our ability to identify those women at highest risk for spontaneous preterm birth. There is increasing evidence that inflammation of the upper genital tract may play a major role in the pathogenesis of preterm labor and preterm premature rupture of membranes. Newer markers of infection and inflammation (e.g. bacterial vaginosis, fetal fibronectin, interleukin-6) may make earlier diagnosis possible and may direct potential therapeutic interventions. A better understanding and more accurate diagnosis of well known risk factors (e.g. cervical dilatation) may also improve treatment options. Additionally, combinations of older risk factors and newer, more sensitive diagnostic methods may greatly increase our ability to predict preterm birth and to identify women who might benefit most from directed intervention strategies.

Female↗
PubMed1995

Reduced incidence of preterm delivery with metronidazole and erythromycin in women with bacterial vaginosis.

BACKGROUND: Pregnant women with bacterial vaginosis may be at increased risk for preterm delivery. We investigated whether treatment with metronidazole and erythromycin during the second trimester would lower the incidence of delivery before 37 weeks' gestation. METHODS: In 624 pregnant women at risk for delivering prematurely, vaginal and cervical cultures and other laboratory tests for bacterial vaginosis were performed at a mean of 22.9 weeks' gestation. We then performed a 2:1 double-blind randomization to treatment with metronidazole and erythromycin (433 women) or placebo (191 women). After treatment, the vaginal and cervical tests were repeated and a second course of treatment was given to women who had bacterial vaginosis at that time (a mean of 27.6 weeks' gestation). RESULTS: A total of 178 women (29 percent) delivered infants at less than 37 weeks' gestation. Eight women were lost to follow-up. In the remaining population, 110 of the 426 women assigned to metronidazole and erythromycin (26 percent) delivered prematurely, as compared with 68 of the 190 assigned to placebo (36 percent, P = 0.01). However, the association between the study treatment and lower rates of prematurity was observed only among the 258 women who had bacterial vaginosis (rate of preterm delivery, 31 percent with treatment vs. 49 percent with placebo; P = 0.006). Of the 358 women who did not have bacterial vaginosis when initially examined, 22 percent of those assigned to metronidazole and erythromycin and 25 percent of those assigned to placebo delivered prematurely (P = 0.55). The lower rate of preterm delivery among the women with bacterial vaginosis who were assigned to the study treatment was observed both in women at risk because of previous preterm delivery (preterm delivery in the treatment group, 39 percent; and in the placebo group, 57 percent; P = 0.02) and in women who weighed less than 50 kg before pregnancy (preterm delivery in the treatment group, 14 percent; and in the placebo group, 33 percent; P = 0.04). CONCLUSIONS: Treatment with metronidazole and erythromycin reduced rates of premature delivery in women with bacterial vaginosis and an increased risk for preterm delivery.

Adult↗
PubMed1995

The effect of zinc supplementation on pregnancy outcome.

OBJECTIVE: To evaluate whether zinc supplementation during pregnancy is associated with an increase in birth weight. DESIGN: A randomized double-blind placebo-controlled trial. SETTING: Outpatient clinic and delivery service at the University of Alabama at Birmingham. PATIENTS: Five hundred eighty medically indigent but otherwise healthy African-American pregnant women with plasma zinc levels below the median at enrollment in prenatal care, randomized at 19 weeks' gestational age. Women were subdivided by the population median body mass index of 26 kg/m2 into two groups for additional analyses. INTERVENTION: Women who were taking a non-zinc-containing prenatal multivitamin/mineral tablet were randomized to receive either a daily dose of 25 mg of zinc or a placebo until delivery. MAIN OUTCOME MEASURES: Birth weight, gestational age at birth, and head circumference at birth. RESULTS: In all women, infants in the zinc supplement group had a significantly greater birth weight (126 g, P = .03) and head circumference (0.4 cm, P = .02) than infants in the placebo group. In women with a body mass index less than 26 kg/m2, zinc supplementation was associated with a 248-g higher infant birth weight (P = .005) and a 0.7-cm larger infant head circumference (P = .007). Plasma zinc concentrations were significantly higher in the zinc supplement group. CONCLUSIONS: Daily zinc supplementation in women with relatively low plasma zinc concentrations in early pregnancy is associated with greater infant birth weights and head circumferences, with the effect occurring predominantly in women with a body mass index less than 26 kg/m2.

Adult↗
PubMed1995

Zidovudine for the prevention of vertical HIV transmission: a decision analytic approach.

The purpose of this study was to quantify the benefits of maternal-neonatal zidovudine (ZDV) administration for the prevention of vertical human immunodeficiency virus (HIV) transmission against the potential risks of drug-induced complications in uninfected children. A decision analysis model was created with use of a Markov cohort simulation, for evaluating both survival and quality of life for two hypothetical cohorts of HIV-exposed neonates: one with in utero and neonatal exposure to preventive ZDV therapy and the other not exposed. The model included the probability of congenital HIV infection with and without ZDV treatment (estimates derived from AIDS Clinical Trials Group study 076), the yearly probability of death with and without congenital HIV infection, a range of probabilities of adverse effects from ZDV use, and a range of ages in life when any adverse effect would manifest. In a series of scenarios, the impact of different estimates for the quality-of-life decrement from any adverse ZDV effect in HIV-uninfected children was assessed, and threshold values for this estimate were established, i.e., critical values below which withholding ZDV would be the preferred choice. Across a wide range of estimates for multiple contingencies, ZDV use was associated with a greater number of quality-adjusted life years than was non-use. Only in implausible, pessimistic scenarios (i.e., a high incidence of profound adverse effects beginning early in life) would withholding ZDV be the rational choice for an asymptomatic HIV-infected pregnant woman.(ABSTRACT TRUNCATED AT 250 WORDS)

Decision Support Techniques↗
PubMed1995

Maternal serum thromboxane B2 reduction versus pregnancy outcome in a low-dose aspirin trial.

OBJECTIVE: Our purpose was to determine whether in a low-dose aspirin trial a longitudinal decrease in maternal serum thromboxane B2 is associated with improvement in pregnancy outcomes. STUDY DESIGN: A total of 606 healthy nulliparous women with singleton gestations were randomized at 24 weeks to either 60 mg of aspirin or a placebo. Maternal serum thromboxane B2 was measured at randomization, at 29 to 31 weeks, at 34 to 36 weeks, and at delivery. After delivery, and without knowledge of patient outcome or group assignment, patients were categorized as having had either a longitudinal twofold or greater (> or = 50%) or less than twofold reduction (< 50%) in thromboxane B2 from baseline levels at randomization. RESULTS: Of 606 entrants, 92% had sufficient thromboxane B2 determinations to allow categorization. Whether patients were assigned to aspirin or placebo, birth weight was significantly greater in women who had a twofold or greater reduction in maternal serum thromboxane B2 levels. When the aspirin and placebo groups were combined, women with a twofold or greater reduction in thromboxane B2 levels had less preeclampsia, 1.9% (6/314) versus 5.7% (14/244) (p = 0.016), less preterm delivery (5.7% vs 10.7%, p = 0.032), fewer small-for-gestational-age newborns, 9 of 314 (2.95) versus 17 of 244 (7%) (p = 0.023), and a higher mean birth weight, 3314 gm versus 3121 gm (p = 0.0001). CONCLUSION: Women with a twofold or greater longitudinal reduction in maternal serum thromboxane B2 had less preeclampsia and prematurity, fewer small-for-gestational-age newborns, and higher birth weights than women with less than a twofold reduction.

Aspirin↗
PubMed1995

Amniotic fluid interleukin-6: correlation with upper genital tract microbial colonization and gestational age in women delivered after spontaneous labor versus indicated delivery.

OBJECTIVE: Our purpose was to determine whether amniotic fluid interleukin-6 is increased and inversely proportional to gestational age in women with chorioamnion colonization and spontaneous labor versus women delivered for medical or obstetric indications. STUDY DESIGN: The chorioamnion and amniotic fluid were cultured at cesarean delivery for aerobic and anaerobic bacteria, fungi, mycoplasmas, Chlamydia trachomatis and Trichomonas vaginalis in 269 women with singleton gestations with intact membranes. The amniotic fluid interleukin-6 concentration was also determined. RESULTS: Amniotic fluid interleukin-6 levels were (1) higher in women with spontaneous labor versus those with indicated deliveries (15.8 +/- 5.0 vs 2.2 +/- 0.2 ng/ml, p = 0.01), (2) inversely proportional to gestational age in women with spontaneous labor (< 34 weeks: 47.4 +/- 18.0 ng/ml vs > or = 34 weeks: 8.7 +/- 4.1 ng/ml, p = 0.001) but not in women with indicated deliveries (1.5 +/- 0.4 vs 2.4 +/- 0.3 ng/ml), (3) higher in women with a positive versus a negative chorioamnion (15.1 +/- 4.8 vs 3.0 +/- 0.8 ng/ml, p < 0.001) or amniotic fluid (17.4 +/- 7.7 vs 3.8 +/- 0.9 ng/ml, p < 0.001) culture, and (4) higher in women with a negative amniotic fluid but positive chorioamnion culture compared with women in whom both cultures were negative (10.0 +/- 4.4 vs 3.0 +/- 0.9 ng/ml, p = 0.002). CONCLUSIONS: Amniotic fluid interleukin-6 levels are (1) higher and inversely proportional to gestational age in women with intact membranes and spontaneous labor versus indicated deliveries, (2) higher in women with one or more microorganisms in the chorioamnion or amniotic fluid, and (3) reflective of chorioamnion microbial colonization, even when the amniotic fluid culture is negative, and may be a useful clinical marker for infection-mediated preterm labor.

Amnion↗
PubMed1995

Cervical examination and tocodynamometry at 28 weeks' gestation: prediction of spontaneous preterm birth.

OBJECTIVE: We determined the value of cervical examination and tocodynamometry in identifying nulliparous women at risk for spontaneous preterm delivery. STUDY DESIGN: At 27.5 +/- 0.8 weeks' gestation 589 women underwent 30 minutes of tocodynamometry, and 570 of these had a cervical examination. Positive findings on these examinations were compared to the rate of spontaneous preterm delivery, defined as those deliveries following the onset of spontaneous labor or premature rupture of membranes. RESULTS: The two best predictors of spontaneous preterm birth were two or more contractions in 30 minutes and the presence of a soft or medium consistency on cervical examination. As the contractions increased from zero to four or more, the rate of spontaneous preterm delivery rose from 4.2% to 18.2%. CONCLUSION: In nulliparous women at 28 weeks' gestation, uterine contractions and several components of the cervical examination predicted spontaneous preterm birth.

Adolescent↗