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Biomedical subjects

Kenneth J Leveno

Publications and source records attributed to Kenneth J Leveno.

At least 55 records · Page 3Linked to original sources
PubMed2003

Prevention of recurrent preterm delivery by 17 alpha-hydroxyprogesterone caproate.

BACKGROUND: Women who have had a spontaneous preterm delivery are at greatly increased risk for preterm delivery in subsequent pregnancies. The results of several small trials have suggested that 17 alpha-hydroxyprogesterone caproate (17P) may reduce the risk of preterm delivery. METHODS: We conducted a double-blind, placebo-controlled trial involving pregnant women with a documented history of spontaneous preterm delivery. Women were enrolled at 19 clinical centers at 16 to 20 weeks of gestation and randomly assigned by a central data center, in a 2:1 ratio, to receive either weekly injections of 250 mg of 17P or weekly injections of an inert oil placebo; injections were continued until delivery or to 36 weeks of gestation. The primary outcome was preterm delivery before 37 weeks of gestation. Analysis was performed according to the intention-to-treat principle. RESULTS: Base-line characteristics of the 310 women in the progesterone group and the 153 women in the placebo group were similar. Treatment with 17P significantly reduced the risk of delivery at less than 37 weeks of gestation (incidence, 36.3 percent in the progesterone group vs. 54.9 percent in the placebo group; relative risk, 0.66 [95 percent confidence interval, 0.54 to 0.81]), delivery at less than 35 weeks of gestation (incidence, 20.6 percent vs. 30.7 percent; relative risk, 0.67 [95 percent confidence interval, 0.48 to 0.93]), and delivery at less than 32 weeks of gestation (11.4 percent vs. 19.6 percent; relative risk, 0.58 [95 percent confidence interval, 0.37 to 0.91]). Infants of women treated with 17P had significantly lower rates of necrotizing enterocolitis, intraventricular hemorrhage, and need for supplemental oxygen. CONCLUSIONS: Weekly injections of 17P resulted in a substantial reduction in the rate of recurrent preterm delivery among women who were at particularly high risk for preterm delivery and reduced the likelihood of several complications in their infants.

17 alpha-Hydroxyprogesterone Caproate↗
PubMed2003

A randomized, placebo-controlled trial of corticosteroids for hyperemesis due to pregnancy.

OBJECTIVE: Hyperemesis gravidarum, a severe form of nausea and vomiting due to pregnancy for which there is no proven pharmacological treatment, is the third leading cause for hospitalization during pregnancy. Corticosteroids are commonly used for the treatment of nausea and vomiting due to cancer chemotherapy-induced emesis and might prove useful in hyperemesis gravidarum. METHODS: A randomized, double-blind, placebo-controlled trial was conducted in 126 women who previously had not responded to outpatient therapy for hyperemesis gravidarum during the first half of pregnancy. Intravenous methylprednisolone (125 mg) was followed by an oral prednisone taper (40 mg for 1 day, 20 mg for 3 days, 10 mg for 3 days, 5 mg for 7 days) versus an identical-appearing placebo regimen. All women also received promethazine 25 mg and metoclopramide 10 mg intravenously every 6 hours for 24 hours, followed by the same regimen administered orally as needed until discharge. The primary study outcome was the number of women requiring rehospitalization for hyperemesis gravidarum. RESULTS: A total of 110 women delivered at our hospital and had pregnancy outcomes available for analysis; 56 were randomized to corticosteroids and 54 were administered placebo. Nineteen women in each study group required rehospitalization (34% versus 35%, P =.89, for corticosteroids versus placebo, respectively). CONCLUSION: The addition of parenteral and oral corticosteroids to the treatment of women with hyperemesis gravidarum did not reduce the need for rehospitalization later in pregnancy.

Adolescent↗
PubMed2003

Inhibin-A and superimposed preeclampsia in women with chronic hypertension.

OBJECTIVE: To determine if maternal serum inhibin-A can be used as a marker for subsequent development of superimposed preeclampsia in women with chronic hypertension. METHODS: Serum for measurement of inhibin-A was obtained at monthly intervals in women with chronic hypertension requiring antihypertensive medications. Superimposed preeclampsia, the primary outcome of interest, was diagnosed when hypertensive women developed proteinuria (at least 300 mg per 24-hour urine specimen). Serum inhibin-A was considered abnormally elevated when the value exceeded the mean plus two standard deviations of the log for chronically hypertensive women who did not develop preeclampsia. RESULTS: A total of 61 women were enrolled in this study, and 21 (34%) developed superimposed preeclampsia. Inhibin-A levels increased with advancing gestational age. Ten women had abnormally increased inhibin-A levels; eight (80%) developed superimposed preeclampsia, compared with 13 of 51 (26%) women with normal inhibin-A levels (P <.001). Sensitivity and specificity were 38% and 95%, respectively, whereas the positive and negative predictive values were 80% and 75%, respectively. CONCLUSION: Although inhibin-A was abnormally increased an average of 3 weeks before the clinical onset of superimposed preeclampsia, the sensitivity of the test as a screen was too limited to be clinically useful.

Adult↗
PubMed2003

Ruptured membranes at term: randomized, double-blind trial of oral misoprostol for labor induction.

OBJECTIVE: To determine if oral misoprostol can replace oxytocin for labor stimulation in women with ruptured membranes at term and without evidence of labor. METHODS: Nulliparous women at 36 to 41 weeks with a singleton, cephalic-presenting fetus and ruptured membranes without evidence of labor were randomized to receive oral misoprostol (100 microg) or a placebo every 4 hours for a maximum of two doses. Intravenous oxytocin was initiated if active labor had not ensued within 8 hours of the initial study drug dose. RESULTS: Fifty-one women were randomized to oral misoprostol and 51 women to the placebo. Misoprostol reduced the use of oxytocin stimulation of labor from 90% to 37% (P <.001) and was associated with approximately a 7-hour shorter elapsed time in the labor unit. Uterine hyperactivity, defined as six or more contractions in 10 minutes without fetal heart rate decelerations, occurred in 25% of women randomized to misoprostol. However, uterine hyperactivity associated with fetal heart rate decelerations occurred in only three (6%) women, none of whom required emergency cesarean delivery. Route of delivery and infant outcomes were not related to misoprostol use. CONCLUSION: Oral misoprostol (100 microg) given in a maximum of two doses 4 hours apart significantly reduced the use of oxytocin in the management of women with ruptured membranes without labor at term.

Administration, Oral↗
PubMed2003

Randomized clinical trial of metronidazole plus erythromycin to prevent spontaneous preterm delivery in fetal fibronectin-positive women.

OBJECTIVE: To estimate whether antibiotic treatment of asymptomatic women with a positive cervical or vaginal fetal fibronectin test in the second trimester would reduce the risk of spontaneous preterm delivery. METHODS: Women were screened between 21 weeks 0 days and 25 weeks 6 days of gestation with cervical or vaginal swabs for fetal fibronectin. Women with a positive test (50 ng/mL or more) were randomized to receive metronidazole (250 mg orally three times per day) and erythromycin (250 mg orally four times per day) or identical placebo pills for 10 days. The primary outcome was spontaneous delivery before 37 weeks' gestation after preterm labor or premature membrane rupture. RESULTS: A total of 16,317 women were screened for fetal fibronectin, and 6.6% had a positive test; 715 fetal fibronectin test-positive women consented to randomization. Outcome data were available for 703 women: 347 in the antibiotic group and 356 in the placebo group. The antibiotic and placebo groups were not significantly different for maternal age (P =.051), ethnicity (P =.849), marital status (P =.127), education (P =.244), and bacterial vaginosis (P =.236). No difference was observed in spontaneous preterm birth before 37 weeks' (odds ratio [OR] 1.17, 95% confidence interval [CI] 0.80, 1.70), less than 35 weeks' (OR 0.92, 95% CI 0.54, 1.56), or less than 32 weeks' (OR 1.94, 95% CI 0.83, 4.52) gestation in antibiotic- compared with placebo-treated women. Among women with a prior spontaneous preterm delivery, the rate of repeat spontaneous preterm delivery at less than 37 weeks' gestation was significantly higher in the active drug compared with the placebo group (46.7% versus 23.9%, P =.039). CONCLUSION: Treatment with metronidazole plus erythromycin of asymptomatic women with a positive cervical or vaginal fetal fibronectin test in the late second trimester does not decrease the incidence of spontaneous preterm delivery.

Adult↗
PubMed2003

Recurrence of mild malformations and dysplasias.

OBJECTIVE: To estimate whether women delivering infants with mild malformations are at increased risk to have a subsequent infant with a mild malformation. METHODS: Both severe and mild malformations detected at birth were cataloged prospectively for 33,701 women with two consecutive singleton births of infants weighing 500 g or more at a tertiary care hospital. Records from a total of 67,402 infants were analyzed from January 1, 1988, through December 31, 2000. Mild malformations and dysplasias were defined to include skin lesions (eg, café au lait spots, nevi, and hemangiomas), extra nipples, and abnormalities involving digits. Pearson and McNemar chi(2) statistics and analysis of variance were used for statistical analysis. Estimation of recurrence risks was accomplished using standard methods for rates and proportions. RESULTS: Of the study women, 2.7% delivered infants with mild malformations in their index pregnancy. Mild malformations recurred in 7% of women whose index infant had a mild malformation (2.7% versus 7%, P <.001). Mild malformations involving the skin or digits also significantly increased in the next delivery (2% versus 5%, P <.001; 0.5% versus 8%, P <.001; recurrence of skin and digit anomalies, respectively). CONCLUSION: Women delivering infants with mild malformations involving the skin and digits of the infant are at increased risk for recurrence during their next pregnancy.

Congenital Abnormalities↗
PubMed2003

A comparison of the effects of epidural and meperidine analgesia during labor on fetal heart rate.

OBJECTIVE: To estimate the effects of initiation of epidural analgesia on fetal heart rate (FHR) patterns compared with intravenous meperidine analgesia. METHODS: Fetal heart rate patterns in 200 nulliparous women with term pregnancies randomized to epidural analgesia with 0.25% bupivacaine were compared with those of 156 similar women given intravenous meperidine. Fetal heart rate patterns occurring within 40 minutes of initiation of labor analgesia were retrospectively read by three maternal-fetal medicine specialists who were blind to clinical events, including type of labor analgesia. RESULTS: Meperidine, compared with epidural analgesia, was associated with statistically significantly less beat-to-beat variability (absent or less than 5 beats per minute) of the FHR (30% versus 7% of fetuses, P <.001) in the first 40 minutes after initiation of analgesia, as well as with fewer FHR accelerations (88% versus 62% of fetuses, P <.001). Neither the incidence of FHR decelerations nor the type of deceleration were significantly different between methods of labor analgesia. Specifically, 41% of women given meperidine exhibited FHR decelerations within 40 minutes, compared with 34% given epidural analgesia (P =.353). CONCLUSION: Epidural analgesia does not have deleterious effects on FHR.

Adult↗
PubMed2003

Asthma morbidity during pregnancy can be predicted by severity classification.

BACKGROUND: The 1993 National Asthma Education Program Working Group on Asthma and Pregnancy defined asthma severity as mild, moderate, or severe on the basis of symptoms and spirometry, but no studies have evaluated the relationship between this classification system and subsequent asthma morbidity during pregnancy. OBJECTIVE: The objective of this study was to evaluate the relationship between asthma severity classification during pregnancy and gestational asthma exacerbations. METHODS: Asthma severity was defined according to the 1993 classification, adjusted to include medication requirements, in a volunteer sample of 1739 pregnant asthmatic patients who were less than 26 weeks' gestation. RESULTS: Initial asthma classification (mild, moderate, or severe) was significantly related to subsequent asthma morbidity during pregnancy (hospitalizations, unscheduled visits, corticosteroid requirements, and asthma symptoms during labor and delivery). Exacerbations during pregnancy occurred in 12.6% of patients initially classified as mild, 25.7% of patients classified as moderate, and 51.9% of patients classified as severe (P <.001). Asthma morbidity was similar, whether patients were classified as moderate or severe by symptoms and spirometry or by medication requirement. Thirty percent of initially mild patients were reclassified as moderate-severe during pregnancy, and 23% of the initially moderate-severe patients were reclassified as mild later in pregnancy; asthma morbidity in these patients changed accordingly. CONCLUSION: The National Asthma Education Program Working Group on Asthma and Pregnancy classification of asthma severity, adapted to include medication use, predicts subsequent asthma morbidity during pregnancy.

Adult↗
PubMed2003

Early pregnancy threshold vaginal pH and Gram stain scores predictive of subsequent preterm birth in asymptomatic women.

OBJECTIVE: The study was undertaken to identify early pregnancy vaginal markers predictive of subsequent preterm birth. STUDY DESIGN: In a multicenter Bacterial Vaginosis (BV) Trial, 21,554 women were screened with a vaginal pH and of these, two populations were studied. These included 12,041 who had a pregnancy outcome in the database and 6838 women who had a vaginal pH of 4.5 or greater and a Gram stain score and a pregnancy outcome in the database. ColorpHast Indicator Strips were used to determine the vaginal pH and the Nugent criteria were used to determine a vaginal Gram stain score of 0 to 10. RESULTS: Delivery at <37, <35, or <32 weeks' gestation was similar for women with a vaginal pH of less than 4.4 or 4.7 (P not significant) but was increased in women with a pH of 5.0 (P =.04,.02,.03, respectively) or with a pH of 5.0 or greater (at each gestational age P <.0001). The effect of pH of 5.0 or greater was similar for women who had a spontaneous preterm birth at each gestational age (P <.0001) or birth weight of less than 2500 g or less than 1500 g (P <.0005). Women with a vaginal pH of 4.5 or greater and a Gram stain score of 9 to 10 (compared with 0-8) had increased preterm births at <37, <35, and <32 weeks' gestation (P <.01), and birth weights less than 2500 g (P <.0001) or less than 1500 g (P <.01). Women whose vaginal pH was 5.0 or greater had a higher prevalence of vaginal fetal fibronectin > or =50 ng/mL (P <.0001), but the proportion of women with a vaginal fetal fibronectin > or =50 mg/mL did not differ by Gram stain score. CONCLUSION: Women with a vaginal pH of 5.0 or greater or a vaginal pH of 4.5 or greater and a Gram stain score of 9 to 10 had significantly increased preterm births at <37, <35, and 32 weeks' gestation and/or a birth weight less than 2500 g or less than 1500 g.

Differential Threshold↗
PubMed2003

Homocysteine plasma concentration levels for the prediction of preeclampsia in women with chronic hypertension.

OBJECTIVE: The purpose of this study was to evaluate prospectively midtrimester homocysteine concentration levels for the prediction of superimposed preeclampsia in women with chronic hypertension. STUDY DESIGN: Between March 1, 2000, and February 1, 2002, pregnancies that were complicated by chronic hypertension that required medication had homocysteine, vitamin B(12), and folate concentrations measured between 16 and 20 weeks of gestation. All women received folate supplementation. An upper limit threshold for increased homocysteine was defined as the mean value plus 2 SDs. RESULTS: Fifty-seven women were enrolled. Mean homocysteine concentration levels were 5.1+/-1.7 micromo/L for the 16 women who had preeclampsia compared with 4.7+/-1.3 micromo/L for the 41 women without preeclampsia (P=.56). Two of 16 women with preeclampsia (13%) had concentration levels that exceeded the 95th percentile (6.9 micromo/L) compared with 2 of 41 women (5%) without preeclampsia (P=.31). The sensitivity and specificity were 13% (95% CI, 1.6-38.3) and 95.1% (95% CI, 83.5-99.4), respectively. CONCLUSION: Second-trimester homocysteine concentration levels were not helpful in the prediction of preeclampsia in chronically hypertensive women.

Adult↗
PubMed2002

Epidural analgesia lengthens the Friedman active phase of labor.

OBJECTIVE: To estimate the effect of epidural analgesia on the Friedman labor curve. METHODS: This study was a secondary analysis of a previously reported randomized trial of the effects of patient-controlled epidural analgesia during labor compared with patient-controlled meperidine on cesarean delivery rate. All subjects had a singleton, cephalic, nonanomalous fetus at or beyond 37 weeks' gestation. This secondary analysis was limited to women who had cervical dilatation commencing of at least 3 cm (ie, active phase of labor). RESULTS: A total of 459 women were randomized. Twenty-five women were excluded for a cervix less than 3 cm dilated, leaving 220 women allocated to patient-controlled epidural analgesia and 214 to patient-controlled intravenous meperidine available for analysis. There were no significant demographic differences between the two groups, including age, race, gestational age, and cervix on admission. The active phase of labor was 1 hour longer in the epidural-treated group (6.0 +/- 3.2 hours versus 5.0 +/- 3.2 hours, P <.001). The rate of cervical dilation was significantly less with epidural analgesia (1.4 cm/h versus 1.6 cm/h, P <.002). The duration of the second stage tended to be longer in the epidural group (1.1 +/- 1.5 hours versus 0.9 +/- 1.0 hours, P =.079). CONCLUSION: Epidural analgesia prolonged the active phase of labor by 1 hour compared with Friedman's original criteria.

Adolescent↗
PubMed2002

Inhibin-A levels and severity of hypertensive disorders due to pregnancy.

OBJECTIVE: To evaluate the use of 3rd trimester inhibin-A levels as an adjunct to assess severity of hypertensive disorders due to pregnancy in women evaluated for preeclampsia. METHODS: Serum inhibin-A concentration was measured in a consecutive series of women evaluated for preeclampsia in the third trimester of pregnancy. RESULTS: Inhibin-A levels were significantly associated with the severity of proteinuric hypertensive disease due to pregnancy. Women with gestational hypertension or those with chronic hypertension without superimposed preeclampsia had levels comparable with normotensive women. The sensitivity to detect proteinuric hypertension was 16%. CONCLUSION: Although inhibin-A levels rise with increasing severity of disease, due to considerable overlap of normal and abnormal serum levels in women with and without preeclampsia, inhibin-A is not a useful adjunct for the classification of hypertensive disorders due to pregnancy.

Adult↗
PubMed2002

Maternal diabetes mellitus and infant malformations.

OBJECTIVE: To investigate the effects of pregestational, as opposed to gestational, diabetes on infant malformations. METHODS: All women delivering infants at Parkland Hospital between January 1, 1991, and December 31, 2000, were ascertained. Screening for gestational diabetes was methodically employed throughout the study period using National Diabetes Data Group criteria for diagnosis of pregestational and gestational diabetes. Standardized definitions of major infant malformations were specified before data analysis and subdivided according to the organ systems involved. RESULTS: A total of 145,196 women were delivered during the study period, and 2687 (1.9%) were diagnosed to have diabetes mellitus. Gestational diabetes was diagnosed in 2277 (1.6%) of whom 230 (10%) had fasting hyperglycemia diagnosed, and the remainder consistently demonstrated fasting serum levels less than 105 mg/dL. Pregestational diabetes was diagnosed in 410 (0.3%) women. Infant malformations occurred in 1.5% of nondiabetic women compared with 1.2% of women with normal fasting glucose gestational diabetes, 4.8% in women with gestational diabetes plus fasting hyperglycemia, and 6.1% in those with pregestational diabetes (P <.001, for comparison of the latter two groups with the nondiabetic population). CONCLUSION: Women with pregestational diabetes or gestational diabetes plus fasting hyperglycemia have a three- to four-fold increased risk of infant malformations, whereas women with mild gestational diabetes have malformation rates no different than the general nondiabetic obstetric population.

Adult↗
PubMed2002

Umbilical vein interleukin-6 levels correlate with the severity of placental inflammation and gestational age.

Interleukin-6 (IL6) and suppurating placental inflammation are markers of neonatal sepsis. The purpose of this study was to define a relationship between IL6 and acute chorioamnionitis and funisitis of the placenta, and to compare IL6 levels in term and preterm neonates. Umbilical venous IL6 was measured in 137 term and 110 preterm neonates. Acute chorioamnionitis was graded as none, mild, moderate, severe, and necrotizing. Funisitis was graded as none, 1 vessel, 2 vessels, 3 vessels, or necrotizing. A 2-way analysis of variance with interaction was used to compare the IL6 levels. There was a stepwise progression of IL6 levels with increasing severity of acute chorioamnionitis and funisitis. Term neonates showed an IL6 elevation with mild acute chorioamnionitis and single-vessel vasculitis, which increased progressively until the inflammation became severe. In contrast, IL6 levels in preterm neonates did not increase significantly until severe acute chorioamnionitis or 3-vessel vasculitis was seen. Statistically significant differences in IL6 levels were seen in term versus preterm infants when the acute chorioamnionitis was mild or moderate or when the funisitis involved either 1 or 2 vessels (P < 0.05). The difference may be related to the relative immaturity of the preterm immune system, as has been demonstrated in vivo and in vitro. However, differences in management could be confounding factors. In conclusion, umbilical venous IL6 levels correlate with the severity of acute placental inflammation, with greater IL6 elevations in term infants compared to preterm infants until the inflammation becomes severe.

Acute Disease↗
PubMed2002

Prevention of neonatal group B streptococcal disease: A combined intrapartum and neonatal protocol.

OBJECTIVE: We sought to assess the efficacy of a clinical protocol to reduce the incidence of early-onset neonatal group B Streptococcus (GBS) infection. STUDY DESIGN: We assessed neonatal sepsis from GBS and other organisms with use of a before-after study design to evaluate the effects of implementation of combined intrapartum antimicrobial prophylaxis given selectively to mothers with GBS risks and penicillin G given to all neonates. RESULTS: In 1994, early-onset GBS infection developed in 31 of 13,887 live births (2.2/1000), 13 preterm and 18 term cases. After implementation of the prophylaxis protocol (1995), 6 of 13,527 live births had early-onset GBS (0.4/1000) (P <.001). There were no preterm (P =.0004) and 6 term GBS cases (P =.02). The efficacy continued through 1999 (0.5/1000) without an increase in neonatal infections from other bacteria. CONCLUSION: Combined maternal and infant antimicrobial prophylaxis can significantly and safely reduce rates of early-onset GBS infection in both preterm and term infants.

Algorithms↗
PubMed2002

Sexual intercourse association with asymptomatic bacterial vaginosis and Trichomonas vaginalis treatment in relationship to preterm birth.

OBJECTIVE: The purpose of this study was to determine whether sexual intercourse was associated with the treatment efficacy or the incidence of preterm birth in two large randomized trials in which metronidazole treatment of bacterial vaginosis or Trichomonas vaginalis did not reduce preterm birth. STUDY DESIGN: Secondary analysis of two multicenter, double-blind, placebo-controlled trials in which women with asymptomatic bacterial vaginosis on Gram stain or asymptomatic T vaginalis on culture were randomized at 16 to 23 weeks of gestation to metronidazole or placebo. In both studies, women took 2 g of metronidazole or placebo in the presence of a nurse (first dose) and were given a second dose to take 48 hours later. This regimen was repeated (third and fourth doses) at 24 to 29 weeks. At the time of the third dose, bacterial vaginosis and T vaginalis specimens were collected again. Patients who were randomly selected to receive metronidazole were analyzed for bacterial vaginosis and T vaginalis at 24 to 29 weeks and for preterm birth of <37 weeks of gestation, according to intercourse between first and second doses and between the second and third doses. Continuous variables were compared with the use of the Wilcoxon rank-sum test; categoric variables were compared with the use of the chi(2 ) test, Fisher exact test, or the Mantel-Haenzel test of trend. RESULTS: Sexual intercourse between the first and second doses or between the second and third doses did not influence the incidence of bacterial vaginosis (18% vs 24%; relative risk, 0.7; 95% CI, 0.5-1.1; and 23% vs 20%; relative risk, 1.2; 95% CI, 0.9-1.6, respectively) or T vaginalis (4% vs 8%; relative risk, 0.5; 95% CI, 0.1-3.6; and 5% vs 10%; relative risk, 0.5; 95% CI, 0.2-1.1; respectively) at 24 to 29 weeks of gestation compared with no intercourse. In the T vaginalis trial, sexual intercourse between the first and second doses or between the second and third doses did not influence the incidence of preterm birth (13% vs 17%; relative risk, 0.8; 95% CI, 0.3-2.1; and 16% vs 17%; relative risk, 1.0; 95% CI, 0.6-1.6; respectively) compared with no intercourse. In the bacterial vaginosis trial, although sexual intercourse between the first and second doses did not influence the incidence of preterm birth (11% vs 12%; relative risk, 0.9; 95 % CI, 0.6-1.5), sexual intercourse between the second and third doses was associated with a reduction in the incidence of preterm birth (10% vs 16%; relative risk, 0.6; 95% CI, 0.4-0.9) compared with no intercourse. CONCLUSION: Sexual intercourse was associated with neither the efficacy of metronidazole treatment of bacterial vaginosis or T vaginalis nor with the incidence of preterm birth. In the bacterial vaginosis study, intercourse between the second and third doses had a negative association with preterm birth.

Black or African American↗