Biomedical subjects

John C Pezzullo

Publications and source records attributed to John C Pezzullo.

At least 19 recordsLinked to original sources

PubMed2005

Measures of placental growth in relation to birth weight and gestational age.

Fetal growth depends in part on placental growth. The authors tested placental measures derived from digital images for reliability and to evaluate their association with birth weight and gestational age. A total of 628 women recruited into the Pregnancy, Infection, and Nutrition Study, a prospective cohort study of preterm birth in central North Carolina between 2002 and 2004, delivered singleton liveborn infants after 24 completed weeks' gestation. Novel chorionic plate morphometric parameters captured off digital images of the gross placenta were analyzed as estimators of gestational age and birth weight. Without acknowledgment to placental weight, digitally obtained lateral chorionic plate growth measures accounted for 17 percent of gestational age variance and 35 percent of birth weight variance, overall. Chorionic plate measures accounted for 10 percent of birth weight variance beyond that accounted for by placental weight alone. Among preterm births, 34 percent of gestational age variance and 63 percent of birth weight variance were accounted for by lateral chorionic plate growth measures. Intraclass correlation coefficients for the novel digital measures ranged from 0.96 to 0.98. Reliable digital measures of lateral chorionic plate growth estimate birth weight variance more strongly than gestational age, project variance that is not accounted for by placental weight, and project these outcomes to a greater degree in preterm births than at term.

Birth Weight↗

PubMed2005

Morphometry of the basal plate superficial uteroplacental vasculature in normal midtrimester and at term.

Uteroplacental (UP) vascular arterial pathology has been associated with pregnancy complications. UP arterial structure has been characterized in placental bed biopsies, at the decidual-myometrial junction. Basal plate UP arteries, which are delivered with the placenta and thus routinely available, are not well characterized. We compared basal plate UP arterial segment morphometry in cases of elective termination of a clinically normal pregnancy at 11 to 24 weeks and of term birth. This study was done in a community-based obstetric service in New York City. UP arteries were identified in placentas of 20 midtrimester (MT) cases and 17 term (TERM) cases. We measured 336 UP artery cross-sections from 46 TERM and 290 MT cases. The basal plate UP artery path length was calculated as the distance between (x,y) coordinates of estimated centers of lumen cross-sections. Basal plate thickness near UP arteries, UP artery cross-sectional areas, vascular luminal eccentricity, and radial standard deviation were directly measured off digital images. Nonparametric and parametric methods compared groups, with P < 0.05 considered statistically significant. In TERM cases, the basal plate thickness near UP arteries was 1.8-fold thinner (P = 0.002) and mean basal plate path lengths were 2.13-fold shorter (P < 0.0001) than in MT cases. Mean TERM UP artery cross-sectional area was 3.15-fold larger, the major axis was 1.95-fold larger, and the minor axis was 1.75-fold larger than in MT arteries (P = 0.001 to 0.008). Our data demonstrate that basal plate UP arteries (delivered with the placenta) are less tortuous, with shorter path lengths and larger areas as gestation advances. Normative morphometric data may allow improved diagnostics of placentas from complicated pregnancies.

Arteries↗

PubMed2005

Duration of labor and risk of cerebral white-matter damage in very preterm infants who are delivered with intrauterine infection.

OBJECTIVE: The purpose of this study was to assess whether the duration of labor has any effect on the occurrence of cerebral white-matter damage in very preterm infants who are delivered in the presence of intrauterine infection. STUDY DESIGN: From a cohort of infants who were born spontaneously at <32 weeks of gestation for whom placental information was available and who survived 7 days from birth, 126 infants had clinical, laboratory, or histologic evidence of intrauterine infection. Among them, variables were compared between those infants with white-matter damage (defined as intraventricular hemorrhage grade 3 plus, periventricular leukomalacia, or ventriculomegaly not associated with hydrocephaly [n = 13]) and those infants without it (n = 113). Comparisons were made with t test, chi-squared test, and survival analysis; a probability value of <.05 was considered significant. RESULTS: There were no differences between the 2 groups in gestational age at delivery and rates of labor or cesarean delivery. Duration of active labor (66 +/- 45 minutes vs 88 +/- 75 minutes; P =.49) and of clinical chorioamnionitis (310 +/- 186 minutes vs 529 +/- 544 minutes; P =.44) were similar in cases with and without neonatal white-matter damage. CONCLUSION: In 126 infants who were born at <32 weeks of gestation with intrauterine infection, we found no correlation between the duration of labor or clinical chorioamnionitis and neonatal white-matter damage.

Adult↗

PubMed2005

Gestational age at preterm premature rupture of membranes: a risk factor for neonatal white matter damage.

OBJECTIVE: Gestational age at delivery and spontaneous prematurity are independent risk factors for white matter damage (WMD). However, among infants delivered spontaneously after preterm premature rupture of membranes (PPROM), latency of PPROM has been inconsistently correlated with risk of WMD. We have explored whether gestational age at membrane rupture is independently associated with WMD. STUDY DESIGN: Using a cohort of 196 liveborn singleton nonanomalous neonates born at 24.0 to 33.6 weeks from January 1993 to December 2002 after pPROM and who survived 7 days, we compared the characteristics of those who developed WMD (n = 15) with those who did not (n = 181) using Fisher exact test, Student t test, and logistic regression analysis, with a 2-tailed P < .05 or odds ratio (OR) with 95% CI not inclusive of the unity considered significant. RESULTS: Stepwise logistic regression analysis demonstrated that gestational age at PPROM (P < .001, OR 0.79) was significantly associated with WMD. The association was independent of corticosteroid administration (P = .016), latency interval (P = .69), gestational age at delivery (P = .99), and birth weight (P = .62). CONCLUSION: Among premature infants born at <34 weeks after pPROM, gestational age at diagnosis is independently associated with WMD.

Adult↗

PubMed2005

Antenatal predictors of neonatal outcome in fetal growth restriction with absent end-diastolic flow in the umbilical artery.

OBJECTIVE: Absent end-diastolic blood flow in the umbilical artery identifies growth-restricted fetuses at high risk of perinatal mortality and severe morbidity. We explored antenatal variables predictive of perinatal mortality or severe neonatal morbidity in such fetuses. STUDY DESIGN: We accessed a cohort of 39 singleton, non-malformed, growth-restricted fetuses with absent end-diastolic blood flow at less than 34 weeks between January 1995 and December 2004. The ratio of umbilical artery pulsatility index to middle cerebral artery pulsatility index was calculated to assess redistribution of the fetal arterial circulation. Prenatal and neonatal variables were compared between subjects with versus those without perinatal mortality or severe morbidity using unpaired Student t test or Fisher exact test. Statistical analysis included stepwise logistic regression and receiver operating characteristic curve analysis. P < .05 was considered significant. RESULTS: Stepwise logistic regression analysis demonstrated that the last umbilical artery/middle cerebral artery ratio (P = .02) and estimated fetal weight before delivery (P = .02) were independent predictors of adverse neonatal outcome, with an umbilical artery/middle cerebral artery ratio 1.9 or greater having a sensitivity of 75% and a 13% false-positive rate. Umbilical artery/middle cerebral artery ratio alone accounted for 54% of the variability in outcome. CONCLUSIONS: Among preterm growth-restricted fetuses with absent end-diastolic blood flow in the umbilical artery, the umbilical artery/middle cerebral artery ratio is the best predictor of neonatal mortality or severe morbidity.

Adult↗

PubMed2005

Antenatal magnesium treatment and neonatal illness severity as measured by the Score for Neonatal Acute Physiology (SNAP).

OBJECTIVE: . To determine if antepartum administration of magnesium sulfate affects the Score for Neonatal Acute Physiology (SNAP). METHODS: We reviewed a database of consecutive preterm admissions to our neonatal intensive care unit over a 12-month period. Information on delivery indication, magnesium sulfate use, betamethasone administration, neonatal SNAP scores, neonatal serum magnesium levels, and other data was collected. Data was analyzed by Chi-square, Student t-test, and multiple linear regression with P < 0.05 considered significant. RESULTS: During the study period, 221 cases fulfilled inclusion and exclusion criteria. Multiple regression revealed a significant association between antepartum magnesium use and improved SNAP scores after controlling for gestational age, glucocorticoid use, chorioamnionitis, and birthweight (SNAP score reduction = -2.25 +/- 0.78, P = 0.005). CONCLUSIONS: Antepartum administration of magnesium sulfate results in a significant improvement in the neonatal SNAP score. These results suggest that antepartum magnesium sulfate may be protective, or at least not detrimental to the newborn infant.

Cohort Studies↗

PubMed2005

Do thyroxine and thyroid-stimulating hormone levels reflect urinary iodine concentrations?

The toxicity of environmental chemicals such as nitrates, thiocynates, and perchlorates, some therapeutics, and dietary goitrogens can lower thyroidal iodine uptake and result in hypothyroidism and goiter. Iodine sufficiency, essential for normal thyroid hormone synthesis, is critical during gestation to assure that sufficient thyroxine (T4) and iodine reach the developing fetus. Spot urinary iodide (UI) measurements are used globally to indicate and monitor iodine sufficiency of populations. In individuals, however, UI are not routinely measured; instead, normal serum thyroid-stimulating hormone (TSH) and T4 concentrations serve as surrogate indicators of iodine sufficiency as well as thyroidal health. Our objective was to examine the relationship between UI concentrations and serum T4 and TSH concentrations in individuals in an "iodine-sufficient population." Using a cross-sectional sample of the US population (n = 7628) from the National Health and Nutrition Examination Survey (NHANES III; 1988-1994) database, we examined the relationship among UI, T4, and TSH in pregnant and nonpregnant women and in men (15-44 years). There was a lack of relationship between UI (or UI/Cr) concentrations and serum T4 or TSH concentrations. Therefore, TSH and T4 are not appropriate markers of UI concentrations in this population. Monitoring the status of iodine nutrition of individuals in the United States may be important because serum TSH and T4 concentrations do not indicate low iodine status.

Adolescent↗

PubMed2005

A retrospective review of 15 years of radical radiotherapy with or without concurrent cisplatin and/or 5-fluorouracil for the treatment of locally advanced cervical cancer.

Radiation therapy is the standard of care treatment for locally advanced cervical cancer in the United States. In 1999 the addition of concomitant chemotherapy to radical radiotherapy became standard. The addition of cisplatin (CDDP) with or without 5-fluorouracil (5-FU) chemotherapy to radiation therapy was based on the near simultaneous reporting of five randomized, controlled clinical trials which all showed an improvement in survival with a magnitude of approximately 35%. The purpose of our study was to test the hypothesis that the addition of chemotherapy improved survival in our patients. We identified 291 patients treated with primary 'intent-to-cure' radiation therapy for locally advanced carcinoma of the cervix between 1985 and 2000. We analyzed patients using a stepwise Cox regression, including as possible predictors: clinical stage, age at diagnosis, use of concurrent chemotherapy with radiation and method of teletherapy delivery. We also examined survival as a function of CRT with a CDDP and/or 5-FU containing regimen using the Kaplan-Meier estimates of overall survival. The use of concurrent CDDP and/or 5-FU chemotherapy with radiation (CRT) was not associated with an increase in disease free survival (p=0.734) or overall survival (p=0.989). In this retrospective study there was no disease free or overall survival benefit from the addition of CDDP and/or 5-FU chemotherapy to radical radiotherapy for the treatment of locally advanced cervical carcinoma, although there was a trend favoring CRT.

Adolescent↗

PubMed2004

Role of lamellar body count for the prediction of neonatal respiratory distress syndrome in non-diabetic pregnant women.

OBJECTIVE: Lamellar body count is a new and fast technique to establish the presence of fetal lung maturity. We have assessed the predictive ability of lamellar body count for neonatal respiratory distress syndrome (RDS) in a non-diabetic population. STUDY DESIGN: We accessed a cohort of amniocenteses in non-diabetic women from 1998 to 2002 (n=102). Neonatal RDS was defined as need for surfactant, intubation, or continuous positive airway pressure (CPAP) in the setting of chest X-ray findings consistent with RDS. The predictive ability of lamellar body count was compared with those of lecithin/sphingomyelin (L/S) ratio and presence of phosphatidylglycerol (PG) using logistic regression analysis. The optimal threshold value of lamellar body count for prediction of neonatal RDS was established with receiver operating characteristic (ROC) curve analysis. RESULTS: Lamellar body count ROC curve analysis identified a lamellar body count >37,000 microl(-1) as optimal diagnostic threshold for diagnosis of lung maturity, having a negative predictive value of 98%. Lamellar body count and PG, but not L/S ratio, added significantly to the prediction of RDS. CONCLUSIONS: Lamellar body count is a reliable predictor of fetal lung maturity in non-diabetic women and it can replace the L/S ratio.

Amniocentesis↗

PubMed2004

Preterm twins: what threshold of birth weight discordance heralds major adverse neonatal outcome?

OBJECTIVE: This study was undertaken to establish the optimal threshold of birth weight discordance for prediction of adverse outcome in liveborn, non-malformed preterm twins. STUDY DESIGN: We accessed a cohort of twin gestations for the period 1990 through 2000 delivered at less than 37.0 weeks' gestation. Adverse neonatal outcome was defined as stillbirth or occurrence of major morbidities. RESULTS: A total of 335 twin gestations (670 twins) were included, of which 104 (31%) experienced adverse neonatal outcome. The average birth weight discordance was 12.4% +/- 10.6% versus 19.4% +/- 14.8% in those with good versus adverse outcome (P < .001). Birth weight discordance was a significant predictor of adverse neonatal outcome that was independent of gestational age at delivery, small for gestational age, and chorionicity. Receiver operating characteristic curve analysis suggested that optimal thresholds of birth weight discordance for clinical use should take into account gestational age. CONCLUSION: Birth weight discordance is an independent predictor of adverse neonatal outcome in liveborn, non-malformed preterm twins.

Birth Weight↗

PubMed2004

Randomized trial of McRoberts versus lithotomy positioning to decrease the force that is applied to the fetus during delivery.

OBJECTIVE: In an effort to reduce shoulder dystocia incidence and morbidity, some obstetricians use prophylactic maternal hip hyperflexion (McRoberts maneuver), with the hope of facilitating delivery and decreasing the traction needed for delivery. The objective of this study was to evaluate whether the delivery force is reduced with the prophylactic McRoberts maneuver in a prospective, objective manner. STUDY DESIGN: Between April 2002 and July 2003, we randomly assigned multiparous women with term, cephalic singleton gestations to delivery in the lithotomy or McRoberts position. A single physician used a force-measuring system that consisted of a custom glove with force sensors to record the amount of force that was exerted on the fetal head. The primary outcomes of the study were peak force (pounds; highest force needed to accomplish entire delivery), peak force for delivery of anterior shoulder (pounds), and peak force rate (pounds per second; the duration required to reach the peak force). RESULTS: The peak force was not different between the patients in the lithotomy position (n=13) versus the McRoberts position (n=14; 7.2 +/- 0.8 lbs vs 8.0 +/- 0.7 lbs; P = .5). The peak force for delivery of the anterior shoulder (6.7 +/- 0.8 lbs vs 7.1 +/- 0.7 lbs; P = .7) and peak force rate (32.3 +/- 7.0 lbs/sec vs 29.1 +/- 3.5 lbs/sec; P = .7) were not different between the patients in the lithotomy position versus the McRoberts position, respectively. There was no difference between the groups for gestational age, birth weight, incidence of diabetes mellitus, or operative vaginal delivery. The subjective degree of difficulty of the delivery correlated with the peak force (R2 = 0.53; P = .001). CONCLUSION: The use of the McRoberts maneuver before clinical diagnosis of shoulder dystocia provides no reduction in the force that is used in traction on the fetal head during vaginal delivery in multiparous patients. The acceptance of this maneuver to be used prophylactically requires re-evaluation.

Adult↗

PubMed2004

Effect of epidural anaesthesia on clinician-applied force during vaginal delivery.

OBJECTIVE: Epidural anesthesia (EA) is used in 80% of vaginal deliveries and is linked to neonatal and maternal trauma. Our objectives were to determine (1) whether EA affected clinician-applied force on the fetus and (2) whether this force influenced perineal trauma. STUDY DESIGN: After informed consent, multiparas with term, cephalic, singletons were delivered by 1 physician wearing a sensor-equipped glove to record force exerted on the fetal head. Those with EA were compared with those without for delivery force parameters. Regression analysis was used to identify predictors of vaginal laceration. RESULTS: The force required for delivery was greater in patients with EA (n = 27) than without (n = 5) (P < .01). Clinical parameters, including birth weight (P = .31) were similar between the groups. Clinician force was similar in those with no versus first- versus second-degree laceration (P = .5). Only birth weight was predictive of laceration (P = .02). CONCLUSION: Epidural use resulted in greater clinician force required for vaginal delivery of the fetus in multiparas, but this force was not associated with perineal trauma.

Anesthesia, Epidural↗

PubMed2004

The frequency of peptic ulcer as a cause of upper-GI bleeding is exaggerated.

BACKGROUND: Peptic ulcer disease is considered the cause of upper-GI bleeding in 50% of cases. A recent decline in the proportion of cases of upper-GI bleeding because of a peptic ulcer was noted by us. The objectives of this study were to evaluate the frequency of peptic ulcer in patients with upper-GI bleeding and the proportion of bleeding peptic ulcers with a non-bleeding visible vessel. METHODS: Patients with upper-GI bleeding seen from December 1999 until April 2001 at a tertiary, university-affiliated medical center were studied prospectively. The Clinical Outcome Research Initiative (CORI) database was used to correlate the single institution data with nationwide data. Endoscopic data in the CORI database for patients who had endoscopy for upper-GI bleeding between December 1999 and July 2001 were retrieved and analyzed. RESULTS: A total of 126 patients were included in the prospective study. The endoscopic findings were: peptic ulcer in 31.8%: 95% confidence interval (CI) [23.7%, 40.6%] of patients; a non-bleeding visible vessel was present in 10%: 95% CI[2.8%, 23.7%] of these peptic ulcers. From the nationwide CORI database, data for 7822 patients with upper-GI bleeding were obtained. The endoscopic findings were: peptic ulcer in 20.6%:95% CI[19.7%, 21.5%] of patients with upper-GI bleeding; a non-bleeding visible vessel was present in 7.3%: 95% CI[6.1%, 8.6%] of the ulcers. CONCLUSIONS: The frequency of peptic ulcer in patients with upper-GI bleeding and the proportion of bleeding ulcers with a non-bleeding visible vessel are less than previously reported.

Adult↗

PubMed2004

A randomised controlled trial of ursodeoxycholic acid and S-adenosyl-l-methionine in the treatment of gestational cholestasis.

OBJECTIVE: To compare the efficacy of S-adenosyl-l-methionine and ursodeoxycholic acid in improving serum biochemical abnormalities in gestational cholestasis. DESIGN: Randomised clinical trial. SETTING: University hospital. POPULATION: All women at <36 weeks of gestation with severe gestational cholestasis during June 1996 to December 2001. METHODS: Enrolled women were randomly assigned oral S-adenosyl-l-methionine 500 mg twice daily or oral ursodeoxycholic acid 300 mg twice daily until delivery. MAIN OUTCOME MEASURES: Reduction in the concentration of serum bile acids. Other variables considered included obstetric and neonatal outcome, clinical symptoms and other laboratory measurements (serum levels of transaminases and bilirubin). The two groups were compared using Student's t test, Wilcoxon's signed rank sum test and Fisher's exact test, with a two-tailed P < 0.05 being considered significant. RESULTS: Of the 46 women enrolled, 24 received ursodeoxycholic acid and 22 S-adenosyl-l-methionine. At enrolment, gestational age, duration of therapy, rate of nulliparity, pruritus score and biochemical characteristics were similar between the groups. Both therapies significantly and equally improved pruritus. Women receiving ursodeoxycholic acid had a significantly greater improvement in the concentration of serum bile acids (P= 0.001), aspartate aminotransferase (P= 0.01), alanine aminotransferase (<0.001) and bilirubin (P= 0.002) compared with those receiving S-adenosyl-l-methionine. Duration of therapy was significantly greater in women receiving ursodeoxycholic acid compared with S-adenosyl-l-methionine (P= 0.04), whereas gestational age at delivery and rate of prematurity were similar in the two groups. CONCLUSIONS: In women with intrahepatic cholestasis of pregnancy, ursodeoxycholic acid is more effective than S-adenosyl-l-methionine at improving the concentration of serum bile acids and other tests of liver function, whereas both therapies are equally effective at improving pruritus.

Administration, Oral↗

PubMed2004

Intraventricular hemorrhage and periventricular leukomalacia in preterm infants.

OBJECTIVE: To evaluate whether intraventricular hemorrhage and periventricular leukomalacia are characterized by different risk factors. METHODS: In a cohort of 653 consecutive singleton neonates born after preterm membrane rupture, spontaneous preterm labor, or indicated preterm delivery at 24 to 33 weeks of gestation from January 1, 1993, to December 31, 2002, we evaluated the obstetric and histopathologic placental variables in reference to the development of intraventricular hemorrhage (n = 44), periventricular leukomalacia (n = 19), or no ultrasonographic cerebral lesion (n = 589). Excluded were stillbirths and congenital anomalies. Statistical analysis included Fisher exact test, Student t test, and stepwise logistic regression analysis with a 2-tailed P <.05 considered significant. RESULTS: Multivariate analysis showed that occurrence of neonatal intraventricular hemorrhage and periventricular leukomalacia were associated only with spontaneous prematurity (odds ratio = 1.9; 95% confidence interval 1.1-3.4) and gestational age at delivery in weeks (odds ratio = 0.8; 95% confidence interval 0.7-0.9). Neonates with intraventricular hemorrhage did not differ from those with periventricular leukomalacia in any obstetric or neonatal variable, but there was a higher risk of neurodevelopmental delay associated with periventricular leukomalacia. CONCLUSION: Among premature infants born at less than 34.0 weeks of gestation, intraventricular hemorrhage and periventricular leukomalacia share common clinical characteristics, with spontaneous preterm delivery and gestational age at delivery as the only independent antenatal predictors.

Adult↗

PubMed2004

Risks of induction of labour in women with a uterine scar from previous low transverse caesarean section.

OBJECTIVE: Recent studies have shown that among women with uterine scars from previous caesarean section of any type, induction of labour is associated with increased risk of uterine rupture compared with spontaneous labour. We have assessed the risk of uterine rupture in a cohort of women with a previous low transverse caesarean section in whom induction and management of labour were performed according to a strict protocol. DESIGN: Cohort study. SETTING: University Hospital. POPULATION: All women with a singleton pregnancy and a previous low transverse caesarean section requiring induction of labour from 1/1/1992 to 12/30/2001 (n = 310) were compared with a control cohort during the same study period constituted of women with a previous low transverse caesarean section in spontaneous labour (n = 1011). METHODS: Clinical characteristics and rate of uterine rupture of women with previous caesarean section undergoing induction of labour were compared with those of women with previous caesarean section in spontaneous labour. MAIN OUTCOME MEASURE: Incidence of uterine rupture. RESULTS: Uterine rupture occurred in 0.3% in the previous caesarean section--induction group versus 0.3% in the previous caesarean section--spontaneous labour group (P = 0.9). Logistic regression analysis showed no significant difference in the rate of uterine rupture between the induction and spontaneous labour group (P = 0.67) after controlling for maternal age, parity, duration of labour, gestational age at delivery and birthweight. CONCLUSION: Among women with a previous low transverse caesarean section, induction of labour is not associated with significantly higher rates of uterine rupture compared with spontaneous labour, provided a consistent protocol with strict criteria for intervention is adopted.

Cesarean Section↗

PubMed2003

Does air travel affect pregnancy outcome?

METHODS: To evaluate if air travel affects pregnancy outcome, all women with singleton, non anomalous fetuses, admitted for delivery at a gestational age >20.0 weeks over a 6-month period were asked if they traveled by airflight during pregnancy, including details of the destination and length of their flights and any complications during the travel. Pregnancy outcome was obtained by chart review. Statistical analysis included Student's t-test, Mann-Whitney U test, chi square, Fisher's exact test where appropriate, and linear and logistic regression analysis, with p<0.05 considered significant. RESULTS: Two hundred twenty-two women were studied. Of these, 53% ( n=118) traveled at least once during pregnancy (median 2 flights, range 1-12). The first flight was taken at a mean +/- standard deviation gestational age of 13.3+/-7.6 weeks with average flight lasting 4+/-2 h. There were no differences in gestational age at delivery (39.1 vs. 38.4 weeks, p=0.07), neonatal birthweight (3,379 vs. 3,273 g, p=0.24), or rates of vaginal bleeding (2% vs. 5%, p=0.26), preterm delivery <37 weeks (9% vs. 14%, p=0.29), preeclampsia (5% vs. 6%, p=0.76), neonatal intensive care unit admission (13% vs. 16%, p=0.56), or cumulative adverse obstetric outcome ( p=0.61) between those who did and did not air travel during pregnancy. Power analysis demonstrated that a sample size of 2,803 women in each group would be necessary to show that air travel has a protective effect against adverse pregnancy outcome (alpha = 0.05, beta = 0.80). There were no thromboembolic events complicating any of the pregnancies. CONCLUSION: Our findings suggest that air travel is not associated with increased risk of complications for pregnancies that reach 20 weeks' gestation.

Adult↗

PubMed2003

Effect of arsenic trioxide on QT interval in patients with advanced malignancies.

PURPOSE: Arsenic trioxide is an effective treatment for patients with acute promyelocytic leukemia (APL) who have relapsed from or are refractory to all-trans-retinoic acid and anthracycline chemotherapy. Since arsenic can prolong the QT interval and lead to torsade de pointes, a life-threatening ventricular arrhythmia, this retrospective analysis was conducted to determine the degree of QT prolongation in patients treated with arsenic trioxide. PATIENTS AND METHODS: Clinical data and serial ECGs from 99 patients with advanced malignancies who received 170 courses of arsenic trioxide in either a phase I or phase II investigational study were reviewed. RESULTS: Prolonged QT intervals developed in 38 patients (26 patients had intervals >/= 500 milliseconds). Compared with baseline, the heart rate-corrected (QTc) interval was prolonged by 30 to 60 milliseconds in 36.6% of treatment courses, and by more than 60 milliseconds in 35.4% of patients. The degree of prolongation was higher in men than in women during the first course of therapy, and in patients with hypokalemia. In patients receiving multiple courses, QTc intervals returned to pretreatment levels before the second course, signifying that arsenic trioxide does not permanently prolong the QTc interval. One hypokalemic, arsenic trioxide-treated patient with relapsed APL developed asymptomatic torsade de pointes, which resolved spontaneously and did not recur after electrolyte replacement. There were no sudden or arrhythmia-related deaths. CONCLUSION: This analysis shows that arsenic trioxide can prolong the QTc interval. However, with appropriate ECG monitoring and management of electrolytes and concomitant medications, arsenic trioxide can be safely administered in patients with relapsed APL.

Adolescent↗