23 results on '"Kuper SG"'
Search Results
2. Patient Satisfaction with Outpatient Cervical Ripening in Parous Women.
- Author
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Wang MJ, Jauk VC, George DM, Kuper SG, Edwards RK, Szychowski JM, Mazzoni SE, Files P, Tita AT, Subramaniam A, and Harper LM
- Subjects
- Adult, Female, Humans, Inpatients, Labor, Induced methods, Outpatients, Parity, Pregnancy, Urinary Catheterization, Ambulatory Care, Cervical Ripening, Patient Satisfaction
- Abstract
Objective: This study aimed to assess whether patient satisfaction differs between women beginning cervical ripening in the outpatient versus inpatient setting., Study Design: We performed a planned secondary analysis evaluating patient satisfaction randomized to outpatient versus inpatient cervical ripening. In the original randomized controlled trial, low-risk parous women ≥39 weeks who required cervical ripening for induction and had reassuring fetal heart rate monitoring were included and randomized to inpatient versus outpatient ripening with a transcervical Foley's catheter. All women were then admitted to the labor ward on the following day. Patient satisfaction was evaluated using three separate surveys. The first two surveys, Six Simple Questions and Lady-X, were previously validated. The third survey used visual analog scales to assess overall pain experienced during Foley's placement, overall pain experienced during labor, how likely they would be to choose the same type of care for their next pregnancy, and how likely they would be to recommend their method of cervical ripening to friends/family., Results: From May 2016 to October 2017, 129 women were randomized (outpatient, 65; inpatient, 64). Based on survey results, there was no difference in satisfaction between outpatient and inpatient cervical ripening with transcervical Foley's catheterization, with high satisfaction in both groups. Patients in both the outpatient and inpatient groups would choose the same type of care for their next pregnancy (on a scale of 1-7, median (25th-75th percentile): 7 [7-7] vs. 7 [6-7], respectively, p = 0.75) and would be very likely to recommend their method of induction to a friend or family member (on a scale of 0-100, 99 [80-100] vs. 99 [65-100], respectively, p = 0.60)., Conclusion: Parous women's satisfaction does not differ between inpatient and outpatient cervical ripening with transcervical Foley's catheterization., Key Points: · Outpatient cervical ripening may allow providers to incorporate the benefits of electively inducing women as well as decrease the time spent in the labor and delivery unit.. · Parous women's satisfaction does not differ between inpatient and outpatient cervical ripening with transcervical Foley.. · Additional prospective evaluation is warranted to further characterize patient preferences in relation to the location of cervical ripening.., Competing Interests: R.K.E. has received research funding for another study and has been remunerated for attending medical advisory board meetings for Ferring Pharmaceuticals, the makers of another product for cervical ripening. The other authors did not report any potential conflicts of interest., (Thieme. All rights reserved.)
- Published
- 2021
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3. Outpatient Foley Catheter for Induction of Labor in Nulliparous Women: A Randomized Controlled Trial.
- Author
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Ausbeck EB, Jauk VC, Xue Y, Files P, Kuper SG, Subramaniam A, Casey BM, Szychowski JM, Harper LM, and Tita AT
- Subjects
- Adolescent, Adult, Ambulatory Care, Cervical Ripening, Female, Humans, Parity, Pregnancy, Time Factors, Young Adult, Labor, Induced methods, Urinary Catheterization
- Abstract
Objective: To assess whether outpatient cervical ripening with a transcervical Foley catheter in nulliparous women undergoing elective labor induction shortens the time from admission to delivery., Methods: We performed a randomized controlled trial of patients with singleton pregnancies undergoing elective labor induction at 39 weeks of gestation or more with a modified Bishop score less than 5. Women were randomized 1:1 to outpatient or inpatient transcervical Foley. In the outpatient group, the Foley was inserted the day before admission for scheduled induction; insertion was performed at scheduled admission in the inpatient group. The primary outcome was duration of time from admission to the labor and delivery unit to delivery. With 80% power and a two-sided α of 0.05, a sample size of 126 was estimated to detect at least a 5-hour mean difference in time from admission to delivery between groups from a baseline duration of 19±10 hours., Results: From May 2018 to October 2019, 126 women were randomized, 63 in each group. Baseline characteristics were balanced between groups, except that body mass index (31±5.4 vs 34±7.5, P=.01) and group B streptococcus colonization (31% vs 54%, P=.01) were lower in the outpatient group. The time from admission to delivery was shorter in the outpatient group (17.4±7.4 vs 21.7±9.1 hours, P<.01, mean difference 4.3 hours, 95% CI 1.3-7.2). Admissions before scheduled induction were higher in the outpatient group (22% vs 5%, relative risk [RR] 4.7, 95% CI 1.4-15.4, P<.01), as was median modified Bishop score on admission (3 vs 1, P<.01). Cesarean delivery (24% vs 32%, RR 0.8, 95% CI 0.4-1.3, P=.32) and chorioamnionitis (22% vs 13%, RR 1.8, 95% CI 0.8-3.9, P=.16) were not significantly different between groups., Conclusion: In nulliparous patients undergoing elective labor induction at term, outpatient cervical ripening with a transcervical Foley catheter reduced the time from admission to delivery., Clincal Trial Registration: ClinicalTrials.gov, NCT03472937.
- Published
- 2020
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4. The added value of screening fetal echocardiography after normal cardiac views on a detailed ultrasound.
- Author
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Cawyer CR, Kuper SG, Ausbeck E, Sinkey RG, and Owen J
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- Adult, False Negative Reactions, Female, Fetal Heart pathology, Fetus diagnostic imaging, Gestational Age, Humans, Male, Multimodal Imaging methods, Predictive Value of Tests, Pregnancy, Reference Values, Ultrasonography, Prenatal standards, Young Adult, Echocardiography methods, Fetal Heart diagnostic imaging, Heart Defects, Congenital diagnosis, Mass Screening methods, Ultrasonography, Prenatal methods
- Abstract
Objective: Evaluate fetal echocardiography's ability to detect critical (lesions requiring immediate neonatal intensive care) congenital heart disease (CHD) after normal anatomic cardiac views on detailed ultrasound., Methods: Singletons with both a detailed ultrasound at 18 + 0 to 22 + 6 weeks and echocardiogram performed at least 14 days later and at 20 + 0 to 24 + 6 weeks. Cases with cardiac pathology on detailed ultrasound were excluded. Different combinations of cardiac views were described: Basic (four-chamber, outflow tracts), Expanded (plus three-vessel view), and Complete (plus ductal/aortic arches). "Normal" was defined on either 2D gray scale or color Doppler. Primary outcome was rates of critical CHD missed on ultrasound but seen on fetal echocardiogram., Results: One thousand two hundred twenty-three women had normal Basic cardiac views. One thousand one hundred ninety (97.3%) were confirmed normal on echocardiogram. Twenty-one (1.71%) total CHDs were missed, and three were critical (0.25%; 95% CI, 0.03%-0.53%). Of the 1,223 women, 763 had Complete views. Ten (1.31%) total CHDs were missed and one (0.13%; 95% CI, 0.13%-0.36%) was confirmed critical., Conclusion: Fetal echocardiography can increase CHD detection despite normal cardiac anatomy on detailed ultrasound; however, CHDs missed are rarely critical. Approximately 750 fetal echocardiograms need to be performed to detect one critical CHD with Complete normal cardiac views on detailed ultrasound., (© 2019 John Wiley & Sons, Ltd.)
- Published
- 2019
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5. Labor Curve Analysis of Medically Indicated Early Preterm Induction of Labor.
- Author
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Becker DA, Szychowski JM, Kuper SG, Jauk VC, Wang MJ, and Harper LM
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- Adult, Female, Humans, Parity, Pregnancy, Premature Birth, Reference Values, Retrospective Studies, Young Adult, Labor, Induced, Labor, Obstetric
- Abstract
Objective: To analyze the labor curves of nulliparous and multiparous women between 23.0 and 34.0 weeks of gestation who underwent induction of labor and achieved vaginal delivery., Methods: This is a retrospective cohort study of all live singletons delivered vaginally after medically indicated induction of labor between 23.0 and 34.0 weeks of gestation from 2011 through 2014 at our institution. We excluded those with one or no cervical examinations available during labor. Prior cesarean delivery, 5-minute Apgar score less than 5, and arterial cord pH less than 7.0 were exclusions. The course of cervical dilation was modeled using repeated measures analysis, and smoothed curves for nulliparous and parous women were generated separately. Estimates of the median (5th-95th percentile) traverse times between two dilations were computed using interval censored regression. Traverse times (ie, the elapsed time between two given dilation measures) were compared between nulliparous and parous women., Results: Sixty-seven nulliparous and 69 multiparous women were included. Each group exhibited similar rates of change from 1 to 3 cm of dilation (median 3.6 hours nulliparous and 3.4 hours multiparous, P=.90). Nulliparous women progressed from 3 to 6 cm more slowly than multiparous women (median 10 hours vs 4.4 hours, P<.001). After 6 cm, both groups rapidly progressed to 10 cm (median 0.3 hours vs 0.3 hours, P=.64). Although the 95th percentile traverse time from 6 to 10 cm was about 2 hours in each group, progression from 1 to 6 cm at the 95th percentile was much longer (64.0 vs 42.2 hours)., Conclusion: Early preterm labor induction takes less time in multiparous women owing to more rapid progression from 3 to 6 cm. At the 95th percentile, both nulliparous and multiparous women delivered vaginally, even with latent labor lasting well longer than 24 hours.
- Published
- 2019
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6. Opioid Detoxification in Pregnancy: Systematic Review and Meta-Analysis of Perinatal Outcomes.
- Author
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Wang MJ, Kuper SG, Sims B, Paddock CS, Dantzler J, Muir S, and Harper LM
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- Buprenorphine therapeutic use, Female, Humans, Infant, Newborn, Methadone therapeutic use, Neonatal Abstinence Syndrome epidemiology, Neonatal Abstinence Syndrome prevention & control, Opioid-Related Disorders drug therapy, Pregnancy, Pregnancy Complications drug therapy, Premature Birth epidemiology, Premature Birth prevention & control, Recurrence, Analgesics, Opioid therapeutic use, Opioid-Related Disorders therapy, Pregnancy Complications therapy, Pregnancy Outcome
- Abstract
Objective: We sought to compare the efficacy and safety of detoxification from opioids compared with opioid replacement therapy (ORT) during pregnancy., Study Design: We searched PubMed, Embase, Cochrane Library, and ClinicalTrials.gov from inception to June 2017 for English-language randomized-controlled trials or cohort studies that compared detoxification with ORT. We sought studies with outcomes data on maternal abstinence at the time of delivery, neonatal abstinence syndrome (NAS), stillbirth, and preterm birth (PTB). We calculated pooled relative risks (RRs) with a random-effects model, assessed heterogeneity using the chi-square test for heterogeneity, and quantified heterogeneity using the I
2 test. We assessed publication bias using funnel plots and the Harbord test., Results: Three cohort studies met the inclusion criteria; eligible studies included 235 women with opioid use disorder in pregnancy. Maternal detoxification was associated with increased risk of relapse (RR = 1.91; 95% confidence interval [CI] = 1.14-3.21); however, no treatment differences were observed for the rates of NAS (RR = 0.99; 95% CI = 0.38-2.53) or PTB (RR = 0.39; 95% CI = 0.10-1.60)., Conclusion: Our findings suggest an increased risk of relapse with detoxification treatment compared with ORT; however, detoxification does not alter the risk of PTB or NAS. Further studies should confirm our findings and explore mechanisms to fight the current opioid epidemic., Competing Interests: None., (Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.)- Published
- 2019
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7. Neonatal Outcomes Based on Duration of Exposure to Antenatal Corticosteroids in Indicated Preterm Deliveries.
- Author
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Cawyer CR, Kuper SG, Dimperio LA, Tita AT, Biggio JR, and Harper LM
- Subjects
- Adult, Cohort Studies, Female, Gestational Age, Humans, Infant, Infant Mortality, Infant, Newborn, Male, Pregnancy, Pregnancy Outcome epidemiology, Premature Birth epidemiology, Retrospective Studies, United States, Bronchopulmonary Dysplasia diagnosis, Bronchopulmonary Dysplasia epidemiology, Enterocolitis, Necrotizing diagnosis, Enterocolitis, Necrotizing epidemiology, Glucocorticoids administration & dosage, Glucocorticoids adverse effects, Medication Therapy Management standards, Prenatal Care methods, Prenatal Care standards, Prenatal Care statistics & numerical data
- Abstract
Objective: To evaluate how duration of exposure to antenatal corticosteroids (ACSs) prior to delivery affects neonatal outcomes in indicated preterm deliveries., Study Design: This is a retrospective cohort of all indicated singleton preterm deliveries (23-34 weeks) in a single tertiary center from 2011 to 2014 comparing those who received ACS 2 to 7 days versus >7 days prior to delivery. The primary neonatal outcome was a composite of arterial cord pH < 7 or base excess ≤ 12, 5-minute Apgar ≤ 3, cardiopulmonary resuscitation, culture-proven neonatal sepsis, intraventricular hemorrhage grade III/IV, necrotizing enterocolitis, and neonatal death. Analyses were stratified by delivering gestational age (23
0/7 -276/7 , 280/7 -316/7 , and 320/7 -336/7 weeks). Multivariate logistic regression refined point estimates and adjusted for confounders., Results: In total, 301 women delivered >48 hours after initial ACS dose, 230 delivered within 2 to 7 days, and 71 delivered >7 days. Infants with an interval of >7 days had no significant increase in the unadjusted composite neonatal outcome ( p = 0.42), but when adjusted, the composite neonatal outcome (adjusted odds ratio [AOR]: 2.7; 95% confidence interval [CI]: 1.18-6.31) and neonatal death (AOR: 4.20; 95% CI: 1.39-12.69) were significantly increased with an ACS interval of >7 day., Conclusion: In this cohort, the benefit of ACS diminished >7 days after administration, particularly when delivery occurred at <32 weeks., Competing Interests: None., (Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.)- Published
- 2019
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8. Validation of the SunTech Medical Advantage Model 2 Series Automated Blood Pressure Module in Pregnancy.
- Author
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Kuper SG, Dotson KN, Anderson SB, Harris SL, Harper LM, and Tita AT
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- Adult, Algorithms, Blood Pressure Determination methods, Blood Pressure Determination standards, Equipment Design, Female, Humans, Materials Testing methods, Pregnancy, Blood Pressure Determination instrumentation, Hypertension diagnosis, Oscillometry instrumentation, Oscillometry methods, Pre-Eclampsia diagnosis, Pregnancy Complications, Cardiovascular diagnosis, Sphygmomanometers classification, Sphygmomanometers standards
- Abstract
Objective: We sought to validate the SunTech Medical Advantage Model 2 Series with firmware LX 3.40.8 algorithm noninvasive blood pressure module in a pregnant population, including those with preeclampsia., Study Design: Validation study of an oscillometric noninvasive blood pressure module using the ANSI/AAMI ISO 81060-2:2013 standard guidelines. Pregnant women were enrolled into three subgroups: normotensive, hypertensive without proteinuria, and preeclampsia (hypertensive with random protein-to-creatinine ratio ≥ 0.3 or a 24-hour urine protein > 300 mg). Two trained research nurses, blinded to each other's measurements, used a mercury sphygmomanometer to validate the module by following the protocol set forth in the ANSI/AAMI ISO 81060-2:2013 standard guidelines., Results: A total of 45 patients, 15 in each subgroup, were included. The mean systolic and diastolic differences with standard deviations between the module and the mean observers' measurements for all participants were -2.3 ± 7.3 and 0.2 ± 6.5 mm Hg, respectively. The systolic and diastolic standard deviations of the mean of the individual patient's paired module and observers' measurements were 6.27 and 5.98 mm Hg, respectively. The test device, relative to a mercury sphygmomanometer, underestimated the systolic blood pressure in patients with preeclampsia by at least 10 mm Hg in 24% (11/45) of paired measurements., Conclusion: The SunTech Medical Advantage Model 2 Series with firmware LX 3.40.8 algorithm noninvasive blood pressure module is validated in pregnancy, including patients with preeclampsia; however, it may underestimate systolic blood pressure measurements in patients with preeclampsia., Competing Interests: Ms. Kristin N. Dotson is an employee of SunTech Medical. Data were collected and verified by UAB coauthors., (Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.)
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- 2019
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9. Association between antenatal corticosteroids and neonatal hypoglycemia in indicated early preterm births .
- Author
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Kuper SG, Baalbaki SH, Parrish MM, Jauk VC, Tita AT, and Harper LM
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- Adrenal Cortex Hormones administration & dosage, Adult, Case-Control Studies, Dose-Response Relationship, Drug, Drug Administration Schedule, Female, Gestational Age, Humans, Infant, Extremely Premature, Infant, Newborn, Pregnancy, Prenatal Care methods, Risk Assessment, Time Factors, Young Adult, Adrenal Cortex Hormones adverse effects, Hypoglycemia chemically induced, Premature Birth
- Abstract
Purpose: We sought to determine if administration of antenatal corticosteroids in early preterm births (<34 weeks) is associated with an increased risk of developing neonatal hypoglycemia (<40 mg/dL) within the first 48 h of neonatal life., Materials and Methods: Retrospective cohort of all indicated singleton preterm births (23-34 weeks) in a single tertiary center from 2011 to 2014. The primary outcome was neonatal hypoglycemia (<40 mg/dL) within the first 48 h of life. The outcome was compared by antenatal corticosteroids received at any point during the gestation, within 2-7 d of delivery, and whether the patient received a partial, full, or repeat course of antenatal corticosteroids. Logistic regression was used to adjust for confounders., Results: Six hundred thirty-five patients underwent an indicated preterm birth during the study period. Six hundred and four (95%) received antenatal corticosteroids prior to delivery and 31 (5%) did not. The incidence of neonatal hypoglycemia within 48 h of life was not significantly different between those who received any antenatal corticosteroids and those who did not (23.0 versus 16.1%, adjusted odds ratio [OR] 1.3, 95%CI 0.5-3.6). Infants who received a full antenatal corticosteroid course within 2-7 d of delivery had similar incidences of hypoglycemia compared with those who received antenatal corticosteroids more than 7 d before delivery (20.4 versus 25.4%, adjusted OR 1.5, 95% confidence interval(CI) 0.8-2.9). Neonatal hypoglycemia was not increased by the number of antenatal corticosteroid doses (partial, full, or repeat course) administered. There was not a correlation between timing of antenatal corticosteroid administration before delivery, up to 250 h, and the lowest neonatal blood sugar in the first 48 h of life., Conclusion: Our findings suggest antenatal corticosteroid administration in indicated early preterm infants (<34 weeks) may not increase the risk of developing neonatal hypoglycemia within the first 48 h of life. Further studies should validate our findings.
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- 2018
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10. In Reply.
- Author
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Kuper SG, Jauk VC, Edwards RK, and Harper LM
- Subjects
- Female, Humans, Labor, Induced, Pregnancy, Labor, Obstetric, Outpatients
- Published
- 2018
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11. Does Early Artificial Rupture of Membranes Speed Labor in Preterm Inductions?
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Parrish MM, Kuper SG, Jauk VC, Baalbaki SH, Tita AT, and Harper LM
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- Adult, Alabama epidemiology, Amniotomy methods, Chorioamnionitis epidemiology, Female, Gestational Age, Humans, Infant, Newborn, Multivariate Analysis, Pregnancy, Pregnancy Outcome, Regression Analysis, Retrospective Studies, Risk Assessment, Tertiary Care Centers, Time Factors, Young Adult, Amniotomy statistics & numerical data, Cesarean Section statistics & numerical data, Labor, Obstetric, Premature Birth
- Abstract
Objective: In full-term patients, early artificial rupture of membranes (AROMs) decreases time in labor. We assessed the impact of early AROM in preterm patients undergoing indicated induction of labor., Study Design: We conducted a retrospective cohort study of all patients undergoing indicated preterm induction (23-34 weeks) at a single tertiary care center from 2011 to 2014. Early AROM was defined as <4 cm and late AROM was defined as ≥4 cm. The primary outcomes evaluated were cesarean delivery and time in labor. Secondary outcomes were chorioamnionitis and a composite of maternal and neonatal adverse outcomes., Results: Of the 149 women included, 65 (43.6%) had early AROM. Early AROM was associated with an increased time from the start of induction to delivery (25.7 ± 13.0 vs. 19.0 ± 10.3 hours, p < 0.01) and with an increase in the risk of cesarean (53.4 vs. 22.6%, adjusted odds ratio: 3.5, 95% confidence interval: 1.60-7.74). Early AROM was not associated with an increased risk of chorioamnionitis or adverse maternal or fetal outcomes., Conclusion: In this observational cohort, early AROM was associated with an increased risk of cesarean. A randomized controlled trial is necessary to determine the optimal timing of AROM in preterm patients requiring delivery., Competing Interests: None., (Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.)
- Published
- 2018
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12. Reply.
- Author
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Kuper SG and Tita AT
- Subjects
- Female, Humans, Pregnancy, Smoking, Dietary Supplements, Pregnancy Outcome
- Published
- 2018
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13. Outcomes of Medically Indicated Preterm Births Differ by Indication.
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Wang MJ, Kuper SG, Steele R, Sievert RA, Tita AT, and Harper LM
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- Adult, Alabama, Cesarean Section adverse effects, Female, Gestational Age, Humans, Infant, Newborn, Labor, Induced adverse effects, Logistic Models, Male, Multivariate Analysis, Pregnancy, Pregnancy Outcome, Retrospective Studies, Treatment Outcome, Young Adult, Delivery, Obstetric methods, Obstetric Labor Complications etiology, Premature Birth epidemiology, Premature Birth therapy
- Abstract
Objective: We aim to examine whether outcomes of preterm birth (PTB) are further modified by the indication for delivery., Study Design: We performed a retrospective cohort study of all singletons delivered at 23 to 34 weeks from 2011 to 2014. Women were classified by their primary indication for delivery: maternal (preeclampsia) or fetal/obstetric (growth restriction, nonreassuring fetal status, and vaginal bleeding). The primary neonatal outcome was a composite of neonatal death, cord pH <7 or base excess < - 12, 5-minute Apgar ≤3, C-reactive protein during resuscitation, culture-proven sepsis, intraventricular hemorrhage, and necrotizing enterocolitis. Secondary outcomes included the individual components of the primary outcome. Groups were compared using Student's t -test and chi-squared tests. Logistic regression was used to adjust for confounding variables., Results: Of 528 women, 395 (74.8%) were delivered for maternal and 133 (25.2%) for fetal/obstetric indications. Compared with those delivered for a maternal indication, those with a fetal/obstetric indication for delivery had an increased risk of the composite neonatal outcome (adjusted odds ratio [AOR]: 1.9, 95% confidence interval [CI]: 1.13-3.21) and acidemia at birth (AOR: 4.2, 95% CI: 1.89-9.55)., Conclusion: Preterm infants delivered for fetal/obstetric indications have worsened outcomes compared with those delivered for maternal indications. Additional research is needed to further tailor counseling specific to the indication for delivery., Competing Interests: None., (Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.)
- Published
- 2018
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14. Outpatient Foley Catheter for Induction of Labor in Parous Women: A Randomized Controlled Trial.
- Author
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Kuper SG, Jauk VC, George DM, Edwards RK, Szychowski JM, Mazzoni SE, Wang MJ, Files P, Tita AT, Subramaniam A, and Harper LM
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- Adult, Cervical Ripening, Female, Humans, Outpatients statistics & numerical data, Oxytocics administration & dosage, Oxytocin administration & dosage, Pregnancy, Time Factors, Delivery, Obstetric statistics & numerical data, Hospitalization statistics & numerical data, Labor, Induced methods, Urinary Catheterization methods
- Abstract
Objective: To assess whether outpatient cervical ripening with a transcervical Foley catheter in parous women undergoing elective induction of labor shortens the total duration of time from admission to the labor ward until delivery., Methods: We performed an open-label randomized controlled trial at a single academic center in parous women at 39 weeks of gestation or greater with a cervix 3 cm or less dilated, or, if 2-3 cm dilated, less than 80% effaced and reassuring fetal heart rate monitoring (defined as moderate variability with a normal baseline and absence of decelerations). Exclusions were obstetric and neonatal conditions deemed unsuitable for outpatient cervical ripening, contraindications to vaginal delivery, or conditions that required immediate hospitalization. Women were randomized in the ambulatory setting to either an outpatient transcervical catheter (with immediate placement) or inpatient transcervical catheter placement and concomitant oxytocin infusion on the labor ward. Women in the outpatient group were instructed to return to the hospital the next day or sooner if labor occurred. Induction of labor was managed per institutional protocol, and once participants were admitted, oxytocin was initiated. The primary outcome was the duration of time from labor ward admission until delivery. Based on a prior study in our institution, a total of 128 women were needed for 80% power to detect a 12-hour difference in total duration spent from labor ward admission until delivery with a two-sided α of 0.05., Results: Of 743 women screened, 129 provided consent and were randomized from May 2016 to October 2017. Baseline characteristics were balanced between groups. Outpatient cervical ripening did not significantly shorten the time from labor ward admission until delivery (12.4±7.4 vs 13.5±7.0 hours, P=.38)., Conclusion: Outpatient cervical ripening in parous women does not shorten the time from labor ward admission until delivery if oxytocin is initiated simultaneously with inpatient transcervical catheter placement., Clinical Trial Registration: ClinicalTrials.gov, NCT02756689.
- Published
- 2018
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15. Impact of Intended Mode of Delivery on Outcomes in Preterm Growth-Restricted Fetuses.
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Baalbaki SH, Kuper SG, Wang MJ, Steele RA, Biggio JR, and Harper LM
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- Adult, Alabama, Cesarean Section statistics & numerical data, Female, Gestational Age, Humans, Infant, Newborn, Infant, Premature, Diseases epidemiology, Logistic Models, Pregnancy, Premature Birth, Retrospective Studies, Ultrasonography, Doppler, Umbilical Arteries diagnostic imaging, Young Adult, Delivery, Obstetric methods, Fetal Growth Retardation physiopathology, Infant, Premature, Diseases etiology, Pregnancy Outcome, Umbilical Arteries physiopathology
- Abstract
Background: Scheduled cesarean is frequently performed for fetal growth restriction due to concerns for fetal intolerance of labor., Objective: We compared neonatal outcomes in preterm growth-restricted fetuses by intended mode of delivery., Study Design: We performed a retrospective cohort study of indicated preterm births with prenatally diagnosed growth restriction from 2011 to 2014 at a single institution. Patients were classified by intended mode of delivery. The primary outcome was a composite of adverse neonatal outcomes, including perinatal death, cord blood acidemia, chest compressions during neonatal resuscitation, seizures, culture-proven sepsis, necrotizing enterocolitis, and grade III-IV intraventricular hemorrhage. Secondary analysis was performed examining the impact of umbilical artery Dopplers., Results: Of 101 fetuses with growth restriction, 75 underwent planned cesarean deliveries. Of those induced, 46.2% delivered vaginally. Delivery by scheduled cesarean was not associated with a decreased risk of the composite outcome (adjusted odds ratio [aOR], 1.61; 95% confidence interval [CI], 0.45-5.78), even when only those with abnormal umbilical artery Dopplers were considered (aOR, 2.8; 95% CI, 0.40-20.2)., Conclusion: In this cohort, planned cesarean was not associated with a reduction in neonatal morbidity, even when considering only those with abnormal umbilical artery Dopplers. In otherwise appropriate candidates for vaginal delivery, fetal growth restriction should not be considered a contraindication to trial of labor., Competing Interests: None., (Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.)
- Published
- 2018
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16. Maternal and Neonatal Outcomes in Indicated Preterm Births Based on the Intended Mode of Delivery.
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Kuper SG, Sievert RA, Steele R, Biggio JR, Tita AT, and Harper LM
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- Adult, Female, Gestational Age, Humans, Infant, Newborn, Odds Ratio, Pregnancy, Pregnancy Outcome, Retrospective Studies, Treatment Outcome, Young Adult, Cesarean Section adverse effects, Delivery, Obstetric methods, Labor, Induced adverse effects, Obstetric Labor Complications etiology, Premature Birth therapy
- Abstract
Objective: To compare maternal and neonatal outcomes in women who underwent induction of labor or planned cesarean delivery in indicated preterm births before 34 weeks of gestation., Methods: We conducted a retrospective cohort study of all indicated singleton preterm births (23-34 weeks of gestation) in a tertiary center from 2011 to 2014. The primary maternal outcome was a composite of early postpartum hemorrhage, blood transfusion, operative complications, postpartum complications, and clinical chorioamnionitis. The primary neonatal outcome was a composite of neonatal death, cardiopulmonary resuscitation in the delivery room, grade 3 or 4 intraventricular hemorrhage, necrotizing enterocolitis, culture-proven sepsis, birth trauma, arterial cord gas pH less than 7 or base excess less than -12, and 5-minute Apgar score 3 or less. Outcomes were compared by intended mode of delivery (induction of labor compared with cesarean) and adjusted for confounders. In secondary analyses, maternal and neonatal outcomes based on the intended mode of delivery were stratified by gestational age (23-27 6/7, 28-31 6/7, and 32-33 6/7 weeks of gestation)., Results: Of 629 patients with indicated early preterm births during the study period, 331 (53%) underwent induction of labor, of whom 208 (63%) delivered vaginally. Induction of labor was not associated with an increased risk of the primary maternal (16.3% compared with 19.5%, adjusted odds ratio [OR] 0.8, 95% CI 0.5-1.3) or neonatal composite outcome (14.5% compared with 35.9%, adjusted OR 0.7, 95% CI 0.4-1.1). Analyses stratified by gestational age were consistent with the overall analysis., Conclusion: Maternal and neonatal outcomes do not differ based on the intended mode of delivery. Induction of labor should be considered when early preterm birth is indicated.
- Published
- 2017
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17. The effect of omega-3 supplementation on pregnancy outcomes by smoking status.
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Kuper SG, Abramovici AR, Jauk VC, Harper LM, Biggio JR, and Tita AT
- Subjects
- 17 alpha-Hydroxyprogesterone Caproate, Adult, Female, Humans, Hydroxyprogesterones administration & dosage, Infant, Low Birth Weight, Infant, Newborn, Injections, Intramuscular, Pregnancy, Progestins administration & dosage, United States epidemiology, Dietary Supplements, Fatty Acids, Omega-3 therapeutic use, Premature Birth prevention & control, Smoking epidemiology
- Abstract
Background: Smoking during pregnancy is associated with adverse maternal and neonatal outcomes such as preterm delivery, intrauterine growth restriction, stillbirth, and low birth weight. Because smoking causes oxidative stress, some have suggested using antioxidants to counteract the effects of oxidative stress. Smokers have lower serum levels of omega-3 fatty acids, an important antioxidant, and thus, investigating whether omega-3 supplementation in smokers reduces adverse maternal and neonatal outcomes represents an important area of research., Objective: To investigate whether the antioxidant effect of omega-3 fatty acid supplementation on the incidence of adverse pregnancy outcomes differs between smokers and nonsmokers., Study Design: Secondary analysis of a multicenter randomized controlled trial of omega-3 supplementation for preterm delivery prevention in women with a singleton pregnancy and a history of a previous singleton spontaneous preterm delivery. Subjects were randomized to begin omega-3 or placebo before 22 weeks, which was continued until delivery. All women received 17 alpha-hydroxyprogesterone caproate intramuscularly weekly beginning between 16 and 20 weeks of gestation and continued until 36 weeks of gestation or delivery, whichever occurred first. The primary outcome was spontaneous preterm delivery. Secondary outcomes were indicated preterm delivery, any preterm delivery (spontaneous and indicated), pregnancy-associated hypertension (gestational hypertension and preeclampsia), a neonatal composite (retinopathy of prematurity, intraventricular hemorrhage grade III or IV, patent ductus arteriosus, necrotizing enterocolitis, sepsis, respiratory morbidity, or perinatal death), low birth weight (<2500 g), small for gestational age (less than the 10th percentile), and neonatal intensive care unit or intermediate nursery admission. The study population was stratified into smokers and nonsmokers, and the incidence of each outcome was compared by omega-3 supplementation versus placebo in each subgroup. Zelen tests were performed to test for homogeneity of effect in smokers and nonsmokers., Results: Of 851 subjects included in the analysis, 136 (16%) smoked. Baseline characteristics between omega-3 and placebo groups did not differ in smokers or nonsmokers. Omega-3 supplementation was associated with a lower risk of spontaneous preterm delivery in smokers (relative risk, 0.56, 95% confidence interval, 0.36-0.87) but not in nonsmokers (relative risk 1.04, 95% confidence interval 0.84-1.29); P value for interaction = 0.013. Low birth weight was also less frequent in smokers receiving omega-3 supplementation (relative risk 0.57, 95% confidence interval 0.36-0.90) compared with nonsmokers (relative risk 0.93, 95% confidence interval 0.71-1.24); P value for interaction = 0.047. The effect on other secondary outcomes did not differ significantly between smokers and nonsmokers., Conclusion: Omega-3 supplementation in smokers may have a protective effect against recurrent spontaneous preterm delivery and low birth weight., (Copyright © 2017 Elsevier Inc. All rights reserved.)
- Published
- 2017
- Full Text
- View/download PDF
18. Predictors of vaginal delivery in medically indicated early preterm induction of labor.
- Author
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Sievert RA, Kuper SG, Jauk VC, Parrish M, Biggio JR, and Harper LM
- Subjects
- Adult, Body Mass Index, Cesarean Section statistics & numerical data, Cohort Studies, Female, Fetal Growth Retardation, Gestational Age, Humans, Hypertension complications, Logistic Models, Male, Pregnancy, Pregnancy Complications, Cardiovascular, Retrospective Studies, Delivery, Obstetric, Labor, Induced, Premature Birth
- Abstract
Background: When delivery is indicated prior to 34 weeks, many providers perform a cesarean delivery rather than induce labor based on perceptions of a high failure rate. Given the morbidity of cesarean delivery, an accurate estimate of the success rate and factors associated with success in preterm induction of labor is important in management decisions., Objective: We sought to develop a prediction model for successful induction of labor in preterm patients using factors known at the time the decision is made to deliver., Study Design: A retrospective cohort study of all live singletons undergoing an indicated induction of labor between 23 and 34 0/7 weeks from 2011 through 2015. Pregnancies with major fetal anomalies or no intrapartum fetal monitoring were excluded. Successful induction of labor was defined as vaginal delivery. The cohort was randomly split into a training cohort to develop a prediction model for vaginal delivery and a validation cohort to test the model. Factors significantly associated with vaginal delivery were identified using univariate analyses, and candidate factors were used in the multivariate logistic regression model. Only factors known at the start of the induction of labor were used in the model. Receiver-operating characteristic curves were created to estimate the predictive value of the model. Sensitivity and specificity of the model were assessed., Results: Of 331 patients who underwent induction of labor, 208 (62.8%) delivered vaginally and 123 (37.1%) by cesarean delivery. Of the factors significantly associated with cesarean delivery, the final model included gestational age, simplified Bishop score, suspected intrauterine growth retardation, chronic hypertension, and body mass index. In the training cohort, the model correctly classified 72.3% of subjects with a sensitivity (cesarean delivery predicted/cesarean delivery performed) of 56.7% and a specificity (vaginal delivery predicted/vaginal delivery performed) of 84.1%. When applied to the validation cohort, 73.9% of subjects were correctly classified, with a sensitivity of 44.6% and specificity of 89.0%. Receiver-operating characteristic curves had an area under the curve of 0.75 for the training cohort and 0.77 for the validation cohort., Conclusion: More than 60% of women undergoing induction of labor at <34 0/7 weeks deliver vaginally. For women undergoing induction of labor at <34 0/7 weeks, this prediction model rarely classifies individuals who can have a vaginal delivery as needing a cesarean delivery. This model may provide an accurate assessment tool to evaluate which patients will likely deliver vaginally to avoid the morbidity of cesarean delivery while conversely identifying subjects at high risk of cesarean delivery <34 0/7 weeks., (Copyright © 2017 Elsevier Inc. All rights reserved.)
- Published
- 2017
- Full Text
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19. Baseline Renal Function Tests and Adverse Outcomes in Pregnant Patients With Chronic Hypertension.
- Author
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Kuper SG, Tita AT, Youngstrom ML, Allen SE, Tang Y, Biggio JR, and Harper LM
- Subjects
- Adult, Alabama epidemiology, Creatinine analysis, Female, Gestational Age, Humans, Infant, Newborn, Infant, Small for Gestational Age, Pre-Eclampsia etiology, Pre-Eclampsia prevention & control, Pregnancy, Pregnancy Outcome epidemiology, Premature Birth epidemiology, Retrospective Studies, Risk Assessment methods, Hypertension blood, Hypertension complications, Hypertension diagnosis, Hypertension epidemiology, Kidney Function Tests methods, Pregnancy Complications, Cardiovascular blood, Pregnancy Complications, Cardiovascular diagnosis, Pregnancy Complications, Cardiovascular epidemiology
- Abstract
Objective: To examine the relationship between baseline renal function tests in pregnant patients with chronic hypertension and adverse pregnancy outcomes., Methods: This was a retrospective cohort study of women with a singleton pregnancy and chronic hypertension with assessment of renal function (urine protein-to-creatinine ratio and serum creatinine) before 20 weeks of gestation. The primary outcome was severe preeclampsia at less than 34 weeks of gestation. Secondary outcomes were severe preeclampsia at any gestational age, any preeclampsia, preterm birth at less than 35 weeks of gestation, composite perinatal outcome (perinatal death, assisted ventilation, cord pH less than 7, 5-minute Apgar score 3 or less, or neonatal seizures), and small for gestational age. The association between baseline renal function and the primary outcome was assessed with receiver operating characteristic (ROC) curves and objective cutoffs determined. Outcomes were compared between those with values above and below the cutoffs using univariable and multivariable analyses., Results: Seven hundred fifty-five pregnant women with chronic hypertension had baseline renal function assessment. The urine protein-to-creatinine ratio and creatinine cutoffs for severe preeclampsia at less than 34 weeks of gestation were 0.12 or greater and 0.75 mg/dL or greater, respectively. The area under the ROC curves for severe preeclampsia at less than 34 weeks of gestation was 0.74 (95% confidence interval [CI] 0.7-0.8) for urine protein-to-creatinine ratio and 0.67 (95% CI 0.6-0.8) for creatinine. A urine protein-to-creatinine ratio 0.12 or greater was associated with an increased risk of developing severe preeclampsia at less than 34 weeks of gestation (16.4% compared with 2.6%, adjusted odds ratio [OR] 7.5, 95% CI 3.9-14.6) as was a creatinine 0.75 mg/dL or greater (15.7% compared with 4.6%, adjusted OR 3.5, 95% CI 1.9-6.3). Severe preeclampsia at less than 34 weeks of gestation occurred in only 1.6% of patients if their baseline tests were below both cutoffs., Conclusion: Baseline assessment of renal function can be used as a risk stratification tool in pregnant patients with chronic hypertension.
- Published
- 2016
- Full Text
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20. Transabdominal Cerclage.
- Author
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Sumners JE, Kuper SG, and Foster TL
- Subjects
- Cerclage, Cervical adverse effects, Female, Humans, Patient Selection, Postoperative Complications, Pregnancy, Cerclage, Cervical methods, Pregnancy, Multiple, Premature Birth prevention & control, Uterine Cervical Incompetence surgery
- Abstract
The transabdominal cerclage procedure was first introduced 50 years ago as an approach in those patients who had failed transvaginal cerclage. We review the history, indications, surgical technique, complications, and reported outcomes of the procedure. The procedure has evolved over time in its application and risks appear to be less than previously perceived. Physicians have found additional patient situations in which the procedure may be beneficial outside the indications defined 50 years ago. This is a valuable surgical technique which is likely underused.
- Published
- 2016
- Full Text
- View/download PDF
21. A randomized controlled trial of early versus delayed skin staple removal following caesarean section in the obese patient.
- Author
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Nuthalapaty FS, Lee CM, Lee JH, Kuper SG, and Higdon HL 3rd
- Subjects
- Adult, Female, Hematoma etiology, Humans, Pain, Postoperative etiology, Seroma etiology, Surgical Stapling, Surgical Wound Infection etiology, Time Factors, Young Adult, Cesarean Section, Device Removal adverse effects, Obesity complications, Surgical Wound Dehiscence etiology, Sutures adverse effects
- Abstract
Objective: To compare wound complications after Caesarean section in the obese patient, following early versus delayed skin staple removal., Methods: We conducted a single-centre, non-inferiority, randomized controlled trial. Following Caesarean section, obese women (BMI ≥ 30 kg/m(2)) with subcutaneous wound depth ≥ 2.0 cm and skin staple closure of a transverse incision were randomized to staple removal on postoperative day 3 (early) or between postoperative day 7 and postoperative day 10 (delayed). The primary outcome was superficial wound dehiscence; a rate of 8% or higher in the early group was defined as inferior. Secondary outcomes were seroma/hematoma, surgical site infection, and visual analogue pain score. The planned sample size was 250 patients per group., Results: The study was halted after 295 patients were randomized because of slow enrolment and exhaustion of funding. The rate of superficial wound dehiscence was 15.2% in the early group (n = 145) versus 11.5% in the delayed group (n = 148). The point estimate for this difference (3.7 %; 95% CI -4.4 to 12.4) favours delayed removal. However, because the 95% CI includes zero and the upper CI exceeds the predefined limit for non-inferiority (8%), non-inferiority was not demonstrated. The rates of all secondary outcomes were similar in the early group and the delayed group: seroma/hematoma (6.9% vs. 4.7%; RR 1.4, 95% CI 0.6 to 3.7, P = 0.4); surgical site infection (9.7% vs. 4.8%; RR 2.0, 95% CI 0.8 to 4.9, P = 0.1); and composite (superficial wound dehiscence, seroma/hematoma, and surgical site infection) wound complication (17.2% vs. 12.8%; RR 1.3, 95% CI 0.8 to 2.3, P = 0.3)., Conclusion: The non-inferiority of early skin staple removal was not demonstrated. Delayed removal of staples should remain the accepted standard in the obese patient following Caesarean section.
- Published
- 2013
- Full Text
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22. Staples compared with subcuticular suture for skin closure after cesarean delivery: a systematic review and meta-analysis.
- Author
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Nuthalapaty FS, Kuper SG, and Higdon HL 3rd
- Subjects
- Device Removal, Humans, Obesity physiopathology, Surgical Wound Infection epidemiology, Time Factors, Wound Healing, Cesarean Section, Suture Techniques, Sutures
- Published
- 2011
- Full Text
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23. Fistula elevation procedure: experience with 295 consecutive cases during a 7-year period.
- Author
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Bronder CM, Cull DL, Kuper SG, Carsten CG, Kalbaugh CA, Cass A, Watkins T, and Taylor SM
- Subjects
- Adolescent, Adult, Aged, Aged, 80 and over, Arm, Arteriovenous Shunt, Surgical adverse effects, Female, Humans, Kidney Failure, Chronic therapy, Leg, Male, Middle Aged, Reoperation, Treatment Outcome, Arteriovenous Shunt, Surgical methods, Catheterization, Renal Dialysis, Vascular Patency
- Abstract
Background: Up to 50% of AV fistulas fail to mature, primarily because of problems with fistula cannulation. Fistula elevation procedure (FEP) is a simple superficialization procedure where the fistula is surgically exposed, mobilized, and elevated into a more superficial position for the purpose of facilitating AV fistula cannulation. The purpose of this study is to review use of FEP as an adjunct to fistula maturation., Study Design: Two hundred ninety-five FEPs were performed between February 1999 and December 2005. FEP was performed if the fistula was considered too deep to cannulate or if nurses were unable to cannulate the fistula. Kaplan-Meier life-table analysis was used to determine patency and for a subanalysis by location of FEP performed (172 brachial-cephalic, 70 brachial-basilic, 46 radial-cephalic, 7 superficial femoral vein). Survival curves were compared using log-rank test., Results: Functional primary patency rates for patients undergoing an adjunctive FEP were 73% at 6 months, 60% at 1 year, and 46% at 2 years. Secondary functional patency rates were 81% at 6 months, 71% at 1 year, and 59% at 2 years. There was no statistical significance in any outcomes based on anatomic site of elevation., Conclusions: AV fistulas that might otherwise have been abandoned because of excessive depth or tortuosity can be successfully salvaged by an adjunctive FEP and achieve satisfactory longterm functional patency. FEP is a valuable adjunct to AV fistula creation, which will enhance fistula maturation rates.
- Published
- 2008
- Full Text
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