Risk of perinatal death associated with labor after previous cesarean delivery in uncomplicated term pregnancies

Context  Trial of labor after previous cesarean delivery is associated with increased risk of uterine rupture. However, no reliable data exist on the effect of a trial of labor on the risk of perinatal death in otherwise uncomplicated term pregnancies. Objective  To determine the risk of intrapartum stillbirth or neonatal death not related to congenital abnormality among women with uncomplicated term pregnancies who had a trial of labor after previous cesarean delivery, compared with women having a planned repeat cesarean delivery, and multiparous and nulliparous women at term not delivered by planned cesarean method. Design and Setting  Population-based, retrospective cohort study of data from the linked Scottish Morbidity Record and Stillbirth and Neonatal Death Enquiry encompassing births in Scotland between January 1, 1992, and December 31, 1997. Population  A total of 313 238 singleton births between 37 and 43 weeks' gestational age in which the fetus was in a cephalic presentation. Main Outcome Measure  Delivery-related perinatal death, defined as intrapartum stillbirth or neonatal death unrelated to congenital anomaly, compared among the 4 groups. Results  Among women who had a trial of labor following previous cesarean delivery (n = 15 515), the overall rate of delivery-related perinatal death was 12.9 (95% confidence interval [CI], 7.9-19.9) per 10 000 women. This was approximately 11 times greater (odds ratio [OR], 11.6; 95% CI, 1.6-86.7) than the risk associated with planned repeat cesarean delivery (n = 9014), more than twice (OR, 2.2; 95% CI, 1.3-3.5) the risk associated with other multiparous women in labor (n = 151 549), and similar to the risk among nulliparous women in labor (n = 137 160; OR, 1.3; 95% CI, 0.8-2.1). The associations were not explained by differences in maternal height, smoking status, socioeconomic status, age, fetal growth, or week of gestation at delivery. Among women having a trial of labor, the rate of death due to mechanical causes, including uterine rupture, was 4.5 (95% CI, 1.8-9.3) per 10 000 women. This was more than 8 times greater than other multiparous women (OR, 8.5; 95% CI, 3.2-22.3) and nulliparous women (OR, 8.8; 95% CI, 3.2-24.2). Conclusions  The absolute risk of perinatal death associated with trial of labor following previous cesarean delivery is low. However, in our study, the risk was significantly higher than that associated with planned repeat cesarean delivery, and there was a marked excess of deaths due to uterine rupture compared with other women in labor.      

Association between method of delivery and maternal rehospitalization

Context  Despite nearly 4 million deliveries in the United States each year, minimal information exists on unintended health consequences following childbirth, particularly in relation to delivery method. Objective  To assess the risk for maternal rehospitalization associated with cesarean or assisted vaginal delivery compared with spontaneous vaginal delivery. Design  Retrospective cohort study of data from the Washington State Birth Events Record Database for 1987 through November 1, 1996. Setting and Participants  All primiparous women without selected chronic medical conditions who delivered live singleton infants in nonfederal short-stay hospitals in Washington State (N=256,795). Main Outcome Measures  Relative risks (RRs) of rehospitalization within 60 days of cesarean or assisted vaginal vs spontaneous vaginal deliveries. Results  A total of 3149 women (1.2%) were rehospitalized within 60 days of delivery. In logistic regression analyses adjusting for maternal age, rehospitalization was found to be more likely among women with cesarean delivery (RR, 1.8; 95% confidence interval [CI], 1.6-1.9) or assisted vaginal delivery (RR, 1.3; 95% CI, 1.2-1.4) than among women with spontaneous vaginal delivery. Cesarean delivery was associated with significantly increased risks of rehospitalization for uterine infection, obstetrical surgical wound complications, and cardiopulmonary and thromboembolic conditions. Among women with assisted vaginal delivery, significant increased risks were seen for rehospitalization with postpartum hemorrhage, obstetrical surgical wound complications, and pelvic injury. Conclusions  Women with cesarean and assisted vaginal deliveries were at increased risk for rehospitalization, particularly with infectious morbidities. Effective strategies for preventing and controlling peripartum infection should be an obstetrical priority.      

Effectiveness of nurses as providers of birth labor support in North American hospitals: a randomized controlled trial

Context  North American cesarean delivery rates have risen dramatically since the 1960s, without concomitant improvements in perinatal or maternal health. A Cochrane Review concluded that continuous caregiver support during labor has many benefits, including reduced likelihood of cesarean delivery. Objective  To evaluate the effectiveness of nurses as providers of labor support in North American hospitals. Design  Randomized controlled trial with prognostic stratification by center and parity. Women were enrolled during a 2-year period (May 1999 to May 2001) and followed up until 6 to 8 postpartum weeks. Setting  Thirteen US and Canadian hospitals with annual cesarean delivery rates of at least 15%. Participants  A total of 6915 women who had a live singleton fetus or twins, were 34 weeks' gestation or more, and were in established labor at randomization. Intervention  Patients were randomly assigned to receive usual care (n = 3461) or continuous labor support by a specially trained nurse (n = 3454) during labor. Main Outcome Measures  The primary outcome measure was cesarean delivery rate. Other outcomes included intrapartum events and indicators of maternal and neonatal morbidity, both immediately after birth and in the first 6 to 8 postpartum weeks. Results  Data were received for all 6915 women and their infants (n = 6949). The rates of cesarean delivery were almost identical in the 2 groups (12.5% in the continuous labor support group and 12.6% in the usual care group; P = .44). There were no significant differences in other maternal or neonatal events during labor, delivery, or the hospital stay. There were no significant differences in women's perceived control during childbirth or in depression, measured at 6 to 8 postpartum weeks. All comparisons of women's likes and dislikes, and their future preference for amount of nursing support, favored the continuous labor support group. Conclusions  In hospitals characterized by high rates of routine intrapartum interventions, continuous labor support by nurses does not affect the likelihood of cesarean delivery or other medical or psychosocial outcomes of labor and birth.      

Birth spacing and risk of adverse perinatal outcomes: a meta-analysis

Context  Both short and long interpregnancy intervals have been associated with an increased risk of adverse perinatal outcomes. However, whether this possible association is confounded by maternal characteristics or socioeconomic status is uncertain. Objective  To examine the association between birth spacing and relative risk of adverse perinatal outcomes. Data Sources  Studies published in any language were retrieved by searching MEDLINE (1966 through January 2006), EMBASE, ECLA, POPLINE, CINAHL, and LILACS, proceedings of meetings on birth spacing, and bibliographies of retrieved articles, and by contact with relevant researchers in the field. Study Selection  Included studies were cohort, cross-sectional, and case-control studies with results adjusted for at least maternal age and socioeconomic status, reporting risk estimates and 95% confidence intervals (or data to calculate them) of birth spacing and perinatal outcomes. Of 130 articles identified in the search, 67 (52%) were included. Data Extraction  Information on study design, participant characteristics, measure of birth spacing used, measures of outcome, control for potential confounding factors, and risk estimates was abstracted independently by 2 investigators using a standardized protocol. Data Synthesis  A random-effects model and meta-regression analyses were used to pool data from individual studies. Compared with interpregnancy intervals of 18 to 23 months, interpregnancy intervals shorter than 6 months were associated with increased risks of preterm birth, low birth weight, and small for gestational age (pooled adjusted odds ratios [95% confidence intervals]: 1.40 [1.24-1.58], 1.61 [1.39-1.86], and 1.26 [1.18-1.33], respectively). Intervals of 6 to 17 months and longer than 59 months were also associated with a significantly greater risk for the 3 adverse perinatal outcomes. Conclusions  Interpregnancy intervals shorter than 18 months and longer than 59 months are significantly associated with increased risk of adverse perinatal outcomes. These data suggest that spacing pregnancies appropriately could help prevent such adverse perinatal outcomes.      

Comparison of on-demand vs planned relaparotomy strategy in patients with severe peritonitis: a randomized trial

Context  In patients with severe secondary peritonitis, there are 2 surgical treatment strategies following an initial emergency laparotomy: planned relaparotomy and relaparotomy only when the patient's condition demands it ("on-demand"). The on-demand strategy may reduce mortality, morbidity, health care utilization, and costs. However, randomized trials have not been performed. Objective  To compare patient outcome, health care utilization, and costs of on-demand and planned relaparotomy. Design, Setting, and Patients  Randomized, nonblinded clinical trial at 2 academic and 5 regional teaching hospitals in the Netherlands from November 2001 through February 2005. Patients had severe secondary peritonitis and an Acute Physiology and Chronic Health Evaluation (APACHE-II) score of 11 or greater. Intervention  Random allocation to on-demand or planned relaparotomy strategy. Main Outcome Measures  The primary end point was death and/or peritonitis-related morbidity within a 12-month follow-up period. Secondary end points included health care utilization and costs. Results  A total of 232 patients (116 on-demand and 116 planned) were randomized. One patient in the on-demand group was excluded due to an operative diagnosis of pancreatitis and 3 in each group withdrew or were lost to follow-up. There was no significant difference in primary end point (57% on-demand [n = 64] vs 65% planned [n = 73]; P = .25) or in mortality alone (29% on-demand [n = 32] vs 36% planned [n = 41]; P = .22) or morbidity alone (40% on-demand [n = 32] vs 44% planned [n = 32]; P = .58). A total of 42% of the on-demand patients had a relaparotomy vs 94% of the planned relaparotomy group. A total of 31% of first relaparotomies were negative in the on-demand group vs 66% in the planned group (P <.001). Patients in the on-demand group had shorter median intensive care unit stays (7 vs 11 days; P = .001) and shorter median hospital stays (27 vs 35 days; P = .008). Direct medical costs per patient were reduced by 23% using the on-demand strategy. Conclusion  Patients in the on-demand relaparotomy group did not have a significantly lower rate of death or major peritonitis-related morbidity compared with the planned relaparotomy group but did have a substantial reduction in relaparotomies, health care utilization, and medical costs. Trial Registration  http://isrctn.org Identifier: ISRCTN51729393      

Impact of bronchopulmonary dysplasia,brain injury,and severe retinopathy on the outcome of extremely low-birth-weight infants at 18 months: results from the trial of indomethacin prophylaxis in preterms

Context  Despite more than 2 decades of outcomes research after very preterm birth, clinicians remain uncertain about the extent to which neonatal morbidities predict poor long-term outcomes of extremely low-birth-weight (ELBW) infants. Objective  To determine the individual and combined prognostic effects of bronchopulmonary dysplasia (BPD), ultrasonographic signs of brain injury, and severe retinopathy of prematurity (ROP) on 18-month outcomes of ELBW infants. Design  Inception cohort assembled for the Trial of Indomethacin Prophylaxis in Preterms (TIPP). Setting and Participants  A total of 910 infants with birth weights of 500 to 999 g who were admitted to 1 of 32 neonatal intensive care units in Canada, the United States, Australia, New Zealand, and Hong Kong between 1996 and 1998 and who survived to a postmenstrual age of 36 weeks. Main Outcome Measures  Combined end point of death or survival to 18 months with 1 or more of cerebral palsy, cognitive delay, severe hearing loss, and bilateral blindness. Results  Each of the neonatal morbidities was similarly and independently correlated with a poor 18-month outcome. Odds ratios were 2.4 (95% confidence interval [CI], 1.8-3.2) for BPD, 3.7 (95% CI, 2.6-5.3) for brain injury, and 3.1 (95% CI, 1.9-5.0) for severe ROP. In children who were free of BPD, brain injury, and severe ROP the rate of poor long-term outcomes was 18% (95% CI, 14%-22%). Corresponding rates with any 1, any 2, and all 3 neonatal morbidities were 42% (95% CI, 37%-47%), 62% (95% CI, 53%-70%), and 88% (64%-99%), respectively. Conclusion  In ELBW infants who survive to a postmenstrual age of 36 weeks, a simple count of 3 common neonatal morbidities strongly predicts the risk of later death or neurosensory impairment.      

Perinatal HIV-1 Transmission: Interaction Between Zidovudine Prophylaxis and Mode of Delivery in the French Perinatal Cohort

Context.— It is unclear whether elective cesarean delivery may have a protective effect against the transmission of human immunodeficiency virus 1 (HIV-1). Objective.— To investigate whether mode of delivery has an impact on perinatal HIV-1 transmission in the presence of zidovudine prophylaxis. Design.— A prospective cohort study. Setting.— The 85 perinatal centers in the French Perinatal Cohort, from 1985 to 1996. Patients.— A total of 2834 singleton children born to mothers with HIV-1 infection. Main Outcome Measure.— Human immunodeficiency virus 1 infection of the infant. Results.— No zidovudine was used in 1917 pregnancies and zidovudine prophylaxis was used in 902 pregnancies. Cesarean deliveries were performed in 10.9% on an emergent basis and in 8.3% electively, prior to labor or membrane rupture. In 1917 mothers who did not receive zidovudine, of 1877 with information on mode of delivery, 17.2% transmitted HIV-1 to their child. Risk factors statistically significantly associated with transmission were maternal p24 antigenemia, cervicovaginal infections during pregnancy, amniotic fluid color, and rupture of membranes 4 hours or more before delivery. Mode of delivery was not related to transmission. In 902 mothers receiving zidovudine, transmission was 6.4% in 872 with information on mode of delivery, and elective cesarean delivery (n=133) was associated with a lower transmission rate than emergent cesarean or vaginal delivery (0.8%, 11.4%, and 6.6%, respectively; P=.002). In a multivariate analysis of all mother-child pairs, including obstetrical risk factors, maternal p24 antigenemia, and zidovudine prophylaxis, interaction between mode of delivery and zidovudine prophylaxis was significant (P=.007). In the multivariate analysis of pregnancies with zidovudine prophylaxis, factors related to transmission rate were maternal p24 antigenemia, amniotic fluid color, and mode of delivery. Adjusted odds ratios (95% confidence intervals) were 1.6 (0.7-3.6) for emergent cesarean delivery and 0.2 (0.0-0.9) for elective cesarean delivery (P=.04) in comparison with vaginal delivery. Conclusions.— We observed an interaction between zidovudine prophylaxis and elective cesarean delivery in decreasing transmission of HIV-1 from mother to child. This observation may have clinical implications for prevention.      

Outcomes of routine episiotomy: a systematic review

Context  Episiotomy at the time of vaginal birth is common. Practice patterns vary widely, as do professional opinions about maternal risks and benefits associated with routine use. Objective  To systematically review the best evidence available about maternal outcomes of routine vs restrictive use of episiotomy. Evidence Acquisition  We searched MEDLINE, Cumulative Index to Nursing and Allied Health Literature, and Cochrane Collaboration resources and performed a hand search for English-language articles from 1950 to 2004. We included randomized controlled trials of routine episiotomy or type of episiotomy that assessed outcomes in the first 3 postpartum months, along with trials and prospective studies that assessed longer-term outcomes. Twenty-six of 986 screened articles provided relevant data. We entered data into abstraction forms and conducted a second review for accuracy. Each article was also scored for research quality. Evidence Synthesis  Fair to good evidence from clinical trials suggests that immediate maternal outcomes of routine episiotomy, including severity of perineal laceration, pain, and pain medication use, are not better than those with restrictive use. Evidence is insufficient to provide guidance on choice of midline vs mediolateral episiotomy. Evidence regarding long-term sequelae is fair to poor. Incontinence and pelvic floor outcomes have not been followed up into the age range in which women are most likely to have sequelae. With this caveat, relevant studies are consistent in demonstrating no benefit from episiotomy for prevention of fecal and urinary incontinence or pelvic floor relaxation. Likewise, no evidence suggests that episiotomy reduces impaired sexual function—pain with intercourse was more common among women with episiotomy. Conclusions  Evidence does not support maternal benefits traditionally ascribed to routine episiotomy. In fact, outcomes with episiotomy can be considered worse since some proportion of women who would have had lesser injury instead had a surgical incision.      

Pregnancy in the sixth decade of life: obstetric outcomes in women of advanced reproductive age

Context  As a result of oocyte donation, women in their sixth decade of life are now able to conceive and carry pregnancies to term. However, little is known about pregnancy outcomes in this population. Objective  To describe pregnancy outcomes in women aged 50 years or older who conceived after in vitro fertilization with donor oocytes. Design and Setting  Retrospective analysis of cycles conducted at a US university assisted reproduction program during calendar years 1991-2001. Patients  Seventy-seven postmenopausal women with no chronic medical conditions (mean [SD] age, 52.8 [2.9] years; range, 50-63 years) who underwent 121 embryo transfer procedures (89 fresh and 32 frozen). Pregnancy outcomes were ascertained by chart review and telephone follow-up. Main Outcome Measures  Maternal and neonatal outcomes. Results  There were 55 clinical pregnancies for a total pregnancy rate of 45.5%. The live birth rate was 37.2%. Of the 45 live births, 31 were singletons, 12 were twins, and 2 were triplets, for which the mean (SD) gestational ages at delivery were 38.4 (2.1) weeks, 35.8 (2.8) weeks, and 32.2 weeks, respectively. Mean (SD) birth weights were 3039 g (703 g), 2254 g (581 g), and 1913 g, respectively. Apgar scores at 1 and 5 minutes were 8.2 (0.9) and 9.1 (0.5), respectively. Of singletons, 68% were delivered by cesarean, and all multiples were delivered by cesarean. Mild preeclampsia was noted in 25% of patients and severe preeclampsia in 10%. Gestational diabetes required diet modification in 17.5%, and 2.5% required insulin. Conclusions  Appropriately screened women aged 50 years or older can successfully conceive via oocyte donation and experience similar pregnancy rates, multiple gestation rates, and spontaneous abortion rates as younger recipients. During pregnancy, they appear at increased risk of preeclampsia and gestational diabetes. A majority can expect to deliver via cesarean. However, there does not appear to be any definitive medical reason for excluding these women from attempting pregnancy on the basis of age alone.      

Evidence of brain overgrowth in the first year of life in autism

Context  Autism most commonly appears by 2 to 3 years of life, at which time the brain is already abnormally large. This raises the possibility that brain overgrowth begins much earlier, perhaps before the first clinically noticeable behavioral symptoms. Objectives  To determine whether pathological brain overgrowth precedes the first clinical signs of autism spectrum disorder (ASD) and whether the rate of overgrowth during the first year is related to neuroanatomical and clinical outcome in early childhood. Design, Setting, and Participants  Head circumference (HC), body length, and body weight measurements during the first year were obtained from the medical records of 48 children with ASD aged 2 to 5 years who had participated in magnetic resonance imaging studies. Of these children, 15 (longitudinal group) had measurements at 4 periods during infancy: birth, 1 to 2 months, 3 to 5 months, and 6 to 14 months; and 33 (partial HC data group) had measurements at birth and 6 to 14 months (n = 7), and at birth only (n = 28). Main Outcome Measures  Age-related changes in infants with ASD who had multiple-age measurements, and the relationship of these changes to brain anatomy and clinical and diagnostic outcome at 2 to 5 years were evaluated by using 2 nationally recognized normative databases: cross-sectional normative data from a national survey and longitudinal data of individual growth. Results  Compared with normative data of healthy infants, birth HC in infants with ASD was significantly smaller (z = –0.66, P<.001); after birth, HC increased 1.67 SDs and mean HC was at the 84th percentile by 6 to 14 months. Birth HC was related to cerebellar gray matter volume at 2 to 5 years, although the excessive increase in HC between birth and 6 to 14 months was related to greater cerebral cortex volume at 2 to 5 years. Within the ASD group, every child with autistic disorder had a greater increase in HC between birth and 6 to 14 months (mean [SD], 2.19 [0.98]) than infants with pervasive developmental disorder-not otherwise specified (0.58 [0.35]). Only 6% of the individual healthy infants in the longitudinal data showed accelerated HC growth trajectories (>2.0 SDs) from birth to 6 to 14 months; 59% of infants with autistic disorder showed these accelerated growth trajectories. Conclusions  The clinical onset of autism appears to be preceded by 2 phases of brain growth abnormality: a reduced head size at birth and a sudden and excessive increase in head size between 1 to 2 months and 6 to 14 months. Abnormally accelerated rate of growth may serve as an early warning signal of risk for autism.      

Reducing suicidal ideation and depressive symptoms in depressed older primary care patients: a randomized controlled trial

Context  Suicide rates are highest in late life; the majority of older adults who die by suicide have seen a primary care physician in preceding months. Depression is the strongest risk factor for late-life suicide and for suicide's precursor, suicidal ideation. Objective  To determine the effect of a primary care intervention on suicidal ideation and depression in older patients. Design and Setting  Randomized controlled trial known as PROSPECT (Prevention of Suicide in Primary Care Elderly: Collaborative Trial) with patient recruitment from 20 primary care practices in New York City, Philadelphia, and Pittsburgh regions, May 1999 through August 2001. Participants  Two-stage, age-stratified (60-74, =" BORDER="0">75 years) depression screening of randomly sampled patients; enrollment included patients who screened positive and a random sample of screened negative patients. This analysis included patients with a depression diagnosis (N = 598). Intervention  Treatment guidelines tailored for the elderly with care management compared with usual care. Main Outcome Measures  Assessment of suicidal ideation and depression severity at baseline, 4 months, 8 months, and 12 months. Results  Rates of suicidal ideation declined faster (P = .01) in intervention patients compared with usual care patients; at 4 months, in the intervention group, raw rates of suicidal ideation declined 12.9% points (29.4% to 16.5%) compared with 3.0% points (20.1% to 17.1% in usual care [P = .01]). Among patients reporting suicidal ideation, resolution of ideation was faster among intervention patients (P = .03); differences peaked at 8 months (70.7% vs 43.9% resolution; P = .005). Intervention patients had a more favorable course of depression in both degree and speed of symptom reduction; group difference peaked at 4 months. The effects on depression were not significant among patients with minor depression unless suicidal ideation was present. Conclusions  Evidence of the intervention's effectiveness in community-based primary care with a heterogeneous sample of depressed patients introduces new challenges related to its sustainability and dissemination. The intervention's effectiveness in reducing suicidal ideation, regardless of depression severity, reinforces its role as a prevention strategy to reduce risk factors for suicide in late life.      

Effect of magnesium sulfate given for neuroprotection before preterm birth: a randomized controlled trial

Context  Prenatal magnesium sulfate may reduce the risk of cerebral palsy or death in very preterm infants. Objective  To determine the effectiveness of magnesium sulfate given for neuroprotection to women at risk of preterm birth before 30 weeks' gestation in preventing pediatric mortality and cerebral palsy. Design, Setting, and Patients  Randomized controlled trial at 16 tertiary hospitals in Australia and New Zealand with stratification by center and multiple pregnancy. A total of 1062 women with fetuses younger than 30 weeks' gestation for whom birth was planned or expected within 24 hours were enrolled from February 1996 to September 2000 with follow-up of surviving children at a corrected age of 2 years. Interventions  Women were randomly assigned to receive a loading infusion of 8 mL (4 g [16 mmol] of 0.5 g/mL of magnesium sulfate solution or isotonic sodium chloride solution [0.9%]) for 20 minutes followed by a maintenance infusion of 2 mL/h for up to 24 hours. Main Outcome Measures  Rates of total pediatric mortality, cerebral palsy, and the combined outcome of death or cerebral palsy at a corrected age of 2 years. Results  Data were analyzed for 1047 (99%) 2-year survivors. Total pediatric mortality (13.8% vs 17.1%; relative risk [RR], 0.83; 95% confidence interval [CI], 0.64-1.09), cerebral palsy in survivors (6.8% vs 8.2%; RR, 0.83; 95% CI, 0.54-1.27), and combined death or cerebral palsy (19.8% vs 24.0%; RR, 0.83; 95% CI, 0.66-1.03) were less frequent for infants exposed to magnesium sulfate, but none of the differences were statistically significant. Substantial gross motor dysfunction (3.4% vs 6.6%; RR, 0.51; 95% CI, 0.29-0.91) and combined death or substantial gross motor dysfunction (17.0% vs 22.7%; RR, 0.75; 95% CI, 0.59-0.96) were significantly reduced in the magnesium group. Conclusions  Magnesium sulfate given to women immediately before very preterm birth may improve important pediatric outcomes. No serious harmful effects were seen.      

Behavioral training with and without biofeedback in the treatment of urge incontinence in older women: a randomized controlled trial

Context  Previous research on urge urinary incontinence has demonstrated that multicomponent behavioral training with biofeedback is safe and effective, yet it has not been established whether biofeedback is an essential component that heightens therapeutic efficacy. Objective  To examine the role of biofeedback in a multicomponent behavioral training program for urge incontinence in community-dwelling older women. Design  Prospective, randomized controlled trial conducted from April 1, 1995, to March 30, 2001. Setting  University-based outpatient continence clinic in the United States. Patients  A volunteer sample of 222 ambulatory, nondemented, community-dwelling women aged 55 to 92 years with urge incontinence or mixed incontinence with urge as the predominant pattern. Patients were stratified by race, type of incontinence (urge only vs mixed), and severity (frequency of accidents). Interventions  Patients were randomly assigned to receive 8 weeks (4 visits) of biofeedback-assisted behavioral training (n = 73), 8 weeks (4 visits) of behavioral training without biofeedback (verbal feedback based on vaginal palpation; n = 74), or 8 weeks of self-administered behavioral treatment using a self-help booklet (control condition; n = 75). Main Outcome Measures  Reduction in the number of incontinence episodes as documented in bladder diaries, patients' perceptions and satisfaction, and changes in quality of life. Results  Intention-to-treat analysis showed that behavioral training with biofeedback yielded a mean 63.1% reduction (SD, 42.7%) in incontinence, verbal feedback a mean 69.4% reduction (SD, 32.7%), and the self-help booklet a mean 58.6% reduction (SD, 38.8%). The 3 groups were not significantly different from each other (P = .23). The groups differed significantly regarding patient satisfaction: 75.0% of the biofeedback group, 85.5% of the verbal feedback group, and 55.7% of the self-help booklet group reported being completely satisfied with treatment (P = .001). Significant improvements were seen across all 3 groups on 3 quality-of-life instruments, with no significant between-group differences. Conclusions  Biofeedback to teach pelvic floor muscle control, verbal feedback based on vaginal palpation, and a self-help booklet in a first-line behavioral training program all achieved comparable improvements in urge incontinence in community-dwelling older women. Patients' perceptions of treatment were significantly better for the 2 behavioral training interventions.      

Rupture rate of large abdominal aortic aneurysms in patients refusing or unfit for elective repair

Context  Among patients with abdominal aortic aneurysm (AAA) who have high operative risk, repair is usually deferred until the AAA reaches a diameter at which rupture risk is thought to outweigh operative risk, but few data exist on rupture risk of large AAA. Objective  To determine the incidence of rupture in patients with large AAA. Design and Setting  Prospective cohort study in 47 Veterans Affairs medical centers. Patients  Veterans (n = 198) with AAA of at least 5.5 cm for whom elective AAA repair was not planned because of medical contraindication or patient refusal. Patients were enrolled between April 1995 and April 2000 and followed up through July 2000 (mean, 1.52 years). Main Outcome Measure  Incidence of AAA rupture by strata of initial and attained diameter. Results  Outcome ascertainment was complete for all patients. There were 112 deaths (57%) and the autopsy rate was 46%. Forty-five patients had probable AAA rupture. The 1-year incidence of probable rupture by initial AAA diameter was 9.4% for AAA of 5.5 to 5.9 cm, 10.2% for AAA of 6.0 to 6.9 cm (19.1% for the subgroup of 6.5-6.9 cm), and 32.5% for AAA of 7.0 cm or more. Much of the increased risk of rupture associated with initial AAA diameters of 6.5-7.9 cm was related to the likelihood that the AAA diameter would reach 8.0 cm during follow-up, after which 25.7% ruptured within 6 months. Conclusion  The rupture rate is substantial in high-operative-risk patients with AAA of at least 5.5 cm in diameter and increases with larger diameter.      

Placental Abruption and Adverse Perinatal Outcomes

Context  Pregnancies complicated by abruption result in increased frequency of perinatal death and decreased fetal size and gestational duration, yet the extent of placental separation and its effect on these adverse outcomes is unknown. Objective  To assess the contribution of placental abruption and extent of placental separation to stillbirth, preterm delivery, and fetal growth restriction. Design  Hospital-based, retrospective cohort study. Setting  Mount Sinai Hospital, New York City, NY. Participants  A total of 53,371 pregnancies occurring in 40,789 women who were delivered of singleton births between 1986 and 1996. Main Outcome Measures  Risks and relative risks for stillbirth (>20 weeks), preterm delivery (<37 weeks), and fetal growth restriction (birth weight below 10th percentile for gestational age) in relation to abruption. Results  The incidence of abruption was 1% (n = 530). Abruption was associated with an 8.9-fold (95% confidence interval [CI], 6.0-13.0) adjusted relative risk (aRR) of stillbirth. Preterm birth proportions among women with and without abruption were 39.6% and 9.1%, respectively, yielding an aRR of 3.9 (95% CI, 3.5-4.4). In the abruption group, 14.3% of neonates were growth restricted, compared with 8.1% among all other births (aRR, 2.0; 95% CI, 1.5-2.4). Extent of placental separation had a profound effect on stillbirth (aRR for 75% separation, 31.5; 95% CI, 17.0-58.4), although evident only among those with at least 50% separation. However, the risk of preterm delivery was substantially increased even for mild abruptions (aRR for 25% separation, 5.5; 95% CI, 4.2-7.3). Conclusions  In this cohort, placental abruption had a profound impact on stillbirth, preterm delivery, and fetal growth restriction. The risk of stillbirth was dramatically increased for severe placental separation, but preterm delivery was common even among women with lesser degrees of placental separation.      

Supplemental perioperative oxygen and the risk of surgical wound infection: a randomized controlled trial

Context  Supplemental perioperative oxygen has been variously reported to halve or double the risk of surgical wound infection. Objective  To test the hypothesis that supplemental oxygen reduces infection risk in patients following colorectal surgery. Design, Setting, and Patients  A double-blind, randomized controlled trial of 300 patients aged 18 to 80 years who underwent elective colorectal surgery in 14 Spanish hospitals from March 1, 2003, to October 31, 2004. Wound infections were diagnosed by blinded investigators using Centers for Disease Control and Prevention criteria. Baseline patient characteristics, anesthetic treatment, and potential confounding factors were recorded. Interventions  Patients were randomly assigned to either 30% or 80% fraction of inspired oxygen (FIO₂) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized. Main Outcome Measures  Any surgical site infection (SSI); secondary outcomes included return of bowel function and ability to tolerate solid food, ambulation, suture removal, and duration of hospitalization. Results  A total of 143 patients received 30% perioperative oxygen and 148 received 80% perioperative oxygen. Surgical site infection occurred in 35 patients (24.4%) administered 30% FIO₂ and in 22 patients (14.9%) administered 80% FIO₂ (P=.04). The risk of SSI was 39% lower in the 80% FIO₂ group (relative risk [RR], 0.61; 95% confidence interval [CI], 0.38-0.98) vs the 30% FIO₂ group. After adjustment for important covariates, the RR of infection in patients administered supplemental oxygen was 0.46 (95% CI, 0.22-0.95; P = .04). None of the secondary outcomes varied significantly between the 2 treatment groups. Conclusions  Patients receiving supplemental inspired oxygen had a significant reduction in the risk of wound infection. Supplemental oxygen appears to be an effective intervention to reduce SSI in patients undergoing colon or rectal surgery. Trial Registration  ClinicalTrials.gov Identifier: NCT00235456      

Effects of tamoxifen vs raloxifene on the risk of developing invasive breast cancer and other disease outcomes: the NSABP Study of Tamoxifen and Raloxifene (STAR) P-2 trial

Context  Tamoxifen is approved for the reduction of breast cancer risk, and raloxifene has demonstrated a reduced risk of breast cancer in trials of older women with osteoporosis. Objective  To compare the relative effects and safety of raloxifene and tamoxifen on the risk of developing invasive breast cancer and other disease outcomes. Design, Setting, and Patients  The National Surgical Adjuvant Breast and Bowel Project Study of Tamoxifen and Raloxifene trial, a prospective, double-blind, randomized clinical trial conducted beginning July 1, 1999, in nearly 200 clinical centers throughout North America, with final analysis initiated after at least 327 incident invasive breast cancers were diagnosed. Patients were 19 747 postmenopausal women of mean age 58.5 years with increased 5-year breast cancer risk (mean risk, 4.03% [SD, 2.17%]). Data reported are based on a cutoff date of December 31, 2005. Intervention  Oral tamoxifen (20 mg/d) or raloxifene (60 mg/d) over 5 years. Main Outcome Measures  Incidence of invasive breast cancer, uterine cancer, noninvasive breast cancer, bone fractures, thromboembolic events. Results  There were 163 cases of invasive breast cancer in women assigned to tamoxifen and 168 in those assigned to raloxifene (incidence, 4.30 per 1000 vs 4.41 per 1000; risk ratio [RR], 1.02; 95% confidence interval [CI], 0.82-1.28). There were fewer cases of noninvasive breast cancer in the tamoxifen group (57 cases) than in the raloxifene group (80 cases) (incidence, 1.51 vs 2.11 per 1000; RR, 1.40; 95% CI, 0.98-2.00). There were 36 cases of uterine cancer with tamoxifen and 23 with raloxifene (RR, 0.62; 95% CI, 0.35-1.08). No differences were found for other invasive cancer sites, for ischemic heart disease events, or for stroke. Thromboembolic events occurred less often in the raloxifene group (RR, 0.70; 95% CI, 0.54-0.91). The number of osteoporotic fractures in the groups was similar. There were fewer cataracts (RR, 0.79; 95% CI, 0.68-0.92) and cataract surgeries (RR, 0.82; 95% CI, 0.68-0.99) in the women taking raloxifene. There was no difference in the total number of deaths (101 vs 96 for tamoxifen vs raloxifene) or in causes of death. Conclusions  Raloxifene is as effective as tamoxifen in reducing the risk of invasive breast cancer and has a lower risk of thromboembolic events and cataracts but a nonstatistically significant higher risk of noninvasive breast cancer. The risk of other cancers, fractures, ischemic heart disease, and stroke is similar for both drugs. Trial Registration  clinicaltrials.gov Identifier: NCT00003906      

Treatment for cervical intraepithelial neoplasia and risk of preterm delivery

Context  It is unclear whether treatments for cervical intraepithelial neoplasia (CIN) increase the subsequent risk of preterm delivery. Most studies have lacked sufficient sample size, mixed heterogeneous subtypes of preterm delivery, and failed to control for confounding factors. Objective  To determine whether cervical laser and loop electrosurgical excision procedure (LEEP) treatments increase risk of preterm delivery and its subtypes. Design, Setting, and Participants  Retrospective cohort study conducted among women evaluated at a colposcopy clinic serving Auckland, New Zealand (1988-2000), comparing delivery outcomes of untreated women (n = 426) and those treated (n = 652) with laser conization, laser ablation, or LEEP. Record linkage using unique health identifiers identified women who had subsequent deliveries. Main Outcome Measures  Total preterm delivery and its subtypes, spontaneous labor and premature rupture of membranes before 37 weeks' gestation (pPROM). Results  The overall rate of preterm delivery was 13.8%. The rate of pPROM was 6.2% and the rate of spontaneous preterm delivery was 3.8%. Analyses showed no significant increase in risk of total preterm delivery (adjusted relative risk [aRR], 1.1; 95% confidence interval [CI], 0.8-1.5) or spontaneous preterm delivery (aRR, 1.3; 95% CI, 0.7-2.6) for any treatment. Risk of pPROM was significantly increased following treatment with laser conization (aRR, 2.7; 95% CI, 1.3-5.6) or LEEP (aRR, 1.9; 95% CI, 1.0-3.8), but not laser ablation (aRR, 1.1; 95% CI, 0.5-2.4). Moreover, risk of pPROM and total preterm delivery increased significantly with increasing height of tissue removed from the cervix in conization. Women in the highest tertile of cone height (=" BORDER="0">1.7 cm) had a greater than 3-fold increase in risk of pPROM compared with untreated women (aRR, 3.6; 95% CI, 1.8-7.5). Conclusions  LEEP and laser cone treatments were associated with significantly increased risk of pPROM. Careful consideration should be given to treatment of CIN in women of reproductive age, especially when treatment might reasonably be delayed or targeted to high-risk cases.      

Impact of thimerosal-related changes in hepatitis B vaccine birth-dose recommendations on childhood vaccination coverage

Context  In July 1999, the longstanding preference to begin hepatitis B vaccination of all US infants at birth was temporarily suspended because of concerns about exposure to mercury contained in the vaccine preservative thimerosal. The suspension was lifted in September 1999 when preservative-free hepatitis B vaccine became available. Objective  To determine the effects of changes in recommendations regarding administration of a hepatitis B birth dose on vaccination coverage. Design, Setting, and Participants  Cohort analysis of vaccination status of 41 589 US children born before, during, and after the recommendation to suspend the birth dose. Main Outcome Measures  Association between birth cohort and age at receipt of hepatitis B vaccine dose 1, and receipt by 19 months of age of all recommended vaccines. Results  The proportion of US infants who received dose 1 of hepatitis B vaccine at birth declined from 47% among those born 7 to 12 months before the suspension to 11% among those born during the suspension. Birth-dose coverage remained significantly lower in the year after the suspension was lifted (23% in the first 6 months and 33% in months 7-12). Coverage with 3 doses of hepatitis B vaccine by 19 months of age declined from 88% among those born 7 to 12 months before the suspension to 81% among those born during the suspension and 85% among those born in the 6 months after the suspension, but returned to baseline levels for those born 7 to 12 months after the suspension was lifted. These reductions represent 750 000 fewer newborns vaccinated during 2000 compared with 1998, and an excess 182 000 children undervaccinated for hepatitis B at 19 months of age compared with 1998 coverage levels. Coverage with other recommended vaccinations did not decline over this time. Conclusions  Reductions in hepatitis B vaccine birth-dose coverage persisted after recommendations were made to resume previous newborn vaccination practices. Although the recommendation to complete the series by 19 months of age was never changed, infants born between July and December 1999 were less likely to have completed the series by 19 months, compared with infants born during the previous year. The lack of impact on other vaccinations suggests that public confidence in immunization remained strong.      

Long-term efficacy of bivalirudin and provisional glycoprotein IIb/IIIa blockade vs heparin and planned glycoprotein IIb/IIIa blockade during percutaneous coronary revascularization: REPLACE-2 randomized trial

Context  In the Randomized Evaluation in PCI Linking Angiomax to Reduced Clinical Events (REPLACE)-2 trial, bivalirudin with provisional glycoprotein IIb/IIIa (Gp IIb/IIIa) inhibition was found to be noninferior to heparin plus planned Gp IIb/IIIa blockade in the prevention of acute ischemic end points and was associated with significantly less bleeding by 30 days after percutaneous coronary intervention (PCI). Objective  To determine whether the efficacy of bivalirudin remains comparable with that of heparin plus Gp IIb/IIIa blockade over 6 months and 1 year. Design, Setting, and Participants  Follow-up study to 1 year of a randomized, double-blind trial conducted among 6010 patients undergoing urgent or elective PCI at 233 community or referral hospitals in 9 countries from October 2001 through August 2002. Interventions  Patients were randomly assigned to receive intravenously bivalirudin (0.75 mg/kg bolus, 1.75 mg/kg per hour for the duration of PCI), with provisional Gp IIb/IIIa inhibition, or to receive heparin (65 U/kg bolus), with planned Gp IIb/IIIa inhibition (abciximab or eptifibatide). Both groups received daily aspirin and a thienopyridine for at least 30 days after PCI. Main Outcome Measures  Incidence of death, myocardial infarction, or repeat revascularization by 6 months and death by 12 months after enrollment. Results  At 6 months, death occurred in 1.4% of patients in the heparin plus Gp IIb/IIIa group and in 1.0% of patients in the bivalirudin group (hazard ratio [HR], 0.70; 95% confidence interval [CI], 0.43-1.14; P = .15). Myocardial infarction occurred in 7.4% and 8.2% of patients, respectively (HR, 1.12; 95% CI, 0.93-1.34; P = .24), and repeat revascularization was required in 11.4% and 12.1% of patients, respectively (HR, 1.06; 95% CI, 0.91-1.23; P = .45). By 1 year, death occurred in 2.46% of patients treated with heparin plus Gp IIb/IIIa blockade and in 1.89% of patients treated with bivalirudin (HR, 0.78; 95% CI, 0.55-1.11; P = .16). Nonsignificant trends toward lower 1-year mortality with bivalirudin were present in all patient subgroups analyzed and were of greatest magnitude among high-risk patients. Conclusion  Long-term clinical outcome with bivalirudin and provisional Gp IIb/IIIa blockade is comparable with that of heparin plus planned Gp IIb/IIIa inhibition during contemporary PCI.