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Fetoscopic compared to open repair of myelomeningocele: a two-delivery cost-effectiveness analysis

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Background: Recent studies have compared maternal and neonatal outcomes associated with fetoscopic surgical approach for repair of myelomeningocele as compared to an open approach. Objective: In this study, we compared the cost-effectiveness of these techniques in the setting of a woman seeking future pregnancies. Study design: A decision-analytic model using TreeAge software was designed to compare the costs, and outcomes of fetoscopic versus open repair in patients with prenatally diagnosed myelomeningocele. We assumed a theoretical cohort of 500 women with a pregnancy affected by myelomeningocele planning to have a future pregnancy. Our model accounted for costs and quality adjusted life years of the woman, the neonate with myelomeningocele, and the neonate in a subsequent pregnancy. Neonatal outcomes from the incident pregnancy included motor function more than two levels better than anatomic level, motor function less than two levels better than anatomic level and same motor function as anatomic level, preterm birth in the index pregnancy, neonatal death in the index pregnancy, major neurodevelopmental disability as a result of preterm birth in the index pregnancy. Neonatal outcomes in the subsequent pregnancy included stillbirth, preterm birth, neonatal and major neurodevelopmental disability as a result of preterm birth. Probabilities were derived from the literature, and we used a willingness-to-pay threshold of $100,000 per QALY. Results: In the index pregnancy, fetoscopic surgical technique resulted in 140 fewer cases of preterm birth, and fewer cases of neurodevelopmental disability and neonatal death. Fetoscopic technique resulted in 130 more cases of functional level >2 levels better than anatomic level, 35 fewer cases of functional level >2 levels worse than anatomic level, and 107 fewer cases of function same as anatomic level. In the subsequent pregnancy, fetoscopic surgery led to 22 fewer cases of delivery complications (uterine dehiscence, uterine rupture and excessive bleeding), 24 fewer cases of stillbirth, and 22 fewer cases of preterm birth. While the fetoscopic approach was more costly, it was cost effective with an ICER of $1,029/QALY in our theoretical cohort of 500 patients. Monte Carlo probabilistic sensitivity analysis showed that fetoscopic technique is cost effective 100% of the time. Conclusion: In our theoretical cohort, the fetoscopic approach was more costly, but resulted in improved outcomes when a subsequent pregnancy was considered.

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The management of myelomeningocele study trial showed significant prognostic improvement in fetal repair before 26 weeks of gestation. Hence, surgery in utero represents the best treatment option for open-neural tube defects (NTDs). Fetal surgery of open-NTDs has specific inclusion and exclusion criteria, which can be adequately studied with fetal MRI. The main concern: the spine (spinal defects other than Myelomeningocele and Myeloschisis, the level of the lesion higher than T1 or lower than S1 and the degree of kyphosis ≥ 30°), the skull/brain (no cerebellum herniation and Chiari II malformation and the presence of any intracranial abnormality unrelated to open NTDs), the uterus (cervix length less than 2 cm, multiple gestations and placental and uterine abnormalities) and any other fetal abnormality not attributed to spinal defect. In this review, we describe the fundamental role of fetal MRI in supporting therapeutic decisions in pre-surgery intrauterine planning through the accurate and comprehensive description of findings, providing a proposal of a structured report. In addition, we describe how post-surgical MRI is important in investigating the effectiveness of surgery and detecting repairing complications.
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Objective: The Management of Myelomeningocele Study demonstrated that fetal surgery, as compared to postnatal repair, decreases the rate of hydrocephalus and improves expected motor function. However, fetal surgery is associated with significant maternal and neonatal risks including uterine wall dehiscence, prematurity, and fetal or neonatal death. The goal of this study was to provide information about counseling expectant mothers regarding myelomeningocele in the era of fetal surgery. Methods: The authors conducted an extensive review of topics pertinent to counseling in the setting of myelomeningocele and introduce a new model for shared decision-making to aid practitioners during counseling. Results: Expectant mothers must decide in a timely manner among several potential options, namely termination of pregnancy, postnatal surgery, or fetal surgery. Multiple factors influence the decision, including maternal health, fetal heath, financial resources, social support, risk aversion, access to care, family planning, and values. In many cases, it is a difficult decision that benefits from the guidance of a pediatric neurosurgeon. Conclusions: The authors review critical issues of prenatal counseling for myelomeningocele and discuss the process of shared decision-making as a framework to aid expectant mothers in choosing the treatment option best for them.
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Objectives-This report presents complete period life tables for the United States by race, Hispanic origin, and sex, based on age-specific death rates in 2008. Methods-Data used to prepare the 2008 life tables are 2008 final mortality statistics; July 1, 2008, population estimates based on the 2000 decennial census; and 2008 Medicare data for persons aged 66-99. The methodology used to estimate the 2008 life tables has been revised from that used for data years 2000-2007. The methodology was refined in two important ways. First, a logistic model rather than a nonlinear least squares model was used to smooth and extrapolate the vital statistics and Medicare blended death rates at the oldest ages. Second, the age at which smoothing is begun was raised from 66 to 85 or so, depending on the population. This modification applies to the life tables for the total population and for the white, black, non-Hispanic white, and non-Hispanic black populations. The methodology used to estimate the life tables for the Hispanic population remains unchanged from that developed for the publication of life tables by Hispanic origin for data year 2006. Results-In 2008, the overall expectation of life at birth was 78.1 years. Between 2007 and 2008, life expectancy at birth increased for all groups considered, although approximately 0.1 years of the increase is due to the change in methodology. Life expectancy increased for both males (from 75.4 to 75.6) and females (80.4 to 80.6) and for the white population (78.4 to 78.5), the black population (73.6 to 74.0), the Hispanic population (80.9 to 81.0), the non-Hispanic white population (78.2 to 78.4), and the non-Hispanic black population (73.2 to 73.7).
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The objective of this study was to estimate national hospital costs for infant admissions that are associated with preterm birth/low birth weight. Infant (<1 year) hospital discharge data, including delivery, transfers, and readmissions, were analyzed by using the 2001 Nationwide Inpatient Sample from the Healthcare Cost and Utilization Project. The Nationwide Inpatient Sample is a 20% sample of US hospitals weighted to approximately >35 million hospital discharges nationwide. Hospital costs, based on weighted cost-to-charge ratios, and lengths of stay were calculated for preterm/low birth weight infants, uncomplicated newborns, and all other infant hospitalizations and assessed by degree of prematurity, major complications, and expected payer. In 2001, 8% (384,200) of all 4.6 million infant stays nationwide included a diagnosis of preterm birth/low birth weight. Costs for these preterm/low birth weight admissions totaled $5.8 billion, representing 47% of the costs for all infant hospitalizations and 27% for all pediatric stays. Preterm/low birth weight infant stays averaged $15,100, with a mean length of stay of 12.9 days versus $600 and 1.9 days for uncomplicated newborns. Costs were highest for extremely preterm infants (<28 weeks' gestation/birth weight <1000 g), averaging $65,600, and for specific respiratory-related complications. However, two thirds of total hospitalization costs for preterm birth/low birth weight were for the substantial number of infants who were not extremely preterm. Of all preterm/low birth weight infant stays, 50% identified private/commercial insurance as the expected payer, and 42% designated Medicaid. Costs per infant hospitalization were highest for extremely preterm infants, although the larger number of moderately preterm/low birth weight infants contributed more to the overall costs. Preterm/low birth weight infants in the United States account for half of infant hospitalization costs and one quarter of pediatric costs, suggesting that major infant and pediatric cost savings could be realized by preventing preterm birth.
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Prenatal repair of myelomeningocele, the most common form of spina bifida, may result in better neurologic function than repair deferred until after delivery. We compared outcomes of in utero repair with standard postnatal repair. We randomly assigned eligible women to undergo either prenatal surgery before 26 weeks of gestation or standard postnatal repair. One primary outcome was a composite of fetal or neonatal death or the need for placement of a cerebrospinal fluid shunt by the age of 12 months. Another primary outcome at 30 months was a composite of mental development and motor function. The trial was stopped for efficacy of prenatal surgery after the recruitment of 183 of a planned 200 patients. This report is based on results in 158 patients whose children were evaluated at 12 months. The first primary outcome occurred in 68% of the infants in the prenatal-surgery group and in 98% of those in the postnatal-surgery group (relative risk, 0.70; 97.7% confidence interval [CI], 0.58 to 0.84; P<0.001). Actual rates of shunt placement were 40% in the prenatal-surgery group and 82% in the postnatal-surgery group (relative risk, 0.48; 97.7% CI, 0.36 to 0.64; P<0.001). Prenatal surgery also resulted in improvement in the composite score for mental development and motor function at 30 months (P=0.007) and in improvement in several secondary outcomes, including hindbrain herniation by 12 months and ambulation by 30 months. However, prenatal surgery was associated with an increased risk of preterm delivery and uterine dehiscence at delivery. Prenatal surgery for myelomeningocele reduced the need for shunting and improved motor outcomes at 30 months but was associated with maternal and fetal risks. (Funded by the National Institutes of Health; ClinicalTrials.gov number, NCT00060606.).
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Comparative evaluation of costs and effects of laparoscopic hysterectomy (LH) and abdominal hysterectomy (AH). Controlled trials from Cochrane Central register of controlled trials, Medline, Embase and prospective trial registers. Twelve (randomized) controlled studies including the search terms costs, laparoscopy, laparotomy and hysterectomy were identified. The type of cost analysis, perspective of cost analyses and separate cost components were assessed. The direct and indirect costs were extracted from the original studies. For the cost estimation, hospital stay and procedure costs were selected as most important cost drivers. As main outcome the major complication rate was taken. Analysis was performed on 2226 patients, of which 1013 (45.5%) in the LH group and 1213 (54.5%) in the AH group. Five studies scored > or =10 points (out of 19) for methodological quality. The reported total direct costs in the LH group ($63,997) were 6.1% higher than the AH group ($60,114). The reported total indirect costs of the LH group ($1,609) were half of the total indirect in the AH group ($3,139). The estimated mean major complication rate in the LH group (14.3%) was lower than in the AH group (15.9%). The estimated total costs in the LH group were $3,884 versus $3,312 in the AH group. The incremental costs for reducing one patient with major complication(s) in the LH group compared to the AH group was $35,750. The shorter hospital stay in the LH group compensates for the increased procedure costs, with less morbidity. LH points in the direction of cost effectiveness, however further research is warranted with a broader costs perspective including long term effects as societal benefit, quality of life and survival.
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To assess the cost effectiveness of laparoscopic hysterectomy compared with conventional hysterectomy (abdominal or vaginal). Cost effectiveness analysis based on two parallel trials: laparoscopic (n = 324) compared with vaginal hysterectomy (n = 163); and laparoscopic (n = 573) compared with abdominal hysterectomy (n = 286). 1346 women requiring a hysterectomy for reasons other than malignancy. One year costs estimated from NHS perspective. Health outcomes expressed in terms of QALYs based on women's responses to the EQ-5D at baseline and at three points during up to 52 weeks' follow up. Laparoscopic hysterectomy cost an average of 401 pounds sterling (708 dollars; 571 euros) more (95% confidence interval 271 pounds sterling to 542 pounds sterling) than vaginal hysterectomy but produced little difference in mean QALYs (0.0015, -0.015 to 0.018). Mean differences in cost and QALYs generated an incremental cost per QALY gained of 267 333 pounds sterling (471 789 dollars; 380 437 euros). The probability that laparoscopic hysterectomy is cost effective was below 50% for a large range of values of willingness to pay for an additional QALY. Laparoscopic hysterectomy cost an average of 186 pounds sterling (328 dollars; 265 euros) more than abdominal hysterectomy, although 95% confidence intervals crossed zero (-26 pounds sterling to 375 pounds sterling); there was little difference in mean QALYs (0.007, -0.008 to 0.023), resulting in an incremental cost per QALY gained of 26 571 pounds sterling (46 893 dollars; 37 813 euros). If the NHS is willing to pay 30 000 pounds sterling for an additional QALY, the probability that laparoscopic hysterectomy is cost effective is 56%. Laparoscopic hysterectomy is not cost effective relative to vaginal hysterectomy. Its cost effectiveness relative to the abdominal procedure is finely balanced.
Article
Background: Open intrauterine MMC repair has been proven to result in a significant improvement of long term milestones like shunt placement rates as well as motor and mental development, when compared to postnatal surgery. A fetoscopic approach offers reduced invasiveness, a lower risk of uterine rupture, and the option of vaginal delivery. Objectives: This observational study reports on postnatal mortality and 30 months outcome of children who underwent total intrauterine percutaneous fetoscopic repair of their MMC in Giessen. Methods: During October 2010 and August 2014 a total of 72 mother-child dyads received intrauterine fetoscopic MMC closure. Of these 72, 52 (72%) participated in this study. However, 30 months mortality data are available for all 72 children. We examined children at four time-points: 1) shortly after birth, 2) at 3 months, 3) at 12 months, and 4) at 30 months of corrected age. Thirty months follow up data are now presented for 50 patients who underwent fetoscopic intrauterine MMC repair. Results: 72 children received intrauterine total fetoscopic surgery between 21+0 and 29+1weeks (mean 23+5). All children survived the intrauterine procedure, however 4 (5.5%) infants died postnatally. 11.7% of children were delivered before the 30th week of gestation (mean 33+1 weeks). In 48.14% of the children VP shunt placement was performed. Independent ambulation, without orthosis, at 30 months was feasible for 46% of children. At 30 months of follow up 46% of children presented with a functional level that was 2 or more segments better than their anatomical level. 70% of the children presented with Bayley Scales II psychomotor score (PDI) of ≥70. Assessment of cognitive development by the Bayley Scales II (MDI) again showed a test score of ≥70 for 80% of children at 30 months. Conclusion: Controlled head to head comparisons of open vs. fetoscopic intrauterine repair investigating long term outcome are lacking. However, concerning mortality, prematurity, shunt placement rates, motor and mental development, and free ambulation, intrauterine repair by percutaneous fetoscopy results in an outcome that seems to lie in range with results reported for open intrauterine repair. This article is protected by copyright. All rights reserved.
Article
Objectives: Prenatal myelomeningocele (MMC) repair has been shown to provide significant benefits to the infant, decreasing the postnatal need for ventriculoperitoneal shunting and improving motor outcomes. Chorioamniotic Membrane Separation (CAS) is a potential complication following prenatal MMC repair and may increase the risk of preterm premature rupture of the membranes (PPROM) and preterm birth. The objectives were: 1) To evaluate the incidence of CAS after prenatal MMC repair; 2) To determine risks factors associated with its occurrence; 3) To study those outcomes associated with CAS after prenatal MMC repair. Methods: Retrospective cohort study of 91 patients that underwent fetal MMC repair between November 2011 and December 2018. Surgery was performed using either a fetoscopic (laparotomy and exteriorized uterus) approach or an open-hysterotomy approach. Eligibility criteria were as reported in the Management of Myelomeningocele Study (MOMS). If CAS was detected by US, its' severity was graded as: "Mild" if amnion detachment encompassed < 25% of the uterine cavity, "Moderate" if 25-50% and "Severe" if >50%. Evolution of CAS was classified as stable, increasing, or decreasing based on the severity grading between the time of first diagnosis and the last US before delivery. Logistic regression analyses were performed to identify pre- or peri-surgical factors associated with the development of CAS and to determine the risk of adverse perinatal outcomes associated with CAS. Results: Fetoscopic and open-hysterotomy repair were performed in 52/91(57%) and 39/91(43%) of the cases at a median gestational age (GA) of 25 (22.9-26) and 25 (21.3-25.9) weeks, respectively. CAS was diagnosed in 31/91 (34%) patients, at a median GA of 28.1 (24.4-37.6) weeks. Anterior placenta was identified as a risk factor for the postoperative development of CAS (Odds Ratio (OR) 3.72 [95% CI(1.46-9.5)(p<0.01)]). This risk was independent of the repair technique. An anterior placenta significantly increased the risk of CAS after fetoscopic repair [OR 3.94; 95% CI (1.14-13.6); p=0.03] but not after open repair [OR: 2.8; 95%CI (0.6-12.5); p=0.16]. There was no significant difference in the rate of CAS after fetoscopic repair [21/52 (40%)] vs. open-hysterotomy repair [(10/39 (26%); p=0.14], and neither were there any differences in GA at diagnosis, interval between surgery and diagnosis, nor distribution of CAS severity and progression between the two groups. CAS increased the risk of PPROM (CAS: 48% vs. no-CAS: 12%; p<0.01) [OR: 7.1; 95% CI (2.47-20.5) (p<0.01)] and preterm delivery (68% vs. 38%; p<0.01) [OR: 3.4; 95% CI (1.3-8.4)(p<0.01)]. Early detection of CAS (less than 30 weeks) was a risk factor for preterm delivery (90% if CAS<30 weeks vs. 36% if CAS ≥ 30 weeks (p<0.01) [OR:15.7; 95% CI(2.3-106.3) (p<0.01)]. Fetoscopically repaired cases with CAS had a higher rate of PPROM and preterm delivery than those who had the same repair technique but did not develop CAS (12/20 with CAS developed PPROM [60%] vs 2/31 without CAS developed PPROM [6.5%]; p<0.01 and 13/20 with CAS had preterm delivery [65%] vs 5/31 without CAS had preterm delivery [16%]; p<0.01). Conclusion: The presence of an anterior placenta was the only factor that increased the risk for postoperative CAS. Detection of CAS after prenatal MMC repair significantly increases the risk for PPROM and preterm delivery, especially if it occurs prior to 30 weeks. This article is protected by copyright. All rights reserved.
Article
Objective: This study compared the morbidities and financial burden associated with prenatal open myelomeningocele repair versus postnatal repair. Materials and Methods: The retrospective study cohort included 23 mother-infant dyads undergoing prenatal repair and 30 with postnatal repair. Financial, demographic, and medical information were obtained for mother-infant dyads from each infant’s birth through the first year of life. Results: Infants in the prenatal repair group were significantly affected by sequelae of prematurity, including apnea, bronchopulmonary dysplasia, and retinopathy of prematurity. Importantly, fewer of these infants required ventriculoperitoneal shunt procedures and the overall improved composite outcome of shunting or death. Infants in the postnatal repair group required more hospital readmissions in the first year of life. Financial costs for mother–infant dyads in the prenatal repair group were higher, driven by the length of stay in the neonatal intensive care unit and maternal hospital admissions. Kaplan–Meier curves analyzing the relative contributions of the length of stay and total charges in the population were constructed. The maternal contribution was markedly different between groups due to postoperative hospitalization, readmission, and close fetal surveillance required. Though these differences did not reach statistical significance, it highlights an important burden on families and the medical system. Conclusions: This is the first study to report the contributions of prematurity in relation to maternal and infant morbidity and financial costs. The benefits of prenatal myelomeningocele repair include lower risk for ventriculoperitoneal shunting and fewer hospital readmissions. The risk of preterm birth and its neonatal sequelae continue to be a significant burden.
Article
Background: Open maternal-fetal surgery for fetal myelomeningocele results in reduction in neonatal morbidity related to spina bifida but may be associated with fetal, neonatal, and maternal complications in subsequent pregnancies. Objective: The objective of this study was to ascertain obstetric risk in subsequent pregnancies after open maternal-fetal surgery for fetal myelomeningocele closure. Study design: An international multicenter prospective observational registry created to track and report maternal, obstetric, fetal/neonatal, and subsequent pregnancy outcomes following open maternal-fetal surgery for fetal myelomeningocele was evaluated for subsequent pregnancy outcome variables. Institutional Review Board approval was obtained for the registry. Results: From 693 cases of open maternal-fetal surgery for fetal myelomeningocele closure entered into the registry, 77 subsequent pregnancies in 60 women were identified. The overall live birth rate was 96.2%, with 52 pregnancies delivering beyond 20 weeks gestational age and median gestational age at delivery of 37 (36.3-37.1) weeks. The uterine rupture rate was 9.6% (n = 5), resulting in 2 fetal deaths. Maternal transfusion was required in 4 patients (7.7%). Conclusion: The risk of uterine rupture or dehiscence in subsequent pregnancies with associated fetal morbidity after open maternal-fetal surgery is significant, but is similar to that reported for subsequent pregnancies after classical cesarean deliveries. Future pregnancy considerations should be included in initial counseling for women contemplating open maternal-fetal surgery.
Article
Objective: To report labor, delivery, and neonatal outcomes in a cohort of women delivering neonates who had undergone fetoscopic neural tube defect repair. Methods: We conducted a retrospective cohort study from April 2014 to January 2018. All patients met Management of Myelomeningocele Study eligibility criteria. We included patients with completed second-trimester fetoscopic neural tube defect repair (laparotomy, uterine exteriorization, and minimally invasive access through two or three uterine ports) followed by standardized management of labor and delivery at our institution. Outcomes included rates of vaginal delivery, term delivery, and intrapartum cesarean delivery as well as obstetric and neonatal outcomes after oxytocin. Complications of interest included preterm prelabor rupture of membranes, chorioamnionitis, uterine dehiscence or rupture, 5-minute Apgar score less than 7, and neonatal acidosis (umbilical artery pH less than 7.15). Results: Thirty-four patients had fetoscopic repair, followed by 17 vaginal deliveries (50%, 95% CI 32-68%). Median gestational age was 38 1/7 weeks at vaginal delivery (range 26 0/7-40 2/7 weeks of gestation) and 37 1/7 weeks of gestation at cesarean delivery (range 25 5/7-40 5/7 weeks of gestation); 62% of deliveries occurred at term. Eight patients had prelabor cesarean delivery: three nonurgent and five urgent (for nonreassuring fetal heart tracings). Twenty-six patients labored; six were induced and 20 labored spontaneously. Of the latter, five were augmented. Of 26 laboring patients, 17 delivered vaginally and nine underwent urgent cesarean delivery (35%, 95% CI 17-56%; seven nonreassuring fetal heart tracings and two breech). There were no cases of uterine rupture or dehiscence. Most (94%, 95% CI 80-99%) had normal 5-minute Apgar scores; one neonate (3%, 95% CI 0-15%) had acidosis but normal Apgar scores. Conclusion: Our data regarding trial of labor, use of low-dose oxytocin, and vaginal delivery after prenatal fetoscopic neural tube defect repair are reassuring. Importantly, fetoscopic repair may permit delivery at advanced gestational ages.
Article
Background/objectives: The Management of Myelomeningocele (MMC) Study (MOMS) showed that prenatal repair of MMC resulted in improved neurological outcomes but was associated with high rates of obstetrical complications. This study compares outcomes of open and fetoscopic MMC repair. Data sources: PubMed and Embase studies reporting outcomes of fetal MMC repair published since the completion of the MOMS. Results: We analyzed 11 studies and found no difference in mortality or the rate of shunt placement for hydrocephalus. Percutaneous fetoscopic repair was associated with higher rates of premature rupture of membranes (91 vs. 36%, p < 0.01) and preterm birth (96 vs. 81%, p = 0.04) compared to open repair, whereas fetoscopic repair via maternal laparotomy reduced preterm birth. The rate of dehiscence and leakage from the MMC repair site was higher after both types of fetoscopic surgery (30 vs. 7%, p < 0.01), while the rate of uterine dehiscence was higher after open repair (11 vs. 0%, p < 0.01). Discussion: Fetoscopic repair is a promising alternative to open fetal MMC repair with a lower risk of uterine dehiscence; however, fetoscopic techniques should be optimized to overcome the high rate of dehiscence and leakage at the MMC repair site. A fetoscopic approach via maternal laparotomy reduces the risk of preterm birth.
Article
Objective: To describe development of a two-port fetoscopic technique for spina bifida repair in the exteriorized, carbon dioxide-filled uterus and report early results of two cohorts of patients: the first 15 treated with an iterative technique and the latter 13 with a standardized technique. Methods: This was a retrospective cohort study (2014-2016). All patients met Management of Myelomeningocele Study selection criteria. The intraoperative approach was iterative in the first 15 patients and was then standardized. Obstetric, maternal, fetal, and early neonatal outcomes were compared. Standard parametric and nonparametric tests were used as appropriate. Results: Data for 28 patients (22 endoscopic only, four hybrid, two abandoned) are reported, but only those with a complete fetoscopic repair were analyzed (iterative technique [n=10] compared with standardized technique [n=12]). Maternal demographics and gestational age (median [range]) at fetal surgery (25.4 [22.9-25.9] compared with 24.8 [24-25.6] weeks) were similar, but delivery occurred at 35.9 (26-39) weeks of gestation with the iterative technique compared with 39 (35.9-40) weeks of gestation with the standardized technique (P<.01). Duration of surgery (267 [107-434] compared with 246 [206-333] minutes), complication rates, preterm prelabor rupture of membranes rates (4/12 [33%] compared with 1/10 [10%]), and vaginal delivery rates (5/12 [42%] compared with 6/10 [60%]) were not statistically different in the iterative and standardized techniques, respectively. In 6 of 12 (50%) compared with 1 of 10 (10%), respectively (P=.07), there was leakage of cerebrospinal fluid from the repair site at birth. Management of Myelomeningocele Study criteria for hydrocephalus-death at discharge were met in 9 of 12 (75%) and 3 of 10 (30%), respectively, and 7 of 12 (58%) compared with 2 of 10 (20%) have been treated for hydrocephalus to date. These latter differences were not statistically significant. Conclusion: Fetoscopic open neural tube defect repair does not appear to increase maternal-fetal complications as compared with repair by hysterotomy, allows for vaginal delivery, and may reduce long-term maternal risks. Clinical trial registration: ClinicalTrials.gov, https://clinicaltrials.gov, NCT02230072.
Article
Objectives—This report presents 2015 data on U.S. births according to a wide variety of characteristics. Data are presented for maternal age, live-birth order, race and Hispanic origin, marital status, attendant at birth, method of delivery, period of gestation, birthweight, and plurality. Selected data by mother's state of residence and birth rates by age and race of father also are shown. Trends in fertility patterns and maternal and infant characteristics are described and interpreted. Methods—Descriptive tabulations of data reported on the birth certificates of the 3.98 million births that occurred in 2015 are presented. Results—In 2015, 3,978,497 births were registered in the United States, down less than 1% from 2014. The general fertility rate was 62.5 per 1,000 women aged 15–44, a decline of 1% from 2014. The birth rate for teenagers aged 15–19 fell 8% in 2015, to 22.3 per 1,000 females. Birth rates declined for women in their 20s but increased for women in their 30s and early 40s. The total fertility rate (estimated number of births over a woman’s lifetime) declined to 1,843.5 births per 1,000 women in 2015. The birth rate for unmarried women declined for the seventh straight year to 43.5 per 1,000. The cesarean delivery rate declined for the third year in a row to 32.0%. The preterm birth rate increased slightly from 2014, to 9.63% in 2015, as did the rate of low birthweight (8.07% in 2015). The twin birth rate declined to 33.5 per 1,000; the triplet and higher-order multiple birth rate was down 9% to 103.6 per 100,000. © 2017, National Center for Health Statistics. All rights reserved.
Book
The increasing prevalence of preterm birth in the United States is a complex public health problem that requires multifaceted solutions. Preterm birth is a cluster of problems with a set of overlapping factors of influence. Its causes may include individual-level behavioral and psychosocial factors, sociodemographic and neighborhood characteristics, environmental exposure, medical conditions, infertility treatments, and biological factors. Many of these factors co-occur, particularly in those who are socioeconomically disadvantaged or who are members of racial and ethnic minority groups. While advances in perinatal and neonatal care have improved survival for preterm infants, those infants who do survive have a greater risk than infants born at term for developmental disabilities, health problems, and poor growth. The birth of a preterm infant can also bring considerable emotional and economic costs to families and have implications for public-sector services, such as health insurance, educational, and other social support systems. Preterm Birth assesses the problem with respect to both its causes and outcomes. This book addresses the need for research involving clinical, basic, behavioral, and social science disciplines. By defining and addressing the health and economic consequences of premature birth, this book will be of particular interest to health care professionals, public health officials, policy makers, professional associations and clinical, basic, behavioral, and social science researchers. © 2007 by the National Academy of Sciences. All rights reserved.
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Importance Since publication of the report by the Panel on Cost-Effectiveness in Health and Medicine in 1996, researchers have advanced the methods of cost-effectiveness analysis, and policy makers have experimented with its application. The need to deliver health care efficiently and the importance of using analytic techniques to understand the clinical and economic consequences of strategies to improve health have increased in recent years. Objective To review the state of the field and provide recommendations to improve the quality of cost-effectiveness analyses. The intended audiences include researchers, government policy makers, public health officials, health care administrators, payers, businesses, clinicians, patients, and consumers. Design In 2012, the Second Panel on Cost-Effectiveness in Health and Medicine was formed and included 2 co-chairs, 13 members, and 3 additional members of a leadership group. These members were selected on the basis of their experience in the field to provide broad expertise in the design, conduct, and use of cost-effectiveness analyses. Over the next 3.5 years, the panel developed recommendations by consensus. These recommendations were then reviewed by invited external reviewers and through a public posting process. Findings The concept of a “reference case” and a set of standard methodological practices that all cost-effectiveness analyses should follow to improve quality and comparability are recommended. All cost-effectiveness analyses should report 2 reference case analyses: one based on a health care sector perspective and another based on a societal perspective. The use of an “impact inventory,” which is a structured table that contains consequences (both inside and outside the formal health care sector), intended to clarify the scope and boundaries of the 2 reference case analyses is also recommended. This special communication reviews these recommendations and others concerning the estimation of the consequences of interventions, the valuation of health outcomes, and the reporting of cost-effectiveness analyses. Conclusions and Relevance The Second Panel reviewed the current status of the field of cost-effectiveness analysis and developed a new set of recommendations. Major changes include the recommendation to perform analyses from 2 reference case perspectives and to provide an impact inventory to clarify included consequences.
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Objective: To compare outcomes of fetoscopic spina bifida aperta repair (FSBAR) with the results of the open approach (OSBAR) as in the Management Of Myelomeningocele Study (MOMS). Methods: This was a systematic comparison of reports on FSBAR with data from the MOMS (n = 78). Inclusion criteria were studies of spina bifida aperta patients who underwent FSBAR and were followed for ≥12 months. Primary outcome was perinatal mortality. Secondary outcomes included operative, maternal, fetal, neonatal and infant outcomes. Results: Out of 16 reports, we included 5 from 2 centers. Due to bias and heterogeneity, analysis was restricted to two overlapping case series (n = 51 and 71). In those, FSBAR was technically different from OSBAR, had comparable perinatal mortality (7.8 vs. 2.6%, p = 0.212) and shunt rate at 12 months (45 vs. 40%, p = 0.619), longer operation time (223 vs. 105 min, p < 0.001), higher preterm prelabor membrane rupture rate (84 vs. 46%, p < 0.001), earlier gestational age at birth (32.9 vs. 34.1 weeks, p = 0.03), higher postnatal reoperation rate (28 vs. 2.56%, p < 0.001) and absence of uterine thinning or dehiscence (0 vs. 36%, p < 0.001). Functional outcomes were not available. Conclusion: FSBAR utilizes a different neurosurgical technique, takes longer to complete, induces more prematurity, requires additional postnatal procedures, yet has a comparable shunt rate and is not associated with uterine thinning or dehiscence. Long-term functional data are awaited.
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Infants who suffer hypoxic-ischaemic encephalopathy (HIE) at term are at risk of dying or developing severe cerebral palsy (CP). Children with severe CP often have other neurodevelopmental disabilities, which may affect their quality of life as much as the CP itself. New treatments for HIE, such as cooling, may improve motor outcomes, but affected infants may still have significant cognitive or communication problems. Infants who have experienced HIE and develop CP will require significant medical input throughout childhood and adult life. The costs of this medical input are high, but the indirect costs to the child, his or her family, and the relevant social services and education systems are many times greater. When demonstrating the cost-effectiveness of interventions aimed at preventing or treating HIE, these additional costs should be taken into account. © The Authors. Journal compilation © 2015 Mac Keith Press.
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Background Percutaneous minimally-invasive fetoscopic closure of spina bifida aperta (SBA) was developed by the author in order to obviate the need for the far more invasive open fetal surgical approach. The manuscript offers an analysis of the current technical approach accompanied by an orienting overview on its development in ovine and human fetuses. Flanked by supporting manuscripts about management and outcome, the author hopes to raise the interest in the further dissemination of minimally-invasive surgery for this condition.Patients & Methods Minimally-invasive percutaneous fetoscopic closure of SBA was performed at the German Center for Fetal Surgery & Minimally-Invasive Therapy (DZFT) in 51 human fetuses between 21.0 and 29.1 weeks of gestation (mean age 23.8 weeks). Various parameters of surgical relevance for the success and safety of the procedure and the early perioperative outcome were retrospectively analyzed. In addition, historical information from the early clinical cases and how it shaped the mature approach is is being discussed.ResultsPercutaneous minimally-invasive fetoscopic closure of SBA was performed with a high rate of technical success, regardless of placental or fetal position. Fetal demise one week after the procedure occurred in one of the 51 cases (2%) from early postoperative chorioamnionitis. All other fetuses survived gestation. Of the surviving fetuses 45 (90%) were born beyond 30 weeks and 25 (49%) beyond 34 weeks of gestation.Conclusions Following an adequate learning curve, minimally-invasive fetoscopic surgery for fetal spina bifida be performed with a high rate of technical success regardless of placental position.
Article
Objective Minimally-invasive fetoscopic surgery of spina bifida aperta aims at improving postnatal neurological outcome of affected fetuses. The objective of this retrospective study was to assess maternal morbidity and outcome of this procedure in 51 women that were operated at a mean gestational age of 24 weeks at our center between July 2010 and June 2013.Methods We studied our charts for the peri- and postoperative occurrence of maternal death, need for maternal blood transfusion, placental abruption, pulmonary edema, spontaneous labor, oligohydramnios, chorioamnionitis, chorioamniotic membrane separation, length of hospitalization, amniotic fluid leakage, gestational age at delivery and status of hysterotomy site.ResultsIn all 51 women, maternal demise, placental abruption or the need for maternal blood transfusion were not observed in the perioperative period. Chorioamniotic membrane separation occurred in two, postoperative uterine contractions in one, mild pulmonary edema in one, and oligohydramnios in seven patients. One patient developed chorioamnionitis one week after fetal surgery; the fetus from this patient died from prematurity. All other babies survived gestation. Amniotic fluid leakage occurred in 43 patients at a mean gestational age of 29.7 (range 22.6-37.3) weeks; two of these patients developed chorioamnionitis. Length of hospitalization after surgery was 7.2 (range 4-12) days. Mean gestational age at delivery was 33 (range 24.6-38.1) weeks. All abdominal and uterine trocar insertion sites were well healed.Conclusion Minimally-invasive fetoscopic surgery for spina bifida aperta was safe for most maternal patients. Despite the common occurrence of amniotic leakage the majority now delivers well beyond 32 weeks of gestation.
Article
To determine whether prenatal myelomeningocele repair is a cost-effective strategy compared to postnatal repair. Decision-analysis modeling was used to calculate the cumulative costs, effects and incremental cost-effectiveness ratio of prenatal myelomeningocele repair compared with postnatal repair in singleton gestations with a normal karyotype that were identified with myelomeningocele between T1 and S1. The model accounted for costs and quality-adjusted life years (QALYs) in three populations: (1) myelomeningocele patients; (2) mothers carrying myelomeningocele patients; and (3) possible future siblings of these patients. Sensitivity analysis was performed using one-way, two-way and Monte Carlo simulations. Prenatal myelomeningocele repair saves $ 2 066 778 per 100 cases repaired. Additionally, prenatal surgery results in 98 QALYs gained per 100 repairs with 42 fewer neonates requiring shunts and 21 fewer neonates requiring long-term medical care per 100 repairs. However, these benefits are coupled to 26 additional cases of uterine rupture or dehiscence and one additional case of neurologic deficits in future offspring per 100 repairs. Results were robust in sensitivity analysis. Prenatal myelomeningocele repair is cost effective and frequently cost saving compared with postnatal myelomeningocele repair despite the increased likelihood of maternal and future pregnancy complications associated with prenatal surgery.
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The National Birth Defects Prevention Network collects state-specific birth defects surveillance data for annual publication of prevalence estimates and collaborative research projects. In 2006, data for 21 birth defects from 1999 through 2001 were presented as national birth prevalence estimates. The purpose of this report was to update these estimates using data from 2004 through 2006. Population-based data from 11 active case-finding programs, 6 passive case-finding programs with case confirmation, and 7 passive programs without case confirmation were used in this analysis. Pooled birth prevalence estimates for 21 birth defects, stratified by case ascertainment approach, were calculated. National prevalence estimates, adjusted for maternal race/ethnicity and maternal age (trisomy 13, trisomy 18, and Down syndrome only) were determined using data from 14 programs. The impact of pregnancy outcomes on prevalence estimates was also assessed for five specific defects. National birth defects prevalence estimates ranged from 0.72 per 10,000 live births for common truncus to 14.47 per 10,000 live births for Down syndrome. Stratification by type of surveillance system showed that active programs had a higher prevalence of anencephaly, anophthalmia/microphthalmia, cleft lip with or without cleft palate, reduction defect of upper limbs, and trisomy 18. The birth prevalence of anencephaly, trisomy 13, and trisomy 18 also varied substantially with inclusion of elective terminations. Accurate and timely national estimates of the prevalence of birth defects are needed for monitoring trends, assessing prevention efforts, determining service planning, and understanding the burden of disease due to birth defects in the United States.
Article
The reproductive and gynecologic outcomes for women after the pregnancy complicated by open maternal-fetal surgery (OMFS) were evaluated. The retrospective review identified 93 women with OMFS from a single institution (1996-2007). Consent and questionnaires were sent to women. Institutional review board approval was obtained from the Committee for Protection of Human Subjects. The total return rate was 57.3%. Total pregnancies reported were 47, with 36 delivering after 20 weeks' gestation. The uterine dehiscence and rupture rates were 14% and 14%, respectively. Fetal anomalies occurred in 4 subsequent pregnancies. Normal conception occurred in 98% of subsequent pregnancies. Gynecologic issues were reported by 8 women, with infertility, abdominal pain, and ovarian and uterine factors. The reproductive outcomes of uterine dehiscence (14%) and rupture (14%) in a subsequent pregnancy continue to be a major counseling issue for OMFS. Fertility and gynecologic factors do not appear to be increased for women undergoing OMFS.
Article
The aim of our study was to investigate survival and causes of death in a complete cohort of open spina bifida at the mean age of 40 years. We conducted a community-based, prospective study of 117 consecutive infants (50 males, 67 females) with open spina bifida whose backs were closed non-selectively within 48 hours of birth between 1963 and 1971 at Addenbrooke's Hospital, Cambridge, UK. Of those who survived to age 1 year, 89% (82 out of 92) had a cerebrospinal fluid shunt. In 2007, all survivors were surveyed by postal questionnaire backed up by telephone interview. Details of deaths were obtained from the Office for National Statistics, medical records, and autopsy reports, and Kaplan-Meier survival curves were constructed. One in three of the cohort (40/117) died before the age of 5 years. A further 26% (31/117) died during the next 35 years, over 10 times the national average. Half the deaths (16/31) after the age of 5 were sudden and unexpected. All occurred in the community and were followed by a coroner's autopsy. The most frequent causes of these unexpected deaths were epilepsy, pulmonary embolus, acute hydrocephalus, and acute renal sepsis. The prognosis for survival was strikingly poor in those with the most extensive neurological deficit. Only 17% (7/42) of those born with a high sensory level (above T11) survived to the mean age of 40 years, compared with 61% (23/38) of those with a low sensory level (below L3; p=0.001). Doctors and care planners need to be aware that, contrary to previous suggestions, there is continuing high mortality throughout adult life in individuals with open spina bifida, and many deaths are unexpected.
Article
To gather and calculate utilities for a wide range of health states in the pediatric population. The study subjects, parents or guardians at least 18 years of age with at least 1 child under age 18 years, were recruited through our Pediatric Research Network (PResNet). Recruitment locations included pediatric clinics, the Indiana State Fair, and public and private conventions. Each subject's utilities were assessed on 3 random health states out of 29 chosen for the study. Both the time trade-off and standard gamble methods were used to measure utilities. Utilities were assessed in a total of 4016 participants (a recruitment rate of 88%). Utility values ranged from a high for acute otitis media (0.96 by standard gamble; 0.97 by time trade-off) to a low for severe mental retardation (0.59 by standard gamble; 0.51 by time trade-off). Our extensive data set of utility assessments for a wide range of disease states can aid future economic evaluations of pediatric health care.
Article
To determine how pregnant women of varying ages, races, ethnicities, and socioeconomic backgrounds value procedure-related miscarriage and Down-syndrome-affected birth. We studied cross-sectionally 534 sociodemographically diverse pregnant women who sought care at obstetric clinics and practices throughout the San Francisco Bay area. Preferences for procedure-related miscarriage and the birth of an infant affected by Down syndrome were assessed using the time trade-off and standard gamble metrics. Because current guidelines assume that procedure-related miscarriage and Down syndrome-affected birth are valued equally, we calculated the difference in preference scores for those two outcomes. We also collected detailed information on demographics, attitudes, and beliefs. On average, procedure-related miscarriage was preferable to Down syndrome-affected birth, as evidenced by positive differences in preference scores for them (time trade-off difference: mean = 0.09, median = 0.06; standard gamble difference: mean = 0.11, median = 0.02; P <.001 for both, one-sample sign test). There was substantial subject-to-subject variation in preferences that correlated strongly with attitudes about miscarriage, Down syndrome, and diagnostic testing. Pregnant women tend to find the prospect of a Down syndrome-affected birth more burdensome than a procedure-related miscarriage, calling into question the equal risk threshold for prenatal diagnosis. Individual preferences for those outcomes varied profoundly. Current guidelines do not appropriately consider individual preferences in lower-risk women, and the process for developing prenatal testing guidelines should be reconsidered to better reflect individual values.
Article
To determine the cost-effective method of delivery, from society's perspective, in patients who have had a previous cesarean. We completed an incremental cost-effectiveness analysis of a trial of labor relative to cesarean using a computerized model for a hypothetical 30-year old parturient. The model incorporated data from peer-reviewed studies, actual hospital costs, and utilities to quantify health-related quality of life. A threshold of $50,000 per quality-adjusted life-years was used to define cost-effective. The model was most sensitive to the probability of successful vaginal delivery. If the probability of successful vaginal birth after cesarean (VBAC) was less than 0.65, elective repeat cesarean was both less costly and more effective than a trial of labor. Between 0.65 and 0.74, elective repeat cesarean was cost-effective (the cost-effectiveness ratio was less than $50,000 per quality-adjusted life-years), because, although it cost more than VBAC, it was offset by improved outcomes. Between 0.74 and 0.76, trial of labor was cost-effective. If the probability of successful vaginal delivery exceeded 0.76, trial of labor became less costly and more effective. Costs associated with a moderately morbid neonatal outcome, as well as the probabilities of infant morbidity occurring, heavily impacted our results. The cost-effectiveness of VBAC depends on the likelihood of successful trial of labor. Our modeling suggests that a trial of labor is cost-effective if the probability of successful vaginal delivery is greater than 0.74. Improved algorithms are needed to more precisely estimate the likelihood that a patient with a previous cesarean will have a successful vaginal delivery.
Article
Our purpose was to assess economic and health consequences of elective induction at term. A decision-tree model incorporating a Markov analysis was used to compare the decision either to electively induce labor at term or expectantly manage the pregnancy until 42 weeks' gestation. Main outcome measures, stratified by parity, cervical ripeness, and gestational age at induction, were number of cesarean deliveries and costs to the health care system. By use of baseline estimates, induction at any gestational age, regardless of parity and cervical ripeness, required expenditures from the medical system. Although never cost saving, inductions were less expensive at later gestational ages, for multiparous patients, and for those women with a favorable cervix. Sensitivity analysis demonstrated a robust model. Elective induction of labor at term is not cost saving and results in a large excess of cesarean deliveries. Costs are significantly altered by the timing of the induction, parity, and cervical ripeness.
Article
Cost-effectiveness evaluations of interventions to prevent or treat spina bifida require quality of life information measured as preference scores. Preference scores of caregivers also may be relevant. This study tested whether the preference scores of children with spina bifida and their caregivers would decrease as disability in the child increased. Families of children aged 0-17 with spina bifida (N = 98) were identified using a birth defect surveillance system in the state of Arkansas. Primary caregivers of children with spina bifida identified other families with an unaffected child (N = 49). Preference scores for child health states were determined using the Health Utilities Index--Mark 2 (HUI2). Caregiver preference scores were determined using the Quality of Well-Being (QWB) scale. Children with spina bifida were categorized into three disability levels according to the location of the child's lesion. Mean preference scores declined for both affected children and the primary caregiver as disability in the child increased. In multivariate analysis, the preference score of the child was a significant and positive predictor of the primary caregiver's preference score. A more modest association was found for caregiver health preference scores by lesion location. The findings can inform cost-effectiveness evaluations of interventions to treat or prevent spina bifida.
Article
To estimate the potential savings, both in terms of costs and lengths of stay, of one-week increases in gestational age for premature infants. The purpose is to provide population-based data that can be used to assess the potential savings of interventions that delay premature delivery. Cohort data for all births in California in 1998-2000 that linked vital records data with those from hospital discharge abstracts, including those of neonatal transport. All infants with a gestational age between 24 and 37 weeks were included. There were 193,167 infants in the sample after deleting cases with incomplete data or gestational age that was inconsistent with birth weight. Hospital costs were estimated by adjusting charges by hospital-specific costs-to-charges ratios. Data were aggregated across transport into episodes of care. Mean and median potential savings were calculated for increasing gestational age, in one-week intervals. The 25th and 75th percentiles were used to estimate ranges. The results are presented in matrix format, for starting gestational ages of 24-34 weeks, with ending gestational ages of 25 to 37 weeks. Costs and lengths of stay decreased with gestational age from a median of $216,814 (92 days) at 24 weeks to $591 (2 days) at 37 weeks. The potential savings from delaying premature labor are quite large; the median savings for a 2 week increase in gestational age were between $28,870 and $64,021 for gestational ages below 33 weeks, with larger savings for longer delays in delivery. Delaying deliveries <29 weeks to term (37 weeks) resulted in savings of over $122,000 per case, with the savings being over $206,000 for deliveries <26 weeks. These results provide population-based data that can be applied to clinical trials data to assess the impacts on costs and lengths of stay of interventions that delay premature labor. They show that the potential savings of delaying premature labor are quite large, especially for extremely premature deliveries.
Article
Caesarean section rates in Chile are reported to be as high as 60% in some populations. The purpose of this study was to determine pregnant Chilean women's preferences towards mode of delivery. Interviewer-administered cross-sectional survey. Prenatal clinics in Santiago, Chile. Population Pregnant women in Santiago, Chile. Of 180 women completing the questionnaire, 90 were interviewed at a private clinic (caesarean delivery rate 60%) and 90 were interviewed at a public clinic (cesarean delivery rate 22%). Data collected included demographics, preferred mode of delivery, and women's attitudes towards vaginal and caesarean deliveries. Mode of delivery preferences, perceptions of mode of delivery measured on a 1-7 Likert scale. The majority of women (77.8%) preferred vaginal delivery, 9.4% preferred caesarean section, and 12.8% had no preference. There was no statistical difference in preference between the public clinic (11% preferred caesarean) and the private clinic (8% preferred caesarean, P= 0.74). Overall, women preferring caesarean birth were slightly older than other groups (31.6 years, versus 28.4 years for women who preferred vaginal and 27.3 years for women who had no preference, P= 0.05), but there were otherwise no differences in parity, income, or education. On a scale of 1-7, women preferring caesarean birth rated vaginal birth as more painful, while women preferring vaginal birth rated it as less painful (5.8 versus 3.7, P= 0.003). Whether vaginal or caesarean, each group felt that their preferred mode of delivery was safer for their baby (P < 0.001). Chilean women do not prefer caesarean section to vaginal delivery, even in a practice setting where caesarean delivery is more prevalent. Thus, women's preferences is unlikely to be the most significant factor driving the high caesarean rates in Chile.
Cost-effectiveness of external cephalic version for term breech presentation
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