Development and validation of a novel fetal vesico-amniotic shunt, the vortex shunt.

Fetal lower urinary tract obstruction (LUTO) is a severe malformation associated with an up to 80% mortality risk as well as significant renal and pulmonary morbidity in survivors. Fetal vesico-amniotic shunts (VAS) bypass the bladder obstruction, improve amniotic fluid volume and enhance in-utero pulmonary development. VAS has been shown to reduce respiratory morbidity and mortality in the neonatal period without proven benefit on long-term renal and bladder function. Clinically available shunts are associated with an up to 80% dislodgement rate, leading to repeat invasive procedures which increase fetal and maternal risks. We developed a novel "Vortex" shunt, which incorporates enhanced fixation to reduce dislodgement, a one-way valve to optimize in-utero bladder function, and enhanced sonographic echogenicity that optimizes the accurate deployment. Following the validation of these characteristics in initial benchtop experiments we have moved to feasibility studies in the fetal lamb model. We hope that the Vortex shunt may ultimately facilitate shunt deployment, reduce dislodgement risk, improve neonatal morbidity and mortality, and decrease the significant healthcare expenditures associated with long-term morbidity in LUTO survivors. In this manuscript, we review the natural history of LUTO, the risks and benefits of clinically available fetal shunts, and our development and early validation experiments.

Photochemical Tissue Bonding of Amnion Allograft Membranes for Peripheral Nerve Repair: A Biomechanical Analysis.

BACKGROUND: Photochemical tissue bonding (PTB) is a technique for peripheral nerve repair in which a collagenous membrane is bonded around approximated nerve ends. Studies using PTB with cryopreserved human amnion have shown promising results in a rat sciatic nerve transection model including a more rapid and complete return of function, larger axon size, and thicker myelination than suture repair. Commercial collagen membranes, such as dehydrated amnion allograft, are readily available, offer ease of storage, and have no risk of disease transmission or tissue rejection. However, the biomechanical properties of these membranes using PTB are currently unknown in comparison to PTB of cryopreserved human amnion and suture neurorrhaphy. METHODS: Rat sciatic nerves (n = 10 per group) were transected and repaired using either suture neurorrhaphy or PTB with one of the following membranes: cryopreserved human amnion, monolayer human amnion allograft (crosslinked and noncrosslinked), trilayer human amnion/chorion allograft (crosslinked and noncrosslinked), or swine submucosa. Repaired nerves were subjected to mechanical testing. RESULTS: During ultimate stress testing, the repair groups that withstood the greatest strain increases were suture neurorrhaphy (69 ± 14%), PTB with crosslinked trilayer amnion (52 ± 10%), and PTB with cryopreserved human amnion (46 ± 20%), although the differences between these groups were not statistically significant. Neurorrhaphy repairs had a maximum load (0.98 ± 0.30 N) significantly greater than all other repair groups except for noncrosslinked trilayer amnion (0.51 ± 0.27 N). During fatigue testing, all samples repaired with suture, or PTBs with either crosslinked or noncrosslinked trilayer amnion were able to withstand strain increases of at least 50%. CONCLUSION: PTB repairs with commercial noncrosslinked amnion allograft membranes can withstand physiological strain and have comparable performance to repairs with human amnion, which has demonstrated efficacy in vivo. These results indicate the need for further testing of these membranes using in vivo animal model repairs.

Prevalence of amniotomy in Sweden: a nationwide register study.

BACKGROUND: Amniotomy is a commonly used labor intervention with uncertain evidence, and there are complications connected to the intervention. Yet, the Swedish prevalence of amniotomy is unknown. The aim of the study was therefore to describe the prevalence of amniotomy in Sweden. METHODS: This nationwide register-based study included 330,913 women giving birth in 2017-2020. Data were collected from the Swedish Pregnancy Register in which the majority of data is collected via direct transfer from medical records. Prevalence of amniotomy was described for all births, for nulliparous and multiparous women with spontaneous onset of labour, and at the hospital level. Descriptive statistics and chi-square test were used to analyse the data. RESULTS: For all births, the prevalence of amniotomy was 40.6%. More amniotomies were performed in Robson group 1 compared to Robson group 3; 41.1% vs 32.3% (p < 0.001). The prevalence for all births remained the same during the study period; however, a decrease from 37.5 to 34.1%, was seen in Robson group 1 and Robson group 3 (p < 0.001). Variations in the prevalence between hospitals were reported. The hospitals with the fewest number of births annually had the highest prevalence of amniotomy (45.0%), and the lowest prevalence was reported at the University hospitals (40.4%) (p < 0.001). CONCLUSIONS: Amniotomy is a common labor intervention in Sweden, given that almost half of the laboring women underwent the intervention. Our results, regarding variations in the prevalence between hospitals, could imply a potential for fewer amniotomies in Swedish childbirth care.

Short- and long-term outcome following thoracoamniotic shunting for fetal hydrothorax.

OBJECTIVES: To assess short- and long-term outcome in a cohort of fetuses diagnosed with hydrothorax (FHT) which underwent thoracoamniotic shunting in utero, and to examine the antenatal predictors of survival and of survival with normal neurodevelopmental outcome. METHODS: This was a retrospective analysis of 132 fetuses that underwent thoracoamniotic shunting at our center between 1991 and 2014. Data were extracted from hospital obstetric and relevant neonatal intensive care and neonatal developmental follow-up databases. Outcomes included survival to discharge and survival with normal neurodevelopmental outcome beyond 18 months. Information on malformations, syndromes and genetic abnormalities were obtained from antenatal, postnatal and pediatric hospital records or by parent report. We compared pregnancy characteristics among those who survived vs non-survivors and among those with normal neurodevelopmental outcome vs those who were abnormal or died. We explored whether there was a trend in survival over the study period. RESULTS: The mean gestational age at diagnosis of FHT was 25.6 weeks. The fetus was hydropic at diagnosis in 61% of cases, 69% had bilateral effusions and 55% had bilateral shunts inserted. Other diagnoses were present in 24% of cases, two-thirds of which were discovered only postnatally. There were 16 intrauterine and 30 neonatal deaths, with a 65% survival rate overall. The mean gestational age at delivery of liveborns was 35.4 (range, 26.9-41.6) weeks, and 88/116 (76%) were preterm (< 37 weeks). Of 87 liveborn at the treatment center, 75% experienced some respiratory and/or cardiovascular morbidity after birth, many with a lengthy hospital stay (mean, 36 (range, 1-249) days). Overall, 84% of survivors were developmentally normal beyond 18 months and outcomes were better when pleural effusions were isolated, 92% of these cases being neurodevelopmentally normal. There was no trend in survival or neurodevelopmental outcome over time. Despite the presence of FHT and neonatal respiratory issues, most (89%) of the 55 survivors with relevant follow-up had no long-term pulmonary complications. Gestational age at delivery was the only factor independently predictive of both survival and survival with normal neurodevelopmental outcome. CONCLUSIONS: FHT is associated with other pathologies in a quarter of cases and carries a significant risk of prematurity, mortality and neonatal morbidity. The outcome is good in survivors but is best in isolated cases. Predictors of outcome at diagnosis are poor. Future improvement in diagnostics at time of identification of FHT may help to identify those that would benefit most from thoracoamniotic shunting. © 2020 International Society of Ultrasound in Obstetrics and Gynecology.

Chorioamniotic membrane separation following fetal myelomeningocele repair: incidence, risk factors and impact on perinatal outcome.

OBJECTIVES: Prenatal myelomeningocele (MMC) repair has been shown to provide significant benefits to the infant, decreasing the postnatal need for ventriculoperitoneal shunt and improving motor outcome. Chorioamniotic membrane separation (CAS) is a potential complication following prenatal MMC repair and may increase the risk of preterm prelabor rupture of membranes (PPROM) and preterm birth. The objectives of this study were: (1) to evaluate the incidence of CAS after prenatal MMC repair; (2) to determine risk factors associated with its occurrence; and (3) to assess its association with adverse perinatal outcomes. METHODS: This was a retrospective cohort study of patients who underwent fetal MMC repair between November 2011 and December 2018. Surgery was performed using either a fetoscopic (laparotomy or exteriorized uterus) approach or an open-hysterotomy approach. Eligibility criteria were those reported in the Management of Myelomeningocele Study. If CAS was detected on ultrasound (US), its severity was graded as 'mild' if amnion detachment involved < 25% of the uterine cavity, 'moderate' if it involved 25-50% and 'severe' if it involved > 50%. Evolution of CAS was classified as stable, increasing or decreasing based on the difference in severity grading between the time at first diagnosis and the last US scan before delivery. Logistic regression analysis was performed to identify pre- or perisurgical factors associated with the development of CAS and to determine the risk of adverse perinatal outcome associated with CAS. RESULTS: In total, 91 cases were included. Fetoscopic or open-hysterotomy repair of MMC was performed in 52/91 (57.1%) and 39/91 (42.9%) cases, at a median gestational age (GA) of 25.0 weeks (range, 22.9-26.0 weeks) and 25.0 weeks (range, 21.3-25.9 weeks), respectively. CAS was diagnosed in 31/91 (34.1%) patients, at a median GA of 28.1 weeks (range, 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 dependent on 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 (40.4%)) vs open-hysterotomy repair (10/39 (25.6%)) (P = 0.14), nor were there any differences in GA at diagnosis of CAS, interval between surgery and diagnosis, distribution of CAS severity or progression of CAS between the two groups. CAS increased the risk of PPROM (50% in those with vs 12% in those without CAS) (OR, 7.6 (95% CI, 2.5-21.9); P < 0.01) and preterm delivery (70% vs 38%) (OR, 3.2 (95% CI, 1.3-8.1); P < 0.01). Fetoscopically repaired cases with CAS had a higher rate of PPROM (12/20 (60.0%) vs 2/31 (6.5%); P < 0.01) and preterm delivery (13/20 (65.0%) vs 5/31 (16.1%); P < 0.01) than those that did not develop CAS, while the differences were not significant in cases with open-hysterotomy repair. Early detection of CAS (before 30 weeks' gestation) was a risk factor for preterm delivery (90% before 30 weeks vs 36% at or after 30 weeks) (OR, 15.7 (95% CI, 2.3-106.3); P < 0.01). There was no association between PPROM or preterm delivery and the severity or progression of CAS. CONCLUSIONS: The presence of an anterior placenta was the only factor that increased the risk for CAS after fetoscopic MMC repair. Detection of CAS after fetoscopic MMC repair significantly increases the risk for PPROM and preterm delivery. Copyright © 2019 ISUOG. Published by John Wiley & Sons Ltd.

Variation of intrapartum care and cesarean rates among practitioners attending births of low-risk, nulliparous women.

BACKGROUND: Variation in hospital cesarean birth rates across the United States is likely because of differences in practitioner practice patterns. Yet, few studies conducted in the last twenty years have examined the relationships between practitioner characteristics and the use of intrapartum interventions and cesarean birth. The objective of this study was to examine associations among practitioner characteristics and the use of amniotomy, epidural, oxytocin augmentation, and cesarean birth in low-risk women with spontaneous onset of labor. METHODS: A secondary analysis was performed using data collected by the Consortium on Safe Labor. The sample included nulliparous term singleton vertex (NTSV) births with spontaneous onset of labor (n = 13 196) from 2002 to 2007 across eight hospitals. Generalized linear mixed models were conducted to examine outcomes. RESULTS: The cesarean birth rate ranged from 7.2% to 18.9% across hospitals and from 0% to 53.3% across physicians. Practice type (P < .05) and specialty type (P < .0001) were associated with physician cesarean birth rates. Compared with obstetrician/gynecologists, midwives were nearly twice as likely to use no intrapartum interventions (relative risk 1.80 [CI 95 1.45-2.24]) and 26% less likely to use amniotomy-epidural-oxytocin (0.74 [0.62-0.89]). Family practice physicians had a 21% lower likelihood of using amniotomy-epidural-oxytocin (0.79 [0.67-0.94]) and a 53% lower likelihood of performing cesarean births (0.47 [0.35-0.63]). CONCLUSIONS: Wide variation in hospital and physician cesarean birth rates was observed in this sample of low-risk, nulliparous women. Practitioner practice type and specialty were significantly associated with the use of intrapartum interventions. Interprofessional practitioner education could be one strategy to reduce variation of intrapartum care and cesarean birth.

A disadvantage of cesarean section en caul: Umbilical velamentous insertion, a risk factor and proposed mechanism of neonatal anemia.

Cesarean section en caul could cause neonatal anemia, but the mechanism remains unknown. We demonstrate an association between neonatal anemia and velamentous insertion of the umbilical cord in cesarean section en caul, and suggest a way to make this procedure safer. We performed cesarean section en caul, but the placenta and the membrane sac were delivered separately. The neonate was severely anemic. The umbilical cord was attached to the membrane and the blood vessel connecting the umbilical cord and placenta was torn. The amniotic membrane covering the placental surface had peeled away. Velamentous insertion of the umbilical cord could be a cause of neonatal anemia associated with cesarean section en caul.

Application of Human Amniotic Membrane in Temporomandibular Joint Osteoarthritis.

Human amniotic membrane (HAM) has recently been used as an interpositional material to prevent ankylosis or primary re-ankylosis after temporomandibular joint (TMJ) arthroplasty. Here, the authors describe an unusual case of a 32-year-old woman who presented with a noninflammatory degenerative osteoarthritis of the TMJ in which a HAM was placed following a high condylar arthroplasty and discectomy and show the clinicoradiological results. The procedure resulted in total pain relief and significant improvement in jaw movements. On the long-term follow-up computed tomography, complete remodeling of the glenoid fossa with formation of new ectopic bone was observed. While the application of a HAM can be an alternative procedure to prevent ankylosis when performing a discectomy and arthroplasty, this clinical report highlights the possibility that it can induce ectopic bone formation at this location.

Long-Term Outcomes After Thoracoamniotic Shunt for Pleural Effusions With Secondary Hydrops.

BACKGROUND: Congenital pleural effusion is a rare condition with an incidence of approximately one per 15,000 pregnancies. The development of secondary hydrops is a poor prognostic indicator and such cases can be managed with a thoracoamniotic shunt (TAS). Our objective is to describe postnatal outcomes in survivors after TAS placement for congenital pleural effusions. MATERIALS AND METHODS: A retrospective study of all cases with fetal pleural effusions treated between 2006 and 2016. Patients with dominant unilateral or bilateral pleural effusions complicated by secondary hydrops fetalis received TAS placement. The results are reported as median (range). RESULTS: A total of 29 patients with pleural effusion with secondary hydrops underwent TAS placement. The gestational age at the initial TAS placement was 27.6 (20.3-36.9) wk. Before delivery, hydrops resolved in 17 (58.6%) patients. The delivery gestational age was 35.7 (25.4-41.0) wk and the overall survival rate was 72.4%. Among the 21 survivors, 19 (90.5%) required admission to the neonatal intensive care unit for 15 (5-64) d. All 21 survivors had postnatal resolution of the pleural effusions. All 21 children were long-term survivors, with a median age of survivorship of 3 y 3 mo (9 mo-7 y 6 mo) at the time of last reported follow-up. CONCLUSIONS: Thoracoamniotic shunting in fetuses with a dominant pleural effusion(s) and secondary hydrops resulted in a 72% survival rate. Nearly all survivors required admission to the neonatal intensive care unit. However, a majority did not have significant long-term morbidity.

US Evaluation of Twin Pregnancies: Importance of Chorionicity and Amnionicity.

The twin birth rate is increasing in the United States. Twin pregnancies can be dichorionic or monochorionic (MC). MC twins account for 20% of twin pregnancies but 30% of all-cause pregnancy-related complications. This article describes the imaging findings that establish chorionicity and amnionicity. Ideally, these are established in the first trimester when accuracy is high, but they can also be determined later in pregnancy. Complications unique to MC twin pregnancy include twin-twin transfusion syndrome, twin anemia polycythemia sequence, twin reversed arterial perfusion sequence, and selective fetal growth restriction. The US features, staging systems, and management of these complications are reviewed, and the consequences of MC twin demise are illustrated. Ongoing surveillance for these conditions starts at 16 weeks gestation. Monoamniotic (MA) twins are a small subset of MC twins. In addition to all of the MC complications, specific MA complications include cord entanglement and conjoined twinning. Radiologists must be able to determine chorionicity and amnionicity and should be aware of potential complications so that patients may be referred to appropriate regional specialized centers. A proposed algorithm for referral to specialized fetal treatment centers is outlined. Online supplemental material is available for this article. ©RSNA, 2019.

Amniotic membrane and placental histopathological findings after open and fetoscopic prenatal neural tube defect repair.

OBJECTIVES: To describe and compare placental and amniotic histology in women who underwent a fetoscopic myelomeningocele repair to those who underwent an open hysterotomy myelomeningocele repair. Also, we intended to compare findings from both prenatal repair groups to age-matched control pregnant patients. METHODS: Placental and membrane histopathology from 43 prenatally repaired spina bifida cases (17 fetoscopic and 26 open) and 18 healthy controls were retrospectively assessed. Quantitative assessment of histopathology included apoptosis count and maternal and fetal underperfusion scores. Qualitative assessment included the detection of pigmented macrophages and/or signs of placental/amniotic inflammation. Associations between the duration of surgery or the duration of CO2 insufflation and quantitative histological parameters were tested. RESULTS: Fetoscopic surgery cases did not show significant differences in any of the studied parameters when compared against controls. No differences were detected either when compared with open repaired cases, except for lower proportion of pigmented laden macrophages in the fetoscopic group (11.8% vs 61.5%, P < 0.01). No associations between the duration of surgery or the duration of CO2 exposure and any of the quantitative histological parameters were detected. CONCLUSIONS: These preliminary results support the lack of detrimental effects of the use of heated and humidified CO2 gas for uterine insufflation to fetal membranes and placenta.

New terminology for adverse events of fetal therapy: Re-evaluation of the thoraco-amniotic shunting in a Japanese study.

AIM: Since fetal therapy has been newly developed, objective evaluation of adverse events (AE), all harmful events that are not always related to the procedures, has not yet been adequately reported. We established new terminology and tried to re-evaluate it based on the Japanese prospective thoraco-amniotic shunting (TAS) study. METHODS: From the literature, all complications that occurred with all fetal therapies were identified as a basis for developing the terminology. Grading was set from 0 to 5. Grade 3 was defined as the need for invasive treatment, such as surgery. Grade 4 was defined as life-threatening, and Grade 5 was defined as death of the mother or fetus. Then, one series of TAS that we had already reported was re-evaluated, including 24 cases with 37 procedures and 200 opportunities those could be evaluated AE after procedures. RESULTS: Grade 4 preterm rupture of the membranes was reported in only 1 of 24 cases. Catheter displacement was reported in 7, 2 and 11 cases, of Grades 1, 2 and 3, respectively. It was found that the double-basket catheter had some association with catheter displacement, but it was clear that there were no life-threatening AE. CONCLUSION: Newly developed AE criteria are now available for fetal therapy. They will contribute to the objective evaluation of AE of new fetal therapies in the future.

Treatment of Rhinophyma With Surgical Excision and Amniotic Membrane.

Rhinophyma is a phenotypic subtype of rosacea affecting the nose. It is characterized by phymatous changes, skin thickening/fibrosis, glandular hyperplasia, and chronic inflammation. Treatment of severe rhinophyma is predominantly surgical excision with closure by secondary intention. Amniotic membrane has been used to promote wound healing, fibrosis, and inflammation. In this case study, the authors present a 63-year-old male with longstanding rhinophyma treated with surgical excision with intraoperative placement of amniotic membrane.

The Use of Dehydrated Human Amniotic/Chorionic Membrane Skin Substitute in the Treatment of Pediatric Facial Burn.

BACKGROUND: Facial burns have lasting physical and psychological effects on pediatric patients. Proper management to minimize morbidities challenges reconstructive surgeons. New technologies allowed the development of skin substitutes such as amniotic and chorionic membranes, yet the use of these skin dressings and their impact on burn outcomes have not been sufficiently studied to guide practices. The objective of this study is to report on the outcomes of dehydrated amniotic membrane as a biologic skin dressing in pediatric facial burn injury compared to cadaveric allografts. METHODS: Retrospective review of data collected from our institutional burn registry from 2012 to 2016. The study population included patients younger than 16 years with facial burns. Patients between 2012 and 2014 received cadaveric allografts, whereas during 2015 to 2016 patients received dehydrated human amniotic/chorionic membrane as standard treatment. Demographic characteristics and outcome measures were compared between the 2 groups. RESULTS: Included 30 patients with a mean age of 3.7 years and with an average total body surface area burn of 6.8% (2%-27%). Mean injury severity scores did not significantly differ between both groups, 1.8 in amniotic group versus 2.3 in cadaveric skin group (P > 0.05). There were 4 complications (3 hypertrophic scars and 1 wound infection) in the cadaveric allografts group versus no complications in the amniotic membrane group (P < 0.05). CONCLUSION: Dehydrated amniotic/chorionic membrane wound dressings are a safe alternative to cadaveric allografts in treating pediatric partial thickness facial burns.

Current State of Fetal Intervention for Lower Urinary Tract Obstruction.

PURPOSE OF THE REVIEW: In this article, we explore the origins of intervention of fetal lower urinary tract obstruction, and we specifically discuss the background and recent outcomes of vesicoamniotic shunt placement and fetal cystoscopy. The article seeks to provide a comprehensive overview of the field while bringing the reader quickly up to speed on the pertinent literature and the critical data that are available to guide decision-making regarding intervention. RECENT FINDINGS: Appropriate patient selection for fetal intervention remains challenging despite advances in prenatal imaging. Both a randomized controlled trial and multiple systematic reviews show evidence of a perinatal survival benefit following fetal intervention but rates of renal morbidity remain very high. Despite 30 years of research, fetal lower urinary tract obstruction remains a difficulty entity to treat. Intervention may lead to survival, but physicians and caregivers must remain alert for the distinct possibility of long-term renal morbidity in survivors.

Abnormally invasive placenta (AIP): pre-cesarean amnion drainage to facilitate exteriorization of the gravid uterus through a transverse skin incision.

The number of pregnant women with abnormally invasive placenta (AIP) including clinical relevant placenta increta and percreta has markedly increased with a reported incidence of as high as one in 731, By 2020 in the United States, there will be an estimated 4504 new cases of AIP and 130 AIP-associated maternal deaths annually. The preoperative diagnosis and operative management of AIP is challenging. In a planned cesarean delivery, a vertical lower abdominal skin incision is widely used in order to have enough space to perform a hysterotomy above the cranial edge of the placenta to avoid significant fetal and/or maternal hemorrhage. We have used preoperative drainage of the amniotic fluid after epidural anesthesia and immediately before a planned cesarean delivery through a transverse skin incision in five patients with AIP of the anterior uterine wall. With less uterine volume, exteriorization of the gravid uterus is easily performed through a transverse laparotomy. The combination of amnion drainage, transverse laparotomy and exteriorization of the gravid uterus facilitates identification of the exact site of placental implantation, provides adequate space for performing fundal or high anterior or even posterior uterine wall incisions and to deliver the fetus safely while minimizing the risk of placental separation and subsequent uncontrolled blood loss. Furthermore, this technique provides the chance to leave the untouched placenta in situ or to remove the placenta in toto with a uterine wall segment.

Autologous Fibroblast-Seeded Amnion for Reconstruction of Neo-vagina in Male-to-Female Reassignment Surgery.

BACKGROUND: Plastic surgeons have used several methods for the construction of neo-vaginas, including the utilization of penile skin, free skin grafts, small bowel or recto-sigmoid grafts, an amnion graft, and cultured cells. PURPOSE: The aim of this study is to compare the results of amnion grafts with amnion seeded with autograft fibroblasts. MATERIALS AND METHODS: Over 8 years, we compared the results of 24 male-to-female transsexual patients retrospectively based on their complications and levels of satisfaction. Sixteen patients in group A received amnion grafts with fibroblasts, and the patients in group B received only amnion grafts without any additional cellular lining. The depths, sizes, secretions, and sensations of the vaginas were evaluated. The patients were monitored for any complications, including over-secretion, stenosis, stricture, fistula formation, infection, and bleeding. RESULTS: The mean age of group A was 28 ± 4 years and group B was 32 ± 3 years. Patients were followed up from 30 months to 8 years, (mean 36 ± 4) after surgery. The depth of the vaginas for group A was 14-16 and 13-16 cm for group B. There was no stenosis in neither group. The diameter of the vaginal opening was 34-38 mm in group A and 33-38 cm in group B. We only had two cases of stricture in the neo-vagina in group B, but no stricture was recorded for group A. All of the patients had good and acceptable sensation in the neo-vagina. Seventy-five percent of patients had sexual experience and of those, 93.7% in group A and 87.5% in group B expressed satisfaction. CONCLUSION: The creation of a neo-vaginal canal and its lining with allograft amnion and seeded autologous fibroblasts is an effective method for imitating a normal vagina. The size of neo-vagina, secretion, sensation, and orgasm was good and proper. More than 93.7% of patients had satisfaction with sexual intercourse. Amnion seeded with fibroblasts extracted from the patient's own cells will result in a vagina with the proper size and moisture that can eliminate the need for long-term dilatation. The constructed vagina has a two-layer structure and is much more resistant to trauma and laceration. No cases of stenosis or stricture were recorded. LEVEL OF EVIDENCE IV: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

Simple limbal epithelial transplantation.

PURPOSE OF REVIEW: Simple limbal epithelial transplant (SLET) is a technique for addressing limbal stem cell deficiency. Limbal tissue from a donor eye, typically the patient's fellow healthy eye, is transplanted onto an amniotic membrane attached to the surface of the diseased eye. SLET was developed to address limitations of other techniques, specifically the technical difficulty of ex-vivo expansion of cells required in some techniques and the larger amount of valuable limbal tissue harvested in techniques not relying on ex-vivo expansion. We described how the provision of this procedure adds to the armamentarium of techniques available to treat some of the many thousands of uniocular corneal blind around the world. RECENT FINDINGS: A total of 125 patients from a recent series from our centre and 68 from a multicentre study provide evidence for efficacy mainly in cases of unilateral corneal burn. Results were comparable to other stem cell techniques described in other papers. Numerous small case reports describe the use of SLET in other contexts including ocular surface squamous neoplasia and pterygium excision. SUMMARY: SLET offers a cheaper and perhaps safer alternative to other techniques. Further evaluation of clinical success against its most similar analogues of conjunctival limbal autograft and cultivated limbal autograft is required.

Predictors of mode of birth and duration of labour following induction using prostaglandin vaginal gel.

BACKGROUND AND AIMS: Using data from a randomised controlled trial (RCT) comparing two policies of prostaglandin (PGE2) vaginal gel induction of labour (IOL) at term, this study aimed to determine: (i) demographic/clinical factors that predict IOL outcomes; and (ii) clinical characteristic(s) of women who would benefit from a policy of amniotomy once technically possible as opposed to giving more PGE2. MATERIAL AND METHODS: Following an initial PGE2 dose, women were randomised to amniotomy or repeat-PGE2. Using RCT data, two multivariate models were developed, assessing the relationship between demographic/clinical characteristics and the outcomes of caesarean section (CS), and vaginal delivery within 24 h (VD < 24 h). Regression-equations were used to predict the likelihood of CS and VD < 24 h, varying independent predictors from the multivariate analyses. RESULTS: Of 245 term women undergoing IOL, 90 had a CS, 155 delivered vaginally and 79 had a VD < 24 h. Controlling for confounders, nulliparity [adjusted odds ratio (aOR) = 3.71 (1.55, 8.88)] and modified Bishop's score (MBS) at first review [aOR = 0.78 (0.66, 0.92)] were independently associated with CS. Nulliparity [aOR = 0.06 (0.02, 0.15)], MBS at first review [aOR = 1.66 (1.35, 2.05)], and a policy of early amniotomy [aOR = 2.28 (1.04, 5.00)] were associated with VD < 24 h. Modelling using regression equations, and varying both MBS at first review and parity, there was no scenario where repeat PGE2 was predicted to be superior to an earlier amniotomy. CONCLUSIONS: Following IOL using PGE2 vaginal gel at term, both parity and cervical favourability at first review are associated with CS and VD < 24 h. All combinations of parity and MBS at first review predicted fewer CS and greater likelihood of VD < 24 h with a policy of amniotomy once technically possible.