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OBJECTIVES: To compare the ambulatory status of a cohort of children who had undergone prenatal repair of an open neural tube defect (ONTD) using one of two different methods (fetoscopic or open hysterotomy) with that of a cohort who had undergone postnatal repair, and to identify the best predictors of ambulation at 30 months of age. METHODS: This was a retrospective review of a cohort of children who underwent ONTD repair either prenatally (n = 110), by fetoscopic surgery (n = 73) or open hysterotomy surgery (n = 37), or postnatally (n = 51), in a single tertiary hospital between November 2011 and May 2023. The cohort comprised a consecutive sample of cases who had undergone ONTD repair in-utero following Management of Myelomeningocele Study (MOMS) trial criteria and cases who had undergone postnatal repair, meeting the same criteria, which were also followed up after birth at the same institution. Motor function assessment by ultrasound was recorded at referral, 6 weeks after prenatal repair, or after referral in postnatally repaired cases, and at the last ultrasound scan before delivery. Clinical examinations to assess motor function at birth and at 12 months were retrieved from records. Intact motor function was defined as first sacral myotome (S1) motor function. Ambulatory status data at each follow-up visit were collected. The proportion of children who were able to walk independently after 30 months of age was compared between those who had undergone fetoscopic vs open prenatal surgery and between prenatal (by either fetoscopic or open surgery) and postnatal ONTD repair. Logistic regression analyses were performed to identify predictors for independent ambulation. RESULTS: After 30 months, the proportion of infants who were able to walk independently was higher in prenatally vs postnatally repaired cases (51.8% vs 15.7%, P < 0.01), and there was no difference between those with fetoscopic (52.1%) vs open (51.4%) prenatal repair (P = 0.66). In the prenatally repaired group, having intact motor function at 12 months (adjusted odds ratio (aOR), 9.14 (95% CI, 2.64-31.63), P < 0.01) and at birth (aOR, 4.50 (95% CI, 1.21-16.80), P = 0.02) were significant predictors of independent walking at 30 months; an anatomical level of lesion below L2 at referral (aOR, 1.83 (95% CI, 1.30-2.58), P = 0.01) and female gender (aOR, 3.51 (95% CI, 1.43-8.61), P < 0.01) were also predictive for this outcome. CONCLUSIONS: Prenatally repaired cases of ONTD have a better chance of being able to walk independently at 30 months than do those who undergo postnatal repair. In patients with prenatally repaired ONTD, ambulatory status at 30 months can be predicted by observing a low lesion level at referral (below L2) and intact motor function postnatally. These results have implications for parental counseling and planning for supportive therapy in pregnancies affected by ONTD. © 2024 International Society of Ultrasound in Obstetrics and Gynecology.
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Fetoscopia , Histerotomia , Defeitos do Tubo Neural , Caminhada , Humanos , Fetoscopia/métodos , Feminino , Estudos Retrospectivos , Gravidez , Histerotomia/métodos , Defeitos do Tubo Neural/cirurgia , Defeitos do Tubo Neural/diagnóstico por imagem , Pré-Escolar , Masculino , Resultado do Tratamento , Recém-NascidoRESUMO
OBJECTIVE: To investigate whether prenatal repair of spina bifida aperta through mini-hysterotomy results in less prematurity, as compared to standard hysterotomy, when adjusting for known prematurity risks. METHODS: We performed a bi-centric, propensity score matched, controlled study, that is, adjusting for factors earlier reported to result in premature delivery or membrane rupture, in consecutive women having prenatal repair either through stapled hysterotomy or sutured mini-hysterotomy (≤3.5 cm). Matches were pairwise compared and cox-regression analysis was performed to define the hazard ratio of delivery <37 weeks. RESULTS: Of 346 meeting the MOMS-criteria, 78 comparable pairs were available for matched-controlled analysis. Mini-hysterotomy patients were younger and had a higher BMI. Mini-hysterotomy was associated with a 1.67-lower risk of delivery <37 weeks (hazard ratio: 0.60; 95% CI: 0.42-0.85; p = 0.004) and 1.72 for delivery <34 + 6 weeks (hazard ratio: 0.58; 95% CI: 0.34-0.97; p = 0.037). The rate of intact uterine scar at birth (mini-hysterotomy: 98.7% vs. hysterotomy: 90.4%; p = 0.070), the rate of reversal of hindbrain herniation within 1 week after surgery (88.9% vs. 97.4%; p = 0.180) and the rate of cerebrospinal fluid leakage (0% vs. 2.7%; p = 0.50) were comparable. CONCLUSION: Prenatal spina bidifa repair through mini-hysterotomy was associated with a later gestational age at delivery and a comparable intact uterus rate without apparent compromise in neuroprotection.
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Histerotomia , Espinha Bífida Cística , Humanos , Feminino , Histerotomia/métodos , Histerotomia/estatística & dados numéricos , Histerotomia/efeitos adversos , Gravidez , Adulto , Espinha Bífida Cística/cirurgia , Nascimento Prematuro/epidemiologia , Nascimento Prematuro/prevenção & controle , Recém-Nascido , Disrafismo Espinal/cirurgia , Pontuação de Propensão , Idade GestacionalRESUMO
OBJECTIVE: To compare the occurrence of fetal bradycardia in open versus fetoscopic fetal spina bifida surgery. METHODS: This is a single-institution retrospective cohort study of patients undergoing open (n = 25) or fetoscopic (n = 26) spina bifida repair between 2017 and 2022. From October 2017 to June 2020, spina bifida repairs were performed via an open classical hysterotomy, and from November 2020 to June 2022 fetoscopic repairs were performed following transition to this technique. Fetal heart rate (FHR) in beats per minute (bpm) was recorded via echocardiography every 15 min during the procedure. Cohort characteristics, fetal bradycardia and maternal physiologic parameters were compared between the groups. RESULTS: Fetuses undergoing an open repair more frequently developed bradycardia defined as <110 bpm (32% vs. 3.8%, p = 0.008), and a trend was observed for FHR decreases more than 25 bpm from baseline (20% vs. 3.8%, p = 0.073). Profound bradycardia less than 80 bpm was rare, occurring in only three operations (two in open, one in fetoscopic repair) with two fetuses (one in each group) requiring emergency cesarean delivery. CONCLUSION: When compared to open fetal surgery, fetal bradycardia occurred less frequently in fetoscopic surgery despite a significantly greater anesthetic exposure and the use of the intraamniotic carbon dioxide insufflation.
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Bradicardia , Fetoscopia , Disrafismo Espinal , Humanos , Fetoscopia/métodos , Fetoscopia/efeitos adversos , Bradicardia/etiologia , Bradicardia/epidemiologia , Feminino , Gravidez , Estudos Retrospectivos , Disrafismo Espinal/cirurgia , Disrafismo Espinal/complicações , Adulto , Frequência Cardíaca Fetal , Histerotomia/métodos , Histerotomia/efeitos adversos , Doenças Fetais/cirurgiaRESUMO
INTRODUCTION: Open spina bifida (OSB) is the most common congenital anomaly of the central nervous system. It is associated with severe neurodevelopmental delay, motor impairment, hydrocephalus, and bowel and bladder dysfunction. In selected cases, intrauterine spina bifida repair has been shown to improve neonatal outcomes. Rarely, the spine can have a double defect compromising two different segments and there is a lack of evidence on the feasibility and benefits of intrauterine repair in these cases. CASE PRESENTATION: We present a case with both cervicothoracic and lumbosacral myelomeningocele, Arnold-Chiari malformation type II and bilateral ventriculomegaly, that was treated successfully at 25 weeks with open micro-neurosurgery. Double myelomeningocele was successfully treated through a single 2-cm micro-hysterotomy, by performing external versions to sequentially expose and repair both defects. Weekly postoperative follow-up showed no progression of ventriculomegaly or complications attributable to the procedure. Preterm rupture of membranes prompted a conventional cesarean delivery at 32 weeks of gestation. Neurodevelopmental outcome at 20 months was within normal ranges, having achieved ambulation without orthopedic support and with no need for ventriculoperitoneal shunting. CONCLUSION: This report demonstrates for the first time the feasibility of double OSB repair through a single 2-cm micro-hysterotomy, suggesting that selected isolated cases of double myelomeningocele could be candidates for fetal intervention. Further prospective studies should be carried out to assess the potential benefit of double OSB intrauterine open repair.
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Histerotomia , Meningomielocele , Humanos , Meningomielocele/cirurgia , Meningomielocele/diagnóstico por imagem , Feminino , Histerotomia/métodos , Gravidez , Recém-Nascido , Malformação de Arnold-Chiari/cirurgia , Malformação de Arnold-Chiari/diagnóstico por imagem , Adulto , Terapias Fetais/métodosRESUMO
OBJECTIVES: Open spina bifida (OSB) is the most common neural tube defect. Prenatal repair reduces the need for ventriculoperitoneal shunting (VPS) due to hydrocephalus from 80-90% to 40-50%. We aimed to determine which variables work as risk factors for VPS at 12 months of age in our population. METHODS: Thirty-nine patients underwent prenatal repair of OSB by mini-hysterotomy. The main outcome was occurrence of VPS in the first 12 months of life. Logistic regression was used to estimate the odds ratios (OR) between prenatal variables and the need for shunting. RESULTS: VPS at 12 months occurred in 34.2% of the children. Larger ventricle size before surgery (62.5% ≥15 mm; 46.2% between 12 and 15 mm; 11.8% <12 mm; p=0.008), higher lesion level (80% >L2, vs. 17.9% ≤L3; p=0.002; OR, 18.4 [2.96-114.30]), and later gestational age at surgery (25.25 ± 1.18 vs. 24.37 ± 1.06 weeks; p=0.036; OR, 2.23 [1.05-4.74]) were related to increased need for shunting. In the multivariate analysis, larger ventricle size before surgery (≥15 mm vs. <12 mm; p=0.046; OR, 1.35 [1.01-1.82]) and higher lesion level (>L2 vs. ≤L3; p=0.004; OR, 39.52 [3.25-480.69]) were risk factors for shunting. CONCLUSIONS: Larger ventricle size before surgery (≥15 mm) and higher lesion level (>L2) are independent risk factors for VPS at 12 months of age in fetuses undergoing prenatal repair of OSB by mini-hysterotomy in the studied population.
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Meningomielocele , Disrafismo Espinal , Gravidez , Feminino , Criança , Humanos , Meningomielocele/cirurgia , Histerotomia/efeitos adversos , Disrafismo Espinal/complicações , Disrafismo Espinal/cirurgia , Feto , Fatores de RiscoRESUMO
INTRODUCTION: The uterine caesarean scar defect, also known as uterine niche or isthmocele, is an irregularity in the anterior uterine wall at the site of a previous cesarean section scar. It is associated with obstetrical complications such as caesarean scar, ectopic pregnancy, uterine rupture, and the placenta accreta spectrum. Women with cesarean scar defects are frequently asymptomatic but may also experience abnormal vaginal bleeding, chronic pelvic pain, and infertility. METHODS: This systematic review aims to determine the best hysterotomy closure technique to prevent subsequent development of uterine scar defects. An electronic search in Medline, Embase, Cochrane Database of Systematic Reviews, ClinicalTrials.gov was performed from January 2001 until December 2020 for studies evaluating hysterotomy closure techniques. RESULTS: Our systematic search strategy identified 1,781 titles. Six studies fulfilled inclusion criteria and were included in the final analysis. The results supported the superiority of the double-layer closure over the single-layer closure. CONCLUSIONS: Hysterotomy closure with continuous running sutures in two layers represents a suitable option to prevent cesarean scar defect formation. Particularly, the first layer should include the decidua and the second layer should overlap the first.
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Cicatriz , Histerotomia , Feminino , Humanos , Gravidez , Cesárea/efeitos adversos , Cicatriz/complicações , Histerotomia/efeitos adversos , Histerotomia/métodos , Útero/cirurgiaRESUMO
OBJECTIVE: To compare perioperative outcomes between knotless barbed sutures (KBSs) and conventional smooth sutures for uterine incision closure at cesarean section. DATA SOURCES: MEDLINE, EMBASE, Web of Sciences, Scopus, the Cochrane Library, and ClinicalTrials.gov were searched from the inception of the study to March 2021 without language restriction. The search terms were as follows: ["Stratafix" OR "Quill" OR "V-Loc" OR "Barbs" OR "barbed"] AND ["Cesarean" OR "Caesarean"] AND ["Suturing" OR "Suture" OR "Closure" OR "Repair"]. Moreover, these terms were combined to complete the search. METHODS OF STUDY SELECTION: Retrospective and randomized peer-reviewed studies comparing the use of KBSs and conventional sutures for uterine incision closure at cesarean section were included. The studies' quality was assessed by the Cochrane risk-of-bias tool. The primary outcome was the time of uterine incision closure in seconds. The secondary outcomes included total operating time (minutes), use of additional hemostatic sutures, rates of blood transfusion, and postoperative complications. TABULATION, INTEGRATION, AND RESULTS: Of 20 reports identified, 4 representing 3332 women (1473 with KBSs and 1859 with conventional sutures) were eligible. All studies were judged to be at low risk of bias. The uterine incision closure time was significantly lower in the KBS group (mean difference, -110.58; 95% confidence interval [CI], -127.37 to -93.79; p = .001). Furthermore, the rate of use of additional hemostatic sutures was significantly lower in the KBS group (odds ratio, 0.14; 95% CI, 0.07-0.26; p = .001). Total operative time, rates of blood transfusion, febrile morbidity, and length of postoperative stay were comparable. The incidence of postoperative ileus was significantly lower in the KBS group (odds ratio, 0.31; 95% CI, 0.11-0.89; p = .029). CONCLUSION: The use of KBSs for uterine incision closure was associated with decreased hysterotomy closure time and less frequent need for the placement of additional hemostatic sutures. Other perioperative outcomes were not affected, although the risk of postoperative ileus was reduced.
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Hemostáticos , Íleus , Cesárea/efeitos adversos , Feminino , Humanos , Histerotomia , Complicações Pós-Operatórias/etiologia , Gravidez , Estudos Retrospectivos , Técnicas de Sutura/efeitos adversos , Suturas/efeitos adversosRESUMO
OBJECTIVE: To compare the prevalence and size of residual niche in the nongravid uterus following Cesarean delivery (CD) with different hysterotomy closure techniques (HCTs). METHODS: Saline infusion sonohysterogram (SIS) was performed in women after one prior CD, documenting the presence or absence of a postoperative niche and measuring its depth, width, length, and residual myometrial thickness. Women were grouped by HCT: Technique A (endometrium-free) and Technique B (routine non-endometrium-free). The primary outcome was the prevalence of a clinically significant niche, defined as a depth of >2 mm. HCT groups were compared using χ2 , T-test (ANOVA), and analyzed using logistic regression and two-sided test (P < .05). RESULTS: Forty-five women had SIS performed, 25 and 20 via Technique A and B, respectively. Technique groups varied by average interval time from CD to SIS (13.6 versus 74.5 months, P = 0.006) but were otherwise similar. Twenty niches were diagnosed, 85% of which were clinically significant, including five following Technique A, nine following Technique B with double-layer closure, and three following Technique B with single-layer (P = .018). The average niche depth was 2.4 mm and 4.9 mm among the two-layer subgroups following Techniques A and B, respectively (P = .005). A clinically significant niche development was six times higher with Technique B when compared to Technique A (OR 6.0, 95% CI 1.6-22.6, P = .008); this significance persisted after controlling for SIS interval on multivariate analysis (OR 4.4, 95% CI 1.1-18.3, P = .04). The average niche depth was 5.7 ± 2.9 mm following Technique B with single-layer. CONCLUSION: Hysterotomy closure techniques determine the prevalence of post-Cesarean delivery niche formation and size. Exclusion of the endometrium at uterine closure reduces the development of significant scar defects.
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Cesárea , Histerotomia , Cicatriz/diagnóstico por imagem , Cicatriz/patologia , Feminino , Humanos , Histerotomia/métodos , Gravidez , Ultrassonografia/métodos , Útero/diagnóstico por imagem , Útero/patologia , Útero/cirurgiaRESUMO
OBJECTIVE: The study aimed to assess the feasibility of creating and transplanting human umbilical cord mesenchymal stem cell sheets applied to a rat model of hysterotomy, and additionally to determine benefits of human umbilical cord mesenchymal stem cell sheet transplantation in reducing uterine fibrosis and scarring. STUDY DESIGN: Human umbilical cord mesenchymal stem cell sheets are generated by culturing human umbilical cord mesenchymal stem cells on thermo-responsive cell culture plates. The temperature-sensitive property of these culture dishes facilitates normal cell culture in a thin contiguous layer and allows for reliable recovery of intact stem cell sheets without use of destructive proteolytic enzymes.We developed a rat hysterotomy model using nude rats. The rat uterus has two distinct horns: one horn provided a control/untreated scarring site, while the second horn was the cell sheet transplantation site.On day 14 following surgery, complete uteri were harvested and subjected to histologic evaluations of all hysterotomy sites. RESULTS: The stem cell sheet culture process yielded human umbilical cord mesenchymal stem cell sheets with surface area of approximately 1 cm2.Mean myometrial thickness in the cell sheet-transplanted group was 274 µm compared with 191 µm in the control group (p = 0.02). Mean fibrotic surface area in the human umbilical cord mesenchymal stem cell sheet-transplanted group was 95,861 µm2 compared with 129,185 µm2 in the control group. Compared with control horn sites, cell sheet-transplanted horns exhibited significantly smaller fibrotic-to-normal myometrium ratios (0.18 vs. 0.27, respectively, p = 0.029). Mean number of fibroblasts in cell sheet-transplanted horns was significantly smaller than the control horns (483 vs. 716/mm2, respectively, p = 0.001). CONCLUSION: Human umbilical cord mesenchymal stem cell sheet transplantation is feasible in a rat model of hysterotomy. Furthermore, use of stem cell sheets reduces fibroblast infiltration and uterine scar fibrotic tissue formation during hysterotomy healing, potentially mitigating risks of uterine scar formation. KEY POINTS: · Stem cell sheet transplanted to hysterotomy promotes myometrial regeneration and reduced fibrotic tissue formation.. · This study demonstrates the feasibility of using human umbilical cord mesenchymal stem cell sheets..
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Transplante de Células-Tronco Mesenquimais , Células-Tronco Mesenquimais , Animais , Cicatriz , Feminino , Humanos , Histerotomia , Gravidez , Ratos , Roedores , ÚteroRESUMO
INTRODUCTION: Uterine incision based on the placental location in open maternal-fetal surgery (OMFS) has never been evaluated in regard to maternal or fetal outcomes. OBJECTIVE: The aim of this study was to investigate whether an anterior placenta was associated with increased rates of intraoperative, perioperative, antepartum, obstetric, or neonatal complications in mothers and babies who underwent OMFS for fetal myelomeningocele (fMMC) closure. METHODS: Data from the international multicenter prospective registry of patients who underwent OMFS for fMMC closure (fMMC Consortium Registry, December 15, 2010-June 31, 2019) was used to compare fetal and maternal outcomes between anterior and posterior placental locations. RESULTS: The placental location for 623 patients was evenly distributed between anterior (51%) and posterior (49%) locations. Intraoperative fetal bradycardia (8.3% vs. 3.0%, p = 0.005) and performance of fetal resuscitation (3.6% vs. 1.0%, p = 0.034) occurred more frequently in cases with an anterior placenta when compared to those with a posterior placenta. Obstetric outcomes including membrane separation, placental abruption, and spontaneous rupture of membranes were not different among the 2 groups. However, thinning of the hysterotomy site (27.7% vs. 17.7%, p = 0.008) occurred more frequently in cases of an anterior placenta. Gestational age (GA) at delivery (p = 0.583) and length of stay in the neonatal intensive care unit (p = 0.655) were similar between the 2 groups. Fetal incision dehiscence and wound revision were not significantly different between groups. Critical clinical outcomes including fetal demise, perinatal death, and neonatal death were all infrequent occurrences and not associated with the placental location. CONCLUSIONS: An anterior placental location is associated with increased risk of intraoperative fetal resuscitation and increased thinning at the hysterotomy closure site. Individual institutional experiences may have varied, but the aggregate data from the fMMC Consortium did not show a significant impact on the GA at delivery or maternal or fetal clinical outcomes.
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Terapias Fetais , Meningomielocele , Feminino , Terapias Fetais/efeitos adversos , Idade Gestacional , Humanos , Histerotomia/efeitos adversos , Recém-Nascido , Meningomielocele/etiologia , Meningomielocele/cirurgia , Placenta/cirurgia , GravidezRESUMO
The purpose of this study was to compare the short-term operative outcomes of three different surgical techniques for uterine incision closure during caesarean section (CS). This trial enrolled 120 patients scheduled for primary caesarean delivery. Patients were randomised into either classical double-layer uterine closure, purse-string double-layer uterine closure (Turan), or our new approach of uterine closure (double layer step up-step down technique). For short-term comparison, transvaginal ultrasonography was planned for all patients 6 weeks after surgery. Compared to group II and Group III, residual myometrial thickness was significantly thinner in group I (p < .001). The number of patients with uterine niche was 10 (50% of all scar defects) in group I whereas it was 4 (20%) in group II and 6 (30%) in group III. Operative time was significantly longer in group II (p < .001). This led to our conclusion that Turan technique and our new approach are associated with thicker myometrial thickness and less frequency of uterine scar defect than classical double-layer uterine incision closure; however, our approach takes less operative time. Clinical Trial Registration: ClinicalTrials.gov Identifier: NCT04681378Impact statementWhat is already known on this subject? Many variations in CS technique have been studied. For example, single-layer uterine incision closure has been compared to double-layer uterine incision closure. Purse string double layer (Turan) has been also compared to the traditional double-layer technique. Double layer unlocked closure has been shown to result in a thicker residual myometrium and as a consequence can possibly lead to the decrease of niche development after a CS compared to single-layer closure with lower frequency of uterine scar defect with Turan technique.What do the results of this study add? Here we introduce a new uterine closure technique, which we have named double-layer step up-step down technique, as an alternative method. With this technique, the uterine incision contract more than with the traditional double layer technique and has similar results to the Turan technique; however, our approach takes less operative time.What are the implications of these findings for clinical practice and/or further research? These alternative techniques of uterine incision closure decrease the frequency of uterine niche that may be associated with many clinical problems such as ectopic pregnancy at the CS scar, placenta accreta, rupture of the uterus during a subsequent pregnancy. Future studies are needed to investigate the frequency of uterine rupture in a subsequent pregnancy following different uterine incision closure techniques.
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Cesárea , Técnicas de Sutura , Cesárea/efeitos adversos , Cesárea/métodos , Cicatriz/etiologia , Cicatriz/cirurgia , Feminino , Humanos , Histerotomia , Gravidez , Útero/cirurgiaRESUMO
BACKGROUND: In utero closure of meningomyelocele using an open hysterotomy approach is associated with preterm delivery and adverse neonatal outcomes. OBJECTIVE: This study compared the neonatal outcomes in in utero meningomyelocele closure using a 2-port, exteriorized uterus, fetoscopic approach vs the conventional open hysterotomy approach. STUDY DESIGN: This retrospective cohort study included all consecutive patients who underwent in utero meningomyelocele closure using open hysterotomy (n=44) or a 2-port, exteriorized uterus, fetoscopic approach (n=46) at a single institution between 2012 and 2020. The 2-port, exteriorized uterus, fetoscopic closure was composed of the following 3 layers: a bovine collagen patch, a myofascial layer, and a skin. The frequency of respiratory distress syndrome and a composite of other adverse neonatal outcomes, including retinopathy of prematurity, periventricular leukomalacia, and perinatal death, were compared between the study groups. Regression analyses were performed to determine any association between the fetoscopic closure and adverse neonatal outcomes, adjusted for several confounders, including gestational age of <37 weeks at delivery. RESULTS: The fetoscopic closure was associated with a lower rate of respiratory distress syndrome than the open hysterotomy closure (11.5% [5 of 45] vs 29.5% [13 of 44]; P=.037). The proportion of neonates with a composite of other adverse neonatal outcomes in the fetoscopic group was half of that observed patients in the open hysterotomy group; however, this difference did not reach statistical significance (4.3% [2 of 46] vs 9.1% [4 of 44]; P=.429). Here, regression analysis has demonstrated that fetoscopic meningomyelocele closure was associated with a lower risk of respiratory distress syndrome (adjusted odds ratio, 0.23; 95% confidence interval, 0.06-0.84; P=.026) than open hysterotomy closure. CONCLUSION: In utero meningomyelocele closure using a 2-port, exteriorized uterus, fetoscopic approach was associated with a lower risk of respiratory distress syndrome than the conventional open hysterotomy meningomyelocele closure.
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Fetoscopia/métodos , Histerotomia/métodos , Meningomielocele/cirurgia , Adulto , Estudos de Coortes , Feminino , Humanos , Recém-Nascido , Pessoa de Meia-Idade , Gravidez , Síndrome do Desconforto Respiratório do Recém-Nascido/epidemiologia , Estudos Retrospectivos , Adulto JovemRESUMO
BACKGROUND: The multicenter randomized controlled trial Management of Myelomeningocele Study demonstrated that prenatal repair of open spina bifida by hysterotomy, compared with postnatal repair, decreases the need for ventriculoperitoneal shunting and increases the chances of independent ambulation. However, the hysterotomy approach is associated with risks that are inherent to the uterine incision. Fetal surgeons from around the world embarked on fetoscopic open spina bifida repair aiming to reduce maternal and fetal/neonatal risks while preserving the neurologic benefits of in utero surgery to the child. OBJECTIVE: This study aimed to report the main obstetrical, perinatal, and neurosurgical outcomes in the first 12 months of life of children undergoing prenatal fetoscopic repair of open spina bifida included in an international registry and to compare these with the results reported in the Management of Myelomeningocele Study and in a subsequent large cohort of patients who received an open fetal surgery repair. STUDY DESIGN: All known centers performing fetoscopic spina bifida repair were contacted and invited to participate in a Fetoscopic Myelomeningocele Repair Consortium and enroll their patients in a registry. Patient data entered into this fetoscopic registry were analyzed for this report. Fisher exact test was performed for comparison of categorical variables in the registry with both the Management of Myelomeningocele Study and a post-Management of Myelomeningocele Study cohort. Binary logistic regression analyses were used to assess the registry data for predictors of preterm birth at <30 weeks' gestation, preterm premature rupture of membranes, and need for postnatal cerebrospinal fluid diversion in the fetoscopic registry. RESULTS: There were 300 patients in the fetoscopic registry, 78 in the Management of Myelomeningocele Study, and 100 in the post-Management of Myelomeningocele Study cohort. The 3 data sets showed similar anatomic levels of the spinal lesion, mean gestational age at delivery, distribution of motor function compared with upper anatomic level of the lesion in the neonates, and perinatal death. In the Management of Myelomeningocele Study (26.16±1.6 weeks) and post-Management of Myelomeningocele Study cohort (23.3 [20.2-25.6] weeks), compared with the fetoscopic registry group (23.6±1.4 weeks), the gestational age at surgery was lower (comparing fetoscopic repair group with the Management of Myelomeningocele Study; P<.01). After open fetal surgery, all patients were delivered by cesarean delivery, whereas in the fetoscopic registry approximately one-third were delivered vaginally (P<.01). At cesarean delivery, areas of dehiscence or thinning in the scar were observed in 34% of cases in the Management of Myelomeningocele Study, in 49% in the post-Management of Myelomeningocele Study cohort, and in 0% in the fetoscopic registry (P<.01 for both comparisons). At 12 months of age, there was no significant difference in the number of patients requiring treatment for hydrocephalus between those in the fetoscopic registry and the Management of Myelomeningocele Study. CONCLUSION: Prenatal and postnatal outcomes up to 12 months of age after prenatal fetoscopic and open fetal surgery repair of open spina bifida are similar. Fetoscopic repair allows for having a vaginal delivery and eliminates the risk of uterine scar dehiscence, therefore protecting subsequent pregnancies of unnecessary maternal and fetal risks.
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Cuidado Pré-Natal , Espinha Bífida Cística/cirurgia , Adolescente , Adulto , Feminino , Fetoscopia , Saúde Global , Humanos , Histerotomia , Pessoa de Meia-Idade , Procedimentos Neurocirúrgicos , Guias de Prática Clínica como Assunto , Gravidez , Sociedades Médicas , Adulto JovemRESUMO
OBJECTIVE: Cesarean delivery is the most prevalent surgical procedure worldwide, reaching approximately 29.7 million cases in 2015. It is directly associated with an increased risk of maternal and neonatal morbidity rates in the absence of malpresentation. Several techniques have been investigated, and there is evidence that cephalad-caudad expansion of the uterine incision might be associated with improved maternal outcomes compared with traditional transverse blunt expansion. The purpose of this meta-analysis was to evaluate the impact of cephalad-caudad expansion on adverse maternal outcomes, including intraoperative blood loss, risk of uterine vessel injury, and tearing of the lower uterine segment. DATA SOURCES: We searched Medline, Scopus, the Cochrane Central Register of Controlled Trials, Google Scholar, and Clinicaltrials.gov databases from inception to January 2021. STUDY ELIGIBILITY CRITERIA: Randomized controlled trials that assessed the impact of the cephalad-caudad blunt expansion of the low transverse uterine incision during cesarean delivery rather than those of transverse blunt expansion were selected for inclusion. METHODS: Effect sizes were calculated with the Hartung-Knapp-Sidik-Jonkman random-effects model in R. Trial sequential analysis was performed to evaluate the adequacy of sample sizes. RESULTS: Cephalad-caudad blunt expansion of the uterine incision was associated with a lower prevalence of unintended incision extension (relative risk, 0.62; 95% confidence interval, 0.45-0.86) and uterine vessel injury (relative risk, 0.55; 95% confidence interval 0.41-0.73). However, these complications were not accompanied by the increased need for additional suture placement (relative risk, 0.62; 95% confidence interval, 0.31-4.12) or transfusion rates (relative risk, 0.75; 95% confidence interval, 0.28-2.03). Similarly, the intraoperative duration was comparable with cases treated with transverse blunt expansion (mean difference = -0.45 minutes; 95% confidence interval -2.12 to 1.21) and the risk of intentional incision extension in the form of an inverted T (relative risk, 0.38; 95% confidence interval, 0.09-1.52). Trial sequential analysis revealed that the required sample size was reached in the unintended incision extension and uterine vessel injury outcomes. CONCLUSION: The findings of our study suggested that cephalad-caudad blunt expansion of the uterine incision is superior to transverse expansion in terms of reducing unintended incision extension and uterine vessel injury.
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Cesárea/métodos , Histerotomia/métodos , Complicações Intraoperatórias/epidemiologia , Complicações Pós-Operatórias/epidemiologia , Lesões do Sistema Vascular/epidemiologia , Transfusão de Sangue/estatística & dados numéricos , Dissecação/métodos , Feminino , Humanos , Duração da Cirurgia , Gravidez , Ensaios Clínicos Controlados Aleatórios como Assunto , Útero/irrigação sanguínea , Útero/cirurgia , Técnicas de Fechamento de Ferimentos/estatística & dados numéricosRESUMO
OBJECTIVE: To identify predictors for intact motor function (MF) at birth and at 12 months of life in babies with prenatally versus postnatally repaired open spina bifida (OSB). DESIGN: Retrospective cohort study. SETTING: Texas Children's Hospital, 2011-2018. POPULATION: Patients who underwent either prenatal or postnatal OSB repair. METHODS: Prenatal MF of the lower extremities was evaluated by ultrasound following a metameric distribution at the time of diagnosis (US1), 6 weeks postoperatively (or 6 weeks after initial evaluation in postnatally repaired cases) (US2) and at the last ultrasound before delivery (US3). At birth and at 12 months, MF was assessed clinically. Intact MF (S1) was defined as the observation of plantar flexion of the ankle. Results from logistic regression analysis are expressed as odds ratios (95% confidence intervals, P values). RESULTS: A total of 127 patients were included: 93 with prenatal repair (51 fetoscopic; 42 open hysterotomy repair) and 34 with postnatal repair. In the prenatal repair group, predictors for intact MF at birth and at 12 months included: absence of clubfeet (OR 11.3, 95% CI 3.2-39.1, P < 0.01; OR 10.8 95% CI 2.4-47.6, P < 0.01); intact MF at US1 (OR 19.7, 95% CI 5.0-76.9, P < 0.01; OR 8.7, 95% CI 2.0-38.7, P < 0.01); intact MF at US2 (OR 22, 95% CI 6.5-74.2, P < 0.01; OR 13.5, 95% 3.0-61.4, P < 0.01); intact MF at US3 (OR 13.7, 95% CI 3.4-55.9, P < 0.01; OR 12.6, 95% CI 2.5-64.3, P < 0.01); and having a flat lesion (OR 11.2, 95% CI 2.4-51.1, P < 0.01; OR 4.1, 95% CI 1.1-16.5, P = 0.04). In the postnatal repair group, the only predictor of intact MF at 12 months was having intact MF at birth (OR 15.2, 95% CI 2.0-113.3, P = 0.03). CONCLUSIONS: The detection of intact MF in utero from mid-gestation to delivery predicts intact MF at birth and at 12 months in babies who undergo prenatal OSB repair. TWEETABLE ABSTRACT: Detection of intact motor function in utero predicts intact motor function at birth and at 1 year in fetuses who undergo prenatal OSB repair.
Assuntos
Doenças Fetais/cirurgia , Fetoscopia , Histerotomia , Atividade Motora/fisiologia , Espinha Bífida Cística/fisiopatologia , Espinha Bífida Cística/cirurgia , Feminino , Doenças Fetais/diagnóstico por imagem , Doenças Fetais/fisiopatologia , Humanos , Lactente , Recém-Nascido , Masculino , Gravidez , Estudos Retrospectivos , Fatores de Risco , Espinha Bífida Cística/diagnóstico por imagem , Resultado do Tratamento , Ultrassonografia Pré-NatalRESUMO
OBJECTIVES: (1) To compare brain findings between large and non-large neural tube defect (NTD); (2) to evaluate the impact of large lesion on the surgical parameters; (3) to study any associations between the size of the lesions and brain findings 6 weeks postoperatively and neurological short-term outcomes. DESIGN: Retrospective cohort study. SETTING: Texas Children's Hospital, between 2011 and 2018. POPULATION: Patients who underwent prenatal NTD repair. METHODS: Large lesion was defined when the lesion's surface was >75th centile of our cohorts' lesions. MAIN OUTCOME MEASURES: Time of referral: ventriculomegaly and anatomical level of the lesion; surgery: duration and need for relaxing incisions. 6 weeks postoperative: hindbrain herniation (HBH) and ventriculomegaly. After delivery: dehiscence, need for hydrocephalus treatment and motor function. RESULTS: A total of 99 patients were included, 25 of whom presented with large lesions. Type of lesion and ventriculomegaly were comparable between individuals with large and non-large lesions. Individuals with large lesions were associated with increased need for relaxing incisions by 5.4 times (95% CI 1.3-23.2, P = 0.02). Six weeks postoperatively, having a large lesion decreased by ten times the likelihood of having a postoperative reversal of HBH (odds ratio = 0.1, 95% CI 0.1-0.4, P < 0.01). At birth, larger lesions increased the risk for repair dehiscence by 6.1 times (95% CI 1.6-22.5, P < 0.01) and the risk of dehiscence or leakage of cerebrospinal fluid at birth by 5.5 times (95% CI 1.6-18.9, P < 0.01). CONCLUSION: Prenatal repair of patients with large NTD presents a lower proportion of HBH reversal 6 weeks after the surgery, a higher risk of dehiscence and a higher need for postnatal repair. TWEETABLE ABSTRACT: Evaluation of the size of fetal NTD can predict adverse neurological outcomes after prenatal NTD repair.
Assuntos
Doenças Fetais/diagnóstico por imagem , Doenças Fetais/cirurgia , Defeitos do Tubo Neural/diagnóstico por imagem , Defeitos do Tubo Neural/cirurgia , Feminino , Doenças Fetais/patologia , Fetoscopia , Humanos , Histerotomia , Recém-Nascido , Imageamento por Ressonância Magnética , Masculino , Atividade Motora/fisiologia , Defeitos do Tubo Neural/patologia , Gravidez , Diagnóstico Pré-Natal , Estudos Retrospectivos , Resultado do TratamentoRESUMO
OBJECTIVE: To compare the evolution of motor function from mid-gestation to 12 months of age between prenatally and postnatally repaired cases of open neural tube defect (ONTD). METHODS: This was a retrospective cohort study of all fetuses that underwent prenatal (fetoscopic or open hysterotomy) or postnatal ONTD repair at a single institution between November 2011 and December 2018. The anatomical level of the lesion was defined as the upper bony spinal defect at initial magnetic resonance imaging assessment. Prenatal motor function of the lower extremities was evaluated by ultrasound according to the metameric level of the neurological lesion, based on the methodology of Carreras et al. Fetal motor function was assessed at referral, at 6 weeks after surgery in prenatally repaired cases or 6 weeks after referral in postnatally repaired cases (6-week follow-up) and at the last scan before delivery. In addition, motor function was assessed by a detailed neurological examination at birth and 12 months of age. First sacral (S1) neurological level of the lesion was considered as intact motor function. For statistical comparisons, we attributed numerical scores to each neurological level and motor function was expressed as median (range) neurological level. Motor function (as numerical score) and the proportion of cases with intact motor function and with motor function two or more levels better than expected based on the anatomical level of the lesion were compared between the prenatal- and postnatal-repair groups. Fetal motor function was compared to the anatomical level of the lesion at referral and a better motor function was defined when it was two or more levels better than the anatomical level of the lesion. To assess the evolution of motor function, we compared motor function at referral with that at each follow-up assessment using paired t-tests. RESULTS: We included 127 patients with ONTD, of whom 93 underwent prenatal (51 fetoscopic and 42 open hysterotomy) and 34 postnatal repair. At the time of referral, cases in the prenatal- and postnatal-repair groups presented with a similar anatomical level of lesion (L3 (T9-S1) vs L3 (T7-S1); P = 0.52), similar motor function (S1 (L1-S1) vs S1 (L1-S1); P = 0.52) and a similar proportion of cases with intact motor function (81% vs 79%; P = 0.88) and with motor function two or more levels better than expected based on the anatomical level of the lesion (62% vs 74%; P = 0.24). When compared with prenatally repaired cases, postnatally repaired cases showed worse motor function at birth (S1 (L1-S1) vs L4 (L1-S1); P < 0.01) and at 12 months of age (S1 (L1-S1) vs L4 (L1-S1); P < 0.01). In the prenatal-repair group, motor function remained stable from the time of referral to 12 months of age (P = 0.26). Furthermore, the proportion of patients with intact motor function at referral (81% (75/93)) was similar to that at the 6-week follow-up (74% (64/87)), at the last scan before birth (74% (42/57)), at birth (68% (63/93)) and at 12 months of age (67% (39/58)) in the prenatal-repair group. In the postnatal-repair group, worse motor function, starting from the third trimester to 12 months of age, was observed. The proportion of patients with intact motor function at referral (79% (27/34)) was similar to that at 6-week follow-up (80% (12/15); P = 0.92), but was lower at the last assessment before birth (25% (2/8); P < 0.01), at birth (24% (8/34); P < 0.01) and at 12 months of age (28% (7/25); P < 0.01). Similar findings were noted when assessing the evolution of the proportion of cases with motor function two or more levels better than expected based on the anatomical level of the lesion in each group. CONCLUSIONS: Infants with ONTD that underwent postnatal repair had worse motor function at birth and at 12 months of age than at mid-gestation and when compared with infants that underwent prenatal ONTD repair. Prenatal motor function assessment by ultrasound is an adequate tool to identify those infants who should have a good clinical motor function after delivery. Information obtained by fetal motor function assessment can have an important role for patient counseling and case selection for surgery. © 2020 International Society of Ultrasound in Obstetrics and Gynecology.
Assuntos
Atividade Motora , Defeitos do Tubo Neural/cirurgia , Adulto , Estudos de Coortes , Feminino , Fetoscopia , Humanos , Histerotomia , Lactente , Recém-Nascido , Estudos Longitudinais , Masculino , Gravidez , Estudos Retrospectivos , Resultado do TratamentoRESUMO
OBJECTIVE: A trial comparing prenatal with postnatal open spina bifida (OSB) repair established that prenatal surgery was associated with better postnatal outcome. However, in the trial, fetal surgery was carried out through hysterotomy. Minimally invasive approaches are being developed to mitigate the risks of open maternal-fetal surgery. The objective of this study was to investigate the impact of a novel neurosurgical technique for percutaneous fetoscopic repair of fetal OSB, the skin-over-biocellulose for antenatal fetoscopic repair (SAFER) technique, on long-term postnatal outcome. METHODS: This study examined descriptive data for all patients undergoing fetoscopic OSB repair who had available 12- and 30-month follow-up data for assessment of need for cerebrospinal fluid (CSF) diversion and need for bladder catheterization and ambulation, respectively, from eight centers that perform prenatal OSB repair via percutaneous fetoscopy using a biocellulose patch between the neural placode and skin/myofascial flap, without suture of the dura mater (SAFER technique). Univariate and multivariate logistic regression analyses were used to examine the effect of different factors on need for CSF diversion at 12 months and ambulation and need for bladder catheterization at 30 months. Potential cofactors included gestational age at fetal surgery and delivery, preoperative ultrasound findings of anatomical level of the lesion, cerebral lateral ventricular diameter, lesion type and presence of bilateral talipes, as well as postnatal findings of CSF leakage at birth, motor level, presence of bilateral talipes and reversal of hindbrain herniation. RESULTS: A total of 170 consecutive patients with fetal OSB were treated prenatally using the SAFER technique. Among these, 103 babies had follow-up at 12 months of age and 59 had follow-up at 30 months of age. At 12 months of age, 53.4% (55/103) of babies did not require ventriculoperitoneal shunt or third ventriculostomy. At 30 months of age, 54.2% (32/59) of children were ambulating independently and 61.0% (36/59) did not require chronic intermittent catheterization of the bladder. Multivariate logistic regression analysis demonstrated that significant prediction of need for CSF diversion was provided by lateral ventricular size and type of lesion (myeloschisis). Significant predictors of ambulatory status were prenatal bilateral talipes and anatomical and functional motor levels of the lesion. There were no significant predictors of need for bladder catheterization. CONCLUSION: Children who underwent prenatal OSB repair via the percutaneous fetoscopic SAFER technique achieved long-term neurological outcomes similar to those reported in the literature after hysterotomy-assisted OSB repair. © 2021 The Authors. Ultrasound in Obstetrics & Gynecology published by John Wiley & Sons Ltd on behalf of International Society of Ultrasound in Obstetrics and Gynecology.
Assuntos
Fetoscopia/estatística & dados numéricos , Procedimentos Neurocirúrgicos/estatística & dados numéricos , Espinha Bífida Cística/cirurgia , Cateterismo Urinário/estatística & dados numéricos , Ventriculostomia/estatística & dados numéricos , Caminhada/estatística & dados numéricos , Feminino , Fetoscopia/métodos , Feto/cirurgia , Seguimentos , Idade Gestacional , Humanos , Histerotomia/métodos , Histerotomia/estatística & dados numéricos , Lactente , Recém-Nascido , Modelos Logísticos , Procedimentos Neurocirúrgicos/métodos , Período Pós-Operatório , Gravidez , Espinha Bífida Cística/complicações , Espinha Bífida Cística/embriologia , Resultado do Tratamento , Bexiga Urinária , Derivação Ventriculoperitoneal/estatística & dados numéricosRESUMO
OBJECTIVE: Fetal repair of an open neural tube defect (ONTD) by open hysterotomy has been shown to reduce the need for ventriculoperitoneal shunting and improve motor outcomes for infants, but increases the risk of Cesarean section and prematurity. Fetoscopic repair is an alternative approach that may confer similar neurological benefits but allows for vaginal delivery and reduces the incidence of hysterotomy-related complications. We sought to compare the costs of care from fetal surgery until neonatal discharge, as well as the clinical outcomes, associated with each surgical approach. METHODS: This was a retrospective cohort study of patients who underwent prenatal ONTD repair, using either the open-hysterotomy or the fetoscopic approach, at a single institution between 2012 and 2018. Clinical outcomes were collected by chart review. A cost-consequence analysis was conducted from the hospital perspective, and included all inpatient and ambulatory hospital and physician costs incurred for the care of mothers and their infants, from the time of maternal admission for fetal ONTD repair up to postnatal maternal and infant discharge. Costs were estimated using cost-to-charge ratios for hospital billing and the Medicare physician fee schedule for physician billing. RESULTS: Seventy-eight patients were included in the analysis, of whom 47 underwent fetoscopic repair and 31 underwent open-hysterotomy repair. In the fetoscopic-repair group, compared with the open-repair group, fewer women underwent Cesarean section (53% vs 100%; P < 0.001) and the median gestational age at birth was significantly higher (38.1 weeks (interquartile range (IQR), 35.2-39.1 weeks) vs 35.7 weeks (IQR, 33.9-37.0 weeks); P < 0.001). No case of uterine dehiscence was observed in the fetoscopic-repair group, compared with an incidence of 16% in the open-repair group. After adjusting for baseline characteristics, there was no significant difference in the total cost of care between the fetoscopic-repair and the open-repair groups (median, $76 978 (IQR, $60 312-$115 386) vs $65 103 (IQR, $57 758-$108 103); P = 0.458). CONCLUSIONS: Fetoscopic repair of ONTD, when compared with the open-hysterotomy approach, reduces the incidence of Cesarean section and preterm delivery with no significant difference in total costs of care from surgery to infant discharge. This novel approach may represent a cost-effective alternative to improve maternal and neonatal outcomes for this high-risk population. © 2021 International Society of Ultrasound in Obstetrics and Gynecology.
Assuntos
Defeitos do Tubo Neural/cirurgia , Adulto , Estudos de Coortes , Análise Custo-Benefício , Feminino , Fetoscopia/economia , Humanos , Histerotomia/economia , Recém-Nascido , Defeitos do Tubo Neural/economia , Gravidez , Estudos Retrospectivos , Texas , Adulto JovemRESUMO
BACKGROUNDS: Pregnancy termination during the second trimester in patients with placenta previa and placenta accreta spectrum (PAS) is a complex and challenging clinical problem. Based on our literature review, there has been a relative increase in the number of such cases being treated by hysterotomy and/or local uterine lesion resection and repair. In the present study, a retrospective analysis was conducted to compare the clinical outcomes when different management strategies were used to terminate pregnancy in the patients with placenta previa and PAS. METHODS: A total of 51 patients who underwent pregnancy termination in the second trimester in Beijing Obstetrics and Gynecology Hospital between June 2013 and December 2018 were retrospectively analyzed in this study. All patients having previous caesarean delivery (CD) were diagnosed with placenta previa status and PAS. RESULTS: â Among the 51 patients, 16 cases received mifepristone and misoprostol medical termination, 15 cases received mifepristone and Rivanol medical termination, but 1 of them was transferred to hysterotomy due to failed labor induction, another 20 cases were performed planned hysterotomy. There was no placenta percreta cases and uterine artery embolization (UAE) was all performed before surgery.â¡ There were 31 cases who underwent medical termination and 30 cases were vaginal delivery. Dilation and evacuation (D&E) were used in 20 cases of medical abortion failure and in all 30 cases of difficult manual removal of placental tissue. ⢠A statistically significant difference was found among the three different strategies in terms of gestational weeks, the type of placenta previa status, main operative success rate and ß-HCG regression time (P < 0.05). ⣠There were 4(7.8%) cases who were taken up for hysterectomy because of life-threatening bleeding or severe bacteremia during or after delivery and hysterotomy. The uterus was preserved with the implanted placenta partly or completely left in situ in 47(92.2%) cases. Combined medical and/or surgical management were used for the residual placenta and the time of menstrual recovery was 52(range: 33 to 86) days after pregnancy termination. CONCLUSIONS: Terminating a pregnancy by vaginal delivery through medical induction of labor may be feasible if clinicians have an overall understanding of gestational age, the type of placenta previa status, the type of placenta accreta, and patients concerns about preserving fertility. A collaborative team effort in tertiary medical centers with a very experience MDT and combined application of multiple methods is required to optimize patient outcomes.