[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"myelomeningocele\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:myelomeningocele":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,45,71,94,123,149,180,209],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100640427","tscs-in-children-with-spina-bifida-100640427",false,"NCT07615686","tSCS in Children With Spina Bifida","Transcutaneous Spinal Cord Stimulation to Improve Strength and Gait in Children With Spina Bifida","Inclusion Criteria:\n\n* Diagnosed myelomeningocele confirmed by a neurosurgeon or neurologist\n* Some difficulty ambulating, but able to ambulate at least a short distance (10 meters) with devices and\u002For assistance.\n* Between the ages of 4 and 17 years of age.\n* Documented neurogenic bladder dysfunction\n* On a stable bladder management regimen at least 4-6 weeks prior to the enrollment in the trial\n\nExclusion Criteria:\n\n* Severe behavioral or cognitive impairments that preclude participation in the study, in the opinion of the investigator.\n* Has an active surgery planned for impairments from spina bifida (e.g. tethered cord syndrome surgery or orthopedic surgery) or has had surgery in the last 6 months.\n* Is pregnant. Pregnancy will be assessed via verbal report.\n* Open wounds at the thoracic or lumbar spine that precludes transcutaneous stimulation.\n* Implanted or attached electronic device in any location of the body (e.g. pacemakers, baclofen pumps, or implanted insulin pumps)\n* Symptomatic urinary tract infection, urinary tract infection for which they are currently receiving treatment, scheduled urological surgery, or inability to perform or receive catheterization.","ALL","4 Years","17 Years",{"count":20,"type":21},20,"ESTIMATED","INTERVENTIONAL",[24],"NA","A single-center, open-label, investigational pilot trial to explore potential effects of transcutaneous spinal cord stimulation on leg muscle strength and walking in children with myelomeningocele.",[27,28],"Spina Bifida","Myelomeningocele",[30,31],"spina bifida","myelomeningocele","RECRUITING","2026-05-22",{"date":35,"type":36},"2026-05-29","ACTUAL",{"date":38,"type":21},"2026-06-10",{"date":40,"type":21},"2029-03-10",{"name":42,"class":43},"Bailey Petersen","OTHER",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":53,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":22,"phases":57,"briefSummary":60,"conditions":61,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":44},"100412619","phase-1-cellular-therapy-for-in-utero-repair-of-myelomeningocele---the-cure-trial-100412619","NCT04652908","Cellular Therapy for In Utero Repair of Myelomeningocele - The CuRe Trial","Phase 1\u002F2a Trial of Placental Mesenchymal Stem Cells for Repair of Fetal Myelomeningocele","CuRe","Inclusion Criteria:\n\nEligibility for fetal surgery per the MOMS trial, which are:\n\n* Myelomeningocele (including myeloschisis) at any level from T1 through S1 with hindbrain herniation. Lesion level will be confirmed by ultrasound and hindbrain herniation will be confirmed by MRI at the UC Davis Fetal Center\n* Maternal age ≥18 years\n* Gestational age at enrollment between 19 weeks 0 days and 25 weeks 6 days gestation as determined by clinical information and evaluation of first ultrasound\n* Normal karyotype. Results by fluorescence in situ hybridization (FISH) will be acceptable if the patient is greater than 24 weeks gestation;\n\nExclusion Criteria:\n\nNot being eligible for fetal surgery per the MOMS trial, which includes:\n\n* Multifetal pregnancy\n* Insulin dependent pregestational diabetes\n* Fetal anomaly not related to myelomeningocele.\n* Kyphosis in the fetus of 30 degrees or more\n* Current or planned cerclage or documented history of incompetent cervix, placenta previa or placental abruption\n* Short cervix \\\u003C 20 mm measured by cervical ultrasound\n* Obesity as defined by body mass index of 35 or greater\n* Previous spontaneous singleton delivery prior to 37 weeks\n* Maternal-fetal Rh isoimmunization, Kell sensitization or a history of neonatal alloimmune thrombocytopenia\n* Maternal HIV or Hepatitis-B status positive due to the increased risk of transmission to the fetus during maternal-fetal surgery. If the patient's HIV or Hepatitis B status is unknown, the patient must be tested and found to have negative results before she can be enrolled\n* Known Hepatitis-C positivity. If the patient's Hepatitis C status is unknown, she does not need to be screened\n* Uterine anomaly such as large or multiple fibroids or Müllerian duct abnormality\n* Other maternal medical condition which is a contraindication to surgery or general anesthesia. This includes any patient with a previous hysterotomy in the active segment of the uterus (whether from a previous classical cesarean, uterine anomaly such as an arcuate or bicornuate uterus, major myomectomy resection, or previous fetal surgery)\n* Patient does not have a support person (e.g., husband, partner, mother)\n* Inability to comply with the travel and follow-up requirements of fetal surgery\n* Patient does not meet other psychosocial criteria (as determined by the psychosocial interviewer) to handle the implications of fetal surgery\n* Participation in another intervention study that influences maternal and fetal morbidity and mortality or participation in this trial in a previous pregnancy;\n* Maternal hypertension which would increase the risk of preeclampsia or preterm delivery (including, but not limited to: uncontrolled hypertension, chronic hypertension with end organ damage and new onset hypertension in current pregnancy)\n* Active COVID-19 infection at time of fetal surgery as determined by positive test","19 Weeks","25 Weeks",{"count":56,"type":21},55,[58,59],"PHASE1","PHASE2","Spina bifida, or myelomeningocele (MMC), is a birth defect that results in paralysis, excess fluid on the brain (hydrocephalus), and impaired ability to urinate and have bowel movements normally. In a previous study (the MOMS trial), surgery before birth (in-utero\u002Ffetal surgery) was shown to reduce the need for shunting for hydrocephalus. There was also some improvement in ambulation, but 58 % of the children still could not walk unassisted.\n\nThis study is testing living stem cells from placenta added to the fetal repair in an effort to improve the ability to walk. Previous animal studies have shown dramatic improvement in walking and bowel and bladder function when placental stem cells are added to MMC repair. Use of these \"living\" cells may protect the developing spinal cord, prevent further injury, and may even reverse existing damage to the nerves that control movement. This study is assessing the safety and efficacy of adding stem cells to open fetal surgery for MMC in humans.",[28],"2026-01-15",{"date":64,"type":36},"2026-01-20",{"date":66,"type":36},"2021-06-21",{"date":68,"type":21},"2027-03",{"name":70,"class":43},"University of California, Davis",{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":4,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":16,"minAge":78,"maxAge":79,"enrollmentInfo":80,"targetDuration":4,"studyType":22,"phases":82,"briefSummary":83,"conditions":84,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":44},"100586649","transcutaneous-spinal-stimulation-for-children-and-youth-with-spina-bifida-100586649","NCT06918119","Transcutaneous Spinal Stimulation for Children and Youth With Spina Bifida","Characterization of Transcutaneous Spinal Cord Stimulation for Enabling Reflex Motor Evoked Responses in Children and Youth With Spina Bifida","Inclusion Criteria\n\n* Congenital diagnosis of myelomeningocele (MMC)\n* Able to follow verbal commands or instructions.\n* If female and able to become pregnant, must be willing to use medically-acceptable method of contraception during study participation.\n\nExclusion Criteria\n\n* Severe cognitive deficits demonstrating inability to communicate needs\n* Gaping, weeping, or unhealed open wounds at the site of electrode placement\n* Unhealed fractures on load bearing bones\n* History of osteoporosis\n* History of implanted electronic devices at the stimulation location(e.g. deep brain stimulator, cardiac pacemaker, diaphragmatic pacer, baclofen pumps, insulin pumps, etc.)\n* Pregnancy\n* Epilepsy\n* History of seizure\n* Ongoing infections (currently being treated or are symptomatic)\n* Any illness or condition which, based on the research team's assessment, will compromise the patient's ability to comply with the protocol, patient safety, or the validity of the data collected during this study.","5 Years","18 Years",{"count":81,"type":21},30,[24],"A study to use transcutaneous spinal cord stimulation to characterize sensorimotor deficits in a pediatric population of individuals with spina bifida.",[28,27],"2025-10-09",{"date":87,"type":36},"2025-10-14",{"date":89,"type":36},"2025-08-07",{"date":91,"type":21},"2030-07",{"name":93,"class":43},"Mayo Clinic",{"id":95,"slug":96,"hasResults":11,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":100,"eligibilityCriteria":101,"healthyVolunteers":11,"sex":102,"minAge":79,"maxAge":4,"enrollmentInfo":103,"targetDuration":4,"studyType":22,"phases":105,"briefSummary":106,"conditions":107,"keywords":110,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":44},"100519330","cryopreserved-human-umbilical-cord-as-a-meningeal-patch-in-fetoscopic-spina-bifida-repair-100519330","NCT06042140","Cryopreserved Human Umbilical Cord as a Meningeal Patch in Fetoscopic Spina Bifida Repair","Cryopreserved Human Umbilical Cord as a Meningeal Patch in Fetoscopic Spina Bifida Repair: Single Arm Phase III Trial.","HUC-FICS","Inclusion Criteria:\n\nMaternal Inclusion Criteria:\n\n1. Singleton pregnancy\n2. Gestational age at screening is 19 to 25 5\u002F7 weeks and gestational age at surgery is 22 to 25 6\u002F7 weeks\n3. Maternal age: 18 years and older\n4. Body mass index ≤45 kg\u002Fm2 (pre-pregnancy)\n5. No preterm birth risk factors (short cervix \\\u003C20 mm or a history of previous preterm delivery)\n6. No previous uterine incision in the active uterine segment\n7. Willing to undergo an open fetal repair if the fetoscopic approach is unsuccessful\n\nFetal Inclusion Criteria:\n\n1. Spina bifida defect between T1 to S1 vertebral levels\n2. Chiari II malformation\n3. No evidence of kyphosis (curved spine)\n4. No major life-threatening fetal anomaly unrelated to spina bifida\n5. Normal karyotype, or a normal chromosomal microarray analysis (CMA), or a CMA with variants of unknown significance \\[fluorescence in situ hybridization (FISH) acceptable if ≥ 24 weeks\\].\n\nExclusion Criteria:\n\nMaternal Exclusion Criteria:\n\n1. Non-resident of the United States\n2. Multifetal pregnancy\n3. Poorly controlled insulin-dependent pregestational diabetes\n4. Poorly controlled A2 diabetes mellitus (A2DM) insulin-dependent diabetes\n5. Current or planned cerclage or documented history of an incompetent cervix\n6. Placenta previa or placental abruption\n7. Short cervix of \\\u003C 20 mm\n8. Obesity as defined by a body mass index of \\> 45 kg\u002Fm2\n9. Previous spontaneous singleton delivery prior to 37 weeks\n10. Maternal-fetal Rh isoimmunization, Kell sensitization, or a history of neonatal alloimmune thrombocytopenia\n11. HIV or Hepatitis-B positive status\n12. Known Hepatitis-C positivity\n13. Uterine anomaly such as large or multiple fibroids or a mullerian duct abnormality that is diagnosed via imaging prior to surgery, which that are unavoidable during surgery\n14. Other medical conditions which are contraindication to surgery or general anesthesia\n15. Patient does not have a support person\n16. Inability to comply with the travel and follow-up requirements of the trial\n17. Patient does not meet psychosocial standardized assessment criteria\n18. Participation in this or another intervention study that influences maternal and fetal morbidity and mortality\n19. Maternal hypertension\n20. Zika virus positivity\n21. Allergy\u002Fhistory of drug reaction to Amphotericin B\n\nFetal exclusion criteria:\n\n1. Major fetal anomaly not related to spina bifida\n2. Kyphosis in the fetus of 30 degrees or more\n3. Ventriculomegaly greater than 15 mm and no movements noted at hip and knee joints","FEMALE",{"count":104,"type":21},100,[24],"The objective is to test the efficacy of a laparotomy-assisted fetoscopic surgical approach to cover spina bifida spinal cord developmental defects using cryopreserved human umbilical cords (NEOX Cord 1K®) as a meningeal and skin patch.",[108,28,109],"Spina Bifida; Fetus","Myeloschisis",[111,112,113],"Fetoscopic fetal intervention","Human umbilical cord","NEOX Cord 1K","2025-08-08",{"date":116,"type":36},"2025-08-13",{"date":118,"type":36},"2023-09-08",{"date":120,"type":21},"2036-09-08",{"name":122,"class":43},"The University of Texas Health Science Center, Houston",{"id":124,"slug":125,"hasResults":11,"nctId":126,"briefTitle":127,"officialTitle":127,"acronym":128,"eligibilityCriteria":129,"healthyVolunteers":130,"sex":16,"minAge":79,"maxAge":4,"enrollmentInfo":131,"targetDuration":4,"studyType":22,"phases":133,"briefSummary":134,"conditions":135,"keywords":136,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":147,"locationsCount":44},"100577336","in-utero-surgery-for-fetal-myelomeningocele-decision-making-mechanisms-and-psychological-impact-of-prenatal-therapy-100577336","NCT06796972","In Utero Surgery for Fetal Myelomeningocele: Decision-making Mechanisms and Psychological Impact of Prenatal Therapy","PriumPsy","Inclusion Criteria:\n\n* Mothers and adult co-parents of the child with MMC operated in utero, having signed informed consent. If both members of the couple have agreed to participate, they will be received separately.\n* Mother who had fetal surgery for in utero repair of a fetal myelomeningocele by laparotomy and hysterotomy aged 18 years or older at the time of surgery, and whose child affected by the surgery is at least 6 months old\n* Speaking French\n* Not presenting a severe psychiatric disorder altering the relationship with reality\n* Patient affiliated to a social security system\n\nExclusion Criteria:\n\n* Patient under guardianship or curatorship, deprived of liberty or unable to sign informed consent to participate in the study\n* Patient under State Medical Aid",true,{"count":132,"type":21},44,[24],"Myelomeningocele is a malformation of the spine and spinal cord, generally diagnosed prenatally, and responsible for a complex disability for the unborn child. In the event of continued pregnancy, in utero surgery can be performed to improve the prognosis of the children. This fetal therapy does not allow a cure and induces risks for the fetus, and for the mother, both during surgery and for her obstetric future.\n\nCurrently, few studies have focused on the factors influencing the choice to resort to in utero surgery and the experience of patients and co-parents before and after this intervention. No qualitative study on the subject has been published to date.",[28],[137,138,139],"Psychology","fetal myelomeningocele","Parents","2025-01-22",{"date":142,"type":36},"2025-01-28",{"date":144,"type":36},"2024-09-23",{"date":146,"type":21},"2026-03",{"name":148,"class":43},"Assistance Publique - Hôpitaux de Paris",{"id":150,"slug":151,"hasResults":11,"nctId":152,"briefTitle":153,"officialTitle":154,"acronym":4,"eligibilityCriteria":155,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":156,"enrollmentInfo":157,"targetDuration":159,"studyType":160,"phases":4,"briefSummary":161,"conditions":162,"keywords":165,"overallStatus":170,"whyStopped":4,"lastUpdateSubmitDate":171,"lastUpdatePostDateStruct":172,"startDateStruct":174,"completionDateStruct":176,"leadSponsor":178,"locationsCount":4},"100559181","the-role-of-csf-in-chiari-ii-brain-malformation-100559181","NCT06560788","The Role of CSF in Chiari II Brain Malformation","Chiari II Brain Malformation: The Role of Cerebrospinal Fluid in Neurodevelopmental Defects Associated With Spina Bifida","Inclusion Criteria:\n\nNewborns with Spina Bifida (Postnatal Closure)\n\n* Diagnosed with open spina bifida (myelomeningocele).\n* Scheduled for postnatal surgical closure of the spinal lesion at Great Ormond Street Hospital (GOSH).\n* Age: Between 1 day to 1 year old.\n\nControl Group 1 (Newborns with Hydrocephalus)\n\n* Newborns scheduled for shunt surgery for hydrocephalus unrelated to spina bifida.\n* Age and sex matched to the spina bifida newborns as closely as possible.\n* Age: Between 1 day to 1 year old.\n\nControl Group 2 (Infants with Spinal Conditions Unrelated to Spina Bifida)\n\n* Infants undergoing paned spinal surgery for conditions such as spinal lipoma, fatty filum, tethered cord, etc.\n* Age and sex matched to the spina bifida newborns as closely as possible.\n* Age: Between 1 day to 1 year old. Fetuses with Spina Bifida (Prenatal Closure)\n* Prenatal diagnosis of spina bifida (myelomeningocele) and scheduled for fetal surgery at UCLH.\n* Reviewed by Mr Thompson at his outpatient clinic at GOSH\n* Gestational age: Between 22 and 24 weeks.\n\nControl Fetal Samples\n\n* Aborted fetuses within the gestational age range of 22-24 weeks.\n* Samples obtained through the Human Developmental Biology Resource (HDBR).\n\nMouse Models\n\n* Genetic mouse model of spina bifida (Cdx2Cre x Pax3flox).\n* At embryonic day (E)13.5 (end of the embryonic period) and E18.5 (just before birth)\n\nControl Mouse Models\n\n* Normal (wild-type) mice to serve as controls.\n* Normal brain development\n* At embryonic day (E)13.5 (end of the embryonic period) and E18.5 (just before birth)\n\nExclusion Criteria:\n\nNewborns with Spina Bifida (Postnatal Closure)\n\n* Newborns who have undergone previous surgical intervention.\n* Presence of additional unrelated congenital anomalies that could affect cerebrospinal fluid (CSF) composition like meningitis or intraventricular bleeding\n* Older than 1 year and 1 month of age.\n* Parents refused to participate\n* Native language different to English with no translation services available\n\nControl Group 1 (Newborns with Hydrocephalus)\n\n* Newborns with hydrocephalus caused by spina bifida.\n* Presence of intraventricular infection or haemorrhage.\n* Older than 1 year and 1 month of age.\n* Parents refused to participate\n* Native language different to English with no translation services available\n\nControl Group 2 (Infants with Spinal Conditions Unrelated to Spina Bifida)\n\n* Infants who were born with spina bifida\n* Infants with coexisting conditions that could affect CSF composition like intraspinal tumours, empyema or haemorrhage.\n* Older than 1 year and 1 month of age.\n* Parents refused to participate\n* Native language different to English with no translation services available\n\nFetuses with Spina Bifida (Prenatal Closure)\n\n* Fetuses with additional major anomalies unrelated to spina bifida like diaphragmatic hernia.\n* Gestational age outside the range of 22-24 weeks.\n* Surgery performed by other neurosurgery team (not GOSH)\n* Parents refused to participate\n* Native language different to English with no translation services available\n\nControl Fetal Samples\n\n* Poorly preserved aborted fetuses not suitable for CSF collection.\n* Gestational age outside the range 22-24 weeks.\n\nMouse Models\n\n* Mice with any genetic modifications other than those specified for the spina bifida model.\n* Mice with other congenital or acquired anomalies affecting the central nervous system.\n\nControl Mouse Models\n\n● Mice with any genetic modifications or health conditions that could influence the study's outcomes.","1 Year",{"count":158,"type":21},18,"1 Day","OBSERVATIONAL","Spina bifida, particularly its most severe form known as open spina bifida (myelomeningocele), is a significant congenital disorder that results in profound neurological impairments, including Chiari II malformation. This malformation is associated with the downward displacement of the cerebellum and brainstem into the spinal canal, often leading to hydrocephalus, a condition where cerebrospinal fluid (CSF) accumulates in the brain1. These conditions can result in a range of complications, including cognitive and motor disabilities, learning difficulties, and, in severe cases, early mortality1,2.\n\nWhile surgical interventions, including prenatal and postnatal surgeries, have been developed to manage the physical manifestations of spina bifida and Chiari II malformation, these procedures have not been fully successful in addressing the associated brain anomalies3. This study aims to explore the hypothesis that the composition of CSF plays a critical role in the development of these brain defects. Specifically, it is hypothesized that the rapid replenishment of CSF, due to its leakage from the open spine in spina bifida, results in a \"less mature\" fluid composition, which negatively affects neurogenesis and neuronal migration during critical periods of brain development.",[28,163,164],"Brain Malformation","Chiari Malformation Type 2",[31,166,167,168,169],"Chiari type 2","brain malformations","cognitive impairment","cerebrospinal fluid","NOT_YET_RECRUITING","2024-08-19",{"date":173,"type":36},"2024-08-21",{"date":175,"type":21},"2024-09-01",{"date":177,"type":21},"2027-08-01",{"name":179,"class":43},"University College, London",{"id":181,"slug":182,"hasResults":11,"nctId":183,"briefTitle":184,"officialTitle":185,"acronym":4,"eligibilityCriteria":186,"healthyVolunteers":11,"sex":16,"minAge":79,"maxAge":187,"enrollmentInfo":188,"targetDuration":4,"studyType":22,"phases":190,"briefSummary":191,"conditions":192,"keywords":195,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":199,"lastUpdatePostDateStruct":200,"startDateStruct":202,"completionDateStruct":204,"leadSponsor":206,"locationsCount":208},"100346238","fetal-surgery-interview-study-parental-perceptions-of-fetal-surgery-100346238","NCT03788122","Fetal Surgery Interview Study: Parental Perceptions of Fetal Surgery","Qualitative In-depth Interviews With Women and Their Partners Concerning the Acceptability of Fetal Surgery","Inclusion Criteria:\n\n* Women\u002Fpartners eligible for one of the two fetal surgery procedures studied (open fetal surgery for spina bifida closure, tracheal balloon occlusion for congenital diaphragmatic hernia (Fetoscopic Endoluminal Tracheal Occlusion, FETO), as clinical care\n* Have given written informed consent for participation\n\nExclusion:\n\n* Women less than 18 years or over 65 years of age\n* Partners less than 18 years or over 65 years of age\n* Women or their partners who are unable to communicate in either English or the local language (if different)","65 Years",{"count":189,"type":21},40,[24],"Open maternal-fetal surgery is currently used on fetuses with myelomeningocele (MMC). Fetoscopic or minimal access fetal surgery is also being used to treat fetuses with congenital diaphragmatic hernia (CDH).\n\nFollowing accurate diagnosis of a congenital malformation such as MMC or CDH, prospective parents face a range of uncertainties regarding the future of their unborn child, and the options provided require major ethical considerations. In the situation under study, termination of pregnancy may be for some parents an alternative option to expectant prenatal management. Fetal therapy provides a tantalising third option for some, where procedures are undertaken to reduce the likelihood of a more complicated neonatal course, potentially improving long term outcome, but at risk of amniotic fluid leakage, infection and most importantly very preterm delivery, itself associated with significant neonatal mortality and morbidity and long-term consequences. Balancing these competing risks is challenging.\n\nFor an intervention to be effective it also needs to be acceptable to women and their families. \"Acceptability\" can be defined as a multi-faceted construct that reflects the extent to which people delivering or receiving a healthcare intervention consider it to be appropriate, based on anticipated or experienced cognitive and emotional responses to the intervention.\n\nWith this study it is the aim to assess how women (and their partners) perceive the acceptability of a fetal surgical intervention for MMC and CDH. Participants will be asked to share their thoughts, views, feelings and experiences with regards to the decision to participate in fetal surgery. Data are collected by the use of in-depth face-to-face interviews. In-depth interviews are used to understand the participant's perspectives and perceptions of a situation they are in. It explicitly includes participants interpretation and understanding of an event\n\nThe interviews will be held in two or three moments in time (for parents opting for fetal surgery, there will be one additional interview, after the intervention while admitted in hospital): after counselling for options, but before eventual intervention; for intervention group shortly after the intervention, and 12 weeks after birth of the baby, or termination of pregnancy.",[193,28,194],"Fetal Surgery","Congenital Diaphragmatic Hernia",[196,197,198],"Acceptability","Qualitative research","Patient Perspectives","2024-06-28",{"date":201,"type":36},"2024-07-01",{"date":203,"type":36},"2018-07-01",{"date":205,"type":21},"2026-02-01",{"name":207,"class":43},"Universitaire Ziekenhuizen KU Leuven",2,{"id":210,"slug":211,"hasResults":11,"nctId":212,"briefTitle":213,"officialTitle":214,"acronym":4,"eligibilityCriteria":215,"healthyVolunteers":11,"sex":102,"minAge":79,"maxAge":4,"enrollmentInfo":216,"targetDuration":4,"studyType":22,"phases":218,"briefSummary":219,"conditions":220,"keywords":223,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":229,"lastUpdatePostDateStruct":230,"startDateStruct":232,"completionDateStruct":234,"leadSponsor":236,"locationsCount":208},"100351453","laparotomy-versus-percutaneous-endoscopic-correction-of-myelomeningocele-100351453","NCT03856034","Laparotomy Versus Percutaneous Endoscopic Correction of Myelomeningocele","In Utero Endoscopic Correction of Myelomeningocele: Laparotomy Versus Percutaneous - A Pilot Study","Inclusion Criteria:\n\n1. Myelomeningocele (including myeloschisis) at level T1 through S1 with hindbrain herniation. Lesion level and hindbrain herniation will be confirmed by MRI and ultrasonography.\n2. Maternal age ≥18 years.\n3. Gestational age of 19 to 27 6\u002F7 weeks' gestation as determined by clinical information and evaluation of first ultrasound.\n4. Balanced karyotype with written confirmation of culture results. Results by fluorescence in situ hybridization (FISH) will be acceptable if the patient is at 24 weeks or more.\n5. Positive evaluation of social work consult indicating the patient is capable of consenting to the procedure and has the appropriate social support system to participate in the study.\n6. Positive evaluation from pediatric neurology consult.\n7. Willing to remain in the greater Wellington or Pasadena area (within a 30-minute car ride) for remainder of the pregnancy and deliver at Wellington Regional Medical Center or Huntington Memorial Hospital for postnatal management. The participants must be willing to return to our center for the 12, 24, 30, 48, and 60 months for follow-up evaluation.\n\nExclusion Criteria:\n\n1. Multiple gestation\n2. Insulin-dependent pregestational diabetes\n3. Presence of a fetal anomaly not related to myelomeningocele. A fetal echocardiogram will be conducted before surgery and if the finding is abnormal, the patient will be excluded.\n4. Fetal kyphosis of 30 degrees or more, assessed by ultrasound or MRI.\n5. Presence of uterine cervical cerclage or history of incompetent cervix.\n6. Placenta previa or placental abruption.\n7. Short cervix \\\u003C 25 mm measured by cervical ultrasound.\n8. Obesity as defined by body mass index (BMI) of 35 or greater.\n9. History of previous spontaneous singleton delivery prior to 37 weeks.\n10. Maternal-fetal Rh isoimmunization, Kell sensitization or a history of neonatal alloimmune thrombocytopenia.\n11. Maternal HIV or Hepatitis-B status positive because of the increased risk of transmission to the fetus during maternal-fetal surgery. If the patient's HIV or Hepatitis B status is unknown, the patient must be tested and found to have negative results before she can be enrolled.\n12. Known Hepatitis-C positivity. If the patient's Hepatitis C status is unknown, she does not need to be screened.\n13. Uterine anomaly such as large (greater than 6 cm) fibroids, cervical fibroids or multiple fibroids or Mullerian duct abnormality.\n14. Other maternal medical condition which is a contraindication to surgery or anesthesia.\n15. Patient does not have a support person (e.g., husband, partner, parents).\n16. Inability to comply with the travel and follow-up requirements of the study.\n17. Patient does not meet psychosocial criteria as determined by the social worker evaluation.\n18. Participation in another intervention study that influences maternal and fetal morbidity and mortality.\n19. Maternal hypertension as determined by the investigator, which would increase the risk of preeclampsia or preterm delivery (including, but not limited to: uncontrolled hypertension, chronic hypertension with end organ damage and new onset hypertension in current pregnancy).\n20. Bicornuate uterus or any other uterine malformation the PI decides is not safe for surgery.\n21. Nickel allergy.\n22. Maternal request to undergo open fetal surgery for the antenatal correction of open spina bifida at our institution primarily or after failed fetoscopic approach.\n23. Known maternal hypersensitivity to bovine collagen or chondroitin materials.",{"count":217,"type":21},12,[24],"The purpose of this study is to evaluate the feasibility of a fetoscopic surgical technique for antenatal correction of fetal myelomeningocele. Two surgical approaches will be utilized. The percutaneous approach will be offered to participants with a posterior placenta. The laparotomy\u002Futerine exteriorization approach will be offered to participants regardless of placental location.",[221,27,28,222],"Neural Tube Defects","Chiari Malformation",[30,31,224,225,226,227,228],"neural tube defect","chiari malformation","fetoscopy","percutaneous","fetus","2019-11-11",{"date":231,"type":36},"2019-11-13",{"date":233,"type":36},"2018-11-02",{"date":235,"type":21},"2027-12-31",{"name":237,"class":43},"USFetus"]