Clinical trials: Spina Bifida; Fetus
Neural Tube Defects, Spina Bifida
Laparotomy Versus Percutaneous Endoscopic Correction of Myelomeningocele
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.
- Conditions
- Neural Tube Defects, Spina Bifida, Myelomeningocele, Chiari Malformation
- Trial name
- NCT03856034
- Testing
- Fetoscopy
- Where
- 2 sites in United States
- Volunteers
- 12 people
- Sponsor
- USFetus
Neural Tube Defect
Fetoscopic Meningomyelocele Repair Study
The purpose of the study is to evaluate the maternal and fetal outcomes of a new technique for the fetoscopic repair of fetal MMC at Texas Children's Hospital Pavilion for Women.
- Trial name
- fMMC (NCT02230072)
- Testing
- fetoscopy
- Where
- 2 sites in United States
- Volunteers
- 60 people
- Sponsor
- Baylor College of Medicine
Neural Tube Defects, Spina Bifida, Open
Fetal Endoscopic Surgery for Spina Bifida
This study aims to assess the feasibility to perform a fetoscopic prenatal repair of an open neural tube defect, and secondly to assess the maternal, fetal and neonatal outcomes.
- Conditions
- Neural Tube Defects, Spina Bifida, Open, Myelomeningocele, Fetal Disease
- Trial name
- FESSB (NCT03315637)
- Testing
- Fetoscopic repair of spina bifida
- Where
- Spain
- Volunteers
- 50 people
- Sponsor
- Hospital Universitari Vall d'Hebron Research Institute
Spina Bifida; Fetus, Myelomeningocele
Cryopreserved Human Umbilical Cord as a Meningeal Patch in Fetoscopic Spina Bifida Repair
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…
- Conditions
- Spina Bifida; Fetus, Myelomeningocele, Myeloschisis
- Trial name
- HUC-FICS (NCT06042140)
- Testing
- NEOX Cord 1K applied fetoscopically
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- The University of Texas Health Science Center, Houston
Pregnancy; Spina Bifida, Fetal, Environmental Exposure
Understanding Effects of Folic Acid on the Methylosome and Transcriptome of Women With Spina Bifida Affected Pregnancies
Folic acid is currently considered to be the standard of care for primary and secondary prevention of spina bifida, but the mechanisms underlying folic acid's benefits are unknown.
- Trial name
- NCT05500690
- Testing
- Folic Acid Tablet
- Where
- Bangladesh
- Volunteers
- 69 people, healthy volunteers welcome
- Sponsor
- Boston Children's Hospital
Fetal Congenital Abnormalities, Fetoscopy
Fetoscopic Robotic Open Spina Bifida Treatment
Fetal spina bifida is a common birth defect that results in hydrocephalus, motor-, bowel-, bladder- and sexual dysfunction in the child. The condition is progressive in utero.
- Conditions
- Fetal Congenital Abnormalities, Fetoscopy, Fetal Surgery, Robotic Surgical Procedure
- Trial name
- FROST (NCT06907732)
- Testing
- Fetoscopic robotic open spina bifida closure
- Volunteers
- 15 people
- Sponsor
- Mount Sinai Hospital, Canada
Spina Bifida, Congenital Diaphragmatic Hernia
Maternal-fetal Immune Responses to Fetal Surgery
Performing surgery in utero on fetuses with certain birth defects has led to significant improvements in outcomes after birth; however, many of these infants are born preterm which can decrease the effectiveness of these…
- Conditions
- Spina Bifida, Congenital Diaphragmatic Hernia, Lower Urinary Tract Obstructive Syndrome, Myelomeningocele
- Trial name
- NCT04484441
- Testing
- Blood and placenta specimen collection.
- Where
- 3 sites in United States
- Volunteers
- 21 people
- Sponsor
- Mayo Clinic
Open Spina Bifida, Myelomeningocele
Fetoscopic Open Spina Bifida Repair Using the SAFER Technique
Children submitted to fetoscopic in utero myelomeningocele repair using the SAFER (Skin-over-biocellulose for Anternatal FEtoscopic Repair) technique will evaluate at 30 months or more, regarding ambulation, neurodevelopment…
- Conditions
- Open Spina Bifida, Myelomeningocele, Meningomyelocele, Chiari Malformation With Spina Bifida
- Trial name
- NCT04356703
- Testing
- Neuropsicomotor developmental test
- Where
- Brazil
- Volunteers
- 30 people
- Sponsor
- Hospital Israelita Albert Einstein
Neural Tube Defects, Spina Bifida
Fetoscopic Neural Tube Defect Repair
This is a single-arm prospective study to record maternal and neonatal outcomes on subjects who undergo fetoscopic repair of Neural Tube Defects (NTD) at Oregon Health \& Science University (OHSU).
- Trial name
- NTD (NCT06946563)
- Testing
- Fetoscopic Neural Tube Defect Repair Devices
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- Oregon Health and Science University
Sacral Myelomeningocele, Neural Tube Defects
In Utero Fetoscopic Repair Program for Sacral Myelomeningoceles and Mye-LDM
The purpose of the study is to evaluate the feasibility and the maternal, fetal and postnatal outcomes of sacral myelomeningocele (MMC) and Myelic Limited Dorsal Myeloschisis (MyeLDM) fetoscopic repair at Trousseau Hospital…
- Conditions
- Sacral Myelomeningocele, Neural Tube Defects, Spina Bifida
- Trial name
- PRIUM2 (NCT04770805)
- Testing
- Fetoscopy
- Where
- France
- Volunteers
- 10 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Foetus With Myelomeningocele
Prenatal Surgical Repair of Fetal Myelomeningocele
The open surgical repair of myelomeningoceles before 26 weeks gestational age provides a correction of the anomaly of Chiarri, reduces the incidence of ventriculomegaly (defined as a measure of the ventricles at the crossroads ≥…
- Trial name
- PRIUM (NCT01983345)
- Testing
- prenatal surgical repair of fetal myelomeningocele
- Where
- France
- Volunteers
- 38 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Myelomeningocele, Pregnancy
Fetal Myelomeningocele Repair With Maternal BMI Between 35.0 and 40.0
Inclusion and exclusion criteria for fetal repair of MMC was established by the Management of Myelomeningocele Study (MOMS Trial) and these criteria are the standard of care throughout the United States.
- Trial name
- MOMSto40BMI (NCT02509377)
- Testing
- Open Fetal Repair of Myelomeningocele
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- St. Louis University
Pregnancy, Fetal and Neonatal Health
Outcome of Fetal Spina Bifida
Neural tube defects are one of the most prevalent congenital abnormalities, surpassed only by cardiac malformations. Spina bifida accounts for the majority of the neural tube defects and is comprised of a wide spectrum of…
- Trial name
- NCT01100697
- Where
- Germany
- Volunteers
- 103 people
- Sponsor
- University of Luebeck
Spina Bifida, Myelomeningocele
Fetoscopic Repair of Isolated Fetal Spina Bifida
The purpose of this investigation is to evaluate maternal and fetal outcomes following fetoscopic repair of fetal spina bifida at the Johns Hopkins Hospital.
- Conditions
- Spina Bifida, Myelomeningocele, Chiari Malformation Type 2, Neural Tube Defects
- Trial name
- NCT03090633
- Testing
- Fetoscopy
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Johns Hopkins University
Myelomeningocele
Prenatal Endoscopic Repair of Fetal Spina Bifida
The purpose of this study is to determine the feasibility of prenatal minimally-invasive fetoscopic closure with i) uterine exteriorization for a minimally-invasive repair under amniotic carbon dioxide insufflation ii) two…
- Trial name
- ENDOSPIN (NCT02390895)
- Testing
- endoscopic repair of myelomeningocele before 26 SA
- Where
- France
- Volunteers
- 7 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Meningomyelocele, Spinal Dysraphism
Management of Myelomeningocele Study (MOMS)
Spina bifida (myelomeningocele) is a complex birth defect in which a portion of the spinal cord is not fully developed. The overlying bones and skin are incompletely formed and the underdeveloped area of the spinal cord is…
- Trial name
- MOMS (NCT00060606)
- Testing
- Prenatal Myelomeningocele Repair Surgery, Postnatal Myelomeningocele Repair Surgery
- Where
- 3 sites in United States
- Volunteers
- 183 people, healthy volunteers welcome
- Sponsor
- The George Washington University Biostatistics Center
Fetal Anomaly, Spinal Dysraphism
An Audit of the Posterior Fossa Characterization in Open Spina Bifida Based on Tertiary Center Experience
Brain stem and posterior fossa measurements in spina bifida aperta fetuses to compare them with normal population. Additionally, Describe the difference between pre- and postoperative findings.
- Conditions
- Fetal Anomaly, Spinal Dysraphism, Chiari Malformation Type 2
- Trial name
- NCT03544970
- Where
- Belgium
- Volunteers
- 316 people
- Sponsor
- Universitaire Ziekenhuizen KU Leuven
Autism Spectrum Disorder, Cerebral Palsy
READYorNot[TM] Brain-Based Disabilities Trial
The purpose of this study is to find out if there is a benefit to using the MyREADY Transition[TM] BBD App for brain-based disabilities, compared to not using it.
- Conditions
- Autism Spectrum Disorder, Cerebral Palsy, Epilepsy, Fetal Alcohol Spectrum Disorders
- Trial name
- NCT03852550
- Testing
- e-health application
- Where
- 9 sites in Canada
- Volunteers
- 52 people
- Sponsor
- McMaster University