NCT06946563 · Oregon Health and Science University
Fetoscopic Neural Tube Defect Repair
(NTD)
What this study is about
This is a single-treatment group$1 forward-looking study to record maternal and neonatal outcomes on subjects who undergo fetoscopic repair of Neural Tube Defects (NTD) at Oregon Health \& Science University (OHSU). Fetoscopic repair will take place between 24 weeks 0 days and 27 weeks 6 days gestation. Surgical, post-operative, delivery, and neonatal outcomes will be collected.
View original scientific description
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). Fetoscopic repair will take place between 24 weeks 0 days and 27 weeks 6 days gestation. Surgical, post-operative, delivery, and neonatal outcomes will be collected.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Maternal age 18 years or older
- Capable of consenting for their own participation in the study
- Decision to have fetoscopic repair following counseling of all options
- Open spina bifida with the upper boundary between T1 and S1
- Gestational age between 24 0/7 to 26 6/7 weeks' gestation at the time of surgery
- Normal karyotype and/or normal chromosomal microarray by invasive testing. In the case of a microdeletion, microduplication, or variant of uncertain significant, the decision to include or exclude will be at the discretion of the Principal Investigators.
- Absence of major cardiac anomalies confirmed by fetal echocardiogram
- Adequate social support throughout pregnancy
- Parental or guardian willingness to undergo follow-up evaluations of the child after birth
Exclusion criteria
- Multiple gestation
- Major fetal anomalies unrelated to the neural tube defect
- Kyphosis in fetus of 30 degrees or more as assessed by ultrasound or MRI
- Previous spontaneous singleton preterm birth prior to 37 weeks
- Presence of cervical cerclage at the time of surgery or history of cervical insufficiency
- Cervical length less than 20 mm by endovaginal ultrasound
- Placenta previa or evidence of placental abruption
- Technical factors such as large uterine fibroids, uterine anomalies, or fetal membrane separation for which the risks of surgery are deemed to outweigh the benefits
- Maternal obesity precluding surgical access with a BMI \> 45 or if the Principal Investigator determines the body habitus to be technically challenging
- Alloimmunization in pregnancy including Kell sensitization or a history of neonatal alloimmune thrombocytopenia
- Maternal HIV or Hepatitis B positive status. If the patient's HIV or Hepatitis B status is unknown, the patient must be tested and found to be negative prior to surgery
- Known Hepatitis C positivity. If the patient's Hepatitis C status is known, they do not need to be screened
- Maternal medical condition which is a contraindication to surgery or general anesthesia. This includes previous hysterotomy in the active segment of the uterus
- Maternal medical co-morbidities which would significantly increase the risk of spontaneous or iatrogenic preterm delivery
- Inability of the patient to comply with travel and follow-up requirements of the study
- Patient not meeting psychosocial criteria determined by fetal care social worked to comply with the medical care and plan for follow ups
- Participation in another interventional study that influences maternal and fetal morbidity and mortality
- Known history of hypersensitivity to collagen products or chondroitin materials
Where
- Portland, Oregon
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 27, 2025 · Source of record for eligibility and locations