| NCT ID | NCT06946563 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Oregon Health and Science University |
| Condition | Neural Tube Defects |
| Study Type | OBSERVATIONAL |
| Enrollment | 25 participants |
| Start Date | 2023-04-01 |
| Primary Completion | 2028-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 25 participants in total. It began in 2023-04-01 with a primary completion date of 2028-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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
Contact & Investigator
Raphael Sun, MD
PRINCIPAL INVESTIGATOR
Oregon Health and Science University
Frequently Asked Questions
Who can join the NCT06946563 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Neural Tube Defects. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06946563 currently recruiting?
Yes, NCT06946563 is actively recruiting participants. Contact the research team at whru@ohsu.edu for enrollment information.
Where is the NCT06946563 trial being conducted?
This trial is being conducted at Portland, United States.
Who is sponsoring the NCT06946563 clinical trial?
NCT06946563 is sponsored by Oregon Health and Science University. The principal investigator is Raphael Sun, MD at Oregon Health and Science University. The trial plans to enroll 25 participants.