Fetoscopic Neural Tube Defect Repair

Launched by OREGON HEALTH AND SCIENCE UNIVERSITY · Apr 20, 2025

Keywords

ClinConnect Summary

This clinical trial, called the Fetoscopic Neural Tube Defect Repair study, is looking at a specific type of surgery to help babies who have a condition called spina bifida, which is a type of neural tube defect (NTD). The surgery will be performed on pregnant women between 24 and 27 weeks into their pregnancy. The goal of the study is to gather information about how this surgery affects both the mothers and their babies, including their health before and after delivery.

To participate in this study, women need to be at least 18 years old and able to make their own decisions about their care. They must be expecting a baby with an open spina bifida diagnosis and meet certain other health criteria. Participants can expect to undergo the fetoscopic repair surgery and will be monitored closely throughout their pregnancy and after the baby is born. It’s important to know that this trial is currently recruiting participants, and those who join will also need to have support during their pregnancy and agree to follow-up visits for the child after birth.

Gender

FEMALE

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