Fetoscopic Robotic Open Spina Bifida Treatment

Launched by MOUNT SINAI HOSPITAL, CANADA · Mar 26, 2025

Keywords

ClinConnect Summary

This clinical trial is exploring a new way to treat spina bifida in unborn babies using a robotic technique. Spina bifida is a condition where the spine doesn’t form properly, which can lead to serious issues for the child, such as difficulties with movement and other bodily functions. Traditionally, fetal surgery to correct this condition can be risky for both the mother and baby, including a higher chance of preterm birth and complications in future pregnancies. The researchers believe that using robotic instruments can make the surgery safer and more effective by reducing these risks while still improving outcomes for the baby.

To participate in this trial, women must be pregnant and diagnosed with isolated open spina bifida, and they should be between 22 and 26 weeks along in their pregnancy. They also need to be healthy enough for surgery without any major complications. Participants will undergo this innovative robotic surgery, and the researchers will monitor both mother and baby for safety and effectiveness. This study aims to gather important information that could pave the way for better treatment options in the future.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Isolated open fetal spina bifida
• • Healthy pregnant patient without risk factors for preterm delivery
• • Candidate for open fetal spina bifida surgery.
• • Maternal age 18 years or more and able to consent
• • Provision of written informed consent to participate in this study
• • Gestational age allowing for fetal surgery prior to 26 weeks gestation.
• Exclusion Criteria:
• • Contraindication for surgery or safe anesthesia due to a severe maternal medical condition, including morbid obesity (BMI \>40 kg/m2)
• • History of preterm birth, short cervical length, cervical cerclage
• • Placenta or vasa previa, invasive placentation
• • Inaccessibility of the uterus due to severe maternal obesity, uterine fibroids, bowel or placental superposition
• • Major fetal structural or genetic anomalies unrelated to spina bifida, requiring surgery or potentially leading to infant death or severe handicap
• • Neural tube defects other than open spina bifida
• • Absence of Chiari II malformation on ultrasound or MRI
• • Severe fetal kyphosis (\>30 degrees)
• • Upper lesion level lower than sacral vertebra S1.
• • Multiple gestation
• • Fetal bleeding disorder (eg. Fetal/neonatal allo-immune thrombocytopenia)
• • Maternal infectious disorder which could result in materno-fetal transmission (eg HIV with high viral load)