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NCT Number: NCT06907732

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. Fetal surgery between 22-26 weeks gestation has been shown to stop the gradual fetal deterioration observed in this disease and improve infant outcomes. Children with spina bifida who have undergone fetal surgery have a lower need for hydrocephalus treatment (80%->40%) and twice the chance to walk independently by the age of 3 years (20%->40%). These benefits are also sustained in the longer term.

The traditional 'open' fetal surgical approach, however, as currently offered clinically at the Ontario Fetal Centre, comes with significant risks: it increases the risk of preterm birth, carries significant maternal morbidity and results in important uterine scarring. The latter comes with a risk of uterine rupture and fetal death both in the index pregnancy and future pregnancies.

To overcome these down sides of open fetal surgery, different centers have attempted a fetoscopic approach to the surgery. Fetoscopy indeed avoids uterine scarring and is likely protective against uterine rupture but is technically complex. This results in long surgical learning curves, poor dissemination of the surgery amongst centers worldwide, longer procedures and suboptimal surgical results which translate in decreased infant benefits - particularly with regards to motor function.

The investigators have developed a fetoscopic robotic approach where they leverage the dexterity of robotic instruments to perform these complex surgeries. The team expects that this will result in easier and faster procedures with better surgical outcomes and therefore fetal benefits comparable to open fetal surgery, while at the same time avoiding the need for hysterotomy.

In this prospective exploratory phase 1 study, the investigators propose to assess the feasibility of such a robotic approach, as developed and trained on a high-fidelity phantom, in 15 patients. The research team will collect maternal and fetal safety and efficacity data to inform later studies.

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Key information

Conditions

Fetal Congenital Abnormalities Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Fetal Surgery Fetoscopy Nervous System Diseases Nervous System Malformations Neural Tube Defect Neural Tube Defects Open Spina Bifida Robotic Surgical Procedure Spina Bifida Cystica Spinal Dysraphism

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Fetoscopic robotic open spina bifida closure

Procedure

Three 9 mm laparoscopic trocars will be inserted into the uterus after the uterus is exteriorized through a maternal laparotomy. Partial amniotic carbon dioxide insufflation will be done with heated humidified gas. Using a surgical robot, multilayer closure of the lesion will be performed, similar to our current protocol in open fetal spina bifida closure (durapatch, myofascial flap, skin closure).

Pre- and postoperative management will be similar to our current open fetal surgery protocol. Delivery will be by cesarean section, either when spontaneous labor occurs or at 39 weeks, whichever presents first.

Primary outcomes

  1. Number of patients with successful closure of the fetal spinal defect using a laparotomy-assisted fetoscopic robotic technique

    Time frame: 1 hour postoperatively

    Number of patients who underwent successful closure of the fetal spinal defect in layers using a laparotomy-assisted fetoscopic robotic technique without conversion to hysterotomy.

Secondary outcomes

  1. Number of patients with severe fetal complications

    Time frame: At delivery

    Number of patients with severe fetal complications defined as a composite of intraoperative fetal heart rate decelerations requiring intervention and/or intra- or postoperative fetal death.

  2. Number of patients with severe maternal complications

    Time frame: At delivery

    Number of severe maternal complications defined as a composite outcome including: need for maternal blood transfusion for hemorrhage, placental abruption, chorioamnionitis as assessed on placental pathology, ileus, wound infection or dehiscence, other serious maternal morbidity requiring admission to an intensive care unit, scar dehiscence or rupture at the time of delivery

  3. Number of patients experiencing preterm prelabor rupture of membranes

    Time frame: At delivery

    Incidence of Preterm Prelabor Rupture of Membranes (PPROM). Gestational age at PPROM (in weeks' gestation) will also be recorded.

  4. Number of patients experiencing preterm birth

    Time frame: At delivery

    Gestational age at birth will be recorded in weeks (in weeks) and categorized as <28, <32 and <37 weeks' gestation. Number of patients experiencing preterm birth is number of those delivering prior to 37 weeks' gestation.

  5. Number of patients with a severe neonatal complication

    Time frame: At discharge from Neonatal Intensive Care Unit or 28 days of life whichever comes last

    Number of patient with a severe neonatal complication defined as a composite of either: Neonatal death, death before discharge from the neonatal intensive care unit (NICU) or severe neonatal morbidity defined as the presence of at least one of the following: chronic lung disease, patent ductus arteriosus needing medical therapy or surgical closure, necrotising enterocolitis grade 2 or higher, retinopathy of prematurity stage 3 or higher or severe cerebral injury defined as intraventricular hemorrhage grade 3 or higher or cystic periventricular leukomalacia grade 2 or higher.

  6. Number of infants requiring neonatal spinal scar revision

    Time frame: At 28 days of life

    Number of infants requiring neonatal spinal scar revision within 28 days of birth

  7. Number of infants with reversal of hindbrain herniation

    Time frame: At 28 days of life

    Number of infants with reversal of hindbrain herniation (chiari II malformation) as assessed by MRI during pregnancy or within first 28 days of life.

Other outcomes

  1. Number of patients undergoing cesarean delivery

    Time frame: At delivery

    Mode of delivery will be recorded as cesarean delivery, spontaneous vaginal delivery or assisted vaginal delivery. Number of patients undergoing cesarean delivery will be reported

  2. Infant birthweight

    Time frame: At delivery

    Infant birthweight measured in grams

  3. Number of neonates requiring respiratory support

    Time frame: At discharge from Neonatal Intensive Care Unit

    Number of neonates requiring respiratory support defined as continuous positive airway pressure (CPAP) or invasive ventilation.

  4. Duration of Neonatal Intensive Care Unit Stay

    Time frame: At discharge from Neonatal Intensive Care Unit

    Length of initial neonatal stay in the Neonatal Intensive Care unit, measured in days.

Study contacts

Contact information is provided by the study sponsor or research team.

Tim Van Mieghem, MD, PhD

CONTACT

[email protected]

416 586 4800 ext. 6406

Sponsors and collaborators

Lead sponsor

Mount Sinai Hospital, Canada

Other

Collaborators

  • The Hospital for Sick Children

Registry information

Official study title

Fetoscopic Robotic Open Spina Bifida Treatment - a Pilot Feasibility Study

Acronym: FROST

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Apr 2, 2025
Registry last updated
May 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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