Fetoscopic Surgery for Spina Bifida

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by Ramen Chmait, MD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: USFetus

Disqualifiers: Diabetes, Obesity, Hypertension, HIV, others

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

The purpose of this study is to evaluate the feasibility of a fetoscopic surgical technique for antenatal correction of fetal myelomeningocele. Two surgical approaches will be utilized. The percutaneous approach will be offered to participants with a posterior placenta. The laparotomy/uterine exteriorization approach will be offered to participants regardless of placental location.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Fetoscopy, Fetoscopic surgery, Percutaneous endoscopic correction, Minimally invasive fetoscopic repair for Spina Bifida?

Research shows that minimally invasive fetoscopic surgery for spina bifida can improve neurological outcomes for babies and reduce the need for postnatal surgery, while also minimizing risks to the mother compared to open fetal surgery. The fetoscopic approach is evolving, with improvements in delivery outcomes and potential benefits similar to open surgery. ^{1 2 3 4 5}

Is fetoscopic surgery for spina bifida generally safe for humans?

Fetoscopic surgery for spina bifida is designed to minimize risks to the mother compared to open fetal surgery, with careful management to ensure safety for both mother and fetus. Studies have shown that with proper anesthetic management and surgical techniques, risks such as preterm birth, anesthesia complications, and maternal trauma can be reduced. ^{1 6 7 8 9}

How is fetoscopic surgery for spina bifida different from other treatments?

Fetoscopic surgery for spina bifida is a minimally invasive procedure that aims to repair the condition before birth, reducing the need for postnatal neurosurgery and minimizing risks to the mother compared to traditional open fetal surgery. This approach avoids large incisions, leading to a quicker recovery for the mother and potentially better neurological outcomes for the baby. ^{1 2 3 9 10}

Research Team

Ruben Quintero, MD

Principal Investigator

Wellington Regional Medical Center

Ramen Chmait, MD

Principal Investigator

University of Southern California/ Huntington Memorial Hospital

Eligibility Criteria

This trial is for pregnant women over 18 with a fetus diagnosed with myelomeningocele, between 19-27 weeks' gestation. They must be able to stay near Wellington or Pasadena for the pregnancy and delivery, and return for follow-ups. Exclusions include multiple pregnancies, certain health conditions like HIV/Hepatitis-B, obesity (BMI of 35+), nickel allergy, pregestational diabetes, uterine anomalies, previous early deliveries.

Inclusion Criteria

Willingness to remain in the greater Wellington or Pasadena area (within a 30-minute car ride) for remainder of the pregnancy and deliver at Wellington Regional Medical Center or Huntington Memorial Hospital for postnatal management

I can come back for check-ups at 12, 24, 30, 48, and 60 months.

My test results confirm a balanced karyotype, acceptable through FISH if I'm 24 weeks along or more.

Exclusion Criteria

I want to have surgery for my baby's spina bifida before birth at this hospital.

The mother has a medical condition that makes surgery or anesthesia unsafe.

Participation in another intervention study influencing maternal and fetal morbidity and mortality

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo fetoscopic surgical correction of myelomeningocele using either laparotomy or percutaneous techniques

Up to 21 weeks

Surgery and follow-up assessments until delivery

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Fetoscopy (Procedure)

Trial Overview The study tests a fetoscopic surgical technique versus traditional surgery to correct fetal myelomeningocele before birth. The percutaneous approach is used if the placenta is at the back; otherwise laparotomy/uterine exteriorization can be done regardless of placental location.

Participant Groups

Group I: Fetoscopic repair Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

USFetus

Lead Sponsor

Trials

2

Recruited

120+

Wellington Hospital

Collaborator

Trials

11

Recruited

1,500+

University of Southern California

Collaborator

Trials

956

Recruited

1,609,000+

Dr. Samir A.

University of Southern California

Chief Executive Officer since 2024

PhD in Molecular Biology from the University of Southern California

Dr. Chung

University of Southern California

Chief Medical Officer since 2016

MD from UC San Diego

Findings from Research

A minimally invasive fetoscopic approach for closing spina bifida aperta in two fetuses resulted in successful neural cord coverage and avoided the need for postnatal neurosurgery, demonstrating its efficacy.

Both neonates showed significant improvements, including reversal of hindbrain herniation and satisfactory leg, bladder, and bowel function, indicating the potential for this technique to enhance outcomes compared to traditional methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Percutaneous fetoscopic patch closure of human spina bifida aperta: advances in fetal surgical techniques may obviate the need for early postnatal neurosurgical intervention. Kohl, T., Tchatcheva, K., Merz, W., et al.[2018]

Prenatal repair of open spina bifida through fetoscopic techniques shows promise in reducing shunt rates and improving postnatal neurological outcomes, comparable to traditional open surgery.

The laparotomy-based fetoscopic approach has been associated with fewer complications and higher gestational ages at delivery compared to the percutaneous method, which is still being refined to improve outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endoscopic fetal surgery for neural tube defects. Lapa, DA.[2020]

The fetoscopic surgical approach for repairing myelomeningocele resulted in significantly better maternal and neonatal outcomes compared to the open approach, including fewer cases of preterm birth, neonatal death, and neurodevelopmental disabilities in both the index and subsequent pregnancies.

Although the fetoscopic technique was more expensive, it was deemed cost-effective, with an incremental cost-effectiveness ratio of $1029 per quality-adjusted life year, indicating that the improved outcomes justify the higher costs in a theoretical cohort of 500 women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fetoscopic compared with open repair of myelomeningocele: a 2-delivery cost-effectiveness analysis. Packer, CH., Hersh, AR., Caughey, AB.[2021]

The laparotomy-assisted 2-port fetoscopic technique for prenatal closure of spina bifida was successfully completed in 84% of cases, indicating its feasibility and effectiveness in a cohort of 19 women.

Postoperative improvements were observed in 86% of undelivered patients regarding hindbrain herniation, suggesting that this technique can lead to significant fetal health benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation Process and Evolution of a Laparotomy-Assisted 2-Port Fetoscopic Spina Bifida Closure Program. Miller, JL., Groves, ML., Ahn, ES., et al.[2021]

Minimally invasive fetoscopic surgery for spina bifida aperta aims to protect exposed neural tissue and preserve neurological function, highlighting its potential as a new therapeutic approach.

In a retrospective analysis of 61 cases, a carefully developed anesthetic protocol was shown to effectively ensure safe maternal and fetal anesthesia, uterine relaxation, and prevention of complications such as pulmonary edema and spontaneous labor.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anesthetic Management for Percutaneous Minimally Invasive Fetoscopic Surgery of Spina Bifida Aperta: A Retrospective, Descriptive Report of Clinical Experience. Arens, C., Koch, C., Veit, M., et al.[2018]

Prenatal repair of open spina bifida through fetoscopic techniques can improve neurological outcomes for infants, reducing the need for shunting and enhancing motor function after birth.

The newly described percutaneous/mini-laparotomy fetoscopy combines the advantages of both laparotomy-assisted and percutaneous methods, potentially offering a safer option for mothers while maintaining effective surgical results for the fetus.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Percutaneous/mini-laparotomy fetoscopic repair of open spina bifida: a novel surgical technique. Chmait, RH., Monson, MA., Pham, HQ., et al.[2022]

References

1. Germany pubmed.ncbi.nlm.nih.gov

[Peri- and postoperative management for minimally invasive fetoscopic surgery of spina bifida]. [2014]

2. Germany pubmed.ncbi.nlm.nih.gov

Percutaneous fetoscopic patch closure of human spina bifida aperta: advances in fetal surgical techniques may obviate the need for early postnatal neurosurgical intervention. [2018]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Endoscopic fetal surgery for neural tube defects. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Fetoscopic compared with open repair of myelomeningocele: a 2-delivery cost-effectiveness analysis. [2021]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Implementation Process and Evolution of a Laparotomy-Assisted 2-Port Fetoscopic Spina Bifida Closure Program. [2021]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Peri-operative management of percutaneous fetoscopic spina-bifida repair: a descriptive review of five cases from the United Kingdom, with focus on anaesthetic implications. [2021]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Laparotomy-Assisted 2-Port Fetoscopic Repair of Spina Bifida Aperta: Report of a Single-Center Experience in Paris, France. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Anesthetic Management for Percutaneous Minimally Invasive Fetoscopic Surgery of Spina Bifida Aperta: A Retrospective, Descriptive Report of Clinical Experience. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

Percutaneous/mini-laparotomy fetoscopic repair of open spina bifida: a novel surgical technique. [2022]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Percutaneous fetoscopic patch coverage of spina bifida aperta in the human--early clinical experience and potential. [2006]