Fetoscopic Repair for Spina Bifida

Recruiting at 1 trial location

Overseen By Jena B Miller, MD

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Johns Hopkins University

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

30 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this investigation is to evaluate maternal and fetal outcomes following fetoscopic repair of fetal spina bifida at the Johns Hopkins Hospital. The hypothesis of this study is that fetoscopic spina bifida repair is feasible and has the same effectiveness as open repair of fetal spina bifida, but with the benefit of significantly lower maternal and fetal complication rates. The fetal benefit of the procedure will be the prenatal repair of spina bifida. The maternal benefit of fetoscopic spina bifida repair will be the avoidance of a large uterine incision. This type of incision increases the risk of uterine rupture and requires that all future deliveries are by cesarean section. The use of the minimally invasive fetoscopic surgical technique may also lower the risk of preterm premature rupture of membranes and preterm birth compared to open fetal surgery. Finally, successful fetoscopic spina bifida repair also makes vaginal delivery possible.

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 Fetoscopic Repair for Spina Bifida?

Research suggests that fetoscopic repair for spina bifida can improve neurological outcomes for babies after birth and reduce risks for mothers compared to open fetal surgery. It seems to achieve similar postnatal results as open repair but with less trauma to the mother. ^{1 2 3 4 5}

How does the fetoscopic repair treatment for spina bifida differ from other treatments?

Fetoscopic repair for spina bifida is a minimally invasive treatment that aims to improve neurological outcomes for the baby while reducing trauma to the mother compared to traditional open fetal surgery. It involves using small instruments and a camera inserted through tiny incisions, which minimizes the risk of complications like uterine rupture in future pregnancies. ^{1 4 5 6 7}

Research Team

Jena B Miller, MD

Principal Investigator

Johns Hopkins University

Eligibility Criteria

This trial is for pregnant women aged 18 or older with a single baby diagnosed with isolated fetal spina bifida, where the defect is between T1-S1 vertebrae. The pregnancy should be between 19 to almost 26 weeks along, and the fetus must have a normal karyotype. Women under 18, carrying multiples, having additional fetal anomalies, facing technical issues for surgery, placenta previa or certain maternal health risks are excluded.

Inclusion Criteria

Gestational age between 19+0 to 25+6 weeks gestation

Normal fetal karyotype

I am a pregnant woman, 18 or older, and can give consent.

Exclusion Criteria

Preterm labor

Cervical length < 25mm

Maternal Beck Depression Inventory score ≥ 17

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Fetoscopic Repair

Participants undergo fetoscopic repair of fetal spina bifida

Up to 21 weeks

Surgery and monitoring visits

Follow-up

Participants are monitored for safety and effectiveness after fetoscopic repair

Up to 28 days post-birth

Regular monitoring visits

Early Childhood Follow-up

Monitoring of early childhood outcomes including motor function and neurodevelopmental assessments

Up to 30 months of age

Treatment Details

Interventions

• Fetoscopic Repair

Trial Overview The study at Johns Hopkins Hospital is testing fetoscopic repair of fetal spina bifida—a minimally invasive surgery expected to be as effective as open repair but with fewer complications. Benefits may include lower risk of uterine rupture in future pregnancies and possibly allowing vaginal birth.

Participant Groups

Group I: Fetoscopy Experimental Treatment 1 Intervention

All participants will undergo fetoscopic repair of fetal spina bifida.

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

Findings from Research

Minimally invasive fetoscopic surgery for spina bifida aims to enhance the neurological outcomes for affected fetuses while reducing maternal trauma compared to traditional open fetal surgery.

The article provides insights into the perioperative and postoperative management practices for these cases, highlighting the advancements in surgical techniques for better patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Peri- and postoperative management for minimally invasive fetoscopic surgery of spina bifida]. Degenhardt, J., Axt-Fliedner, R., Enzensberger, C., et al.[2014]

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]

In a study involving 7 women with spina bifida aperta, laparotomy-assisted fetoscopic repair was performed successfully without fetal demise, demonstrating its potential as a safe prenatal surgical option.

The procedure resulted in watertight repairs at birth for most cases, with some needing postnatal surgery; however, 50% of the infants required shunting within 6 months, indicating the need for careful monitoring post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Laparotomy-Assisted 2-Port Fetoscopic Repair of Spina Bifida Aperta: Report of a Single-Center Experience in Paris, France. Arthuis, C., James, S., Bussieres, L., et al.[2023]

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 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]

References

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

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

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

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

3. 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]

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

Fetoscopic Open Neural Tube Defect Repair: Development and Refinement of a Two-Port, Carbon Dioxide Insufflation Technique. [2022]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Endoscopic fetal surgery for neural tube defects. [2020]

6. Switzerland pubmed.ncbi.nlm.nih.gov

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

7. England pubmed.ncbi.nlm.nih.gov

Percutaneous minimally invasive fetoscopic surgery for spina bifida aperta. Part III: neurosurgical intervention in the first postnatal year. [2022]