Fetoscopic Repair for Spina Bifida

Not currently recruiting at 1 trial location

Overseen By Jena B Miller, MD

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: Multiple gestation, Fetal anomaly, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to treat spina bifida in unborn babies using a less invasive surgery called fetoscopic repair. The researchers aim to determine if this method is as effective as traditional open surgery but with fewer risks for both mother and baby. Potential benefits include correcting the baby's spina bifida before birth and allowing the mother to avoid a large incision, which could reduce complications and enable future vaginal deliveries. Pregnant women who are 19 to 25 weeks along with a baby diagnosed with isolated spina bifida might be suitable candidates for this trial. As an unphased study, this trial offers a unique opportunity to contribute to groundbreaking research that could enhance treatment options for future families.

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 prior data suggests that this fetoscopic repair technique is safe for maternal and fetal outcomes?

Research has shown that fetoscopic repair for spina bifida is generally safe for both mothers and babies. One study found that the risk of death for the baby during or after this procedure is about 3%, similar to the risk with traditional open surgery for spina bifida. The less invasive nature of the fetoscopic technique might reduce the chances of complications such as early birth or premature rupture of membranes. This suggests the procedure could be safer than open surgery. Overall, these findings indicate that fetoscopic repair of spina bifida is well-tolerated, with risks comparable to those of established methods. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Fetoscopic repair for spina bifida is unique because it offers a less invasive approach compared to traditional open fetal surgery. Typically, spina bifida is treated with postnatal surgery or open fetal surgery, which involves a large incision in the mother's abdomen and uterus. However, fetoscopic repair uses tiny instruments and cameras inserted through small incisions, potentially reducing risks for both the mother and baby. Researchers are excited about this technique because it could lower complications like preterm labor and improve neurological outcomes for the baby without the need for a major operation.

What evidence suggests that fetoscopic repair is effective for spina bifida?

This trial will evaluate the effectiveness of fetoscopic repair for spina bifida. Studies have shown that repairing spina bifida with a small camera (fetoscopic repair) can be as effective as traditional open surgery. Research indicates that this method reduces the future need for a wheelchair and lowers the chances of requiring a VP shunt to drain fluid from the brain. Previous studies found similar rates of death for the baby before and after birth between the two types of surgery, suggesting that fetoscopic repair is safe. Additionally, fetoscopic repair is less invasive, potentially lowering the risk of complications for the mother, such as avoiding a large incision and reducing the chances of early birth. Overall, this approach aims to provide effective treatment while minimizing risks for both the mother and baby. ^{1 3 6 7 8}

Who Is on the Research Team?

Jena B Miller, MD

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8360048/

Fetoscopic myelomeningocoele closure: Is the scientific ... Likewise, fetal and neonatal deaths (4/131, 3%; two fetal and two neonatal deaths) were similar to what is reported for open spina bifida repair (2/91, 2%; one ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03090633

Fetoscopic Repair of Isolated Fetal Spina Bifida 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 ...

3. obgyn.onlinelibrary.wiley.com obgyn.onlinelibrary.wiley.com/doi/10.1002/uog.29289

Comparison of open fetal, fetoscopic and postnatal surgical ... Open fetal and fetoscopic surgery yielded the greatest number of QALYs due to a substantial reduction in the incidence of wheelchair use and the ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2666577825000036

Implementation of in utero laparotomy-assisted fetoscopic ... This study evaluated the safety, efficacy, and outcomes of laparotomy-assisted fetoscopic in-utero SB repair in Latin America compared to traditional open- ...

5. mdpi.com mdpi.com/2077-0383/14/5/1402

Fetoscopic Myelomeningocele (MMC) Repair: Evolution of ... Open fetal repair has proven to be superior to traditional postnatal repair in reducing the need for VP shunt placement and improving motor outcomes at 30 ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT03090633

Fetoscopic Repair of Isolated Fetal Spina Bifida 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 ...

7. obgyn.onlinelibrary.wiley.com obgyn.onlinelibrary.wiley.com/doi/10.1002/uog.29240?af=R

Benefits and complications of fetal and postnatal surgery for ... Objective. To derive pooled estimates of maternal, fetal and pediatric outcomes up to the age of 30 months in patients undergoing pre- or ...

8. karger.com karger.com/fdt/article/52/5/521/927726/Safety-and-Effectiveness-of-Fetal-Myelomeningocele

Safety and Effectiveness of Fetal Myelomeningocele ... Conclusion: Exteriorized uterus fetoscopic repair of MMC proved safe for the mother and effective in closing the neural tube defect. It also ...