Fetoscopic Repair Techniques for Spina Bifida

Recruiting at 1 trial location

Age: 18 - 65

Sex: Female

Trial Phase: Phase 1

Sponsor: Baylor College of Medicine

Disqualifiers: Fetal anomaly, Preterm labor, Placental abnormalities, BMI ≥40, others

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

Compensation: Varies

Number of Visits: 2

38 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of the study is to compare the maternal, fetal and neonatal outcomes of a cohort of 60 patients in whom a multilayer closure with a Durepair patch is performed with a prior cohort of patients in whom a standardized repair without patch (n = 32) was performed using the same minimally invasive fetoscopic repair technique. The hypothesis is that there will be a thicker repair (as measured by MRI at 6 weeks post surgery) and less MMC repair dehiscence and/or CSF leak with the patch repair.

Do I need to stop my current medications for the trial?

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 Patch for fetoscopic repair of spina bifida?

Research shows that using a patch in fetoscopic surgery for spina bifida can reduce the need for additional surgeries after birth and has been successfully tested in both animal models and early human cases. This approach is less invasive than traditional methods, which involve larger surgical openings. ^{1 2 3 4 5}

Is fetoscopic repair for spina bifida generally safe for humans?

Fetoscopic repair for spina bifida is being developed to reduce risks associated with open fetal surgery, and studies focus on minimizing risks like fetal acidosis (too much acid in the blood), sepsis (infection), and fluid overload. Research in animal models and early human cases suggests careful management can help ensure safety, but more data is needed to fully understand the risks. ^{1 2 6 7 8}

How is the fetoscopic patch treatment for spina bifida different from other treatments?

The fetoscopic patch treatment for spina bifida is unique because it is a minimally invasive procedure that uses a small camera and instruments inserted through tiny incisions to repair the defect, reducing trauma to the mother compared to traditional open fetal surgery. This approach aims to provide similar benefits to the fetus while minimizing risks for the mother. ^{1 3 5 9 10}

Research Team

Michael A. Belfort, M.D., Ph.D.

Principal Investigator

Baylor College of Medicine

Eligibility Criteria

This trial is for pregnant women aged 18 or older with a single pregnancy, carrying a fetus with spina bifida (MMC) located between T1 and S1 vertebrae, without chromosomal abnormalities. The surgery occurs between 19-25 weeks of gestation. Candidates must have declined pregnancy termination, meet psychosocial criteria, and consent to child follow-up post-birth. Exclusions include fetal anomalies unrelated to MMC, obesity (BMI ≥40), certain placental/uterine conditions, severe depression, collagen hypersensitivity, specific infections like HIV/Hepatitis-B/C.

Inclusion Criteria

Gestational age at the time of the procedure will be between 19 0/7 weeks and 25 6/7 weeks

Parental/guardian permission (informed consent) for follow up of the child after birth

My ultrasound shows a clear area on my uterus for surgery without placental interference.

Exclusion Criteria

The pregnant person is allergic to collagen.

Participation in another intervention study that influences maternal and fetal morbidity and mortality or participation in this trial in a previous pregnancy

I have a health condition that makes surgery or anesthesia unsafe for me.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgical Repair

Participants undergo fetoscopic surgical repair of the neural tube defect using either a Durepair patch or without it.

1 day

1 visit (in-person)

Post-Surgery Monitoring

Approximately 6 weeks after the surgery, a post-procedure fetal MRI will be performed to assess the closure of the neural tube defect and reversal of the Chiari II malformation.

6 weeks

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with visits every 3-4 months after birth up to 12 months, and yearly up to 5 years.

5 years

Multiple visits (in-person and phone)

Treatment Details

Interventions

• Patch

Trial Overview The study tests if using a Durepair patch in fetoscopic repair of spina bifida leads to better outcomes compared to standard no-patch repair. Outcomes are measured by MRI at 6 weeks post-surgery focusing on the thickness of the repair and incidences of dehiscence or CSF leaks.

Participant Groups

Group I: fetoscopic surgical repair Experimental Treatment 1 Intervention

Single arm study. All patients will receive the fetoscopic repair.

Who Is Running the Clinical Trial?

Baylor College of Medicine

Lead Sponsor

Trials

1,044

Recruited

6,031,000+

Findings from Research

Percutaneous fetoscopic patch coverage for spina bifida aperta in human fetuses is technically feasible and results in less maternal trauma compared to traditional open fetal repair methods.

Out of three cases, two children survived after the procedure, indicating potential for this approach, but further clinical experience is needed to fully assess its efficacy in protecting neural tissue and improving outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Percutaneous fetoscopic patch coverage of spina bifida aperta in the human--early clinical experience and potential. Kohl, T., Hering, R., Heep, A., et al.[2006]

The first five percutaneous fetoscopic in-utero spina bifida repair procedures in the UK highlighted the critical importance of managing anesthesia and analgesia to ensure the safety of both the mother and fetus during surgery.

Key strategies were implemented to minimize risks such as fetal acidosis and maternal fluid overload, emphasizing the need for careful monitoring and optimization of conditions to support fetal well-being during these complex procedures.

NCBI (Pubmed)

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. Goonasekera, CD., Skelton, VA., Zebian, B., et al.[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]

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 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]

References

1. 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]

2. England pubmed.ncbi.nlm.nih.gov

Local host response of commercially available dural patches for fetal repair of spina bifida aperta in rabbit model. [2023]

3. Switzerland pubmed.ncbi.nlm.nih.gov

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

4. England pubmed.ncbi.nlm.nih.gov

Fetoscopic single-layer repair of open spina bifida using a cellulose patch: preliminary clinical experience. [2022]

5. 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]

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. England pubmed.ncbi.nlm.nih.gov

Procedure-related complications of open vs endoscopic fetal surgery for treatment of spina bifida in an era of intrauterine myelomeningocele repair: systematic review and meta-analysis. [2018]

9. Switzerland pubmed.ncbi.nlm.nih.gov

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

10. Germany pubmed.ncbi.nlm.nih.gov

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