Fetoscopic Repair Techniques for Spina Bifida

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to repair spina bifida, a condition where a baby's spine does not develop properly. Researchers aim to determine if using a special patch (a surgical material) during surgery can improve healing and reduce complications compared to past methods. Pregnant women with a single baby who has spina bifida and meet specific health criteria can consider joining. The goal is to improve health outcomes for both the mother and baby after surgery. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative approach.

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 prior data suggests that this fetoscopic repair technique is safe?

Research has shown that fetoscopic surgery for spina bifida is generally safe, though some risks exist. In past studies, the rates of fetal and newborn deaths with fetoscopic surgery were about 3%, similar to those with traditional open surgery.

However, fetoscopic surgery carries specific risks. One study found a 26% chance of chorioamniotic membrane separation, where the membranes around the baby separate. Additionally, there is a 46% chance of spontaneous rupture of membranes, where the amniotic sac breaks early. These risks are higher than those associated with open surgery.

Overall, while fetoscopic surgery is considered safe and well-tolerated, it presents unique risks that potential participants should consider. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about fetoscopic repair techniques for spina bifida because they offer a minimally invasive approach compared to the traditional open fetal surgery. Unlike standard procedures that require a large incision in the uterus, this technique uses tiny instruments and a camera inserted through small incisions, significantly reducing risks for both the mother and the baby. This method also aims to improve postnatal outcomes by addressing the condition earlier and with less trauma. Overall, the fetoscopic approach promises a safer, more precise option for managing spina bifida before birth.

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

Research has shown that repairing spina bifida using a small camera and tools (fetoscopic repair) is as effective as the traditional open surgery method. Studies have found that this less invasive approach can lead to fewer complications, such as a reduced risk of early births. In this trial, all participants will receive the fetoscopic repair. The researchers are also investigating the use of a special patch called Durepair during the procedure, which might help create a stronger and thicker closure. This could reduce the risk of the repair coming apart or leaking spinal fluid. Although complete data is not yet available, early results are promising for better managing the condition. ^{1 3 6 7 8}

Who Is on the Research Team?

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

Principal Investigator

Baylor College of Medicine

Are You a Good Fit for This Trial?

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

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

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

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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

Implementation of in utero laparotomy-assisted fetoscopic ... Moreover, and the fetoscopic repair group exhibited a significantly lower rate of spontaneous preterm births (<34 weeks) at 15.8%, compared to 46.2% in the MOMs ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12317308/

Benefits and complications of fetal and postnatal surgery for ... The most common neonatal complication following fetal surgery for OSB was RDS, which occurred in 29% (95% CI, 15–46%) of neonates following open ...

5. obgyn.onlinelibrary.wiley.com obgyn.onlinelibrary.wiley.com/doi/10.1111/tog.12603

Fetal surgery for open spina bifida - Sacco - 2019 Open fetal repair of the spinal lesion has been shown to improve short-term outcomes for the child, with the consequent risks of prematurity and ...

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

Fetoscopic Repair of Isolated Fetal Spina Bifida The major risks of prenatal surgery for the fetus include chorioamniotic membrane separation (26% vs. 0%, p < 0.001), spontaneous rupture of membranes (46 vs. 8 ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5113790/

Fetoscopic repair of spina bifida: safer and better? - PMC In the MOMS trial, 67% (43/64) of cases treated prenatally showed the same or better motor than anatomical level compared with only 46% (46/70) ...

8. fetalmedicine.org fetalmedicine.org/var/pdf/publications/1270.pdf

Experience of 300 cases of prenatal fetoscopic open spina ... This study aimed to report short-term outcomes of prenatal fetoscopic open spina bifida (OSB) repair and compare these with data from open fetal surgery repair.