What side effects are associated with this type of intervention?

The most common treatments for neural tube defects, such as myelomeningocele, include open fetal surgery and minimally invasive fetoscopic repair. Open fetal surgery involves a hysterotomy, which carries risks such as uterine rupture, preterm premature rupture of membranes (PPROM), and the necessity for cesarean sections in future pregnancies. Minimally invasive fetoscopic repair aims to avoid these complications by not requiring a hysterotomy. This technique has been associated with a lower risk of respiratory distress syndrome and potentially allows for vaginal delivery if the repair is skin-covered. However, it still carries risks of preterm labor and other surgical complications.

What prior FDA approvals exist?

The FDA has not specifically approved any drugs for the treatment of Neural Tube Defects (NTDs) like myelomeningocele. However, surgical interventions, particularly the open fetal surgery for spina bifida repair, have been the standard approach. Recent advancements include minimally invasive techniques such as fetoscopic repair, which aim to reduce maternal and fetal risks associated with open surgery. These techniques are still under clinical investigation and have not yet received FDA approval.

What other types of research exist?

Promising novel alternatives to fetoscopic repair of fetal myelomeningocele for neural tube defects patients include: 1) Robotic-assisted fetoscopic surgery, which offers enhanced precision and control, potentially reducing maternal and fetal risks. 2) Advanced imaging techniques combined with minimally invasive procedures to improve the accuracy and outcomes of fetal surgeries. 3) Stem cell therapy and regenerative medicine approaches, which are being explored for their potential to repair or mitigate the effects of NTDs. These alternatives aim to provide effective treatment while minimizing the risks associated with traditional open fetal surgery.

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Fetoscopic Repair for Spina Bifida (fMMC Trial)

Phase 1

Waitlist Available

Led By Michael A. Belfort, M.D.

Research Sponsored by Baylor College of Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Family has considered and declined the option of termination of the pregnancy at less than 24 weeks

Absence of chromosomal abnormalities and associated anomalies

Must not have

Maternal medical condition that is a contraindication to surgery or anesthesia

Severe kyphosis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at birth

Awards & highlights

Summary

This trial is testing a new minimally invasive surgery to fix a spinal defect in unborn babies. The surgery uses tiny tools and cameras inserted through small openings, aiming to reduce risks for both mother and baby. It targets pregnant women whose fetuses have been diagnosed with myelomeningocele (MMC), a severe form of spina bifida. This new treatment technique allows early closure of the spinal defect to prevent potential neurological and psychomotor complications.

Who is the study for?

This trial is for pregnant women aged 18 or older with a single pregnancy and fetal MMC located between T1 and S1, showing hindbrain herniation. The fetus must not have chromosomal abnormalities, be within 19-25 weeks gestation, and the family should reject termination of pregnancy. Women must have social support, understand study requirements, and consent to follow-up after birth.

What is being tested?

The study tests a new fetoscopic technique to repair fetal MMC without making a uterine incision in the mother. This could reduce maternal-fetal risks compared to open surgery, potentially avoid cesarean sections for future births, decrease premature membrane rupture risk, and allow vaginal delivery if successful.

What are the potential side effects?

While specific side effects are not listed for this minimally invasive procedure, potential risks may include complications from anesthesia or surgery such as infection or bleeding. There's also a chance of preterm labor or issues related to the surgical intervention on the fetus.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My family and I have decided against ending the pregnancy before 24 weeks.

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My genetic tests show no chromosomal abnormalities.

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I have been diagnosed with Arnold-Chiari type II malformation.

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My spinal condition is between the T1 and S1 vertebrae.

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I have a severe curvature in my upper back.

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I cannot have surgery due to a past uterine procedure or condition.

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I cannot have fetoscopic surgery due to conditions like uterine fibroids.

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My BMI was 40 or more before I got pregnant.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ time of procedure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~time of procedure

This trial's timeline: 3 weeks for screening, Varies for treatment, and time of procedure for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Feasibility

Secondary study objectives

Reversal of the Chiari II malformation with complete closure of the spinal defect.

Trial Design

1Treatment groups

Experimental Treatment

Group I: fetoscopic surgical repairExperimental Treatment1 Intervention

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

0 / 10Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Neural Tube Defects (NTDs), such as myelomeningocele, include in utero surgical interventions like fetoscopic repair and open hysterotomy. Fetoscopic repair, a minimally invasive technique, involves using small ports to access and close the spinal defect, thereby avoiding a large uterine incision. This method aims to reduce maternal and fetal risks, such as uterine rupture and preterm birth, associated with open hysterotomy. By preventing prolonged exposure of neural tissue to amniotic fluid and reducing cerebrospinal fluid leakage, these treatments help mitigate progressive nerve damage and potential hydrocephalus. This is crucial for improving postnatal motor function and overall outcomes for NTD patients.

Congenital vaginal malformation: clinical experiences on vaginal agenesia.Experimental foetal microsurgery as related to myelomeningocele.Two-port, exteriorized uterus, fetoscopic meningomyelocele closure has fewer adverse neonatal outcomes than open hysterotomy closure.