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Device

Fetoscopic Repair for Spina Bifida

N/A
Waitlist Available
Led By Jena Miller, MD
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Pregnant women age 18 years and older who are able to consent
Isolated fetal spina bifida with the upper lesion level between T1-S1
Must not have
Pregnant women less than 18 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 months of age
Awards & highlights
No Placebo-Only Group

Summary

This trial will compare the outcomes of fetoscopic repair of fetal spina bifida to the outcomes of open repair of fetal spina bifida.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While not explicitly listed here, potential side effects could include risks associated with anesthesia and surgical procedures such as infection or bleeding. Fetoscopy might also carry specific risks like preterm labor or harm to the fetus during surgery.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a pregnant woman, 18 or older, and can give consent.
Select...
My unborn baby has spina bifida with the defect between the upper back and lower back.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am pregnant and under 18.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 months of age
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 months of age for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Ability to perform fetoscopic spina bifida repair
Secondary study objectives
Adverse early childhood outcome as evidenced by need for a cerebrospinal fluid shunt
Adverse fetal or neonatal outcome as evidenced by fetal or neonatal death
Early childhood motor function on physical examination
+5 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: FetoscopyExperimental Treatment1 Intervention
All participants will undergo fetoscopic repair of fetal spina bifida.

Find a Location

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor
2,327 Previous Clinical Trials
14,874,584 Total Patients Enrolled
1 Trials studying Spina Bifida
7 Patients Enrolled for Spina Bifida
Jena Miller, MDPrincipal InvestigatorJohns Hopkins University

Media Library

Fetoscopic Repair (Device) Clinical Trial Eligibility Overview. Trial Name: NCT03090633 — N/A
Spina Bifida Research Study Groups: Fetoscopy
Spina Bifida Clinical Trial 2023: Fetoscopic Repair Highlights & Side Effects. Trial Name: NCT03090633 — N/A
Fetoscopic Repair (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03090633 — N/A
~7 spots leftby Apr 2027
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