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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 months of age
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 months of age
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 months of age
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Ability to perform fetoscopic spina bifida repair
Secondary outcome measures
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 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: FetoscopyExperimental Treatment1 Intervention
All participants will undergo fetoscopic repair of fetal spina bifida.
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Who is running the clinical trial?
Johns Hopkins UniversityLead Sponsor
2,262 Previous Clinical Trials
14,823,134 Total Patients Enrolled
1 Trials studying Spina Bifida
7 Patients Enrolled for Spina Bifida
Jena Miller, MDPrincipal InvestigatorJohns Hopkins University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am pregnant and under 18.I cannot have surgery using a scope due to technical reasons.I am a pregnant woman, 18 or older, and can give consent.My unborn baby has spina bifida with the defect between the upper back and lower back.
Research Study Groups:
This trial has the following groups:- Group 1: Fetoscopy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are participating in the research project?
"Affirmative. The clinicaltrials.gov website attests to the fact that this research trial, initially announced on 5th November 2017, is still in search of 30 participants across 2 medical centres."
Answered by AI
Does the research encompass seniors over seventy years of age?
"This trial has an age-range of 18 to 50 for all participants. There are also 66 clinical trials tailored for minors, and 88 studies reserved exclusively for the geriatric population."
Answered by AI
Can I enroll in this clinical investigation?
"Qualification criteria for this clinical trial includes having acrania and being aged between 18-50 years. The number of participants required is approximately 30."
Answered by AI
Is this experiment taking in new participants?
"The trial is still actively recruiting participants, as indicated on clinicaltrials.gov. This medical study was published in May of 2017 and last modified this October."
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