Your session is about to expire
← Back to Search
Other
Fetoscopic Repair Techniques for Spina Bifida
Phase 1
Waitlist Available
Led By Michael A. Belfort, M.D., Ph.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
The family has considered and declined the option of termination of the pregnancy at less than 24 weeks
Pregnant women - maternal age 18 years or older and capable of consenting for their own participation in this study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at birth
Awards & highlights
Study Summary
This trial will compare two techniques for repairing a birth defect called myelomeningocele. One technique uses a patch and the other does not. The hypothesis is that the technique with the patch will result in a thicker repair and less chance of the repair coming apart.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects aren't specified but may include risks associated with any surgical procedure such as infection risk at the incision site, adverse reactions to anesthesia or materials used like the Durepair patch (if allergic), and complications related to preterm labor.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My family and I decided against ending the pregnancy before 24 weeks.
Select...
I am a pregnant woman, 18 or older, and can consent for myself.
Select...
My spinal condition is between the T1 and S1 vertebrae.
Select...
My genetic tests show no chromosomal abnormalities.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at birth
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at birth
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
MMC Repair Dehiscence and/or CSF leak
Trial Design
1Treatment groups
Experimental Treatment
Group I: fetoscopic surgical repairExperimental Treatment1 Intervention
Single arm study. All patients will receive the fetoscopic repair.
Find a Location
Who is running the clinical trial?
Baylor College of MedicineLead Sponsor
1,001 Previous Clinical Trials
6,002,214 Total Patients Enrolled
3 Trials studying Neural Tube Defects
161 Patients Enrolled for Neural Tube Defects
Michael A. Belfort, M.D., Ph.D.Principal InvestigatorBaylor College of Medicine
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- The pregnant person is allergic to collagen.My ultrasound shows a clear area on my uterus for surgery without placental interference.I have a health condition that makes surgery or anesthesia unsafe for me.I do not have HIV or Hepatitis, or I have tested negative for them.I cannot have surgery due to a past uterine procedure or condition.You have a condition where your immune system might harm your baby during pregnancy.The umbilical cord is twisted or attached in a certain way.You have a specific type of brain malformation, and if you can't have an MRI for medical reasons, your malformation will be checked with ultrasonography instead.My family and I decided against ending the pregnancy before 24 weeks.The fetus has a condition not related to MMC (myelomeningocele).I do not have a spouse, partner, or mother to support me during pregnancy.I have a severe curvature in my upper back.I am a pregnant woman, 18 or older, and can consent for myself.You have a very high score on the Edinburgh Postnatal Depression Scale, indicating severe depression.My spinal condition is between the T1 and S1 vertebrae.You are pregnant with only one baby.You have a high chance of giving birth early due to a short cervix, past issues with the cervix, or a previous early birth.My BMI was 40 or more before I got pregnant.You are pregnant and have certain placental problems such as previa, abruption, or accreta.My pregnancy involves the placenta covering the cervix.My genetic tests from amniocentesis or CVS show normal results, or I have a balanced translocation with no other anomalies.My low amniotic fluid is due to a fetal issue, poor placenta function, or membrane rupture.My genetic tests show no chromosomal abnormalities.I cannot have fetoscopic surgery due to conditions like fibroids or uterine issues.
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.
Are new volunteers still being accepted for this investigation?
"According to clinicaltrials.gov, the recruitment phase for this study is currently inactive. This trial was first announced on December 18th 2018 and has most recently been updated on April 2nd 2022. Nevertheless, there are 27 other trials actively searching for participants at present."
Answered by AI
What risks are associated with fetoscopic surgery?
"Our team at Power ranks the safety of fetoscopic surgical repair as a 1 due to its limited data demonstrating efficacy and safety in this initial Phase 1 clinical trial."
Answered by AI
Do I meet the criteria to join this research endeavor?
"This trial is seeking 38 individuals between 18 and 64 years old who are diagnosed with acrania. To be eligible, they must meet the following criteria: parental/guardian consent for post-birth follow up, singleton pregnancy status, Arnold-Chiari type II malformation (with an exception made for those unable to have MRI due to medical reasons), normal karyotype or chromosomal microarray (CMA) by invasive testing such as amniocentesis or Chorionic Villus Sampling (CVS); FISH results will also suffice if patient is at 24 weeks or more gestation; family has considered and declined"
Answered by AI
Is there an upper age limit to participate in this research project?
"The age requirement for this medical trial is 18 years of age or older, with a maximum threshold at 64."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger