Your session is about to expire
← Back to Search
Regenerative Medicine
Fetoscopic Repair for Spina Bifida
N/A
Waitlist Available
Led By Rodrigo Ruano, MD, PhD
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new, less invasive surgery to fix spina bifida in unborn babies during pregnancy. The goal is to see if this method is safer for mothers while still effectively treating the baby's condition. Previous research showed that fixing spina bifida before birth helped babies but was riskier for mothers.
Eligible Conditions
- Spina Bifida
- Tethered Spinal Cord Syndrome
- Neural Tube Defects
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Maternal adverse events
Neonatal adverse events
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: Pregnant women diagnosed with fetal myelomeningoceleExperimental Treatment1 Intervention
Women subjects who are pregnant and diagnosed with myelomeningocele (MMC), also known as fetal spina bifida or neural tube defect, will undergo a minimally invasive fetoscopic repair of MMC.
Find a Location
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,326 Previous Clinical Trials
3,059,479 Total Patients Enrolled
1 Trials studying Spina Bifida
60 Patients Enrolled for Spina Bifida
Rodrigo Ruano, MD, PhDPrincipal InvestigatorMayo Clinic
4 Previous Clinical Trials
111 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- An unborn baby has a medical condition not related to the mother's medical condition.You are pregnant with more than one baby.You have refused to undergo invasive testing for checking the baby's chromosomes.Your spine is severely curved at an angle greater than 30 degrees.You have a higher chance of giving birth too early, including having a short cervix, a history of cervix problems, or a previous early birth.You have placental issues such as previa, abruption, or accreta.Your body-mass index is 40 or higher when you first visit the doctor during pregnancy.You have a medical condition that makes surgery risky, such as a previous surgery involving the uterus or certain uterine anomalies.You are unable to have fetoscopic surgery due to certain medical conditions like uterine fibroids or abnormal uterus shape.You have a condition that can cause problems for your baby during pregnancy.You have a specific type of brain abnormality called Arnold-Chiari type II malformation, confirmed by MRI.Expectant mothers with HIV, Hepatitis-B, or Hepatitis-C must test negative before joining the study to lower the risk of passing the infections to the baby during surgery.Your score on the Beck Depression Inventory (BDI) is 29 or higher during the screening.The pregnant person is allergic to collagen.Your baby's chromosomes are normal and there are no other genetic abnormalities. If there is a specific type of balanced translocation with no other issues, you may still be included.You are pregnant with only one baby.You have a diagnosis of a type of cancer called medulloblastoma and the upper part of the cancer is between the first thoracic vertebra and the first sacral vertebra.You do not have any abnormal chromosomes or related health issues.If the amniotic fluid is low because of a problem with the baby, the placenta, or the amniotic sac, you cannot participate. However, if the low amniotic fluid improves when the mother drinks more water, then it is not a problem.
Research Study Groups:
This trial has the following groups:- Group 1: Pregnant women diagnosed with fetal myelomeningocele
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.
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger