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Procedure
In-Utero Surgery Techniques for Spina Bifida
N/A
Recruiting
Led By Ruben Quintero, MD
Research Sponsored by University of Southern California
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Maternal age ≥18 years
Myelomeningocele (including myeloschisis) at level T1 through S1 with hindbrain herniation confirmed by MRI and ultrasonography
Timeline
Screening 3 weeks
Treatment Varies
Follow Up prior to delivery
Awards & highlights
Study Summary
This trial will study two ways to fix spina bifida in fetuses. One is done by going through the skin and the other is by opening the belly and taking the uterus out.
Who is the study for?
This trial is for pregnant women over 18 with a fetus diagnosed with spina bifida (T1-S1 level) and hindbrain herniation, between 19-27 weeks' gestation. Candidates must have normal genetic test results, be able to consent and follow the study plan, and have support systems in place. Exclusions include multiple pregnancies, certain maternal health issues like diabetes or obesity (BMI ≥40), previous early deliveries, positive HIV/Hepatitis-B status or other conditions that risk surgery/anesthesia.Check my eligibility
What is being tested?
The trial tests two surgical methods to correct fetal spina bifida before birth: one through small incisions using cameras (percutaneous technique) and another by opening the abdomen to access the uterus directly (laparotomy/uterine exteriorization). The goal is to see which method might be safer or more effective.See study design
What are the potential side effects?
Potential side effects could include complications from anesthesia, risks of preterm labor or delivery due to uterine surgery, infection risks for both mother and baby, possible harm to the fetus during surgery including bleeding or trauma, and postoperative issues such as scarring.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I have a spinal defect from T1 to S1 with brain tissue protrusion, confirmed by MRI and ultrasound.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at time of surgery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at time of surgery
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 the endoscopic procedure
Secondary outcome measures
Chiari II malformation reversal
Trial Design
2Treatment groups
Experimental Treatment
Group I: Percutaneous TechniqueExperimental Treatment1 Intervention
The percutaneous technique uses endoscopic scopes through the maternal skin and uterus to perform the surgery. A variation of the percutaneous technique is the mini-laparotomy technique, which uses an endoscopic scope through an incision on the abdomen, smaller than a laparotomy ("mini-laparotomy"), and smaller endoscopic scopes through the maternal skin and uterus to perform the surgery.
Group II: Laparotomy/Uterine Exteriorization TechniqueExperimental Treatment1 Intervention
The laparotomy/uterine exteriorization technique consists of performing a laparotomy (incision into the abdominal cavity), exteriorizing the uterus, and using endoscopic scopes through the uterus to perform the correction.
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Who is running the clinical trial?
University of Southern CaliforniaLead Sponsor
906 Previous Clinical Trials
1,596,178 Total Patients Enrolled
1 Trials studying Spina Bifida
12 Patients Enrolled for Spina Bifida
USFetusOTHER
1 Previous Clinical Trials
12 Total Patients Enrolled
1 Trials studying Spina Bifida
12 Patients Enrolled for Spina Bifida
Ruben Quintero, MDPrincipal InvestigatorUS Fetus
2 Previous Clinical Trials
149 Total Patients Enrolled
1 Trials studying Spina Bifida
12 Patients Enrolled for Spina Bifida
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.You are extremely overweight, with a body mass index (BMI) of 40 or higher.You have placenta previa or placental abruption.If you have high blood pressure during pregnancy that could lead to complications like preeclampsia or having a baby too early, you may not be able to participate.Your cervix is shorter than 25 millimeters when measured by ultrasound.You are allergic to bovine collagen or chondroitin materials.You have had issues with blood type complications during pregnancy or childbirth.You are not meeting the social worker's assessment of your emotional and social well-being.I have a large fibroid or multiple fibroids, or an abnormality in my uterus.I have a spinal defect from T1 to S1 with brain tissue protrusion, confirmed by MRI and ultrasound.I know I am positive for Hepatitis C.My unborn baby has a condition not related to Chiari II Malformation.I have a cervical stitch or a history of weak cervix.You have given birth to a single baby before 37 weeks without any medical intervention.You are allergic to nickel.My uterus shape is not safe for surgery, as decided by my doctor.A pediatric neurologist has given their approval.The baby's spine is curved at an angle of 30 degrees or more, as seen on ultrasound or MRI.My genetic test results are normal or balanced, confirmed by a specific test.You have diabetes that requires insulin treatment before getting pregnant.I do not have HIV or Hepatitis B, or I have tested negative for both.I have a health condition that makes surgery or anesthesia unsafe for me.I am able to consent and have the support needed for the study.I want to have open fetal surgery for spina bifida at this hospital.
Research Study Groups:
This trial has the following groups:- Group 1: Laparotomy/Uterine Exteriorization Technique
- Group 2: Percutaneous Technique
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.
Could I potentially join this clinical investigation?
"This study seeks 33 individuals aged 18-52 with acrania. Additional prerequisites include: myelomeningocele (incl. myeloschisis) at T1 to S1 levels and hindbrain herniation confirmed by MRI/ultrasonography; maternal age of >=18 years; balanced karyotype or normal microarray results, FISH accepted if the patient is >24 weeks gestation; positive social work consult for consenting & appropriate support system in place; approval from pediatric neurology evaluation willing to come back to our clinic 6, 12, 24, 30, 48 & 60 months after procedure"
Answered by AI
Is recruitment still open for this clinical trial?
"As reported on clinicaltrials.gov, this medical trial is in the recruitment phase and was originally posted on November 2nd 2018 before being updated most recently on May 6th 2022."
Answered by AI
How many participants have been accepted into the current clinical trial?
"Affirmative. Clinicaltrials.gov data reports that this study is presently welcoming participants, with 33 subjects sought from 2 locations since it was initially posted on November 2nd 2018 and last edited on May 6th 2022."
Answered by AI
Does this research endeavor include elderly participants?
"This medical study seeks out subjects between 18 and 52 years of age."
Answered by AI
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