Actively Recruiting
Laparotomy Versus Percutaneous Endoscopic Correction of Myelomeningocele
Led by USFetus · Updated on 2019-11-13
12
Participants Needed
2
Research Sites
478 weeks
Total Duration
On this page
Sponsors
U
USFetus
Lead Sponsor
W
Wellington Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this study is to evaluate the feasibility of a fetoscopic surgical technique for antenatal correction of fetal myelomeningocele. Two surgical approaches will be utilized. The percutaneous approach will be offered to participants with a posterior placenta. The laparotomy/uterine exteriorization approach will be offered to participants regardless of placental location.
CONDITIONS
Official Title
Laparotomy Versus Percutaneous Endoscopic Correction of Myelomeningocele
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of myelomeningocele (including myeloschisis) at spinal levels T1 through S1 with hindbrain herniation confirmed by MRI and ultrasound
- Maternal age 18 years or older
- Gestational age between 19 and 27 weeks and 6 days confirmed by clinical evaluation and ultrasound
- Balanced fetal karyotype confirmed by culture or FISH if 24 weeks or more
- Positive social work evaluation confirming ability to consent and adequate social support
- Positive pediatric neurology evaluation
- Willingness to stay near Wellington or Pasadena and deliver at designated hospitals
- Commitment to return for follow-up visits at 12, 24, 30, 48, and 60 months after delivery
You will not qualify if you...
- Multiple pregnancies (twins or more)
- Insulin-dependent pregestational diabetes
- Fetal anomalies unrelated to myelomeningocele, including abnormal fetal echocardiogram
- Fetal kyphosis of 30 degrees or more
- Uterine cervical cerclage or history of incompetent cervix
- Placenta previa or placental abruption
- Short cervix less than 25 mm
- Obesity with body mass index (BMI) of 35 or greater
- History of spontaneous singleton birth before 37 weeks
- Maternal-fetal Rh isoimmunization, Kell sensitization, or neonatal alloimmune thrombocytopenia history
- Maternal HIV or Hepatitis B positive status; negative test required if unknown
- Known Hepatitis C positivity
- Uterine anomalies such as large fibroids or Mullerian duct abnormalities
- Medical conditions contraindicating surgery or anesthesia
- Lack of a support person
- Inability to comply with travel and follow-up requirements
- Failure to meet psychosocial criteria
- Participation in other intervention studies affecting maternal or fetal health
- Maternal hypertension increasing risks of preeclampsia or preterm delivery
- Uterine malformations deemed unsafe for surgery
- Nickel allergy
- Request for open fetal surgery primarily or after failed fetoscopic approach
- Known hypersensitivity to bovine collagen or chondroitin materials
AI-Screening
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Trial Site Locations
Total: 2 locations
1
University of Southern California / Huntington Memorial Hospital
Los Angeles, California, United States, 91105
Actively Recruiting
2
Wellington Regional Medical Center
Wellington, Florida, United States, 33141
Actively Recruiting
Research Team
R
Ruben Quintero, MD
CONTACT
R
Ramen Chmait, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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