Actively Recruiting
In Utero Endoscopic Correction of Myelomeningocele: Laparotomy Versus Percutaneous - A Pilot Study
Led by USFetus · Updated on 2019-11-13
12
Participants Needed
2
Research Sites
373 weeks
Total Duration
On this page
Sponsors
U
USFetus
Lead Sponsor
W
Wellington Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying a surgical technique called fetoscopy to correct fetal myelomeningocele, a form of spina bifida, before birth. This pilot study compares two surgical approaches: a percutaneous method offered to patients with a posterior placenta, and a laparotomy with uterine exteriorization method available to all participants regardless of placental location. The goal is to see if these techniques can successfully close the myelomeningocele defect before delivery. Participants will receive fetoscopic repair of the myelomeningocele using one of the two surgical approaches based on their placental position and preference. Those with an anterior placenta will undergo the laparotomy method, while those with a posterior placenta may choose either the percutaneous or laparotomy approach. The study evaluates the success rate of these in-utero surgeries from the time of operation until delivery, lasting up to 21 weeks. During the study, participants will undergo MRI and ultrasound to confirm lesion and hindbrain herniation levels. Social work and pediatric neurology consultations will assess eligibility and support. Participants must remain near the medical center for pregnancy and delivery and return for follow-up visits at 12, 24, 30, 48, and 60 months after birth. The study tracks surgical outcomes and monitors safety and development over time.
CONDITIONS
Brief Title
Laparotomy Versus Percutaneous Endoscopic Correction of Myelomeningocele
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Myelomeningocele (including myeloschisis) at level T1 through S1 with hindbrain herniation, confirmed by MRI and ultrasound
- Female aged 18 years or older
- Gestational age between 19 and 27 weeks and 6 days
- Balanced fetal karyotype confirmed by culture or FISH if at 24 weeks or more
- Positive social work evaluation confirming ability to consent and social support
- Positive pediatric neurology consultation
- Willingness to stay near the medical center for pregnancy, delivery, and return for follow-up visits up to 60 months
You will not qualify if you...
- Multiple pregnancy
- Insulin-dependent pregestational diabetes
- Fetal anomalies unrelated to myelomeningocele
- Fetal kyphosis of 30 degrees or more
- Presence of uterine cervical cerclage or history of incompetent cervix
- Placenta previa or placental abruption
- Short cervix under 25 mm
- Obesity with BMI 35 or higher
- History of spontaneous singleton delivery before 37 weeks
- Maternal-fetal Rh isoimmunization, Kell sensitization, or neonatal alloimmune thrombocytopenia
- Maternal HIV or Hepatitis B positive status
- Known Hepatitis C positivity
- Uterine anomalies or large fibroids
- Other medical conditions contraindicating surgery or anesthesia
- Lack of a support person
- Inability to comply with study travel and follow-up
- Failure to meet psychosocial criteria
- Participation in another intervention study affecting maternal or fetal outcomes
- Maternal hypertension increasing risk of preeclampsia or preterm delivery
- Bicornuate or unsafe uterine malformations
- Nickel allergy
- Maternal request for open fetal surgery instead of fetoscopy
- Known allergy to bovine collagen or chondroitin materials
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - From time of surgery until delivery, up to 21 weeks
Participants undergo fetoscopic repair of myelomeningocele using either the laparotomy with uterine exteriorization approach or the percutaneous approach depending on placenta location and preference.
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
R
Ramen Chmait, MD
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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