Actively Recruiting
Fetal Repair of Complex Gastroschisis: A Safety and Feasibility Trial
Led by Baylor College of Medicine · Updated on 2026-04-23
10
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and feasibility of repairing complex gastroschisis before birth using a minimally invasive fetoscopic surgical approach. Complex gastroschisis is a serious birth defect where the intestines develop outside the baby's abdomen and may have complications like twisting or damage. The study aims to see if this early fetal repair can reduce risks and improve outcomes for both mother and baby. The treatment involves injecting botulinum toxin (Botox) into the fetus to relax abdominal muscles 1 to 2 weeks before surgery. The surgery is performed through a laparotomy where the uterus is opened, exteriorized, and the fetal defect repaired fetoscopically. After closing the uterus, the pregnancy continues. This is a single-arm study where all participants receive the fetoscopic repair. Participants will have close monitoring with ultrasounds and consultations after surgery. Delivery is planned at Texas Children's Hospital, with infants followed for 12 months to assess survival, feeding milestones, hospital stay, growth, and development. Researchers will track multiple outcomes including surgical success, fetal and infant health complications, and long-term neurodevelopment.
CONDITIONS
Brief Title
Fetal Repair of Complex Gastroschisis: A Safety and Feasibility Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pregnant women 18 years or older able to consent for themselves
- Singleton pregnancy
- Ultrasound evidence of gastroschisis with bowel outside the fetal abdomen
- Intraabdominal bowel dilation of 8 mm or more at 20 to 24 weeks gestation
- No significant associated anomalies on ultrasound or MRI
- Gestational age between 20 0/7 and 27 6/7 weeks at procedure time
- Normal chromosomal testing by invasive methods (amniocentesis or CVS)
- Family has declined pregnancy termination before 24 weeks and standard postnatal treatment
- Meets psychosocial criteria with sufficient social support and understanding
- Parental permission for follow-up of the child after birth
You will not qualify if you...
- Significant fetal anomaly unrelated to gastroschisis
- Evidence of bowel perforation shown by calcification on ultrasound
- Increased risk for preterm labor such as short cervix ≤ 2.0 cm, history of incompetent cervix, or previous preterm birth
- Known placental abnormalities at enrollment (previa, abruption, accreta)
- Pre-pregnancy BMI of 40 or higher
- Contraindications to surgery including previous uterine surgery in active segment
- Technical limitations preventing fetoscopic surgery like uterine fibroids or membrane separation
- Maternal-fetal Rh alloimmunization or neonatal alloimmune thrombocytopenia
- Maternal HIV, Hepatitis B or C positive status
- Maternal medical conditions contraindicating surgery or anesthesia
- Low amniotic fluid volume due to fetal or placental issues
- Lack of a support person available for pregnancy duration
- Inability to comply with travel and follow-up requirements
- Severe depression by Edinburgh Postnatal Depression Scale
- Enrollment in another intervention study affecting mother or fetus
- Maternal allergy to components of AlloDerm tissue matrix used in surgery
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.
1 visit (in-person)
Duration - 1 to 2 weeks
Participants receive botulinum toxin type A (Botox) injections to help relax the abdominal wall muscles 1 to 2 weeks before fetoscopic surgery.
1 to 2 visits (in-person)
Duration - Day of surgery
Participants undergo fetoscopic surgical repair of the gastroschisis defect through laparotomy and exteriorization of the uterus.
1 visit (in-person, surgical procedure)
Duration - Up to 12 months
Participants are closely followed with ultrasound and consultations after surgery, and delivery is scheduled at Texas Children's Hospital. The infants are followed for 12 months after birth.
Multiple follow-up visits over 12 months
Trial Site Locations
Total: 1 location
1
Texas Children's Hospital
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
S
Sundeep Keswani, MD
B
Becky Johnson
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DEVICE_FEASIBILITY
Number of Arms
1
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