Fetal repair of complex gastroschisis using a fetoscopic approach

Fetal Repair of Complex Gastroschisis: A Safety and Feasibility Trial

This trial will try a minimally invasive fetoscopic surgery, with preoperative Botox, to repair complex gastroschisis before birth in eligible pregnant people between about 20 and 28 weeks to see if it lowers newborn complications and death.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Baylor College of Medicine (Academic / other)
• Locations: 1 site (Houston, Texas)
• Trial ID: NCT05704257 on ClinicalTrials.gov

What this trial studies

Gastroschisis is a congenital abdominal wall defect in which bowel lies outside the fetus's abdomen and complex cases can include bowel atresia, necrosis, or perforation. This single-center feasibility cohort will enroll 10 pregnant people and offer an in-utero fetoscopic repair approach performed after a short course of fetal botulinum toxin injections to relax the abdominal wall. The procedure uses a maternal laparotomy with uterus exteriorization (as used for other open fetal procedures) to allow fetoscopic instruments to repair the defect and reposition bowel, followed by uterine closure and continuation of the pregnancy. Maternal, fetal, neonatal, and infant safety and outcomes will be tracked to determine feasibility and early signals of benefit.

Who should consider this trial

Good fit: Pregnant people aged 18 or older with a singleton fetus diagnosed with complex gastroschisis, intraabdominal bowel dilation ≥ 8 mm at 20–24 weeks, no major associated anomalies, normal karyotype/CMA, and who are between 20 0/7 and 27 6/7 weeks gestation are ideal candidates.

Not a fit: Patients with simple gastroschisis, significant associated anomalies or chromosomal abnormalities, multiple gestation, or those outside the gestational window are unlikely to benefit from this in‑utero procedure.

Why it matters

Potential benefit: If successful, prenatal repair could reduce newborn mortality and severe bowel complications, potentially leading to less intensive neonatal surgery and faster recovery.

How similar studies have performed: Fetal surgery for other conditions (for example spina bifida) has shown benefit in selected cases, but fetoscopic in‑utero repair specifically for complex gastroschisis is novel and largely untested in humans.

Eligibility criteria

Inclusion Criteria:

1. Pregnant women - maternal age 18 years or older and capable of consenting for her own participation in this study
2. Singleton pregnancy
3. Sonographic evidence of gastroschisis (exteriorization of bowel content outside the fetal abdominal cavity into the amniotic cavity)
4. Intraabdominal bowel dilation ≥ 8 mm at 20-24 weeks GA reviewed by prenatal ultrasound
5. Absence of significant associated anomalies\* diagnosed on prenatal ultrasound or MRI
6. Gestational age at the time of the procedure will be between 20 0/7 weeks and 27 6/7 weeks
7. Absence of chromosomal and clinically significant abnormalities, i.e., normal karyotype and/or normal chromosomal microarray (CMA) by invasive testing (amniocentesis or Chorionic Villus Sampling (CVS)). If there is a balanced translocation with normal CMA with no other anomalies the candidate can be included. Results by fluorescence in situ hybridization (FISH) will be accepted, if the candidate's gestation age is ≥ 22 0/7 weeks. Patients declining invasive testing will be excluded
8. The family has considered and declined the option of termination of the pregnancy at less than 24 weeks and of standard postnatal treatment
9. The family meets psychosocial criteria (sufficient social support, ability to understand the requirements of the study)
10. Parental/guardian permission (informed consent) for follow up of the child after birth

    * Significant associated anomalies are defined as such anomalies that would, in and of themselves, be life limiting or life threatening. A minor anomaly, such as a small VSD or ASD not deemed to be life limiting or threatening, or a cleft lip or other such anomaly, unless part of a genetic syndrome, will not disqualify the patient.

Exclusion Criteria:

1. Significant fetal anomaly unrelated to gastroschisis
2. Evidence of bowel perforation (presence of intraabdominal bowel calcification on ultrasonography)
3. Increased risk for preterm labor including short cervical length (≤ 2.0 cm), history of incompetent cervix with or without cerclage, and previous preterm birth in a singleton pregnancy (other than a patient delivered for a non-repeating medical or surgical indication)
4. Placental abnormalities (previa, abruption, accreta) known at time of enrollment
5. Pre-pregnancy body-mass index (BMI) ≥40
6. Contraindications to surgery including previous hysterotomy (whether from a previous classical cesarean, uterine anomaly such as an arcuate or bicornuate uterus, major myomectomy resection, or previous fetal surgery) in active uterine segment
7. Technical limitations precluding fetoscopic surgery, such as extensive uterine fibroids, fetal membrane separation, or uterine anomalies
8. Maternal-fetal Rh alloimmunization, Kell sensitization, or neonatal alloimmune thrombocytopenia affecting the current pregnancy.
9. Maternal HIV, Hepatitis-B, Hepatitis-C status positive because of the increased risk of transmission to the fetus during maternal-fetal surgery. If the patient's HIV or Hepatitis status is unknown, the patient must be tested and found to have negative results before enrollment
10. Maternal medical condition that is a contraindication to surgery or general anesthesia
11. Low amniotic fluid volume (Amniotic Fluid Index less than 6 cm) if deemed to be due to fetal anomaly, poor placental perfusion or function, or membrane rupture. Low amniotic fluid volume that responds to maternal hydration is not an exclusion criterion
12. Patient does not have a support person (i.e., spouse, partner, or mother) available to support her for the duration of the pregnancy
13. Inability to comply with the travel and follow-up requirements of the trial
14. Patient scores as severely depressed on the Edinburgh Postnatal Depression Scale (EPDS)
15. Patients that are enrolled or have been enrolled in any another intervention study that affects the mother or fetus
16. Maternal hypersensitivity to any of the entities associated w/ AlloDerm™. The use of AlloDerm™ Regenerative Tissue Matrix distributed by Allergan Aesthetics is contraindicated for patients sensitive to any of the antibiotics listed on the AlloDerm package, i.e., Gentamycin, Cefoxitin, Lincomycin, Polymyxin B and Vancomycin or Polysorbate 20

Where this trial is running

Houston, Texas

• Texas Children's Hospital — Houston, Texas, United States (Recruiting)

Study contacts

• Principal investigator: Sundeep Keswani, MD — Baylor College of Medicine and Texas Children's Hospital
• Study coordinator: Sundeep Keswani, MD

Conditions Gastroschisis; Abdominal Wall Defect