An interventional study of fetoscopy in Gastroschisis, sponsored by Baylor College of Medicine. Recruiting at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by Baylor College of Medicine · Not applicable, Interventional, and Device feasibility
The goal of this clinical trial is to evaluate the safety and feasibility of fetal repair of complex gastroschisis (GS) via a fetoscopic surgical approach by assessing maternal, fetal, neonatal, and infant outcomes in a cohort of 10 patients. The hypothesis is that in utero repair of GS will reduce postnatal mortality and morbidity in complex GS infants with minimal maternal and fetal risk.
Gastroschisis is a congenital abdominal wall defect by which the intestinal structures eviscerate from the abdomen, with a current prevalence of 4.9 per 10,000 pregnancies in the United States. Not only is it the most common abdominal wall defect, but the incidence of GS has increased by nearly 30% in the US (Jones et al., 2016) and 25 % in Europe (EUROCAT, 2021) between 2006 and 2012 for reasons that are still unknown. Two subtypes of the disease have been identified - simple and complex GS. Simple GS presents as an otherwise healthy bowel that may have an inflammatory peel over the bowel surface. By contrast, complex GS is characterized by serious bowel complications, such as bowel volvulus, atresia, stenosis, necrosis, and perforation.
Participants will be offered the minimally invasive in-utero repair technique as an alternative to the traditional standard postnatal GS surgical repair. To try to help relax the abdominal wall muscles, fetuses enrolled in the trial will receive botulinum toxin type A (Botox) injections one to two weeks before the fetoscopic surgery to repair the defect. During surgery, the mother's uterus is opened using the standard laparotomy approach that we currently use in our open fetal surgeries and fetoscopic spina bifida repair through an exteriorized uterus, and then fetal surgeons repair the fetus' defect. The uterus is closed, and the pregnancy continues. When babies are treated in this way, they may be less likely to be born with their intestines coming out of their belly and if this is the case, they may be less likely to have other problems that occur with gastroschisis because the intestines are not covered.
All participants will be closely followed with ultrasound and consultation after the surgery. Delivery will be scheduled at Texas Children's Hospital, and the infants will be followed for 12 months by our research team.
42 studies on the registry are indexed under Gastroschisis; 6 are open to participants now.
This study's planned enrollment of 10 is below the median of 44 across 26 interventional studies indexed under Gastroschisis.
Browse Gastroschisis studies →Baylor College of Medicine is the lead sponsor of 747 studies on the registry; 110 are open to participants now.
Of its 84 completed or terminated interventional studies of FDA-regulated products, 45 (54%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Parental/guardian permission () for follow up of the child after birth
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
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A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The human immunodeficiency virus, which weakens the immune system.
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An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Single arm study. All patients will receive the fetoscopic repair.
Device: fetoscopy
The fetoscopic arm is described above. All patients will have a laparotomy, exteriorization of the uterus, and a fetoscopic repair of the gastroschisis.
Successful Repair of Complex Gastroschisis
Success of primary skin closure after complete bowel reduction.
Time frame: At end of surgical repair
Intrauterine Fetal Death (IUFD)
Demise of fetus while still in the womb
Time frame: At delivery
Preterm Birth
Number of patients that deliver at \< 37 weeks gestation
Time frame: At delivery
Time to initiation of enteral feeds (days)
The number of days until initiation of enteral feeding
Time frame: At hospital discharge, an average of 1.5 months
Time on total parenteral nutrition (TPN) (days)
The number of days on total parenteral nutrition (TPN)
Time frame: At hospital discharge, an average of 1.5 months
Necrotizing Enterocolitis
As measured by presence in medical record
Time frame: At hospital discharge, an average of 1.5 months
Short Bowel Syndrome
As measured by presence in medical record
Time frame: At hospital discharge, an average of 1.5 months
Length of Hospital Stay
Length of stay in the hospital measured in days
Time frame: At the time of discharge from the NICU, an average of 1.5 months
Intracranial hemorrhage
Measured as presence in neonate during first month by MRI and/or ultrasound.
Time frame: During first month of life
Retinopathy of Prematurity
Postnatal grade classification presence of grade III or higher using standardized system (yes/no)
Time frame: At the time of discharge from the NICU, an average of 1.5 months
Respiratory Distress Syndrome
As measured by presence in medical record
Time frame: At the time of discharge from the NICU, an average of 1.5 months
Bronchopulmonary Dysplasia
As measured by presence in medical record
Time frame: At the time of discharge from the NICU, an average of 1.5 months
Need for Gastroschisis related surgery
As measured by presence in medical record ≤12 months
Time frame: 12 months of age
Small Bowel Obstruction
As measured by presence in medical record ≤12 months
Time frame: 12 months of age
Central Line Associated Bloodstream Infection (CLABSI)
As measured by presence in medical record ≤12 months
Time frame: 12 months of age
Neuro-developmental Outcome at 12 months
As measured by the Capute Scales at 12 months
Time frame: 12 months of age
Survival at 12 months
Number of patients alive at 12 months of age
Time frame: 12 months of age
Started Oct 2023 (actual). Primary completion is estimated for Dec 2029, 74 months after the start.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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