GastroschisisNCT05704257
Fetal Repair of Complex Gastroschisis: A Safety and Feasibility Trial
A study testing fetoscopy in people with Gastroschisis, run by Baylor College of Medicine at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gastroschisis
- What is being tested?
- fetoscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Oct 2023to Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pregnant women - maternal age 18 years or older and capable of consenting for her own participation in this study
- Singleton pregnancy
- Sonographic evidence of gastroschisis (exteriorization of bowel content outside the fetal abdominal cavity into the amniotic cavity)
- Intraabdominal bowel dilation ≥ 8 mm at 20-24 weeks GA reviewed by prenatal ultrasound
- Absence of significant associated anomalies* diagnosed on prenatal ultrasound or MRI
- Gestational age at the time of the procedure will be between 20 0/7 weeks and 27 6/7 weeks
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- 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
- The family has considered and declined the option of termination of the pregnancy at less than 24 weeks and of standard postnatal treatment
- The family meets psychosocial criteria (sufficient social support, ability to understand the requirements of the study)
- 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.
Who cannot join
- Significant fetal anomaly unrelated to gastroschisis
- Evidence of bowel perforation (presence of intraabdominal bowel calcification on ultrasonography)
- 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)
- Placental abnormalities (previa, abruption, accreta) known at time of enrollment
- Pre-pregnancy body-mass index (BMI) ≥40
- 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
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- Technical limitations precluding fetoscopic surgery, such as extensive uterine fibroids, fetal membrane separation, or uterine anomalies
- Maternal-fetal Rh alloimmunization, Kell sensitization, or neonatal alloimmune thrombocytopenia affecting the current pregnancy.
- 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
- Maternal medical condition that is a contraindication to surgery or general anesthesia
- 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
- Patient does not have a support person (i.e., spouse, partner, or mother) available to support her for the duration of the pregnancy
- Inability to comply with the travel and follow-up requirements of the trial
- Patient scores as severely depressed on the Edinburgh Postnatal Depression Scale (EPDS)
- Patients that are enrolled or have been enrolled in any another intervention study that affects the mother or fetus
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Texas Children's Hospital
Houston, Texas, 77030
Sundeep Keswani, MD, 832-824-0462, sgkeswan@texaschildrens.org
Becky Johnson, 832-826-7451, rj2@bcm.edu
About this study
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.
Read the detailed description
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.
- Conditions
- Gastroschisis
- Being tested
- fetoscopy
- Keywords
- Gastroschisis, Abdominal Wall Defect
- Medical subject headings
- Gastroschisis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fetoscopyDevice
The fetoscopic arm is described above. All patients will have a laparotomy, exteriorization of the uterus, and a fetoscopic repair of the gastroschisis.
| Study group | Role | What they receive |
|---|---|---|
| fetoscopic surgical repair | Experimental | Single arm study. All patients will receive the fetoscopic repair. Receives: Device: fetoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful Repair of Complex Gastroschisis
Success of primary skin closure after complete bowel reduction.
Measured: At end of surgical repair
Secondary outcomes (16)
Intrauterine Fetal Death (IUFD)
Demise of fetus while still in the womb
Measured: At delivery
Preterm Birth
Number of patients that deliver at < 37 weeks gestation
Measured: At delivery
Time to initiation of enteral feeds (days)
The number of days until initiation of enteral feeding
Measured: 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)
Measured: At hospital discharge, an average of 1.5 months
Necrotizing Enterocolitis
As measured by presence in medical record
Measured: At hospital discharge, an average of 1.5 months
Short Bowel Syndrome
As measured by presence in medical record
Measured: At hospital discharge, an average of 1.5 months
Length of Hospital Stay
Length of stay in the hospital measured in days
Measured: 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.
Measured: During first month of life
Retinopathy of Prematurity
Postnatal grade classification presence of grade III or higher using standardized system (yes/no)
Measured: At the time of discharge from the NICU, an average of 1.5 months
Respiratory Distress Syndrome
As measured by presence in medical record
Measured: At the time of discharge from the NICU, an average of 1.5 months
Bronchopulmonary Dysplasia
As measured by presence in medical record
Measured: 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
Measured: 12 months of age
Small Bowel Obstruction
As measured by presence in medical record ≤12 months
Measured: 12 months of age
Central Line Associated Bloodstream Infection (CLABSI)
As measured by presence in medical record ≤12 months
Measured: 12 months of age
Neuro-developmental Outcome at 12 months
As measured by the Capute Scales at 12 months
Measured: 12 months of age
Survival at 12 months
Number of patients alive at 12 months of age
Measured: 12 months of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2023
- Study start20 Oct 2023
- Primary completionDec 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GastroschisisStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sundeep Keswani, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05704257
- Sponsor's protocol ID
- H-51929
- Status last verified
- Nov 2026
- First submitted
- 3 Jan 2023
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fetal Repair of Complex Gastroschisis: A Safety and Feasibility Trial
- ClinicalTrials.gov ID
- NCT05704257
- Acronym / sponsor ID
- H-51929
- Conditions
- Gastroschisis
- Keywords
- Gastroschisis, Abdominal Wall Defect
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Study start
- 20 Oct 2023 (actual)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 30 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| fetoscopic surgical repair | Experimental | Device: fetoscopySingle arm study. All patients will receive the fetoscopic repair. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Pregnant women - maternal age 18 years or older and capable of consenting for her own participation in this study
- Singleton pregnancy
- Sonographic evidence of gastroschisis (exteriorization of bowel content outside the fetal abdominal cavity into the amniotic cavity)
- Intraabdominal bowel dilation ≥ 8 mm at 20-24 weeks GA reviewed by prenatal ultrasound
- Absence of significant associated anomalies* diagnosed on prenatal ultrasound or MRI
Key exclusion criteria (16 listed)
- Significant fetal anomaly unrelated to gastroschisis
- Evidence of bowel perforation (presence of intraabdominal bowel calcification on ultrasonography)
- 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)
- Placental abnormalities (previa, abruption, accreta) known at time of enrollment
- Pre-pregnancy body-mass index (BMI) ≥40
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fetoscopyThe fetoscopic arm is described above. All patients will have a laparotomy, exteriorization of the uterus, and a fetoscopic repair of the gastroschisis. | Device | fetoscopic surgical repair |
Primary outcome
Successful Repair of Complex Gastroschisis
Time frame: At end of surgical repair
Success of primary skin closure after complete bowel reduction.
16 secondary outcomes
Intrauterine Fetal Death (IUFD)
Time frame: At delivery
Preterm Birth
Time frame: At delivery
Time to initiation of enteral feeds (days)
Time frame: At hospital discharge, an average of 1.5 months
Time on total parenteral nutrition (TPN) (days)
Time frame: At hospital discharge, an average of 1.5 months
Necrotizing Enterocolitis
Time frame: At hospital discharge, an average of 1.5 months
Short Bowel Syndrome
Time frame: At hospital discharge, an average of 1.5 months
Length of Hospital Stay
Time frame: At the time of discharge from the NICU, an average of 1.5 months
Intracranial hemorrhage
Time frame: During first month of life
Retinopathy of Prematurity
Time frame: At the time of discharge from the NICU, an average of 1.5 months
Respiratory Distress Syndrome
Time frame: At the time of discharge from the NICU, an average of 1.5 months
Bronchopulmonary Dysplasia
Time frame: At the time of discharge from the NICU, an average of 1.5 months
Need for Gastroschisis related surgery
Time frame: 12 months of age
Small Bowel Obstruction
Time frame: 12 months of age
Central Line Associated Bloodstream Infection (CLABSI)
Time frame: 12 months of age
Neuro-developmental Outcome at 12 months
Time frame: 12 months of age
Survival at 12 months
Time frame: 12 months of age
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fetoscopy in people with Gastroschisis, run by Baylor College of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sundeep Keswani, MD (832-824-0462, sgkeswan@texaschildrens.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful Repair of Complex Gastroschisis (time frame: At end of surgical repair). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.