Fetal Repair of Complex Gastroschisis: A Safety and Feasibility Trial

NCT05704257 | Recruiting DMC FDA Device

• 1 other identifier: H-51929
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Gastroschisis

Keywords

Gastroschisis; Abdominal Wall Defect

Outcome Measures

Primary Outcomes (1)

• Successful Repair of Complex Gastroschisis

  Success of primary skin closure after complete bowel reduction.

  At end of surgical repair

Secondary Outcomes (16)

• Intrauterine Fetal Death (IUFD)

  At delivery

• Preterm Birth

  At delivery

• Time to initiation of enteral feeds (days)

  At hospital discharge, an average of 1.5 months

• Time on total parenteral nutrition (TPN) (days)

  At hospital discharge, an average of 1.5 months

• Necrotizing Enterocolitis

  At hospital discharge, an average of 1.5 months

Study Arms (1)

fetoscopic surgical repair

EXPERIMENTAL

Single arm study. All patients will receive the fetoscopic repair.

Device: fetoscopy

Interventions

fetoscopy DEVICE

The fetoscopic arm is described above. All patients will have a laparotomy, exteriorization of the uterus, and a fetoscopic repair of the gastroschisis.

fetoscopic surgical repair

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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
• 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
• 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

Sponsors & Collaborators

• Baylor College of Medicine: lead

Study Sites (1)

Texas Children's Hospital

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Gastroschisis

Interventions

Fetoscopy

Condition Hierarchy (Ancestors)

Musculoskeletal Abnormalities; Musculoskeletal Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Prenatal Diagnosis; Diagnostic Techniques, Obstetrical and Gynecological; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Fetal Therapies; Therapeutics; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Obstetric Surgical Procedures

Study Officials

• Sundeep Keswani, MD

  Baylor College of Medicine and Texas Children's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sundeep Keswani, MD

CONTACT

832-824-0462; sgkeswan@texaschildrens.org

Becky Johnson

CONTACT

832-826-7451; rj2@bcm.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Pediatric Surgery, Professor, Departments of Surgery, Pediatrics & OB/Gyn

Study Record Dates

• First Submitted: January 3, 2023
• First Posted: January 30, 2023
• Study Start: October 20, 2023
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: April 23, 2026

Record last verified: 2026-04

Locations

US (1)