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Naprawa płodu złożonego wytrzewienia: próba bezpieczeństwa i wykonalności

4 listopada 2026 zaktualizowane przez: Sundeep Keswani, Baylor College of Medicine

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.

Przegląd badań

Status

Rekrutacyjny

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

10

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

  • Nazwa: Becky Johnson
  • Numer telefonu: 832-826-7451
  • E-mail: rj2@bcm.edu

Kopia zapasowa kontaktu do badania

Lokalizacje studiów

  • Stany Zjednoczone
    • Texas
      • Houston, Texas, Stany Zjednoczone, 77030
        • Rekrutacyjny
        • Texas Children's Hospital
        • Pod-śledczy:
          • Roopali Donepudi, MD
        • Kontakt:
          • Becky Johnson
          • Numer telefonu: 832-826-7451
          • E-mail: rj2@bcm.edu
        • Pod-śledczy:
          • Luc Joyeux, MD, PhD
        • Kontakt:
        • Pod-śledczy:
          • Michael A Belfort, MD, PhD
        • Pod-śledczy:
          • Larry Hollier Jr., MD
        • Pod-śledczy:
          • Timothy Lee, MD
        • Pod-śledczy:
          • Alice King, MD
        • Pod-śledczy:
          • Magdalena Sanz Cortes, MD, PhD
        • Pod-śledczy:
          • Ahmed Nassr, MD, PhD
        • Pod-śledczy:
          • Jonathan Castillo Porter, MD, MPH
        • Pod-śledczy:
          • Caitlin Sutton, MD
        • Główny śledczy:
          • Sundeep Keswani, MD
        • Pod-śledczy:
          • Becky Johnson, MS, CCRP

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Kobieta

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Wykonalność urządzenia
  • Przydział: Nie dotyczy
  • Model interwencyjny: Zadanie dla jednej grupy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: fetoscopic surgical repair

Single arm study. All patients will receive the fetoscopic repair.
Urządzenie: fetoscopy

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

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Successful Repair of Complex Gastroschisis
Ramy czasowe: At end of surgical repair

Success of primary skin closure after complete bowel reduction.
At end of surgical repair

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Intrauterine Fetal Death (IUFD)
Ramy czasowe: At delivery

Demise of fetus while still in the womb
At delivery
Preterm Birth
Ramy czasowe: At delivery

Number of patients that deliver at < 37 weeks gestation
At delivery
Time to initiation of enteral feeds (days)
Ramy czasowe: At hospital discharge, an average of 1.5 months

The number of days until initiation of enteral feeding
At hospital discharge, an average of 1.5 months
Time on total parenteral nutrition (TPN) (days)
Ramy czasowe: At hospital discharge, an average of 1.5 months

The number of days on total parenteral nutrition (TPN)
At hospital discharge, an average of 1.5 months
Necrotizing Enterocolitis
Ramy czasowe: At hospital discharge, an average of 1.5 months

As measured by presence in medical record
At hospital discharge, an average of 1.5 months
Short Bowel Syndrome
Ramy czasowe: At hospital discharge, an average of 1.5 months

As measured by presence in medical record
At hospital discharge, an average of 1.5 months
Length of Hospital Stay
Ramy czasowe: At the time of discharge from the NICU, an average of 1.5 months

Length of stay in the hospital measured in days
At the time of discharge from the NICU, an average of 1.5 months
Intracranial hemorrhage
Ramy czasowe: During first month of life

Measured as presence in neonate during first month by MRI and/or ultrasound.
During first month of life
Retinopathy of Prematurity
Ramy czasowe: At the time of discharge from the NICU, an average of 1.5 months

Postnatal grade classification presence of grade III or higher using standardized system (yes/no)
At the time of discharge from the NICU, an average of 1.5 months
Respiratory Distress Syndrome
Ramy czasowe: At the time of discharge from the NICU, an average of 1.5 months

As measured by presence in medical record
At the time of discharge from the NICU, an average of 1.5 months
Bronchopulmonary Dysplasia
Ramy czasowe: At the time of discharge from the NICU, an average of 1.5 months

As measured by presence in medical record
At the time of discharge from the NICU, an average of 1.5 months
Need for Gastroschisis related surgery
Ramy czasowe: 12 months of age

As measured by presence in medical record ≤12 months
12 months of age
Small Bowel Obstruction
Ramy czasowe: 12 months of age

As measured by presence in medical record ≤12 months
12 months of age
Central Line Associated Bloodstream Infection (CLABSI)
Ramy czasowe: 12 months of age

As measured by presence in medical record ≤12 months
12 months of age
Neuro-developmental Outcome at 12 months
Ramy czasowe: 12 months of age

As measured by the Capute Scales at 12 months
12 months of age
Survival at 12 months
Ramy czasowe: 12 months of age

Number of patients alive at 12 months of age
12 months of age

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Baylor College of Medicine

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

20 października 2023

Zakończenie podstawowe (Szacowany)

1 grudnia 2029

Ukończenie studiów (Szacowany)

1 grudnia 2029

Daty rejestracji na studia

Pierwszy przesłany

3 stycznia 2023

Pierwszy przesłany, który spełnia kryteria kontroli jakości

20 stycznia 2023

Pierwszy wysłany (Rzeczywisty)

30 stycznia 2023

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

6 listopada 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

4 listopada 2026

Ostatnia weryfikacja

1 listopada 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • H-51929

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Tak

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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