Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
NCT05704257

Fetal Repair of Complex Gastroschisis: A Safety and Feasibility Trial

Led by Baylor College of Medicine · Updated on 2026-04-23

10

Participants Needed

1

Research Sites

319 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Fetal Repair of Complex Gastroschisis: A Safety and Feasibility Trial

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Pregnant women aged 18 years or older who can consent for themselves
  • Singleton pregnancy
  • Ultrasound evidence showing gastroschisis with bowel outside the fetal abdomen
  • Intraabdominal bowel dilation of 8 mm or more at 20 to 24 weeks gestation
  • No significant life-threatening anomalies found by ultrasound or MRI
  • Pregnancy between 20 weeks 0 days and 27 weeks 6 days at the time of procedure
  • Normal chromosomes confirmed by invasive testing (amniocentesis or CVS) or acceptable balanced translocation
  • Family has declined pregnancy termination before 24 weeks and standard postnatal treatment
  • Family meets psychosocial criteria including social support and study understanding
  • Parental or guardian consent for child follow-up after birth
Not Eligible

You will not qualify if you...

  • Major fetal anomalies unrelated to gastroschisis
  • Signs of bowel perforation such as calcifications on ultrasound
  • Risks for preterm labor including short cervix (2.0 cm or less), history of incompetent cervix, or previous preterm birth
  • Placental problems like previa, abruption, or accreta
  • Pre-pregnancy body mass index of 40 or higher
  • Surgical contraindications including previous uterine surgeries in active segment
  • Technical issues preventing fetoscopic surgery like uterine fibroids or membrane separation
  • Maternal-fetal blood incompatibility conditions affecting current pregnancy
  • Maternal HIV, Hepatitis B or C infection or unknown status without negative testing
  • Maternal medical conditions preventing surgery or anesthesia
  • Low amniotic fluid due to fetal or placental problems, not responsive to hydration
  • Lack of available support person during pregnancy
  • Inability to meet travel and follow-up study requirements
  • Severe depression based on Edinburgh Postnatal Depression Scale
  • Participation in other intervention studies affecting mother or fetus
  • Allergy to components of AlloDerm or associated antibiotics

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Texas Children's Hospital

Houston, Texas, United States, 77030

Actively Recruiting

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Research Team

S

Sundeep Keswani, MD

CONTACT

B

Becky Johnson

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DEVICE_FEASIBILITY

Number of Arms

1

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