Fetal Repair of Complex Gastroschisis: A Safety and Feasibility Trial
ConditionGastroschisis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorBaylor College of Medicine
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- fetoscopy
Treatment groups
10 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov