Fetal Repair of Complex Gastroschisis: A Safety and Feasibility Trial (NCT05704257) | Clinical Trial Compass
RecruitingNot Applicable
Fetal Repair of Complex Gastroschisis: A Safety and Feasibility Trial
United States10 participantsStarted 2023-10-20
Plain-language 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.
Who can participate
Age range18 Years
SexFEMALE
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Inclusion criteria
✓. 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
Exclusion criteria
✕. 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.