VALENCIA, Spain—The details of a phase 1 feasibility trial for the minimally invasive in utero repair of gastroschisis were presented in a lecture by Michael A. Belfort, MD, PhD, from Texas Children’s Hospital in Houston at the 20th World Congress in Fetal Medicine.
The trial, which was approved by the US Food and Drug Administration on October 12, 2022, will evaluate the safety and feasibility of fetal repair of complex gastroschisis using a fetoscopic surgical approach. Investigators will assess maternal, fetal, neonatal, and infant outcomes in 10 participants to see whether in utero repair of gastroschisis can reduce postnatal mortality and morbidity.
The study is recruiting participants ages 18 years and above and gestational age 20 to 26 weeks with sonographic evidence of gastroschisis, an intra-abdominal bowel dilation of more than 10 mm at 20 to 24 weeks, and no chromosomal or clinically significant genetic abnormalities, at Texas Children’s Hospital.
Participants with significant fetal anomaly unrelated to gastroschisis, evidence of bowel perforation, a prepregnancy body mass index of 40 or more, and those who do not have a support person that is available for the duration of the study are not eligible to take part in the trial.
The primary outcome measures include the feasibility and safety of fetal repair and 12-month mortality. The secondary outcome measures include fetal and infant morbidity in the first 12 months, and maternal mortality and morbidity.
The trial is estimated to start in August 2023 and be completed by December 2029.
Gastroschisis is a birth defect characterized by the presence of a hole in the abdominal wall beside the belly button, which the baby’s intestines, and sometimes other organs, exit through.
It could be a new indication for fetal surgery due to its accurate diagnosis, established natural history, the absence of effective postnatal therapy, and experimental evidence of feasibility, safety, and efficacy.
Belfort M. Gastroschisis: prenatal repair – phase 1 study. Oral presentation at: 20th World Congress in Fetal Medicine; June 25, 2023; Valencia, Spain.