This record was last updated July 1, 2025 (before its estimated December 31, 2025 completion). Its status may not reflect the trial's current state.
Summary
The purpose of this observational study is to evaluate selected epidemiological aspects of gastroschisis (GS) and factors affecting health outcomes of newborns with this diagnosis in a population of fetuses with gastroschisis. The main questions the study aims to answer are:
* Are there correlations between the parameters of ultrasound evaluation of the bowel with the condition of the newborn's bowel as assessed by the surgeon?
* What is the prevalence of the different forms of GS (classification according to the methodology of Molik et al. 2002, Perrone et al. 2018)?
* What is the incidence of perioperative and postoperative complications and other complications of the neonatal period?
* What is the relationship between the form of the defect (simple GS vs complex GS) and feeding milestones - TFEF, TPN, TSEF, TSOF, TFOF?
* What is the relationship between clinical parameters, diagnostic and therapeutic management, including method and timing of delivery, and final outcomes? Participants will not perform any active tasks or receive interventions as part of this study. Data will be collected passively from historical medical records including prenatal test results, details of pregnancy, delivery, and postnatal information on the newborn's treatment. The information collected will be anonymized. The study aims to collect information on prenatal diagnosis and neonatal outcomes, analyze factors affecting final results, and develop the most optimal management regimen for GS in Poland.
Protocol Amendment History
2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2025-06-17; most recent amendment 2025-06-26.
Status change: Not Yet Recruiting → Active, Not Recruiting2025-06-23