NCT07030309

MEGA STUDY - Multicenter Evaluation of Gastroschisis Anomaly Study

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: ResearchSkills · Network
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Gastroschisis

Interventions

Type	Name	Description
OTHER	Gastroschisis	Gastroschisis (GS) is a congenital abdominal wall defect in which the intestine is located outside the abdominal cavity. The prevalence of the GS classifies it as a rare disease (ORPHA:2368) Pregnancy complicated by gastroschisis is associated with an increased risk of serious perinatal complications. The presence of accompanying intestinal anomalies (atresia, necrosis, perforation, and volvulus), which qualifies the defect in the cGS (complex gastroschisis) group, as opposed to sGS (simple gastroschisis), where these anomalies are absent. cGS is associated with significantly increased neonatal morbidity and mortality when compared to sGS.

Timeline

• Start date: 2025-06-21
• Primary completion: 2025-12-31
• Completion: 2026-06-30
• First posted: 2025-06-22
• Last updated: 2025-07-01

Locations

9 sites across 1 country: Poland