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MEGA STUDY - Multicenter Evaluation of Gastroschisis Anomaly Study

Study acronym: MEGA
StatusActive, Not Recruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Record status
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.

Record History

  1. Minor Secondary endpoints: details revised at 8 of 22 entriesv3
  2. Minor Trial status: Not Yet Recruiting to Active, Not Recruiting
    • Study sites: 6 to 9
    • Start date changed from estimate of Jun 10, 2025 to Jun 21, 2025
    v2
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07030309
Lead Sponsor ResearchSkills
Conditions
(from sponsor)
Gastroschisis
Related terms Congenital Abnormalities, Gastroschisis
Enrollment 200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov