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MEGA STUDY - Multicenter Evaluation of Gastroschisis Anomaly Study

R

ResearchSkills

Status

Active, not recruiting

Conditions

Gastroschisis

Treatments

Other: Gastroschisis

Study type

Observational

Funder types

NETWORK

Identifiers

NCT07030309
1/2025/MEGAStudy

Details and patient eligibility

About

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.

Enrollment

200 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

  • A fetus with a diagnosis of gastroschisis;
  • Availability of prenatal, delivery and postnatal records (for hospital discharge, transfer to another facility or death).

Exclusion criteria

  • pregnancies terminated before the 22nd week of pregnancy

Trial design

200 participants in 2 patient groups

simple gastroschisis
Description:
isolated gastroschisis, without intestinal anomalies
Treatment:
Other: Gastroschisis
complex gastroschisis
Description:
gastroschisis with intestinal atresias, perforations, necrosis or volvulus
Treatment:
Other: Gastroschisis

Trial contacts and locations

9

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Central trial contact

Renata Jaczyńska, PhD; Dorota Sys, PhD

Data sourced from clinicaltrials.gov

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