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MEGA Study

Multicenter Evaluation of Gastroschisis Anomaly Study

An observational study evaluating epidemiological aspects of gastroschisis and factors affecting health outcomes of newborns with prenatally diagnosed malformation.

ClinicalTrials.gov ID: NCT07030309
Study Status: Recruiting
Estimated Enrollment: 200 participants
Learn More About the Study

About the Study

Study Overview

The MEGA Study is an observational, retrospective cohort study designed to evaluate selected epidemiological aspects of gastroschisis and factors affecting health outcomes of newborns with prenatally diagnosed malformation.

Study Design

  • Type: Observational, Retrospective Cohort Study
  • Timeline: 2011-2024 data collection period
  • Population: Fetuses diagnosed with gastroschisis
  • Sample Size: Estimated 200 participants
  • Duration: June 2025 - June 2026

Primary Objectives

1

Evaluate correlations between ultrasound bowel parameters and surgical assessment

2

Determine prevalence of different gastroschisis forms (simple vs complex)

3

Assess incidence of perioperative and postoperative complications

4

Analyze relationship between defect type and feeding milestones

5

Examine clinical parameters affecting final outcomes

Methodology

Inclusion Criteria

  • 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

Data Collection

Data will be collected passively from historical medical records including prenatal test results, details of pregnancy, delivery, and postnatal information on newborn treatment. All information will be anonymized to protect patient privacy.

Primary Outcome Measures

  • The prevalence of different forms of gastroschisis (simple vs complex)
  • Agreement rate between prenatal and neonatal assessment of bowel condition

Key Secondary Outcome Measures

  • Time to full enteral feeding (TFEF)
  • Duration of total parenteral nutrition (TPN)
  • Length of hospital stay (LOS)
  • Prevalence of necrotizing enterocolitis (NEC)
  • Prevalence of short bowel syndrome (SBS)
  • Neonatal mortality rates
  • Gastroschisis prognostic score (GPS)

Clinical Trial Information

ClinicalTrials.gov ID: NCT07030309
Study Type: Observational
Estimated Enrollment: 200 participants
Study Timeline: June 2025 - June 2026
View on ClinicalTrials.gov

MEGA Study TEAM

Principal Investigator

Renata Jaczyńska MD, PhD

+48 691 666 587
renatajaczynska@tlen.pl

Research Project Manager and Methodologist

Dorota Sys, PhD

+48 661 554 056
dsys@cmkp.edu.pl

Study Locations

Participating Medical Centers in Poland

Poznań

Szpital Kliniczny Uniwersytetu Medycznego w Poznaniu

Principal Investigator(s):

dr hab. n. med. Jakub Kornacki dr n. med. Małgorzata Rzanny-Owczarek

Ruda Śląska/Katowice

Śląski Uniwersytet Medyczny

Principal Investigator(s):

dr n. med. Bogusława Piela dr hab. n. med. Tomasz Koszutski, prof. SUM

Rzeszów

Kliniczny Szpital Wojewódzki nr 2 im. Świętej Jadwigi Królowej

Principal Investigator(s):

dr n. med. Anna Guzik dr n. med. Tomasz Wasyluk

Warszawa

Instytut Matki i Dziecka

Principal Investigator(s):

dr hab. n. med. Ewa Sawicka, prof. IMID dr n. med. Tomasz Maciejewski

Warszawa

Uniwersyteckie Centrum Kliniczne WUM, Dziecięcy Szpital Kliniczny

Principal Investigator(s):

dr n. med. Renata Jaczyńska dr n. med. Aleksandra Jasińska

Join Our Study

Interested in Participating?

If your medical center has data on pregnancies, deliveries, and newborns with gastroschisis, you can apply to join our research team and participate in the MEGA Study.

Contact us to learn more about participation requirements and application process.

Contact Us

Key Publications by Study Team related to gastroschisis

Prenatal ultrasound markers for prediction of complex gastroschisis-single-center retrospective cohort study

Jaczynska R, Mikulska B, Nimer A, Mydlak D, Sawicka E, Maciejewski T

J Perinatol. 2024 Sep;44(9):1325-1334

DOI: 10.1038/s41372-024-02009-y 2024

Perinatal Outcomes of Neonates with Complex and Simple Gastroschisis after Planned Preterm Delivery-A Single-Centre Retrospective Cohort Study

Jaczynska R, Mydlak D, Mikulska B, Nimer A, Maciejewski T, Sawicka E

Diagnostics (Basel). 2023 Jun 30;13(13):2225

DOI: 10.3390/diagnostics13132225 2023

Influence of selected factors on the treatment and prognosis in newborns with gastroschisis on the basis of own experience

Sawicka E, Wieprzowski L, Jaczyńska R, Maciejewski T

Med. Wieku Rozwoj. 2013 Jan-Mar;17(1):37-46

DOI: 2013