MEGA STUDY - Multicenter Evaluation of Gastroschisis Anomaly Study

NCT07030309 | Active Not Recruiting DMC

• 1 other identifier: 1/2025/MEGAStudy
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 9

Brief 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

Keywords

gastroschisis; ORPHA:2368; congenital anomaly; MEGA Study; Observational study; Epidemiology; Prenatal diagnosis; Multicenter study; prenatal ultrasound

Outcome Measures

Primary Outcomes (1)

• The prevalence of different forms of GS

  The prevalence of different forms of GS: simple, complex

  During primary surgery

Secondary Outcomes (22)

• Agreement rate between prenatal and neonatal assessment of the bowel condition

  Prenatal assessment - during every US examination up to the time of delivery; newborn's evaluation - during primary surgery

• Prevalence of necrotizing enterocolitis (NEC)

  Up to 28 days after birth

• Prevalence of short bowel syndrome (SBS)

  During primary surgery or reoperation

• Prevalence of newborn sepsis

  Up to 28 days after birth

• Time to full enteral feeding (TFEF)

  From date of birth until the first day when full enteral feeding is achieved, assessed up to 28 days after birth.

Study Arms (2)

simple gastroschisis

isolated gastroschisis, without intestinal anomalies

Other: Gastroschisis

complex gastroschisis

gastroschisis with intestinal atresias, perforations, necrosis or volvulus

Other: Gastroschisis

Interventions

Gastroschisis OTHER

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.

complex gastroschisis; simple gastroschisis

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population for the MEGA Study consists of fetuses diagnosed with gastroschisis. The specific criteria for inclusion in the study are: * Fetuses with a diagnosis of gastroschisis. * Availability of prenatal, delivery, and postnatal documentation (up to hospital discharge, transfer to another center, or death). The exclusion criterion for the study is: • Pregnancies terminated before 22 weeks of gestation. The time frame for data included in the study is 2011 - 2024, although a shorter observation period may be applied depending on the availability of data at a participating center.

You may qualify if:

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

You may not qualify if:

• pregnancies terminated before the 22nd week of pregnancy

Sponsors & Collaborators

• ResearchSkills: lead

Study Sites (9)

Górnośląskie Centrum Zdrowia Dziecka, Szpital Uniwersytecki ŚUM, Klinika Chirurgii Dziecięcej i Urologii Dziecięcej

Katowice, 40-752, Poland

Location

Szpital Kliniczny Uniwersytetu Medycznego w Poznaniu, Oddział Ginekologiczno-Położniczy, Pododdział Rozrodczości i Medycyny Perinatalnej

Poznan, Poland

Location

Szpital Kliniczny Uniwersytetu Medyczny w Poznaniu, Klinika Chirurgii Traumatologii i Urologii Dziecięcej

Poznan, Poland

Location

Szpital Miejski w Rudzie Śląskiej, Katedra i Oddział Kliniczny Ginekologii i Położnictwa, Wydziału Nauk o Zdrowiu

Ruda Śląska, Poland

Location

Kliniczny Szpital Wojewódzki nr 2 im. Świętej Jadwigi Królowej. Klinika Położnictwa Ginekologii i Perinatologii

Rzeszów, 35-301, Poland

Location

Szpital Wojewódzki Nr 2 im. Św. Jadwigi Królowej w Rzeszowie, Klinika Chirurgii Dziecięcej

Rzeszów, Poland

Location

Uniwersyteckie Centrum Kliniczne WUM, Dziecięcy Szpital Kliniczny. Klinika Chirurgii i Urologii Dziecięcej i Pediatrii

Warsaw, 02-091, Poland

Location

Instytut Matki i Dziecka

Warsaw, Poland

Location

Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego. Klinika Położnictwa, Perinatologii, Ginekologii i Rozrodczości

Warsaw, Poland

Location

Related Publications (26)

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Related Links

• Related Info

MeSH Terms

Conditions

Gastroschisis; Congenital Abnormalities

Condition Hierarchy (Ancestors)

Musculoskeletal Abnormalities; Musculoskeletal Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Renata Jaczyńska, PhD

  Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego [University Clinical Center Medical University of Warsaw]

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 3, 2025
• First Posted: June 22, 2025
• Study Start: June 21, 2025
• Primary Completion: December 31, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: July 1, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share

Locations

PL (9)