MEGA STUDY - Multicenter Evaluation of Gastroschisis Anomaly Study
NCT ID: NCT07030309
Last Updated: 2025-07-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
200 participants
OBSERVATIONAL
2025-06-21
2026-06-30
Brief Summary
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* 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.
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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simple gastroschisis
isolated gastroschisis, without intestinal anomalies
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.
complex gastroschisis
gastroschisis with intestinal atresias, perforations, necrosis or volvulus
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Availability of prenatal, delivery and postnatal records (for hospital discharge, transfer to another facility or death).
Exclusion Criteria
ALL
No
Sponsors
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ResearchSkills
NETWORK
Responsible Party
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Renata Jaczynska
Principal Investigator
Principal Investigators
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Renata Jaczyńska, PhD
Role: PRINCIPAL_INVESTIGATOR
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego [University Clinical Center Medical University of Warsaw]
Locations
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Górnośląskie Centrum Zdrowia Dziecka, Szpital Uniwersytecki ŚUM, Klinika Chirurgii Dziecięcej i Urologii Dziecięcej
Katowice, , Poland
Szpital Kliniczny Uniwersytetu Medycznego w Poznaniu, Oddział Ginekologiczno-Położniczy, Pododdział Rozrodczości i Medycyny Perinatalnej
Poznan, , Poland
Szpital Kliniczny Uniwersytetu Medyczny w Poznaniu, Klinika Chirurgii Traumatologii i Urologii Dziecięcej
Poznan, , Poland
Szpital Miejski w Rudzie Śląskiej, Katedra i Oddział Kliniczny Ginekologii i Położnictwa, Wydziału Nauk o Zdrowiu
Ruda Śląska, , Poland
Kliniczny Szpital Wojewódzki nr 2 im. Świętej Jadwigi Królowej. Klinika Położnictwa Ginekologii i Perinatologii
Rzeszów, , Poland
Szpital Wojewódzki Nr 2 im. Św. Jadwigi Królowej w Rzeszowie, Klinika Chirurgii Dziecięcej
Rzeszów, , Poland
Uniwersyteckie Centrum Kliniczne WUM, Dziecięcy Szpital Kliniczny. Klinika Chirurgii i Urologii Dziecięcej i Pediatrii
Warsaw, , Poland
Instytut Matki i Dziecka
Warsaw, , Poland
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego. Klinika Położnictwa, Perinatologii, Ginekologii i Rozrodczości
Warsaw, , Poland
Countries
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References
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Molik KA, Gingalewski CA, West KW, Rescorla FJ, Scherer LR, Engum SA, Grosfeld JL. Gastroschisis: a plea for risk categorization. J Pediatr Surg. 2001 Jan;36(1):51-5. doi: 10.1053/jpsu.2001.20004.
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Related Links
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Related Info
Other Identifiers
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1/2025/MEGAStudy
Identifier Type: -
Identifier Source: org_study_id
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