GastroschisisMEGANCT07030309

MEGA STUDY - Multicenter Evaluation of Gastroschisis Anomaly Study

An observational study of Gastroschisis, run by ResearchSkills at 9 sites in Poland.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Trial 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. Read more about this study

Who is it for?: Any age
Conditions the study is for: Gastroschisis
What is being tested?: Gastroschisis
How many people: 200 participants
Where: 9 sitesPoland
Study dates: 21 Jun 2025to 30 Jun 2026
Phase: Observational
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

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.

Who may be able to join

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

Who cannot join

pregnancies terminated before the 22nd week of pregnancy

Trial locations and contacts

9 sites in 1 country.

City, postcode or hospital

9 sites in 1 country

Poland9 sites

Górnośląskie Centrum Zdrowia Dziecka, Szpital Uniwersytecki ŚUM, Klinika Chirurgii Dziecięcej i Urologii Dziecięcej
Katowice, 40-752
Szpital Kliniczny Uniwersytetu Medycznego w Poznaniu, Oddział Ginekologiczno-Położniczy, Pododdział Rozrodczości i Medycyny Perinatalnej
Poznan
Szpital Kliniczny Uniwersytetu Medyczny w Poznaniu, Klinika Chirurgii Traumatologii i Urologii Dziecięcej
Poznan
Szpital Miejski w Rudzie Śląskiej, Katedra i Oddział Kliniczny Ginekologii i Położnictwa, Wydziału Nauk o Zdrowiu
Ruda Śląska
Kliniczny Szpital Wojewódzki nr 2 im. Świętej Jadwigi Królowej. Klinika Położnictwa Ginekologii i Perinatologii
Rzeszów, 35-301
Szpital Wojewódzki Nr 2 im. Św. Jadwigi Królowej w Rzeszowie, Klinika Chirurgii Dziecięcej
Rzeszów
Uniwersyteckie Centrum Kliniczne WUM, Dziecięcy Szpital Kliniczny. Klinika Chirurgii i Urologii Dziecięcej i Pediatrii
Warsaw, 02-091
Instytut Matki i Dziecka
Warsaw
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego. Klinika Położnictwa, Perinatologii, Ginekologii i Rozrodczości
Warsaw

Other trials in Poland

About this study

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
Being tested: Gastroschisis
Keywords: gastroschisis, ORPHA:2368, congenital anomaly, MEGA Study, Observational study, Epidemiology, Prenatal diagnosis, Multicenter study, prenatal ultrasound
Medical subject headings: Gastroschisis, Congenital Abnormalities

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

GastroschisisOther
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.

Study groups in NCT07030309
Study group	Role	What they receive
simple gastroschisis		isolated gastroschisis, without intestinal anomalies Receives: Other: Gastroschisis
complex gastroschisis		gastroschisis with intestinal atresias, perforations, necrosis or volvulus Receives: Other: Gastroschisis

What is being measured

The primary outcome is the main question the study is designed to answer.

The prevalence of different forms of GS
The prevalence of different forms of GS: simple, complex
Measured: During primary surgery

Secondary outcomes (22)

Agreement rate between prenatal and neonatal assessment of the bowel condition
Comparison of the prenatal ultrasound bowel condition and the newborn's bowel assessment by the surgeon
Measured: Prenatal assessment - during every US examination up to the time of delivery; newborn's evaluation - during primary surgery
Prevalence of necrotizing enterocolitis (NEC)
Diagnosis of necrotizing enterocolitis (NEC) is based on sudden onset of feeding intolerance, abdominal distention, bloody stools, and signs of sepsis (i.e., changes in the heart rate, respiratory rate, temperature, and blood pressure) in preterm infants, according to the Bell scale, which integrates the clinical and radiological manifestations.
Measured: Up to 28 days after birth
Prevalence of short bowel syndrome (SBS)
Diagnosis of short bowel syndrome (SBS) is in case of loss of bowel length or function significantly enough to cause malabsorption, requiring lifelong parenteral support
Measured: During primary surgery or reoperation
Prevalence of newborn sepsis
Newborn sepsis - an infection involving the bloodstream in infants under 28 days old. The clinical syndrome with symptomatology and laboratory findings consistent with a systemic inflammatory response to a multimodal infection caused by bacteria viruses, fungi potentially leading to multiple organ dysfunction, failure and even death within the first 28 days of life.
Measured: Up to 28 days after birth
Time to full enteral feeding (TFEF)
Time to full enteral feeding (TFEF) - the time when neonates start to receive all of their prescribed nutrition as milk feeds
Measured: From date of birth until the first day when full enteral feeding is achieved, assessed up to 28 days after birth.
Duration of the total parenteral nutrition (TPN)
Total Parenteral Nutrition (TPN) - duration of parenteral nutrition, the time of intravenous feeding of nutritional products
Measured: From the first day of TPN initiation until the last day of TPN administration, assessed up to 28 days after birth.
Time to start enteral feeding (TSEF)
Time to start enteral feeding (TSEF) - the time when neonates start enteral nutrition
Measured: From date of birth until the first day enteral feeding is initiated, assessed up to 14 days after birth.
Time to start oral feeding (TSOF)
Time to start oral feeding (TSOF)- the time when neonates start oral feeding
Measured: From date of birth until the first day of oral feeding initiation, assessed up to 28 days after birth.
Time to full oral feeding (TFOF)
Time to full oral feeding (TFOF) - the time to achieve oral exclusive feeding, without using additional or alternative feeding methods (such as gavage or nasogastric tube)
Measured: From date of birth until the first day full oral feeding is achieved, assessed up to 28 days after birth.
Lenght of hospital stay (LOS)
Lenght of hospital stay (LOS) - duration of hospitalization - a clinical metric that measures the time elapsed between a patient's hospital admittance and discharge. For newborns - the time between the day of birth and its discharge
Measured: Time from the newborn's birth to discharge from the hospital, up to 28 days after birth
Prevalence of modes of delivery
Mode of delivery - method of pregnancy termination: vaginal delivery or cesarean delivery
Measured: At delivery
Duration of pregnancy
Duration of pregnancy [days]
Measured: At delivery
Time to repair (primary surgery)
Time to repair (primary surgery); even primary closure or SILO [hours]
Measured: From date and time of birth until the start of the primary surgical repair, up to 28 days after birth
Time to closure abdominal wall defect
Time to abdominal wall defect closure, even primary or secondary [hour]
Measured: From date and time of birth until the completion of definitive abdominal wall defect closure, up to 28 days after birth
Prevalence of neonatal death
Neonatal death within the first 28 days of life
Measured: Up to 28 days after birth
Prevalence of intrauterine death
Intrauterine death after 22 gestational weeks
Measured: After 22 gestational weeks
Prevalence of gastroschis types by Perrone et al. 2018
Type A: ischemic bowel, significantly constricted at the ring without atresia Type B: ischemic bowel, significantly constricted at the ring (but viable) with an associated atresia Type C: ischemic bowel with a closing ring with nonviable external bowel (necrosis) with or without an associated atresia Type D: a completely closed defect with either a nubbin of exposed tissue or no external bowel
Measured: During primary surgery, up to 28 days after birth
GPS (gastroschisis prognostic score) score by Cowan et al. 2012
GPS (gastroschisis prognostic score) based on bowel appearance in newborns (within 6 hours of birth)
1. Bowel matting:
0 -none (normal bowel without inflammation)
1. mild (slight inflammation or with a visible plaque on the surface (mild bowel matting), always needs to expand (required widening) the abdominal wall defect during primary closure)
2. severe (moderate to massive inflammation with fibrous plaque (severe bowel matting) on the surface, stiffness of the intestinal wall EABL)
II. Bowel atresia 0 - absent
1. - suspected
2. - present
III. Bowel necrosis 0 - none
1. focal
2. - diffuse
IV. Bowel perforation 0 - none 2 - present
Measured: During primary surgery, up to 28 days after birth
Prevalence of Adverse Ultrasound Signs (AUS)
US 0-no adverse ultrasound signs: normal, stable, and adequate for the gestational age look of EABL (extra-abdominal bowel loops): normal bowel wall (non-hyperechoic, without oedema or/and thickening), free-floating loops without dilatation; no IABL (intra abdominal bowel loops) dilatation; no gastric dilatation.
US 1-any ultrasound-adverse signs or progression: hyperechoic bowel wall or/and oedema or/and thickening; EABL dilatation; lack of lumen of EABL (collapsed bowel), non-free-floating loops with/or without bowel dilatation; IABL dilatation; gastric dilatation.
Measured: During every prenatal ultrasound examination, up to the time of delivery
Prevalence of Fetal Growth Restriction (FGR)
Fetal Growth Restriction (FGR) - "For early FGR (< 32 weeks), three solitary parameters (abdominal circumference (AC) < 3(rd) centile, estimated fetal weight (EFW) < 3(rd) centile and absent end-diastolic flow in the umbilical artery (UA)) and four contributory parameters (AC or EFW < 10(th) centile combined with a pulsatility index (PI) > 95(th) centile in either the UA or uterine artery) were agreed upon. For late FGR (≥ 32 weeks), two solitary parameters (AC or EFW < 3(rd) centile) and four contributory parameters (EFW or AC < 10(th) centile, AC or EFW crossing centiles by > two quartiles on growth charts and cerebroplacental ratio < 5(th) centile or UA-PI > 95(th) centile) were defined." Gordijn SJ, Beune IM, Thilaganathan B, Papageorghiou A, Baschat AA, Baker PN, Silver RM, Wynia K, Ganzevoort W. Consensus definition of fetal growth restriction: a Delphi procedure. Ultrasound Obstet Gynecol. 2016 Sep;48(3):333-9. doi: 10.1002/uog.15884.
Measured: Assessed throughout pregnancy, up to the time of delivery
Prevalence of Composite Intestinal Complications (CIC)
Composite Intestinal Complications (CIC) - intestinal complication (atresia, necrosis, perforation, volvulus) resulting from the definition of complex gastroschisis and peri-/post-operative complications in both forms (sGS and cGS) of defect (post-closure reoperation, adhesion-related bowel obstruction, bowel resection, Ileostomy/colostomy, the requirement to improve bowel anastomosis
Measured: Up to 28 days after birth
Prevalence of bowel matting
Bowel matting: slight inflammation or with a visible plaque on the surface (mild bowel matting), always needs to expand (required widening) the abdominal wall defect during primary closure or moderate to massive inflammation with fibrous plaque (severe bowel matting) on the surface, stiffness of the intestinal wall EABL
Measured: During primary surgery, up to 28 days after birth

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Jun 202530 Jun 2026

First posted22 Jun 2025
Study start21 Jun 2025
Primary completion31 Dec 2025 (estimated)
Study completion30 Jun 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (26)Papers the sponsor has linked to this study.
Other trials for GastroschisisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Retrospective
Enrolment: 200 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07030309
Sponsor's protocol ID: 1/2025/MEGAStudy
Acronym: MEGA
Status last verified: Jun 2025
First submitted: 3 May 2025
Last updated: 1 Jul 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Individual participant data (IPD) will be analyzed for the purposes of the study but will not be shared. Only aggregate results will be published. Reason for not sharing IPD: The study protocol does not include plans for IPD sharing. Due to ethical considerations and data protection policies, only anonymized, group-level data will be included in publications and reports.

Publications

Dekonenko C, Fraser JD, Deans KJ, Fallat ME, Helmrath M, Kabre R, Leys CM, Burns RC, Corkumd K, Dillon PA, Downard C, Wright TN, Gadepalli SK, Grabowski JE, Hernandez E, Hirschl R, Johnson KN, Kohler JE, Landman MP, Landisch RM, Lawrence AE, Mak GZ, Minneci PC, Rymeski B, Sato TT, Slater BJ, St Peter SD. Outcomes in gastroschisis: expectations in the postnatal period for simple vs complex gastroschisis. J Perinatol. 2021 Jul;41(7):1755-1759. doi: 10.1038/s41372-021-01093-8. Epub 2021 May 25.
PubMed 34035447
Emil S, Canvasser N, Chen T, Friedrich E, Su W. Contemporary 2-year outcomes of complex gastroschisis. J Pediatr Surg. 2012 Aug;47(8):1521-8. doi: 10.1016/j.jpedsurg.2011.12.023.
PubMed 22901911
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.
PubMed 11150437
Burjonrappa S, Snyder AN. Regional variation in gastroschisis: a nationwide database review of demographics and outcomes. Pediatr Surg Int. 2021 Jul;37(7):911-917. doi: 10.1007/s00383-021-04894-2. Epub 2021 Mar 31.
PubMed 33787981
Lap CCMM, Pistorius LR, Mulder EJH, Aliasi M, Kramer WLM, Bilardo CM, Cohen-Overbeek TE, Pajkrt E, Tibboel D, Wijnen RMH, Visser GHA, Manten GTR; FLAMINGO Study Working Group. Ultrasound markers for prediction of complex gastroschisis and adverse outcome: longitudinal prospective nationwide cohort study. Ultrasound Obstet Gynecol. 2020 Jun;55(6):776-785. doi: 10.1002/uog.21888.
PubMed 31613023
Ferreira RG, Mendonca CR, Goncalves Ramos LL, de Abreu Tacon FS, Naves do Amaral W, Ruano R. Gastroschisis: a systematic review of diagnosis, prognosis and treatment. J Matern Fetal Neonatal Med. 2022 Dec;35(25):6199-6212. doi: 10.1080/14767058.2021.1909563. Epub 2021 Apr 25.
PubMed 33899664
Arnold MA, Chang DC, Nabaweesi R, Colombani PM, Bathurst MA, Mon KS, Hosmane S, Abdullah F. Risk stratification of 4344 patients with gastroschisis into simple and complex categories. J Pediatr Surg. 2007 Sep;42(9):1520-5. doi: 10.1016/j.jpedsurg.2007.04.032.
PubMed 17848242
South AP, Stutey KM, Meinzen-Derr J. Metaanalysis of the prevalence of intrauterine fetal death in gastroschisis. Am J Obstet Gynecol. 2013 Aug;209(2):114.e1-13. doi: 10.1016/j.ajog.2013.04.032. Epub 2013 Apr 26.
PubMed 23628262
Bergholz R, Boettcher M, Reinshagen K, Wenke K. Complex gastroschisis is a different entity to simple gastroschisis affecting morbidity and mortality-a systematic review and meta-analysis. J Pediatr Surg. 2014 Oct;49(10):1527-32. doi: 10.1016/j.jpedsurg.2014.08.001. Epub 2014 Sep 4.
PubMed 25280661
D'Antonio F, Virgone C, Rizzo G, Khalil A, Baud D, Cohen-Overbeek TE, Kuleva M, Salomon LJ, Flacco ME, Manzoli L, Giuliani S. Prenatal Risk Factors and Outcomes in Gastroschisis: A Meta-Analysis. Pediatrics. 2015 Jul;136(1):e159-69. doi: 10.1542/peds.2015-0017.
PubMed 26122809
Wilson RD, Johnson MP. Congenital abdominal wall defects: an update. Fetal Diagn Ther. 2004 Sep-Oct;19(5):385-98. doi: 10.1159/000078990.
PubMed 15305094
Benjamin B, Wilson GN. Anomalies associated with gastroschisis and omphalocele: analysis of 2825 cases from the Texas Birth Defects Registry. J Pediatr Surg. 2014 Apr;49(4):514-9. doi: 10.1016/j.jpedsurg.2013.11.052. Epub 2013 Nov 18.
PubMed 24726103
Syngelaki A, Hammami A, Bower S, Zidere V, Akolekar R, Nicolaides KH. Diagnosis of fetal non-chromosomal abnormalities on routine ultrasound examination at 11-13 weeks' gestation. Ultrasound Obstet Gynecol. 2019 Oct;54(4):468-476. doi: 10.1002/uog.20844.
PubMed 31408229
Garne E, Loane M, Dolk H, De Vigan C, Scarano G, Tucker D, Stoll C, Gener B, Pierini A, Nelen V, Rosch C, Gillerot Y, Feijoo M, Tincheva R, Queisser-Luft A, Addor MC, Mosquera C, Gatt M, Barisic I. Prenatal diagnosis of severe structural congenital malformations in Europe. Ultrasound Obstet Gynecol. 2005 Jan;25(1):6-11. doi: 10.1002/uog.1784.
PubMed 15619321
Jones AM, Isenburg J, Salemi JL, Arnold KE, Mai CT, Aggarwal D, Arias W, Carrino GE, Ferrell E, Folorunso O, Ibe B, Kirby RS, Krapfl HR, Marengo LK, Mosley BS, Nance AE, Romitti PA, Spadafino J, Stock J, Honein MA. Increasing Prevalence of Gastroschisis--14 States, 1995-2012. MMWR Morb Mortal Wkly Rep. 2016 Jan 22;65(2):23-6. doi: 10.15585/mmwr.mm6502a2.
PubMed 26796490

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Gastrointestinal Complication, Intestinal Obstruction
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Fetal Repair of Complex Gastroschisis: A Safety and Feasibility Trial
Gastroschisis
Recruiting
Early Feeds in Gastroschisis
Gastroschisis
RecruitingObservational study
Fetal Electrophysiologic Abnormalities in High-Risk Pregnancies Associated With Fetal Demise
High Risk Pregnancy, Congenital Heart Disease

All Gastroschisis trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: MEGA STUDY - Multicenter Evaluation of Gastroschisis Anomaly Study
ClinicalTrials.gov ID: NCT07030309
Acronym / sponsor ID: MEGA / 1/2025/MEGAStudy
Conditions: Gastroschisis
Keywords: gastroschisis, ORPHA:2368, congenital anomaly, MEGA Study, Observational study, Epidemiology, Prenatal diagnosis, Multicenter study
Study type: Observational
Recruitment status: Active, not recruiting
Enrolment: 200 participants (estimated)
Lead sponsor: ResearchSkillsResearch network
Study start: 21 Jun 2025 (actual)
Primary completion: 31 Dec 2025 (estimated)
Study completion: 30 Jun 2026 (estimated)
First posted: 22 Jun 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Observational model: Cohort
Time perspective: Retrospective
Number of arms: 2

Arm	Type	Receives
simple gastroschisis	–	Other: Gastroschisisisolated gastroschisis, without intestinal anomalies
complex gastroschisis	–	Other: Gastroschisisgastroschisis with intestinal atresias, perforations, necrosis or volvulus

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
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.

Key inclusion criteria (2 listed)

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

Key exclusion criteria (1 listed)

pregnancies terminated before the 22nd week of pregnancy

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
GastroschisisGastroschisis (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.	Other	complex gastroschisis, simple gastroschisis

Primary outcome

The prevalence of different forms of GS
Time frame: During primary surgery
The prevalence of different forms of GS: simple, complex

22 secondary outcomes

Agreement rate between prenatal and neonatal assessment of the bowel condition
Time frame: Prenatal assessment - during every US examination up to the time of delivery; newborn's evaluation - during primary surgery
Prevalence of necrotizing enterocolitis (NEC)
Time frame: Up to 28 days after birth
Prevalence of short bowel syndrome (SBS)
Time frame: During primary surgery or reoperation
Prevalence of newborn sepsis
Time frame: Up to 28 days after birth
Time to full enteral feeding (TFEF)
Time frame: From date of birth until the first day when full enteral feeding is achieved, assessed up to 28 days after birth.
Duration of the total parenteral nutrition (TPN)
Time frame: From the first day of TPN initiation until the last day of TPN administration, assessed up to 28 days after birth.
Time to start enteral feeding (TSEF)
Time frame: From date of birth until the first day enteral feeding is initiated, assessed up to 14 days after birth.
Time to start oral feeding (TSOF)
Time frame: From date of birth until the first day of oral feeding initiation, assessed up to 28 days after birth.
Time to full oral feeding (TFOF)
Time frame: From date of birth until the first day full oral feeding is achieved, assessed up to 28 days after birth.
Lenght of hospital stay (LOS)
Time frame: Time from the newborn's birth to discharge from the hospital, up to 28 days after birth
Prevalence of modes of delivery
Time frame: At delivery
Duration of pregnancy
Time frame: At delivery
Time to repair (primary surgery)
Time frame: From date and time of birth until the start of the primary surgical repair, up to 28 days after birth
Time to closure abdominal wall defect
Time frame: From date and time of birth until the completion of definitive abdominal wall defect closure, up to 28 days after birth
Prevalence of neonatal death
Time frame: Up to 28 days after birth
Prevalence of intrauterine death
Time frame: After 22 gestational weeks
Prevalence of gastroschis types by Perrone et al. 2018
Time frame: During primary surgery, up to 28 days after birth
GPS (gastroschisis prognostic score) score by Cowan et al. 2012
Time frame: During primary surgery, up to 28 days after birth
Prevalence of Adverse Ultrasound Signs (AUS)
Time frame: During every prenatal ultrasound examination, up to the time of delivery
Prevalence of Fetal Growth Restriction (FGR)
Time frame: Assessed throughout pregnancy, up to the time of delivery
Prevalence of Composite Intestinal Complications (CIC)
Time frame: Up to 28 days after birth
Prevalence of bowel matting
Time frame: During primary surgery, up to 28 days after birth

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2025.
Background: PubMed 34035447Dekonenko C, Fraser JD, Deans KJ, Fallat ME, Helmrath M, Kabre R, Leys CM, Burns RC, Corkumd K, Dillon PA, Downard C, Wright TN, Gadepalli SK, Grabowski JE, Hernandez E, Hirschl R, Johnson KN, Kohler JE, Landman MP, Landisch RM, Lawrence AE, Mak GZ, Minneci PC, Rymeski B, Sato TT, Slater BJ, St Peter SD. Outcomes in gastroschisis: expectations in the postnatal period for simple vs complex gastroschisis. J Perinatol. 2021 Jul;41(7):1755-1759. doi: 10.1038/s41372-021-01093-8. Epub 2021 May 25.
Background: PubMed 22901911Emil S, Canvasser N, Chen T, Friedrich E, Su W. Contemporary 2-year outcomes of complex gastroschisis. J Pediatr Surg. 2012 Aug;47(8):1521-8. doi: 10.1016/j.jpedsurg.2011.12.023.
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Related InfoLink provided by the sponsor.
Individual participant dataSharing planned: Yes. Individual participant data (IPD) will be analyzed for the purposes of the study but will not be shared. Only aggregate results will be published. Reason for not sharing IPD: The study protocol does not include plans for IPD sharing. Due to ethical considerations and data protection policies, only anonymized, group-level data will be included in publications and reports.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Renata Jaczyńska, PhD principal investigator

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

9 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Gastroschisis, run by ResearchSkills at 9 sites in Poland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 1 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The prevalence of different forms of GS (time frame: During primary surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07030309, which also lists 26 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2025.