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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| simple gastroschisis | isolated gastroschisis, without intestinal anomalies |
| |
| complex gastroschisis | gastroschisis with intestinal atresias, perforations, necrosis or volvulus |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The prevalence of different forms of GS | The prevalence of different forms of GS: simple, complex | During primary surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Prenatal assessment - during every US examination up to the time of delivery; newborn's evaluation - during primary surgery |
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Inclusion Criteria:
Exclusion Criteria:
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The study population for the MEGA Study consists of fetuses diagnosed with gastroschisis.
The specific criteria for inclusion in the study are:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Renata Jaczyńska, PhD | Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego [University Clinical Center Medical University of Warsaw] | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Górnośląskie Centrum Zdrowia Dziecka, Szpital Uniwersytecki ŚUM, Klinika Chirurgii Dziecięcej i Urologii Dziecięcej | Katowice | 40-752 | Poland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34035447 | Background | 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. | |
| 22901911 |
| Label | URL |
|---|---|
| Related Info | View source |
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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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| ID | Term |
|---|---|
| D020139 | Gastroschisis |
| D000013 | Congenital Abnormalities |
| ID | Term |
|---|---|
| D009139 | Musculoskeletal Abnormalities |
| D009140 | Musculoskeletal Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D046449 | Hernia, Abdominal |
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|
| 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. |
| 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 | 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. | 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 | 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 | 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 | 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 | 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) | 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 | 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 | At delivery |
| Duration of pregnancy | Duration of pregnancy [days] | At delivery |
| Time to repair (primary surgery) | Time to repair (primary surgery); even primary closure or SILO [hours] | 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] | 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 | Up to 28 days after birth |
| Prevalence of intrauterine death | Intrauterine death after 22 gestational weeks | 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 | 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) I. Bowel matting: 0 -none (normal bowel without inflammation)
II. Bowel atresia 0 - absent
III. Bowel necrosis 0 - none
IV. Bowel perforation 0 - none 2 - present | 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. | 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. | 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 | 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 | During primary surgery, up to 28 days after birth |
| 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 | 35-301 | 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 | 02-091 | Poland |
| Instytut Matki i Dziecka | Warsaw | Poland |
| Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego. Klinika Położnictwa, Perinatologii, Ginekologii i Rozrodczości | Warsaw | Poland |
| Background |
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| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |