NCT07030309Active, not recruitingNot Applicable
MEGA STUDY - Multicenter Evaluation of Gastroschisis Anomaly Study
ResearchSkills9 sites in 1 country200 target enrollmentStarted: June 21, 2025Last updated:
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 200
- Locations
- 9
- Primary Endpoint
- The prevalence of different forms of GS
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •A 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
Outcomes
Primary Outcomes
The prevalence of different forms of GS
Time Frame: During primary surgery
The prevalence of different forms of GS: simple, complex
Secondary Outcomes
- 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)
- Lenght of hospital stay (LOS)(Time from the newborn's birth to discharge from the hospital, up to 28 days after birth)
- 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.)
- Duration of the total parenteral nutrition (TPN)(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)(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)(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)(From date of birth until the first day full oral feeding is achieved, assessed up to 28 days after birth.)
- Prevalence of modes of delivery(At delivery)
- Duration of pregnancy(At delivery)
- Time to repair (primary surgery)(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(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(Up to 28 days after birth)
- Prevalence of intrauterine death(After 22 gestational weeks)
- Prevalence of gastroschis types by Perrone et al. 2018(During primary surgery, up to 28 days after birth)
- GPS (gastroschisis prognostic score) score by Cowan et al. 2012(During primary surgery, up to 28 days after birth)
- Prevalence of Adverse Ultrasound Signs (AUS)(During every prenatal ultrasound examination, up to the time of delivery)
- Prevalence of Fetal Growth Restriction (FGR)(Assessed throughout pregnancy, up to the time of delivery)
- Prevalence of Composite Intestinal Complications (CIC)(Up to 28 days after birth)
- Prevalence of bowel matting(During primary surgery, up to 28 days after birth)
Investigators
Renata Jaczynska
Principal Investigator
ResearchSkills
Study Sites (9)
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