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FetaL Abdominal Markers Identified by ultrasound to predict Neonatal Gastroschisis Outcome

 

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Rationale
Gastroschisis is a congenital disorder with evisceration of the intestine through a small paraumbilical abdominal wall defect. Survival rate of newborns is excellent (>90%).  However, the rate of intrauterine fetal death and morbidity is considerable; up to 12,5% and 30%, respectively. Severe bowel damage during the last trimester of gestation is believed to be the major cause of morbidity. If intestinal complications could be predicted antenatally, this could lead to improvement of parental counselling as well as the identification of those patients that could profit from obstetric interventions.

Various attempts have been made to correlate findings on antenatal ultrasound examination with neonatal outcome. Reports are conflicting because of the small size of study populations, retrospective study designs, the short time of follow up and the non standardized method and timing of ultrasound examination.

In contrast to previous studies we propose a prospective longitudinal multi centre study with fetal ultrasound assessment and surveillance according to a standard protocol.

 

Objective

Our overall objective is to identify antenatal ultrasound markers that predict the time to full enteral feeding in children with gastroschisis. These antenatal ultrasound markers may influence the antenatal obstetric management in order to improve the neonatal outcome.


Study design
prospective observational longitudinal study

Study population
Pregnant women with a fetus affected with gastroschisis

Methods
During the first part of the study, the antenatal period, the participating subjects will receive the care according to a standard protocol. In addition the participating women are asked to fill in a questionnaire with their gynaecologist.

The mode and timing of delivery will be according to the local hospital policy.

The second part of the study is the follow up of the newborns with gastroschisis.

Data will be collected during: labour, birth, surgery, admission on neonatal intensive care unit, admission on paediatric surgery department and out-patient visits.

Patients are asked to complete a questionnaire concerning the development of their child at when it is 24 months of age.

 

Outcome measures
Primary outcome:

         Time to introduction of full enteral feeding after birth expressed in days. Corresponding with the discontinuation of parenteral nutrition.

         Secondary outcome:

         Intra uterine death

         Visual bowel condition at birth

         Number of days to complete defect closure

         Complications (gastro intestinal tract or others)

         Mortality

         Neurologic development

         Growth

 

Power/data analysis

The prevalence of gastroschisis is 1-3 per 10.000 living births. The total number of living births in the Netherlands is approximately 180.000.  This means there are at least 18 cases of gastroschisis in the Netherlands a year. During a study period of 4 years, this amount can be expected to be over 70 cases.

We assume that the majority of patients with gastroschisis will participate in the study, since there is no associated risk and the only burden of the study is to complete two short questionnaires.


Time schedule
48 months of inclusion and follow up

Projectmembers

drs. C.C.M.M. Lap, PhD student

dr. G.T.R. Manten, Gynaecologist, UMC Utrecht

dr. L.R. Pistorius, Gynaecologist UMC Utrecht

prof. dr. G.H.A. Visser, Gynaecologist, UMC Utrecht

 

Contact

drs. C.C.M.M. Lap

PhD student

UMC Utrecht

flamingo@studies-obsgyn.nl