Early Delivery in Fetal Gastroschisis: a Randomized Controlled Trial of Elective Early Delivery Versus Routine Obstetrical Care

Gastroschisis is a congenital malformation in which abdominal organs protrude through an abdominal wall defect, leading to considerable morbidity and mortality during infancy. In contrast to the second class of congenital abdominal wall defects, omphalocele, there is no association of gastroschisis with aneuploidy and there are no familial cohorts or heritability indices to suggest genetic etiology to gastroschisis. Although multiple population and cohort based-studies have implicated various environmental and maternal factors in the pathogenesis of gastroschisis (e.g. young age, smoking), the causes and mechanisms of this condition remain relatively unclear.

The herniated bowel often accumulates a fibrinous covering possibly due to inflammation induced by the amniotic fluid. There is usually a 25% or greater risk of intrauterine growth restriction with gastroschisis. Although long term intact survival is excellent (exceeding 95%), the associated morbidity is significant including gastrointestinal complications such as stricture, adhesions, and volvulus. Furthermore, there is a known association between fetal gastroschisis and late gestational intra-uterine fetal demise (IUFD). Late gestation IUFD is believed to result from acute volvulus of the small bowel and resultant bowel necrosis and death.

Until recently, there were no indications for early delivery, however; now there is mounting evidence supporting delivery at an earlier gestational age. This is supported with the prevailing hypothesis that early delivery prevents further insult from the amniotic fluid to the small bowel. However, these hypotheses have yet to be examined in a well designed, adequately powered, randomized clinical trial. Consequently, it is our primary objective to test the hypothesis that elective early delivery will protect the fetal bowel from the deleterious intrauterine factors late in the pregnancy. Our secondary objective is to introduce a standardized protocol for diagnostic, antepartum, and post-natal surgical management of infants with gastroschisis.

To date, four studies have attempted to evaluate the effect of delivery timing on neonatal outcomes. In a retrospective review of 57 cases, Huang was unable to demonstrate an association between earlier delivery and shorter time to surgical repair or oral feeds. Logge and colleagues performed a randomized controlled trial of delivery at 36 weeks (early) versus awaiting spontaneous labor (later). Although the study did demonstrate a trend toward improved outcomes in the earlier group, it was underpowered especially considering that the mean gestational age for delivery in the early versus later groups differed by only a week and were 35.8 and 36.7 weeks, respectively. In a recent report by Serra, 13 patients were delivered electively at 34 weeks and compared to historical controls. The early delivery group demonstrated shorter time to oral feeds and closure, along with decreased acute and late complications. This corroborated similar findings by Peiro where 6 patients were delivered at 34 weeks. In the latter, the morphology of the bowel demonstrated no evidence of inflammation or thickening, which was uniformly seen in those delivered at term.

As mentioned earlier the hypothesis of improved benefit from early delivery has yet to be examined in a well designed, adequately powered, randomized clinical trial. The preliminary data underscore the need for 1) an adequately powered randomized controlled trial, 2) clearly defined objective outcome measures, and 3) a standardized evidence-based management protocol to attempt and control varying practices by obstetricians and pediatric surgeons, which may undoubtedly impact the results.