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Hypothesis: Elective late preterm delivery of the fetus with gastroschisis may help limit injury to extruded fetal gut and thus promote faster recovery of neonatal gut function and earlier hospital discharge. We therefore compared outcomes of elective late preterm delivery (ED) with routine obstetric care (RC) in babies with gastroschisis.
Between May 2013 and September 2015, all women with a sonographically diagnosed gastroschisis referred to a single tertiary center before 34 weeks' gestation were invited to participate in this randomized controlled trial. Eligible patients were randomized to elective delivery at 34 weeks (ED) versus routine obstetric care (RC). The mode of delivery was not stipulated. The primary outcome measure was duration on total parenteral nutrition (TPN). Outcome variables were reported as mean (SD), median [range] or rate (%) and compared using appropriate statistical methods. The analysis was done according to intention to treat principle.
21/25 (84%) eligible women were randomized; 10 to elective late preterm delivery and 11 to routine obstetric care (Fig). The trial was stopped at the first interim analysis after 21 of an expected 86 patients were enrolled (24%) for both patient safety concerns and for futility. The median gestational age at delivery was 34.3 weeks [34, 36] in the ED group and 36.7 [27, 38] in the RC group. There was significantly more neonatal sepsis in the ED group than in the RC group (40% vs 0%, P=0.03). The number of days on TPN was non-significantly higher in the ED group [ED: 54 [17, 248] vs RC: 21 [9, 465] days, P= 0.08]. The time to closure of the gastroschisis was similar between the groups [ED: 7 [2, 21] vs RC: 5.5 [1, 8] days, P=0.18] (Table). The length of stay (LOS) was not statistically different [ED: 70.5 [22, 137] vs RC: 31 [19, 186], P= 0.15] (Table).
This study demonstrates no benefit of elective late preterm delivery of fetuses with gastroschisis when postnatal gastroschisis management is similar to that used in routine care. (ClinicalTrials.gov number, NCT01884324).