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Wednesday, July 11 • 12:15 - 12:27
Session 5 | Novel approaches to predict adverse fetal outcome: 5-3 Early delivery in fetal gastroschisis: A randomized controlled trial of elective 34 week delivery versus routine obstetrical care

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Early delivery in fetal gastroschisis: A randomized controlled trial of elective 34 week delivery versus routine obstetrical care
Alireza Shamshirsaz1, Timothy Lee2, Amy Hair2, Hadi Erfani2, Jimmy Espinoza2, Amir Shamshirsaz2, Karin Fox2, Manisha Gandhi2, Ahmed Nassr2, Steven Abrams3, Oluyinka Olutoye2, Michael Belfort2

1Baylor College of Medicine, Houston, TX, United States
2Baylor College of Medicine, Houston, United States
3University of Texas at Austin, Houston, United States
Objectives
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.
Methods
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.
Results
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) (Table).  
Conclusions
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.  

Moderators
avatar for Monique Haak

Monique Haak

Gynaecologist, Leiden University Medical Center (LUMC)
avatar for Sebastian Illanes

Sebastian Illanes

Feto Maternal Medicine, Universidad de los Andes

Speakers
avatar for Alireza Shamshirsaz

Alireza Shamshirsaz

Assistant Professor, Baylor College of Medicine - Medical Genetics Laboratories


Wednesday July 11, 2018 12:15 - 12:27 CEST
Okapi Room 2&3