BACKGROUND AND PURPOSE:

• Shamshirsaz et al. (Ultrasound in Obstetrics & Gynecology, 2019) assessed whether elective preterm delivery at 34 weeks for gastroschisis to limit bowel exposure to amniotic fluid was of benefit compared with routine obstetric care

METHODS:

• Randomized controlled trial (RCT)
• Participants
  • Sonographic diagnosis of fetal gastroschisis
  • Referred <34 weeks
• Exposures
  • Early delivery
    • Induction of labor at 34 weeks
  • Routine care (standardized protocol)
    • From 32 weeks: Fetal assessment weekly or twice a weekly
    • Delivery by 37 to 38 weeks
• Primary outcome
  • Length of time on total parenteral nutrition (TPN)
• Secondary outcomes
  • Time to closure of gastroschisis
  • Length of stay in hospital
• Data analysis was based on intention-to-treat
  • For 90% power, total sample size of 86 patients (43 in each arm) would be needed to demonstrate a 7 day reduction in the time on TPN from the historic control of 25 days

RESULTS:

• 10 women in early delivery group | 11 in routine care group
  • Trial stopped early at the first planned interim analysis due to patient safety concerns and for futility
• Median gestational age at delivery:
  • Early delivery: 34.3 weeks
  • Routine care: 36.7 weeks
• Primary outcome: There were no differences between neonates of women who underwent early delivery vs routine care
  • Median number of days on TPN (P = 0.08)
    • Early delivery: 54 days
    • Routine care: 21 days
  • Length of stay in hospital (P = 0.15)
    • Early delivery: 70.5 days
    • Routine care: 31 days
• Neonates in the early delivery group experienced more late-onset sepsis vs the routine care group (P = 0.03)
  • Early delivery: 40%
  • Routine delivery: 0%

CONCLUSION:

• There is no benefit to early delivery for fetuses with gastroschisis compared to routine care
• The study needed to be terminated early because evidence pointed to harmful effects of early delivery vs routine care for prenatally identified gastroschisis

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Learn More – Primary Sources:

Elective delivery at 34 weeks vs routine obstetric care in fetal gastroschisis: randomized controlled trial

Related ObG Topics:

Gastroschisis – Detection and Implications

Does Delivery Location Really Impact Gastroschisis Outcomes?

Amnioexchange for Fetal Gastroschisis: Does it Reduce Morbidity?

Fetal Megacystis: More than Just Lower Urinary Tract Obstruction?