Clinical Trial: Gastroschisis Outcomes of Delivery (GOOD) Study
Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional
Official Title: Gastroschisis Outcomes of Delivery (GOOD) Study
Brief Summary: The objective of this study is to investigate the hypothesis that delivery at 36 0/7- 36 6/7 weeks in stable patients with gastroschisis is superior to observation and expectant management. To test this hypothesis, we will complete a randomized, prospective, multi-institutional trial across North American Fetal Therapy Network-affiliated institutions. Patients may be enrolled in the study any time prior to 34 weeks, but will be randomized at 34 weeks to delivery at 36 weeks or observation. The primary composite outcomes will include stillbirth, neonatal death prior to discharge, respiratory morbidity, and need for parenteral nutrition at 30 days.
Detailed Summary:
Gastroschisis is the most common congenital abdominal wall abnormality in which the intestines are herniated through the defect into the amniotic fluid. This is diagnosed by prenatal ultrasound at 18-20 weeks gestation. Gastroschisis occurs in 1 out of every 4000 births and the incidence is increasing. The majority of patients with gastroschisis have an uncomplicated neonatal course and recover well after surgical repair. However, subsets of gastroschisis patients have more complicated courses due to loss of intestine or atresias. This may be due to exposure of the herniated intestines to the caustic effects of amniotic fluid or the narrowing of the abdominal wall defect over time causing constriction of the intestinal blood supply. Additionally, gastroschisis patients have an increased risk of in-utero fetal demise.
The potential risk of pregnancy loss late in the third trimester has prompted some providers to deliver gastroschisis patients prior to term. This results in additional prematurity-related morbidity. There is no consensus about the ideal time to deliver a baby with gastroschisis and practice patterns vary widely.
Retrospective data published show inconsistent results on outcomes with early delivery or later gestational age delivery in gastroschisis. There has been one randomized, prospective trial with delivery at 36 weeks versus awaiting spontaneous labor. This included 42 patients rendering the study largely underpowered. There was a trend towards decreased length of hospital stay and earlier time to full enteral feeding in the 36 week delivery group, but this did not reach statistical significance.
As the current available literature does not adequately answer the question of optimal gestational age of delivery in patients with gastroschisis, the objective o
Sponsor: Medical College of Wisconsin
Current Primary Outcome: The primary endpoint is a composite outcome composed of stillbirth, neonatal/infant death prior to discharge, respiratory morbidity, and need for parenteral nutrition at 30 days. [ Time Frame: elements of composite vary in duration (ie stillborn would be collected at time of delivery, nutrition status is evaluated at day of life 30, etc); data collection will occur until infant is discharged from the neonatal intensive care unit ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Medical College of Wisconsin
Dates:
Date Received: May 11, 2016
Date Started: June 2016
Date Completion: June 2026
Last Updated: May 12, 2016
Last Verified: May 2016
