Gastroschisis Outcomes of Delivery (GOOD) Study

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 an increased chance of
additional prematurity-related morbidity. There is no consensus about the ideal time to
deliver a baby with gastroschisis and practice patterns vary widely. It is unclea4r which
offers the fetus a chance at a better outcome: early delivery to mitigate risk of demise and
intestinal injury versus delivery closer to term.

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 early delivery group, but this
did not reach statistical significance.

Standard delivery times for uncomplicated gastroschisis are between 34 and 39 weeks
gestation. As the current available literature does not adequately answer the question of
optimal gestational age of delivery in patients with gastroschisis, the objective of this
study is to investigate the hypothesis that delivery at 35 0/7 - 35 6/7 weeks in stable
patients with gastroschisis is superior to observation and expectant management with a goal
of delivery at 38 0/7 - 38 6/7 weeks. To test this hypothesis, we will complete a randomized,
prospective, multi-institutional trial. Patients may be enrolled in the study any time prior
to 33 weeks, but will be randomized at 33 weeks to delivery at 35 weeks or observation with a
goal of 38 weeks. The primary composite outcome will include stillbirth, neonatal death prior
to discharge, respiratory morbidity, and need for parenteral nutrition at 30 days. Secondary
maternal outcomes include need and indication for cesarean section, whether the patient
required induction of labor or had spontaneous labor, and values of antenatal testing
including amniotic fluid index (AFI), bowel diameter, and estimated fetal weight. Secondary
neonatal outcomes include differences in birth weight, need for respiratory support
independent of the operating room, gastroschisis bowel prognostic score, intestinal atresia,
necrotizing enterocolitis, central venous catheter days, length of respiratory support, need
for caffeine, bacteremia, discharge weight, and length of stay.

Inclusion Criteria:

- Subjects must (1) speak English or French, (2) be ≥18 years old, (3) have a
sonographic diagnosis of gastroschisis ≤33 weeks gestation, (4) have a singleton
pregnancy, and (5) provide written informed consent for study participation.

Exclusion Criteria:

- Subjects cannot have (1) a fetal anomaly unrelated to gastroschisis, such as a
chromosomal abnormality or another congenital structural abnormality, (2) severe
intrauterine growth retardation, (3) a maternal history of previous stillbirth or
preterm delivery (<36 weeks), (4) maternal hypertension or insulin dependent diabetes
(5) prenatal care began after 24 weeks of gestation (or) an unstable pregnancy.
Additionally, subjects will be excluded if they are incapable of informed consent or
are not their own legally authorized representative. Severe intrauterine growth
retardation will be defined as growth below the 5th percentile for age. Patients will
be considered to have an unstable pregnancy if any of the following criteria are met:

1. Amniotic Fluid Index (AFI) with maximal vertical pocket (MVP) <2cm or >8cm in
third trimester

2. Umbilical artery Dopplers with S/D ratio or resistive index (RI) >97th percentile
for age with or without absent or reverse end diastolic flow.

3. Non-stress test (NST) and/or biophysical profile (BPP) deemed non-reassuring by
treating clinician