Gastroschisis Outcomes of Delivery (GOOD) Study

Conditions

• Gastroschisis

Eligibility Criteria

Sex

FEMALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• 35-week delivery — OTHER
  Induction at 35 weeks gestational age
• 38-week delivery — OTHER
  Observation to spontaneous delivery or induction at 38 weeks gestational age

Study Details

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 across NAFTNet-affiliated institutions. 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.

Key Dates

Start date

Feb 23, 2018

Status verified

Apr 2026

Primary completion

Mar 31, 2029

Completion

Mar 31, 2029

Study Design

Enrollment

300 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: 35-week delivery group
  Subjects to be delivered at 35 0/7 weeks through 35 6/7 weeks.
• Active Comparator: 38-week delivery group
  Subjects to be expectantly managed to spontaneous delivery, delivered by 38 0/7 weeks through 38 6/7 weeks.

Primary Outcome Measure

Comparison of the proportion of the primary composite outcome (occurrence of any of the 3 clinical risks: IUFD, neonatal death, and sepsis) between groups as estimated from the ITT population. [ Time Frame: Date of consent until NICU Discharge. Discharge dates for patients vary and depend on each individual's recovery progress, medical needs, and overall condition. In general, this entire time frame can take up to 30 weeks. ]

Central Contacts

• Rachel Bailey, BS
  414-337-7348
  [email protected]
• Sam Oswald, MS
  414-337-6725
  [email protected]

Locations (38)

Find similar trials in Phoenix, AZ

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