NCT02774746 · Medical College of Wisconsin
Gastroschisis Outcomes of Delivery (GOOD) Study
What this study is about
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 randomly assigned, forward-looking, multi-institutional trial across NAFTNet-affiliated institutions.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- To be eligible for study inclusion, subjects are required to meet the following criteria:
- Speak English or Spanish
- Age of ≥18 years old
- Have a diagnosis of an isolated fetal gastroschisis confirmed via sonogram at ≤33 weeks gestation
- Have a singleton pregnancy
- Capable of providing written informed consent for study participation
- Established Estimated Date of Confinement (EDC) prior to 22 0/7 weeks GA by last menstrual period (LMP) with ultrasound confirmation or ultrasound dating when LMP is unknown.
Exclusion criteria
- Subjects will be excluded from enrollment for any of the following criteria
- Fetal anomaly unrelated to gastroschisis, such as a chromosomal abnormality or another congenital structural abnormality (if known; no additional testing required for research participation)
- Severe intrauterine growth restriction / fetal growth restriction (defined as growth below the 5th percentile for gestational age)
- Maternal history of previous stillbirth (intrauterine fetal demise)
- Maternal history of spontaneous preterm (\<36 weeks) delivery
- Maternal cervical length \< 25 mm prior to 24 weeks of gestation if documented
- Maternal hypertension
- Maternal insulin-dependent diabetes
- Prenatal care initiated after 24 weeks of gestation
- An active case of COVID-19 (confirmed by a positive test for COVID-19) that is not recovered (confirmed by a negative test for COVID-19) by the date of randomization
- Unstable pregnancy defined as meeting any of the following criteria
- Abnormal amniotic fluid volume defined as oligohydramnios or polyhydramnios where the maximal vertical pocket (MVP) is \< 2 cm or \> 8 cm in the third trimester, respectively
- Umbilical artery Dopplers with S/D ratio or resistive index (RI) \> 97th percentile for age with or without absent or reversed end diastolic flow
- Non-stress test (NST) or biophysical profile (BPP) deemed non-reassuring by treating clinician
- Concurrent enrollment in another study that requires either a treatment or intervention which would either alter the delivery plan or potentially influence the maternal, fetal, and neonatal outcomes of this study
- Traditional surrogacy, gestational surrogacy, gestational carrier, or gestational surrogate
- Incapable of providing informed consent
- Are not their own legally authorized representative.
Where
- Phoenix, Arizona
- Loma Linda, California
- Stanford, California
- Aurora, Colorado
- Hartford, Connecticut
- Wilmington, Delaware
- Tampa, Florida
- Atlanta, Georgia
- Chicago, Illinois
- Peoria, Illinois
- Indianapolis, Indiana
- Lousiville, Kentucky
And 21 more locations — see the full list below.
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 27, 2026 · Source of record for eligibility and locations