Trial Search Results

Gastroschisis Outcomes of Delivery (GOOD) Study

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.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Medical College of Wisconsin

Stanford Investigator(s):

Intervention(s):

  • Other: 35-week delivery
  • Other: 38-week delivery

Phase:

Phase 3

Eligibility


Inclusion criteria:

To be eligible for study inclusion, subjects are required to meet the following criteria:

   1. Speak English

   2. Age of ≥18 years old

   3. Have a diagnosis of an isolated fetal gastroschisis confirmed via sonogram at ≤33
   weeks gestation

   4. Have a singleton pregnancy

   5. Capable of providing written informed consent for study participation

   6. 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

   1. Fetal anomaly unrelated to gastroschisis, such as a chromosomal abnormality or another
   congenital structural abnormality (if known; no additional testing required for
   research participation)

   2. Severe intrauterine growth restriction / fetal growth restriction (defined as growth
   below the 5th percentile for gestational age)

   3. Maternal history of previous stillbirth (intrauterine fetal demise)

   4. Maternal history of spontaneous preterm (<36 weeks) delivery

   5. Maternal cervical length < 25 mm prior to 24 weeks of gestation if documented

   6. Maternal hypertension

   7. Maternal insulin-dependent diabetes

   8. Prenatal care initiated after 24 weeks of gestation

   9. 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

10. Unstable pregnancy defined as meeting any of the following criteria

      1. 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

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

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

11. 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

12. Traditional surrogacy, gestational surrogacy, gestational carrier, or gestational
   surrogate

13. Incapable of providing informed consent

14. Are not their own legally authorized representative.

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

Female

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Yair J Blumenfeld, MD
650-724-2221
Recruiting