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Gastroschisis Outcomes of Delivery (GOOD) Study

RecruitingNAAges 18 Years - anyFemaleMedical College of Wisconsin
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion criteria: To be eligible for study inclusion, subjects are required to meet the following criteria: 1. Speak English or Spanish 2. Age of โ‰ฅ18 years old 3. Have a diagnosis of an isolated fetal gastroschisis confirmed via sonogram at โ‰ค33 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.
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What it tests

  • 35-week delivery
  • 38-week delivery
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Where

38 sites
Phoenix Children's Hospital
Phoenix, United States
Loma Linda University Children's Hospital
Loma Linda, United States
Lucile Packard Children's Hospital Stanford
Stanford, United States
Children's Hospital of Colorado
Aurora, United States
Connecticut Children's Medical Center
Hartford, United States
Nemours Children's Hospital, Delaware
Wilmington, United States
University of South Florida & Tampa General Hospital
Tampa, United States
Emory University
Atlanta, United States

โ€ฆand 30 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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