Gastroschisis Outcomes of Delivery (GOOD) Study

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.

Conditions

Gastroschisis

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Study Overview

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Study Details

Study overview

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.

Gastroschisis Outcomes of Delivery (GOOD) Study

Gastroschisis Outcomes of Delivery (GOOD) Study

Condition
Gastroschisis
Intervention / Treatment

-

Contacts and Locations

Phoenix

Phoenix Children's Hospital, Phoenix, Arizona, United States, 85016

Loma Linda

Loma Linda University Children's Hospital, Loma Linda, California, United States, 92354

Stanford

Lucile Packard Children's Hospital Stanford, Stanford, California, United States, 94305

Aurora

Children's Hospital of Colorado, Aurora, Colorado, United States, 80045

Hartford

Connecticut Children's Medical Center, Hartford, Connecticut, United States, 06106

Wilmington

Nemours Children's Hospital, Delaware, Wilmington, Delaware, United States, 19803

Tampa

University of South Florida & Tampa General Hospital, Tampa, Florida, United States, 33606

Atlanta

Emory University, Atlanta, Georgia, United States, 30322

Chicago

Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, Illinois, United States, 60611

Peoria

OSF St. Francis Medical Center, Peoria, Illinois, United States, 61637

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Speak English or Spanish
  • 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.
  • 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 to

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Medical College of Wisconsin,

Amy Wagner, MD, PRINCIPAL_INVESTIGATOR, Medical College of Wisconsin

Study Record Dates

2027-03-31