RECRUITING

Gastroschisis Outcomes of Delivery (GOOD) Study

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Gastroschisis Outcomes of Delivery (GOOD) Study

Quick Facts

Study Start:2018-02-23
Study Completion:2027-03-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT02774746

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Speak English or Spanish
  2. 2. Age of ≥18 years old
  3. 3. Have a diagnosis of an isolated fetal gastroschisis confirmed via sonogram at ≤33 weeks gestation
  4. 4. Have a singleton pregnancy
  5. 5. Capable of providing written informed consent for study participation
  6. 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. 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. 2. Severe intrauterine growth restriction / fetal growth restriction (defined as growth below the 5th percentile for gestational age)
  3. 3. Maternal history of previous stillbirth (intrauterine fetal demise)
  4. 4. Maternal history of spontaneous preterm (\<36 weeks) delivery
  5. 5. Maternal cervical length \< 25 mm prior to 24 weeks of gestation if documented
  6. 6. Maternal hypertension
  7. 7. Maternal insulin-dependent diabetes
  8. 8. Prenatal care initiated after 24 weeks of gestation
  9. 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. 10. Unstable pregnancy defined as meeting any of the following criteria
  11. 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
  12. 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
  13. 3. Non-stress test (NST) or biophysical profile (BPP) deemed non-reassuring by treating clinician
  14. 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
  15. 12. Traditional surrogacy, gestational surrogacy, gestational carrier, or gestational surrogate
  16. 13. Incapable of providing informed consent
  17. 14. Are not their own legally authorized representative.

Contacts and Locations

Study Contact

Rachel Bailey, BS
CONTACT
414-337-7348
rbailey@childrenswi.org
Loran Zwiefelhofer, MBA
CONTACT
414-266-6551
lzwiefelhofer@childrenswi.org

Principal Investigator

Amy Wagner, MD
PRINCIPAL_INVESTIGATOR
Medical College of Wisconsin

Study Locations (Sites)

Phoenix Children's Hospital
Phoenix, Arizona, 85016
United States
Loma Linda University Children's Hospital
Loma Linda, California, 92354
United States
Lucile Packard Children's Hospital Stanford
Stanford, California, 94305
United States
Children's Hospital of Colorado
Aurora, Colorado, 80045
United States
Connecticut Children's Medical Center
Hartford, Connecticut, 06106
United States
Nemours Children's Hospital, Delaware
Wilmington, Delaware, 19803
United States
University of South Florida & Tampa General Hospital
Tampa, Florida, 33606
United States
Emory University
Atlanta, Georgia, 30322
United States
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
United States
OSF St. Francis Medical Center
Peoria, Illinois, 61637
United States
Riley Children's Hospital
Indianapolis, Indiana, 46202
United States
Norton Healthcare, Inc.
Lousiville, Kentucky, 40207
United States
University of Maryland, Baltimore
Baltimore, Maryland, 21201
United States
Johns Hopkins Hospital
Baltimore, Maryland, 21287
United States
Brigham and Women's Hospital & Boston Children's Hospital
Boston, Massachusetts, 02115
United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
United States
CS Mott Children's & Von Voigtlander Women's Hospital, Michigan Medicine
Ann Arbor, Michigan, 48109
United States
Children's MN, Midwest Fetal Care Center
Minneapolis, Minnesota, 55404
United States
Children's Mercy Hospital
Kansas City, Missouri, 64108
United States
St. Louis University, SSM Health Cardinal Glennon Children's Hospital & SSM Health St. Mary's Hospital
Saint Louis, Missouri, 63104
United States
Washington University in St. Louis & St. Louis Children's Hospital
Saint Louis, Missouri, 63110
United States
Columbia University Irving Medical Center
New York, New York, 10032
United States
New York Presbyterian - Weill Cornell Medicine
New York, New York, 10065
United States
University of Rochester Medical Center
Rochester, New York, 14642
United States
University of North Carolina Hospitals
Chapel Hill, North Carolina, 27599
United States
Cleveland Clinic
Cleveland, Ohio, 44195
United States
Oregon Health and Science University
Portland, Oregon, 97239
United States
Women & Infants Hospital/Rhode Island Hospital (Hasbro Children's)
Providence, Rhode Island, 02905
United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
United States
Cook Children's Medical Center
Fort Worth, Texas, 76104
United States
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
United States
The Woman's Hospital of Texas / Obstetrix Maternal-Fetal Medicine Specialists of Houston
Houston, Texas, 77054
United States
Christus Children's / Baylor College of Medicine
San Antonio, Texas, 78207
United States
University of Utah & Primary Children's Hospital
Salt Lake City, Utah, 84123
United States
University of Virginia
Charlottesville, Virginia, 22903
United States
Medical College of Wisconsin & Children's Wisconsin
Milwaukee, Wisconsin, 53226
United States

Collaborators and Investigators

Sponsor: Medical College of Wisconsin

  • Amy Wagner, MD, PRINCIPAL_INVESTIGATOR, Medical College of Wisconsin

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-02-23
Study Completion Date2027-03-31

Study Record Updates

Study Start Date2018-02-23
Study Completion Date2027-03-31

Terms related to this study

Additional Relevant MeSH Terms

  • Gastroschisis