Gastroschisis Outcomes of Delivery (GOOD) Study
- Conditions
- Gastroschisis
- Interventions
- Other: 38-week deliveryOther: 35-week delivery
- Registration Number
- NCT02774746
- Lead Sponsor
- Medical College of Wisconsin
- Brief Summary
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.
- Detailed Description
Gastroschisis is the most common congenital abdominal wall abnormality in which the intestines are outside of body floating in the amniotic fluid. This is diagnosed by prenatal ultrasound at 18-20 weeks gestation. Gastroschisis occurs in 1 out of every 4000 births and the incidence is increasing. The majority of patients with gastroschisis have an uncomplicated neonatal course and recover well after surgical repair. However, subsets of gastroschisis patients have more complicated courses due to loss of intestine or blockages of the intestine These infants have a higher risk of death and long-term morbidity. Additionally, gastroschisis patients have an increased risk of in-utero fetal demise or stillbirth.
The potential risk of pregnancy loss late in the third trimester has prompted some physicians to deliver gastroschisis patients prior to term. This results in an increased chance of additional prematurity-related complications. There is no consensus about the ideal time to deliver a baby with gastroschisis and practice patterns vary widely. It is unclear which offers the fetus a chance at a better outcome: early delivery to mitigate risk of stillbirth and intestinal injury versus delivery closer to term.
Retrospective data published show inconsistent results on outcomes with early delivery or later gestational age delivery in gastroschisis. There have been two randomized, prospective trials with delivery early versus awaiting spontaneous labor. The first included 42 patients rendering the study largely underpowered. There was a trend towards decreased length of hospital stay and earlier time to full enteral feeding in the early delivery group, but this did not reach statistical significance. The latest study was stopped early because of futility and an increased risk of sepsis in the early group. There was no increase in sepsis in the early group in the first trial, and the study design of this trial varies greatly from both studies.
Standard delivery times for uncomplicated gastroschisis are between 34 and 39 weeks gestation. As the current available literature does not adequately answer the question of optimal gestational age of delivery in patients with gastroschisis, 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. 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 outcome will be based on a weighted composite comprised of intrauterine fetal demise, neonatal/infant death prior to discharge, respiratory morbidity, gastrointestinal morbidity, and sepsis. We will compare the rates of the composite outcome as well as the individual components to determine whether a significant difference between the two strategies can be detected. Secondary maternal outcomes include need for labor induction, need for cesarean section, and complications of delivery including infection, blood transfusions, and thromboembolic events. We will also evaluate antenatal test values, such as amniotic fluid index, estimated fetal weight, and intra- and extra-abdominal bowel dilation. Secondary neonatal outcomes include birth and discharge weight, central venous catheter days, sepsis, intestinal atresia, necrotizing enterocolitis, time to enteral autonomy, individual components of respiratory morbidity, need for caffeine, and length of stay.
Given the unprecedented patient data being collected for the randomized trial, we plan to leverage the infrastructure built for this study to generate the largest prospective, multicenter database of gastroschisis-related (maternal, fetal, and neonatal) outcomes in the United States. The database will provide data for future development of both hypotheses and study design regarding gastroschisis-related outcomes. The associated biobank will collect blood from the neonatal participants to be stored and analyzed in future research.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 800
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 38-week delivery group 38-week delivery Subjects to be expectantly managed to spontaneous delivery, delivered by 38 0/7 weeks through 38 6/7 weeks. 35-week delivery group 35-week delivery Subjects to be delivered at 35 0/7 weeks through 35 6/7 weeks.
- Primary Outcome Measures
Name Time Method Comparison of the proportion of the primary weighted composite outcome (occurrence of any of the 5 clinical risks: IUFD, neonatal death, respiratory morbidity, GI morbidity, and sepsis) between groups as estimated from the ITT population. NICU Discharge The primary outcome is the weighted composite endpoint combining the following five clinical risks: intrauterine fetal demise, neonatal death prior to NICU discharge, sepsis, respiratory morbidity, and gastrointestinal morbidity. Mortality (intrauterine or neonatal death) will be considered an exclusive event.
The composite endpoint score for each subject will be computed as the sum of the weights corresponding to the events observed in the subject. The mean composite score will be compared between groups as defined by the ITT population using a two-sided test at a 4.58% nominal significance level. The nominal significance level will be adjusted based on the timing of the interim analysis if different from the original plan. This test is asymptotically equivalent to a t-test performed on the composite endpoint score. We will report the estimated difference in the weighted endpoint score along with the estimated confidence interval using the nominal significance level.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (37)
University of Wisconsin - Madison
๐บ๐ธMadison, Wisconsin, United States
Phoenix Children's Hospital
๐บ๐ธPhoenix, Arizona, United States
Loma Linda University Children's Hospital
๐บ๐ธLoma Linda, California, United States
Lucile Packard Children's Hospital Stanford
๐บ๐ธStanford, California, United States
Children's Hospital of Colorado
๐บ๐ธAurora, Colorado, United States
Connecticut Children's Medical Center
๐บ๐ธHartford, Connecticut, United States
Nemours Children's Hospital, Delaware
๐บ๐ธWilmington, Delaware, United States
University of South Florida & Tampa General Hospital
๐บ๐ธTampa, Florida, United States
Emory University
๐บ๐ธAtlanta, Georgia, United States
Ann & Robert H. Lurie Children's Hospital of Chicago
๐บ๐ธChicago, Illinois, United States
OSF St. Francis Medical Center
๐บ๐ธPeoria, Illinois, United States
Riley Children's Hospital
๐บ๐ธIndianapolis, Indiana, United States
Norton Healthcare, Inc.
๐บ๐ธLousiville, Kentucky, United States
University of Maryland, Baltimore
๐บ๐ธBaltimore, Maryland, United States
Johns Hopkins Hospital
๐บ๐ธBaltimore, Maryland, United States
Brigham and Women's Hospital & Boston Children's Hospital
๐บ๐ธBoston, Massachusetts, United States
Beth Israel Deaconess Medical Center
๐บ๐ธBoston, Massachusetts, United States
CS Mott Children's & Von Voigtlander Women's Hospital, Michigan Medicine
๐บ๐ธAnn Arbor, Michigan, United States
Children's MN, Midwest Fetal Care Center
๐บ๐ธMinneapolis, Minnesota, United States
Children's Mercy Hospital
๐บ๐ธKansas City, Missouri, United States
St. Louis University, SSM Health Cardinal Glennon Children's Hospital & SSM Health St. Mary's Hospital
๐บ๐ธSaint Louis, Missouri, United States
Washington University in St. Louis & St. Louis Children's Hospital
๐บ๐ธSaint Louis, Missouri, United States
Columbia University Irving Medical Center
๐บ๐ธNew York, New York, United States
New York Presbyterian - Weill Cornell Medicine
๐บ๐ธNew York, New York, United States
University of Rochester Medical Center
๐บ๐ธRochester, New York, United States
University of North Carolina Hospitals
๐บ๐ธChapel Hill, North Carolina, United States
Cleveland Clinic
๐บ๐ธCleveland, Ohio, United States
Oregon Health and Science University
๐บ๐ธPortland, Oregon, United States
Women & Infants Hospital/Rhode Island Hospital (Hasbro Children's)
๐บ๐ธProvidence, Rhode Island, United States
Vanderbilt University Medical Center
๐บ๐ธNashville, Tennessee, United States
Cook Children's Medical Center
๐บ๐ธFort Worth, Texas, United States
The University of Texas Health Science Center at Houston
๐บ๐ธHouston, Texas, United States
The Woman's Hospital of Texas / Obstetrix Maternal-Fetal Medicine Specialists of Houston
๐บ๐ธHouston, Texas, United States
Christus Children's / Baylor College of Medicine
๐บ๐ธSan Antonio, Texas, United States
University of Utah & Primary Children's Hospital
๐บ๐ธSalt Lake City, Utah, United States
University of Virginia
๐บ๐ธCharlottesville, Virginia, United States
Medical College of Wisconsin & Children's Wisconsin
๐บ๐ธMilwaukee, Wisconsin, United States