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Trial record 1 of 1 for:    NCT02774746.
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Gastroschisis Outcomes of Delivery (GOOD) Study

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ClinicalTrials.gov Identifier: NCT02774746
Recruitment Status : Recruiting
First Posted : May 17, 2016
Last Update Posted : May 13, 2020
Sponsor:
Information provided by (Responsible Party):
Amy Wagner, 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.

Condition or disease Intervention/treatment Phase
Gastroschisis Other: 35-week delivery Other: 38-week delivery Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Gastroschisis Outcomes of Delivery (GOOD) Study
Actual Study Start Date : August 9, 2017
Estimated Primary Completion Date : April 2025
Estimated Study Completion Date : April 2030

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 35-week delivery group
Subjects to be delivered at 35 0/7 weeks through 35 6/7 weeks.
Other: 35-week delivery
Induction at 35 weeks gestational age

Active Comparator: 38-week delivery group
Subjects to be expectantly managed to spontaneous delivery, delivered by 38 0/7 weeks through 38 6/7 weeks.
Other: 38-week delivery
Observation to spontaneous delivery or induction at 38 weeks gestational age




Primary Outcome Measures :
  1. 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. [ Time Frame: 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.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects must (1) speak English, (2) be ≥18 years old, (3) have a sonographic diagnosis of gastroschisis ≤33 weeks gestation, (4) have a singleton pregnancy, and (5) provide written informed consent for study participation.

Exclusion Criteria:

  • Subjects cannot have (1) a fetal anomaly unrelated to gastroschisis, such as a chromosomal abnormality or another congenital structural abnormality, (2) severe intrauterine growth retardation, (3) a maternal history of previous stillbirth or preterm delivery (<36 weeks), (4) maternal hypertension or insulin dependent diabetes (5) prenatal care began after 24 weeks of gestation (or) an unstable pregnancy. Additionally, subjects will be excluded if they are incapable of informed consent or are not their own legally authorized representative. Severe intrauterine growth retardation will be defined as growth below the 5th percentile for age. Patients will be considered to have an unstable pregnancy if any of the following criteria are met:

    1. Amniotic Fluid Index (AFI) with maximal vertical pocket (MVP) <2cm or >8cm in third trimester
    2. Umbilical artery Dopplers with S/D ratio or resistive index (RI) >97th percentile for age with or without absent or reverse end diastolic flow.
    3. Non-stress test (NST) and/or biophysical profile (BPP) deemed non-reassuring by treating clinician

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02774746


Contacts
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Contact: Chris Fueger, MS 414-337-6725 cfueger@chw.org
Contact: Melissa Lingongo, BS 414-266-6551 MLingongo@chw.org

Locations
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United States, California
Lucile Packard Children's Hospital Stanford Not yet recruiting
Stanford, California, United States, 94305
Contact: Yair J Blumenfeld, MD    650-724-2221    yairb@stanford.edu   
Contact: Anna Girsen, PhD    650-725-5720    agirsen@stanford.edu   
United States, Colorado
Children's Hospital of Colorado Suspended
Aurora, Colorado, United States, 80045
United States, Florida
University of South Florida/Tampa General Hospital Not yet recruiting
Tampa, Florida, United States, 33606
Contact: Sarah Običan, MD    813-259-0828    sobican@usf.edu   
Contact: Linda Odibo, MN    813-259-0655    lodibo@usf.edu   
United States, Maryland
University of Maryland, Baltimore Suspended
Baltimore, Maryland, United States, 21201
United States, Michigan
CS Mott Children's & Von Voigtlander Women's Hospital, Michigan Medicine Not yet recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Erin E Perrone, MD    734-936-8464    eperrone@med.umich.edu   
Contact: Uzma Umar, MPH    734-232-6097    uzmau@med.umich.edu   
United States, North Carolina
University of North Carolina Hospitals Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: William Goodnight, MD, MSCR    919-966-1601    william_goodnight@med.unc.edu   
Contact: Karen Dorman, RN, MS    984-974-9012    karen_dorman@med.unc.edu   
United States, Texas
Fetal Care Center Dallas at Medical City Children's Hospital Not yet recruiting
Dallas, Texas, United States, 75205
Contact: Timothy M Crombleholme, MD    972-566-5600    timothy.crombleholme@fetalcaredallas.com   
Contact: Madeline Crank, MSN    972-566-5600    madeline.crank@fetalcaredallas.com   
United States, Wisconsin
Medical College of Wisconsin & Children's Wisconsin Suspended
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Medical College of Wisconsin
Investigators
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Principal Investigator: Amy Wagner, MD Medical College of Wisconsin

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Amy Wagner, Assistant Professor, Pediatric Surgery, Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT02774746    
Other Study ID Numbers: 898740-1
First Posted: May 17, 2016    Key Record Dates
Last Update Posted: May 13, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Plan to share data if NIH funded.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Gastroschisis
Musculoskeletal Abnormalities
Musculoskeletal Diseases
Congenital Abnormalities
Hernia, Abdominal
Hernia
Pathological Conditions, Anatomical