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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02774746
Recruitment Status : Recruiting
First Posted : May 17, 2016
Last Update Posted : May 3, 2022
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 Phase 3

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 : February 23, 2018
Estimated Primary Completion Date : September 30, 2025
Estimated Study Completion Date : September 30, 2025

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

Inclusion criteria:

To be eligible for study inclusion, subjects are required to meet the following 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.

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.

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 identifier (NCT number): NCT02774746

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Contact: Chris Fueger, MS 414-337-6725
Contact: Maddie Rundell, BS 414-266-6572

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Sponsors and Collaborators
Medical College of Wisconsin
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Principal Investigator: Amy Wagner, MD Medical College of Wisconsin
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Responsible Party: Amy Wagner, Assistant Professor, Pediatric Surgery, Medical College of Wisconsin Identifier: NCT02774746    
Other Study ID Numbers: 898740-1
First Posted: May 17, 2016    Key Record Dates
Last Update Posted: May 3, 2022
Last Verified: May 2022
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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Musculoskeletal Abnormalities
Musculoskeletal Diseases
Congenital Abnormalities
Hernia, Abdominal
Pathological Conditions, Anatomical