Gastroschisis Outcomes of Delivery (GOOD) Study
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| ClinicalTrials.gov Identifier: NCT02774746 |
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Recruitment Status :
Recruiting
First Posted : May 17, 2016
Last Update Posted : January 12, 2021
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Gastroschisis | Other: 35-week delivery Other: 38-week delivery | Phase 3 |
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.
| 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 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: 35-week delivery group
Subjects to be delivered at 35 0/7 weeks through 35 6/7 weeks.
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Other: 35-week delivery
Induction at 35 weeks gestational age |
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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.
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Other: 38-week delivery
Observation to spontaneous delivery or induction at 38 weeks gestational age |
- 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.
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.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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:
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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:
- Amniotic Fluid Index (AFI) with maximal vertical pocket (MVP) <2cm or >8cm in third trimester
- Umbilical artery Dopplers with S/D ratio or resistive index (RI) >97th percentile for age with or without absent or reverse end diastolic flow.
- Non-stress test (NST) and/or biophysical profile (BPP) deemed non-reassuring by treating clinician
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
| Contact: Chris Fueger, MS | 414-337-6725 | cfueger@chw.org | |
| Contact: Melissa Lingongo, BS | 414-266-6551 | MLingongo@chw.org |
| United States, Arizona | |
| Phoenix Children's Hospital | Not yet recruiting |
| Phoenix, Arizona, United States, 85016 | |
| Contact: Kathleen van Leeuwen, MD 602-933-0016 kvan@phoenixchildrens.com | |
| Contact: Erica M Weidler Baimbridge, MEd 602-933-3524 ebaimbridge@phoenixchildrens.com | |
| United States, California | |
| Loma Linda University Children's Hospital | Not yet recruiting |
| Loma Linda, California, United States, 92354 | |
| Contact: Ciprian P Georghe, MD 909-558-8000 ext 15708 CGheorghe@llu.edu | |
| Contact: Nikia M Gray-Hutto, RN 909-558-8000 ext 15841 nhutto@llu.edu | |
| 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 | Recruiting |
| Aurora, Colorado, United States, 80045 | |
| Contact: Nick Behrendt, MD 855-413-3825 Nicholas.Behrendt@childrenscolorado.org | |
| Contact: Hilary Hoffman, BS 720-777-9904 Hilary.Hoffman@childrenscolorado.org | |
| 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: Susan A Hajmohammad, BA 813-259-0899 susanhaj@usf.edu | |
| United States, Maryland | |
| University of Maryland, Baltimore | Recruiting |
| Baltimore, Maryland, United States, 21201 | |
| Contact: Ozhan Turan, MD, PhD 410-328-7830 oturan@som.umaryland.edu | |
| Contact: Arica M Stockett, BSN 410-328-7791 arica.guthrie@som.umaryland.edu | |
| Johns Hopkins Hospital | Recruiting |
| Baltimore, Maryland, United States, 21287 | |
| Contact: Angie C Jelin, MD 443-287-0190 ajelin1@jhmi.edu | |
| Contact: Kami Skurow-Todd, MSN 443-287-3384 kskurow1@jhmi.edu | |
| United States, Michigan | |
| CS Mott Children's & Von Voigtlander Women's Hospital, Michigan Medicine | Recruiting |
| Ann Arbor, Michigan, United States, 48109 | |
| Contact: Erin E Perrone, MD 734-936-8464 eperrone@med.umich.edu | |
| Contact: Heather Cameron, MPH 734-763-4255 hcameron@med.umich.edu | |
| United States, Minnesota | |
| Children's MN, Midwest Fetal Care Center | Recruiting |
| Minneapolis, Minnesota, United States, 55404 | |
| Contact: Joseph B Lillegard, MD, PhD 612-813-8000 jlillegard@pediatricsurgical.com | |
| Contact: Eric A Dion, BA 612-813-6874 eric.dion@childrensmn.org | |
| United States, Missouri | |
| Children's Mercy Hospital | Not yet recruiting |
| Kansas City, Missouri, United States, 64108 | |
| Contact: Shawn D St. Peter, MD 816-234-3575 ext 53575 sspeter@cmh.edu | |
| Contact: Yara K Duran, MSN 816-289-6852 ext 56852 ykduran@cmh.edu | |
| United States, New York | |
| Columbia University Irving Medical Center | Not yet recruiting |
| New York, New York, United States, 10032 | |
| Contact: Russell S Miller, MD 212-305-3151 rsm20@cumc.columbia.edu | |
| Contact: Vilmarie Carmona 212-305-5041 vc2007@cumc.columbia.edu | |
| University of Rochester Medical Center | Recruiting |
| Rochester, New York, United States, 14642 | |
| Contact: Kathryn J Drennan, MD 585-275-7480 kathryn_drennan@urmc.rochester.edu | |
| Contact: Sarah J Caveglia, MPH 585-273-5734 sarah_caveglia@urmc.rochester.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 | |
| The University of Texas Health Science Center at Houston | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Mary T Austin, MD, MPH 713-500-7273 Mary.T.Austin@uth.tmc.edu | |
| Contact: Elisa I Garcia, BSN, RN 713-500-7434 Elisa.I.Garcia@uth.tmc.edu | |
| United States, Wisconsin | |
| Medical College of Wisconsin & Children's Wisconsin | Recruiting |
| Milwaukee, Wisconsin, United States, 53226 | |
| Contact: Amy Wagner, MD 414-266-6551 amwagner@mcw.edu | |
| Contact: Chris Fueger, MS 414-337-6725 cfueger@chw.org | |
| Principal Investigator: | Amy Wagner, MD | Medical College of Wisconsin |
| 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: | January 12, 2021 |
| Last Verified: | January 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Plan Description: | Plan to share data if NIH funded. |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Gastroschisis Musculoskeletal Abnormalities Musculoskeletal Diseases Congenital Abnormalities |
Hernia, Abdominal Hernia Pathological Conditions, Anatomical |