GastroschisisNCT02774746
Gastroschisis Outcomes of Delivery (GOOD) Study
A study testing 35-week delivery and 38-week delivery in people with Gastroschisis, run by Medical College of Wisconsin at 38 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gastroschisis
- What is being tested?
- 35-week delivery and 38-week delivery
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 38 sitesUnited States
- Study dates
- 23 Feb 2018to 31 Mar 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- To be eligible for study inclusion, subjects are required to meet the following criteria:
- Speak English or Spanish
- Age of ≥18 years old
- Have a diagnosis of an isolated fetal gastroschisis confirmed via sonogram at ≤33 weeks gestation
- Have a singleton pregnancy
- Capable of providing written informed consent for study participation
- 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.
Who cannot join
- Subjects will be excluded from enrollment for any of the following criteria
- Fetal anomaly unrelated to gastroschisis, such as a chromosomal abnormality or another congenital structural abnormality (if known; no additional testing required for research participation)
- Severe intrauterine growth restriction / fetal growth restriction (defined as growth below the 5th percentile for gestational age)
- Maternal history of previous stillbirth (intrauterine fetal demise)
- Maternal history of spontaneous preterm (<36 weeks) delivery
- Maternal cervical length < 25 mm prior to 24 weeks of gestation if documented
Show all 18Show fewer
- Maternal hypertension
- Maternal insulin-dependent diabetes
- Prenatal care initiated after 24 weeks of gestation
- 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
- Unstable pregnancy defined as meeting any of the following criteria
- 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
- Umbilical artery Dopplers with S/D ratio or resistive index (RI) > 97th percentile for age with or without absent or reversed end diastolic flow
- Non-stress test (NST) or biophysical profile (BPP) deemed non-reassuring by treating clinician
- 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
- Traditional surrogacy, gestational surrogacy, gestational carrier, or gestational surrogate
- Incapable of providing informed consent
- Are not their own legally authorized representative.
Trial locations and contacts
38 sites in 1 country. Contact the study team or a site near you to ask about taking part.
38 sites in 1 country
United States38 sites, 36 recruiting
- Recruiting
CS Mott Children's & Von Voigtlander Women's Hospital, Michigan Medicine
Ann Arbor, Michigan, 48109
Erin E Perrone, MD, 734-936-8464, eperrone@med.umich.edu
Ashly Chimner, BA, 734-763-4255, ashlych@med.umich.edu
- Recruiting
Emory University
Atlanta, Georgia, 30322
Heidi Karpen, M.D., 404-727-5832, heidi.karpen@emory.edu
Beatrice Connor, BSN, MScA, 770-845-4399, beatrice.connor@emory.edu
- Recruiting
Children's Hospital of Colorado
Aurora, Colorado, 80045
Nick Behrendt, MD, 855-413-3825, Nicholas.Behrendt@childrenscolorado.org
Deion Pena, MS, 303-243-2885, Deion.Pena@childrenscolorado.org
- Recruiting
University of Maryland, Baltimore
Baltimore, Maryland, 21201
Ozhan Turan, MD, PhD, 410-328-7830, oturan@som.umaryland.edu
Suleyman Bozkurt, sbozkurt@som.umaryland.edu
- Recruiting
Johns Hopkins Hospital
Baltimore, Maryland, 21287
Angie C Jelin, MD, 443-287-0190, ajelin1@jhmi.edu
Laurie Smith, mwey1@exchange.johnshopkins.edu
- Recruiting
Brigham and Women's Hospital & Boston Children's Hospital
Boston, Massachusetts, 02115
Stephanie H Guseh, MD, 617-732-5452, sguseh@bwh.harvard.edu
Louise E Wilkins-Haug, MD, PhD, 617-732-5452, lwilkinshaug@bwh.harvard.edu
- Recruiting
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Cassandra Duffy, MD, 617-355-6512, cduffy3@bidmc.harvard.edu
Michele Hacker, 617-667-2933, mhacker@bidmc.harvard.edu
- Recruiting
University of North Carolina Hospitals
Chapel Hill, North Carolina, 27599
William Goodnight, MD, MSCR, 919-966-1601, william_goodnight@med.unc.edu
Amber Ivins, Amber_ivins@med.unc.edu
- Recruiting
University of Virginia
Charlottesville, Virginia, 22903
Christopher Ennen, MD, 434-924-9700, CE4JD@uvahealth.org
Amanda Urban, 434-924-1311, AJR5Y@uvahealth.org
- Recruiting
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
Aimen Shaaban, MD, 312-227-4747, ashaaban@luriechildrens.org
Joy Ito, BSN, RN, 312-227-8524, JIto@luriechildrens.org
- Recruiting
Cleveland Clinic
Cleveland, Ohio, 44195
Amanda Kalan, M.D., 440-312-7177, kalana@ccf.org
Susan Grendzynski, R.N., 216-636-6196, sugren@ccf.org
- Recruiting
Cook Children's Medical Center
Fort Worth, Texas, 76104
David Riley, MD, 682-885-4283, David.Riley@cookchildrens.org
Alexis Gossett, BSN, RN, 682-885-6740, Alexis.Gossett@cookchildrens.org
- Recruiting
University of Texas Medical Branch Galveston
Galveston, Texas, 77555
Ravi Radhakrishnan, MD, MBA, 409-772-5666, rsradhak@utmb.edu
- Recruiting
Connecticut Children's Medical Center
Hartford, Connecticut, 06106
Timothy Chrombleholme, MD, 860-545-9237, tcrombleholme@connecticutchildrens.org
Katie Boyle, MPH, 860-837-6547, KBoyle01@connecticutchildrens.org
- Recruiting
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
Allison Speer, MD, 713-500-7300, Allison.L.Speer@uth.tmc.edu
Elisa I Garcia, BSN, RN, 713-500-7434, Elisa.I.Garcia@uth.tmc.edu
- Withdrawn
The Woman's Hospital of Texas / Obstetrix Maternal-Fetal Medicine Specialists of Houston
Houston, Texas, 77054
- Recruiting
Riley Children's Hospital
Indianapolis, Indiana, 46202
Hiba J Mustafa, MD, 317-944-7010, hmustafa@iu.edu
Alison Modesitt, amodesitt@iuhealth.org
- Recruiting
Children's Mercy Hospital
Kansas City, Missouri, 64108
Laura Vricella, MD, 816-302-8505, lvricella@cmh.edu
Kathleen Adderley, kadderley@cmh.edu
- Recruiting
Loma Linda University Children's Hospital
Loma Linda, California, 92354
Ciprian P Georghe, MD, 909-558-8000 ext. 15708, CGheorghe@llu.edu
Nikia M Gray-Hutto, RN, 909-558-8000 ext. 15841, nhutto@llu.edu
- Recruiting
Norton Healthcare, Inc.
Lousiville, Kentucky, 40207
Helen How, MD, 502-629-7181, Helen.How@nortonhealthcare.org
Christina Waldon, RN, 502-899-6900, Christina.Waldon@nortonhealthcare.org
- Recruiting
University of Wisconsin - Madison
Madison, Wisconsin, 53715
Michael Beninati, MD, 608-417-6009, beninati@wisc.edu
- Recruiting
Medical College of Wisconsin & Children's Wisconsin
Milwaukee, Wisconsin, 53226
Amy Wagner, MD, 414-266-6551, amwagner@mcw.edu
Rachel Bailey, rbailey@chw.org
- Recruiting
Children's MN, Midwest Fetal Care Center
Minneapolis, Minnesota, 55404
Clifton Brock, MD, 612-863-9924, clifton.brock@allina.com
Eric A Dion, BA, 612-813-6874, eric.dion@childrensmn.org
- Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
J Newton, MD, PhD, 615-343-6275, j.m.newton@vumc.org
Emily Taylor, NP, 615-343-5700, emily.j.whitesell@vumc.org
- Recruiting
Columbia University Irving Medical Center
New York, New York, 10032
Vincent Duron, MD, 212-305-3151, vd2312@cumc.columbia.edu
Jooyoung Paul Park, Jp4790@cumc.columbia.edu
- Recruiting
New York Presbyterian - Weill Cornell Medicine
New York, New York, 10065
Jessica Scholl, MD, 212-746-3148, jes9188@med.cornell.edu
Ananya Sen, ase4003@med.cornell.edu
- Recruiting
OSF St. Francis Medical Center
Peoria, Illinois, 61637
Paul M Jeziorczak, MD, 309-655-3800, Paul.M.Jeziorczak@osfhealthcare.org
Anthony Dwyer, PhD, MS, AHFP, adwyer1@uic.edu
- Withdrawn
Phoenix Children's Hospital
Phoenix, Arizona, 85016
- Recruiting
Oregon Health and Science University
Portland, Oregon, 97239
Raphael Sun, MD, 503-494-7776, sunr@ohsu.edu
Monica Rincon, MD, 503-494-8748, rincon@ohsu.edu
- Recruiting
Women & Infants Hospital/Rhode Island Hospital (Hasbro Children's)
Providence, Rhode Island, 02905
Francois I Luks, MD, PhD, 401-228-0559, Francois_Luks@brown.edu
Debra Watson-Smith, RN, 401-228-0559, debra.watson-smith@brownphysicians.org
- Recruiting
University of Rochester Medical Center
Rochester, New York, 14642
Kathryn J Drennan, MD, 585-275-7480, kathryn_drennan@urmc.rochester.edu
Sarah J Caveglia, MPH, 585-273-5734, sarah_caveglia@urmc.rochester.edu
- Recruiting
University of Utah & Primary Children's Hospital
Salt Lake City, Utah, 84123
Stephen J Fenton, MD, 801-662-2989, Stephen.Fenton@hsc.utah.edu
Kezlyn Larsen, BS, 801-662-2989, kezlyn.larsen@hsc.utah.edu
- Recruiting
Christus Children's / Baylor College of Medicine
San Antonio, Texas, 78207
Reinaldo Acosta, MD, 210-704-3030 ext. 3030, reinaldo.acosta@christushealth.org
Donna Rodney, Donna.rodney@christushealth.org
- Recruiting
St. Louis University, SSM Health Cardinal Glennon Children's Hospital & SSM Health St. Mary's Hospital
St Louis, Missouri, 63104
Chris Buchanan, MD, 314-268-4037, Christopher.Buchanan@slucare.ssmhealth.com
Amanda Criebaum, MSN, RN, 314-678-4486, Amanda.Criebaum@ssmhealth.com
- Recruiting
Washington University in St. Louis & St. Louis Children's Hospital
St Louis, Missouri, 63110
Jesse Vrecenak, MD, 314-454-6022, vrecenak@wustl.edu
Jessica Conway, BSN, RN, 314-454-5083, jessica.conway@wustl.edu
- Recruiting
Lucile Packard Children's Hospital Stanford
Stanford, California, 94305
Yair J Blumenfeld, MD, 650-724-2221, yairb@stanford.edu
Janet Hurtado, BA, 650-725-0728, janethurtado@stanford.edu
- Recruiting
University of South Florida & Tampa General Hospital
Tampa, Florida, 33606
Sarah Običan, MD, 813-259-0828, sobican@usf.edu
Maha S Al Jumaily, MBBS, 813-259-8680, mahaaljumaily@usf.edu
- Recruiting
Nemours Children's Hospital, Delaware
Wilmington, Delaware, 19803
Matthew Boelig, MD, 302-651-5888, matthew.boelig@nemours.org
Alexa Turpin, alexa.turpin@nemours.org
About this study
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.
Read the 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.
- Conditions
- Gastroschisis
- Being tested
- 35-week delivery, 38-week delivery
- Medical subject headings
- Gastroschisis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
35-week deliveryOther
Induction at 35 weeks gestational age
38-week deliveryOther
Observation to spontaneous delivery or induction at 38 weeks gestational age
| Study group | Role | What they receive |
|---|---|---|
| 35-week delivery group | Active comparator | Subjects to be delivered at 35 0/7 weeks through 35 6/7 weeks. Receives: Other: 35-week delivery |
| 38-week delivery group | Active comparator | Subjects to be expectantly managed to spontaneous delivery, delivered by 38 0/7 weeks through 38 6/7 weeks. Receives: Other: 38-week delivery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the proportion of the primary composite outcome (occurrence of any of the 3 clinical risks: IUFD, neonatal death, and sepsis) between groups as estimated from the ITT population.
The primary outcome is the composite endpoint combining the following three clinical risks: (1) intrauterine fetal demise, (2) neonatal/infant death prior to neonatal intensive care unit (NICU) discharge, (3) sepsis.
The probability of the composite endpoint will be compared between groups as defined by the ITT population using a one-sided test at a 2.3% nominal significance level for the alternative hypothesis that the experimental early delivery group has lower probability of the composite endpoint compared to term delivery group. The nominal significance level will be adjusted based on the timing of the interim analysis if different from the original plan. The Wald test for two proportions will be used. We will report the estimated difference in the probabilities along with the Wald confidence interval using the nominal significance level.
Measured: Date of consent until NICU Discharge. Discharge dates for patients vary and depend on each individual's recovery progress, medical needs, and overall condition. In general, this entire time frame can take up to 30 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2016 (estimated)
- Study start23 Feb 2018
- Primary completion31 Mar 2029 (estimated)
- Study completion31 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GastroschisisStudies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amy Wagner, Medical College of Wisconsin
- Investigators
- Amy Wagner, MD, Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02774746
- Sponsor's protocol ID
- 898740-1
- Status last verified
- Apr 2026
- First submitted
- 11 May 2016
- Last updated
- 27 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Plan to share data if NIH funded.
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gastroschisis Outcomes of Delivery (GOOD) Study
- ClinicalTrials.gov ID
- NCT02774746
- Acronym / sponsor ID
- 898740-1
- Conditions
- Gastroschisis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Study start
- 23 Feb 2018 (actual)
- Primary completion
- 31 Mar 2029 (estimated)
- Study completion
- 31 Mar 2029 (estimated)
- First posted
- 17 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 35-week delivery group | Active comparator | Other: 35-week deliverySubjects to be delivered at 35 0/7 weeks through 35 6/7 weeks. |
| 38-week delivery group | Active comparator | Other: 38-week deliverySubjects to be expectantly managed to spontaneous delivery, delivered by 38 0/7 weeks through 38 6/7 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Speak English or Spanish
- Age of ≥18 years old
- Have a diagnosis of an isolated fetal gastroschisis confirmed via sonogram at ≤33 weeks gestation
- Have a singleton pregnancy
- Capable of providing written informed consent for study participation
Key exclusion criteria (18 listed)
- Subjects will be excluded from enrollment for any of the following criteria
- Fetal anomaly unrelated to gastroschisis, such as a chromosomal abnormality or another congenital structural abnormality (if known; no additional testing required for research participation)
- Severe intrauterine growth restriction / fetal growth restriction (defined as growth below the 5th percentile for gestational age)
- Maternal history of previous stillbirth (intrauterine fetal demise)
- Maternal history of spontaneous preterm (<36 weeks) delivery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 35-week deliveryInduction at 35 weeks gestational age | Other | 35-week delivery group |
| 38-week deliveryObservation to spontaneous delivery or induction at 38 weeks gestational age | Other | 38-week delivery group |
Primary outcome
Comparison of the proportion of the primary composite outcome (occurrence of any of the 3 clinical risks: IUFD, neonatal death, and sepsis) between groups as estimated from the ITT population.
Time frame: Date of consent until NICU Discharge. Discharge dates for patients vary and depend on each individual's recovery progress, medical needs, and overall condition. In general, this entire time frame can take up to 30 weeks.
The primary outcome is the composite endpoint combining the following three clinical risks: (1) intrauterine fetal demise, (2) neonatal/infant death prior to neonatal intensive care unit (NICU) discharge, (3) sepsis. The probability of the composite endpoint will be compared between groups as defined by the ITT population using a one-sided test at a 2.3% nominal significance level for the alternative hypothesis that the experimental early delivery group has lower probability of the composite endpoint compared to term delivery group. The nominal significance level will be adjusted based on the timing of the interim analysis if different from the original plan. The Wald test for two proportions will be used. We will report the estimated difference in the probabilities along with the Wald confidence interval using the nominal significance level.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2026.
- Individual participant dataSharing planned: Undecided. Plan to share data if NIH funded.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Amy Wagner, MD principal investigator
Medical College of Wisconsin
38 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 35-week delivery and 38-week delivery in people with Gastroschisis, run by Medical College of Wisconsin at 38 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rachel Bailey, BS (414-337-7348, rbailey@childrenswi.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of the proportion of the primary composite outcome (occurrence of any of the 3 clinical risks: IUFD, neonatal death, and sepsis) between groups as estimated from the ITT population. (time frame: Date of consent until NICU Discharge. Discharge dates for patients vary and depend on each individual's recovery progress, medical needs, and overall condition. In general, this entire time frame can take up to 30 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2026.