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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 : October 24, 2017
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 herniated through the defect into 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 atresias. This may be due to exposure of the herniated intestines to the caustic effects of amniotic fluid or the narrowing of the abdominal wall defect over time causing constriction of the intestinal blood supply. Additionally, gastroschisis patients have an increased risk of in-utero fetal demise.

The potential risk of pregnancy loss late in the third trimester has prompted some providers to deliver gastroschisis patients prior to term. This results in an increased chance of additional prematurity-related morbidity. There is no consensus about the ideal time to deliver a baby with gastroschisis and practice patterns vary widely. It is unclea4r which offers the fetus a chance at a better outcome: early delivery to mitigate risk of demise 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 has been one randomized, prospective trial with delivery at 36 weeks versus awaiting spontaneous labor. This 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.

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 composite outcome will include stillbirth, neonatal death prior to discharge, respiratory morbidity, and need for parenteral nutrition at 30 days. Secondary maternal outcomes include need and indication for cesarean section, whether the patient required induction of labor or had spontaneous labor, and values of antenatal testing including amniotic fluid index (AFI), bowel diameter, and estimated fetal weight. Secondary neonatal outcomes include differences in birth weight, need for respiratory support independent of the operating room, gastroschisis bowel prognostic score, intestinal atresia, necrotizing enterocolitis, central venous catheter days, length of respiratory support, need for caffeine, bacteremia, discharge weight, and length of stay.


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 : August 2022
Estimated Study Completion Date : August 2027

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. The primary endpoint is a composite outcome composed of stillbirth, neonatal/infant death prior to discharge, respiratory morbidity, and need for parenteral nutrition at 30 days. [ Time Frame: elements of composite vary in duration (ie stillborn would be collected at time of delivery, nutrition status is evaluated at day of life 30, etc); data collection will occur until infant is discharged from the neonatal intensive care unit ]


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 or French, (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
Contact: Mary Emanuelson, BS 414-337-6725 memanuelson@chw.org
Contact: Melissa Christensen, BS 414-266-6551 machristensen@chw.org

Locations
United States, Wisconsin
Medical College of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Amy Wagner, MD    414-266-6551    amwagner@mcw.edu   
Contact: Mary Emanuelson, BS    414-337-6725    memanuelson@chw.org   
Sponsors and Collaborators
Medical College of Wisconsin

Responsible Party: Amy Wagner, Assistant Professor, Pediatric Surgery, Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT02774746     History of Changes
Other Study ID Numbers: 898740-1
First Posted: May 17, 2016    Key Record Dates
Last Update Posted: October 24, 2017
Last Verified: October 2017
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

Additional relevant MeSH terms:
Gastroschisis
Musculoskeletal Abnormalities
Musculoskeletal Diseases
Congenital Abnormalities
Hernia, Abdominal
Hernia
Pathological Conditions, Anatomical