Early vs Standard Delivery for Gastroschisis
Recruiting in Palo Alto (17 mi)
+41 other locations
Overseen byAmy Wagner, MD
Age: 18+
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Medical College of Wisconsin
Disqualifiers: Fetal anomaly, Growth restriction, Hypertension, Insulin-dependent diabetes, others
No Placebo Group
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?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.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. Please consult with the study team or your healthcare provider for guidance.
What data supports the effectiveness of the treatment for early vs standard delivery in gastroschisis?
Research suggests that elective preterm delivery for gastroschisis can lead to better surgical outcomes and fewer complications, such as serious bowel issues, compared to waiting for a later delivery. Babies delivered earlier had shorter hospital stays and recovered faster, indicating potential benefits of early delivery in managing gastroschisis.
12345Is early delivery for gastroschisis generally safe for humans?
Research suggests that early delivery for gastroschisis, particularly around 34-35 weeks, is generally safe, but it may increase the risk of complications like respiratory distress syndrome (breathing problems) compared to delivery at 37-38 weeks.
12678How does early delivery at 35 weeks differ from other treatments for gastroschisis?
Early delivery at 35 weeks for gastroschisis is unique because it involves delivering the baby preterm to allow for immediate surgical repair, potentially reducing complications. This approach contrasts with standard delivery at full term, which may involve higher risks of complications like respiratory distress.
268910Eligibility Criteria
This trial is for pregnant women over 18 with a single baby diagnosed with gastroschisis via sonogram by 33 weeks. They must have started prenatal care before 24 weeks, speak English or Spanish, and be able to consent. Excluded are those with certain health issues like preterm delivery history, severe diabetes, hypertension, or unstable pregnancies.Inclusion Criteria
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.
My unborn baby has been diagnosed with gastroschisis before 33 weeks of pregnancy.
I am 18 years old or older.
+3 more
Exclusion Criteria
My baby has no known birth defects unrelated to gastroschisis.
My baby is growing slower than expected in the womb.
I currently have COVID-19, confirmed by a positive test.
+7 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
Up to 33 weeks gestation
Randomization
Participants are randomized at 33 weeks to either delivery at 35 weeks or observation with a goal of delivery at 38 weeks
1 week
Delivery and Initial Neonatal Care
Participants are delivered at either 35 weeks or 38 weeks, followed by initial neonatal care and monitoring
3-4 weeks
Follow-up
Participants are monitored for safety and effectiveness after delivery until NICU discharge
Until NICU discharge
Participant Groups
The GOOD Study is comparing outcomes of delivering babies at either 35 weeks or waiting until around 38 weeks in cases of gastroschisis. It's a randomized study across multiple hospitals to see if earlier delivery reduces risks like stillbirth and respiratory problems.
2Treatment groups
Active Control
Group I: 35-week delivery groupActive Control1 Intervention
Subjects to be delivered at 35 0/7 weeks through 35 6/7 weeks.
Group II: 38-week delivery groupActive Control1 Intervention
Subjects to be expectantly managed to spontaneous delivery, delivered by 38 0/7 weeks through 38 6/7 weeks.
35-week delivery is already approved in United States for the following indications:
🇺🇸 Approved in United States as 35-week delivery for:
- Gastroschisis
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Connecticut Children's Medical CenterHartford, CT
Nemours Children's Hospital, DelawareWilmington, DE
Beth Israel Deaconess Medical CenterBoston, MA
Cook Children's Medical CenterFort Worth, TX
More Trial Locations
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Who Is Running the Clinical Trial?
Medical College of WisconsinLead Sponsor
References
Effects of gestational age at delivery and type of labor on neonatal outcomes among infants with gastroschisis†. [2022]To investigate the effect of preterm gestational age (GA) on neonatal outcomes of gastroschisis and to compare the neonatal outcomes after spontaneous labor versus iatrogenic delivery both in the preterm and early term gestational periods.
Elective delivery at 34 weeks vs routine obstetric care in fetal gastroschisis: randomized controlled trial. [2021]To evaluate whether elective preterm delivery (ED) at 34 weeks is of postnatal benefit to infants with isolated gastroschisis compared with routine obstetric care (RC).
Preterm vs term delivery in antenatally diagnosed gastroschisis: a systematic review and meta-analysis. [2022]To review the evidence regarding gestational age at birth, length of stay, sepsis incidence, days on mechanical ventilation, and mortality between preterm and term deliveries in pregnancies complicated by gastroschisis.
Outcomes of newborns with gastroschisis: the effects of mode of delivery, site of delivery, and interval from birth to surgery. [2019]Our purpose was to determine the impact of delivery site, delivery mode, and delivery-to-surgery interval on outcomes for neonates diagnosed with gastroschisis.
A prospective trial of elective preterm delivery for fetal gastroschisis. [2016]To test the hypothesis that preterm delivery of fetal gastroschisis prevents serious gastrointestinal compromise, facilitates primary surgical closure, and improves surgical outcome, we enrolled 16 women in a management plan. This included high-resolution ultrasound, weekly re-evaluation of the fetal gut (> or = 26 weeks), corticosteroids, and delivery if evidence of bowel compromise was present > 30 weeks. These fetuses were compared with 16 consecutive patients treated prior to establishment of this plan. Comparison of prospective trial patients with controls revealed significant differences in age at delivery (34.2 versus 37.7 weeks), serious bowel compromise (0 versus 70%), use of a surgically constructed silo (0 versus 77%), wound complications (0 versus 23%), duration of total parenteral nutrition (18.7 versus 34.7 days), time to full enteral feeding (19.1 versus 35.1 days), and hospital discharge (22.7 versus 37.7 days). Elective preterm delivery using specific ultrasound criteria resulted in improved surgical outcome without significant morbidity secondary to prematurity.
[Gastroschisis. Preterm elective cesarean and immediate primary closure: our experience]. [2014]Our experience en treatment of gastroschisis using a protocol with elective preterm delivery by caesarean section at 34-35 weeks and immediate primary abdominal wall closure.
Mode of delivery and neonatal survival of infants with gastroschisis in Australia and New Zealand. [2009]The aim of the study was to examine the short-term outcome of infants with gastroschisis by route of delivery, comparing vaginal delivery vs elective and emergency cesarean delivery (CD).
A new regime in the management of gastroschisis. [2019]In this review of 24 patients with gastroschisis, we illustrate a regime of management with a low morbidity and no mortality. The essence of the technique relies on antenatal diagnosis, intrauterine transfer, and a planned cesarean section with immediate repair performed at 37 to 38 weeks' gestation. Although the operation may be technically easier at lower gestational ages, we believe the concomitant increase in complications such as respiratory distress syndrome outweigh the advantage of easier surgery. The results of this series compare favorably with other published results.
Outcome of neonates with gastroschisis at different gestational ages using a national database. [2018]The optimal time for delivery of neonates with a prenatal diagnosis of gastroschisis (GS) is controversial. We compared the outcomes for GS at three different gestational ages (GAs), 33-34 weeks, 35-36 weeks, and ≥ 37 weeks.
Postnatal outcome in gastroschisis: effect of birth weight and gestational age. [2007]Early elective delivery of antenatally diagnosed gastroschisis has been proposed as a strategy to minimize postnatal morbidity. This hypothesis was tested by analyzing outcome in relationship to gestational age and birth weight at delivery.