Early vs Standard Delivery for Gastroschisis

Recruiting at 44 trial locations

Overseen By Sam Oswald, MS

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Medical College of Wisconsin

Disqualifiers: Fetal anomaly, Growth restriction, Hypertension, Insulin-dependent diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

300 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the optimal timing for delivering babies with gastroschisis, a condition where a baby is born with intestines outside the body. It compares delivery at 35 weeks (early delivery) to waiting until 38 weeks (standard delivery) to determine which option results in better health outcomes for the baby, such as fewer breathing problems or reduced need for IV nutrition. The trial is open to mothers who are at least 18 years old, speak English or Spanish, have a single pregnancy, and have a confirmed diagnosis of gastroschisis in their baby by 33 weeks. As an unphased trial, this study provides a unique opportunity to contribute to important research that could improve delivery timing for babies with gastroschisis.

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 prior data suggests that early delivery for gastroschisis is safe?

Research has shown that delivering babies with gastroschisis at 35 weeks might reduce the risk of stillbirth and lower death rates. However, this approach could also lead to more health issues for the baby, such as breathing problems or the need for extra nutrition. The evidence on whether early delivery is better or worse remains unclear. Some studies have shown mixed results when comparing early delivery to waiting until later in pregnancy. Prospective participants should carefully consider these factors when deciding about joining a trial for early delivery in gastroschisis cases. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it could redefine the timing of delivery for babies with gastroschisis. Unlike the standard practice of waiting until around 38 weeks for delivery, this trial explores the potential benefits of delivering at 35 weeks. The primary goal is to determine if earlier delivery can reduce complications for these newborns, offering a potentially safer and more effective approach to managing gastroschisis. By pinpointing the optimal delivery time, this research could lead to better outcomes and improved health for both mothers and their babies.

What evidence suggests that this trial's treatments could be effective for gastroschisis?

This trial will compare early delivery at 35 weeks with standard delivery at 38 weeks for babies with gastroschisis. Research has suggested that delivering a baby with gastroschisis at 35 weeks might reduce the risk of stillbirths and deaths in the first year compared to waiting until 38 weeks. Some studies indicate that earlier delivery could decrease the chances of serious problems, such as breathing difficulties and the need for intravenous feeding after birth. However, results are mixed, and further research is needed to confirm these benefits. Nonetheless, earlier delivery appears to have some positive effects on the baby's health. ^{1 2 4 5 6}

Who Is on the Research Team?

Amy Wagner, MD

Principal Investigator

Medical College of Wisconsin

Are You a Good Fit for This Trial?

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.

Have a singleton pregnancy

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• 35-week delivery
• 38-week delivery

Trial Overview 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.

How Is the Trial Designed?

Group I: 35-week delivery group Active Control 1 Intervention

Subjects to be delivered at 35 0/7 weeks through 35 6/7 weeks.

Group II: 38-week delivery group Active Control 1 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

Who Is Running the Clinical Trial?

Medical College of Wisconsin

Lead Sponsor

Trials

645

Recruited

1,180,000+

Published Research Related to This Trial

In a review of 24 patients with gastroschisis, a management strategy involving antenatal diagnosis and planned cesarean section at 37 to 38 weeks resulted in low morbidity and no mortality.

The approach emphasizes that while surgery may be easier at earlier gestational ages, the risk of complications like respiratory distress syndrome makes later intervention preferable, leading to better overall outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A new regime in the management of gastroschisis. Swift, RI., Singh, MP., Ziderman, DA., et al.[2019]

A management protocol involving elective preterm delivery by caesarean section at 34-35 weeks and immediate surgical correction for gastroschisis was implemented in 5 patients, resulting in no cases of inflammatory peel and successful gut reduction during surgery.

This approach allowed for earlier initiation of oral feeding, reduced the duration of parenteral nutrition, and shortened the overall hospital stay, with a mean stay of 33.4 days, indicating improved outcomes for infants with gastroschisis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Gastroschisis. Preterm elective cesarean and immediate primary closure: our experience]. Glasmeyer, P., Grande, C., Margarit, J., et al.[2014]

Elective preterm delivery (ED) at 34 weeks for infants with isolated gastroschisis showed no significant benefits in terms of reduced time on total parenteral nutrition (TPN), time to closure of gastroschisis, or length of hospital stay compared to routine care (RC).

However, infants delivered electively were significantly more likely to experience late-onset sepsis (40% in the ED group vs 0% in the RC group), indicating that ED may be harmful rather than beneficial for these infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Elective delivery at 34 weeks vs routine obstetric care in fetal gastroschisis: randomized controlled trial. Shamshirsaz, AA., Lee, TC., Hair, AB., et al.[2021]

Newborns with gastroschisis delivered at a regional center had significantly better outcomes, including fewer days to enteral feeding and shorter hospital stays, compared to those delivered elsewhere.

Cesarean section deliveries were linked to longer hospital stays and higher charges, indicating that the mode of delivery can impact the recovery of neonates with this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of newborns with gastroschisis: the effects of mode of delivery, site of delivery, and interval from birth to surgery. Quirk, JG., Fortney, J., Collins, HB., et al.[2019]

In a study of 16 women with fetuses diagnosed with gastroschisis, elective preterm delivery after 30 weeks significantly reduced serious bowel complications to 0%, compared to 70% in the control group.

The preterm delivery approach also led to improved surgical outcomes, including fewer wound complications and shorter hospital stays, demonstrating that this management plan can enhance safety and efficacy without significant risks from prematurity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A prospective trial of elective preterm delivery for fetal gastroschisis. Moir, CR., Ramsey, PS., Ogburn, PL., et al.[2016]

In a study of 631 infants with gastroschisis, the method of delivery (vaginal vs cesarean) did not significantly affect the risk of neonatal death, indicating that vaginal delivery is a safe option for these infants.

The study found no differences in infection rates, ventilation duration, or length of stay in the neonatal intensive care unit among infants delivered vaginally or by cesarean, suggesting similar short-term outcomes regardless of delivery method.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mode of delivery and neonatal survival of infants with gastroschisis in Australia and New Zealand. Abdel-Latif, ME., Bolisetty, S., Abeywardana, S., et al.[2009]

Neonates with gastroschisis born before 37 weeks of gestation experienced longer hospital stays, but the overall rate of adverse outcomes was similar between preterm and term deliveries, indicating that gestational age alone may not determine immediate neonatal health.

Among preterm neonates, those delivered spontaneously had a higher incidence of bowel atresia compared to those delivered through planned iatrogenic methods, suggesting that the mode of delivery may influence specific complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of gestational age at delivery and type of labor on neonatal outcomes among infants with gastroschisis†. Girsen, AI., Davis, AS., Hintz, SR., et al.[2022]

In a study of 110 infants with gastroschisis, those born at lower gestational ages (<35 weeks) had longer hospital stays and delayed feeding compared to those born at later gestational ages (35-37 weeks and >37 weeks).

Birth weight was found to be a more significant predictor of outcomes than gestational age, with lower birth weights (<2 kg) associated with increased hospital duration, need for ventilation, and complications like necrotizing enterocolitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postnatal outcome in gastroschisis: effect of birth weight and gestational age. Charlesworth, P., Njere, I., Allotey, J., et al.[2007]

In pregnancies complicated by gastroschisis, elective early term delivery may lead to a lower incidence of sepsis and fewer days on mechanical ventilation compared to expectant management, suggesting potential benefits in specific cases.

However, preterm deliveries are associated with increased length of hospital stay, higher sepsis rates, longer mechanical ventilation, and greater mortality compared to term deliveries, indicating that gestational age significantly impacts outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preterm vs term delivery in antenatally diagnosed gastroschisis: a systematic review and meta-analysis. Goldstein, MJ., Bailer, JM., Gonzalez-Brown, VM.[2022]

Infants with gastroschisis delivered at 33-34 weeks had significantly higher rates of complications such as respiratory distress syndrome and necrotizing enterocolitis compared to those delivered at later gestational ages.

Delivering infants with gastroschisis at 35-36 weeks or ≥37 weeks showed no significant differences in outcomes, suggesting that waiting for spontaneous labor may be a safer approach than early delivery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcome of neonates with gastroschisis at different gestational ages using a national database. Gupta, R., Cabacungan, ET.[2018]

Citations

1. reporter.nih.gov reporter.nih.gov/search/dP-66NqTsECcCDux3HFVmw/project-details/10611305

Gastroschisis Outcomes of Delivery (GOOD) Study Retrospective data published show inconsistent results with early versus later gestational age delivery in gastroschisis. Only two randomized, single ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT02774746

Gastroschisis Outcomes of Delivery (GOOD) Study Retrospective data published show inconsistent results on outcomes with early delivery or later gestational age delivery in gastroschisis. ... 35-week delivery ...

3. obgyn.onlinelibrary.wiley.com obgyn.onlinelibrary.wiley.com/doi/full/10.1002/uog.14721

Timing of elective delivery in gastroschisis: a decision and ... Planned elective delivery at 35 weeks resulted in the fewest stillbirths and lowest composite mortality, but was associated with the highest ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4861040/

Timing of Elective Delivery in Gastroschisis: A Decision ... Delivery at 38 weeks is the most cost-effective strategy. Planned delivery at 35 weeks was associated with the fewest stillbirths and deaths within 1 year.

5. med.uth.edu med.uth.edu/obgyn/divisions/division-of-fetal-intervention/gastroschisis-outcomes-of-delivery-good-study/

Gastroschisis Outcomes of Delivery (GOOD) Study Some physicians think that delivering a stable baby in the 35th week of pregnancy will be far better for the baby's outcome than at a later time, and this study ...

6. centerwatch.com centerwatch.com/clinical-trials/listings/NCT02774746/gastroschisis-outcomes-of-delivery-good-study

Gastroschisis Outcomes of Delivery (GOOD) Study Retrospective data published show inconsistent results on outcomes with early delivery or later gestational age delivery in gastroschisis. There ...