Early vs Standard Delivery for Gastroschisis

Recruiting at 41 trial locations

Overseen By Loran Zwiefelhofer, MBA

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

800 Participants Needed

What You Need to Know Before You Apply

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.

Is 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. ^{1 2 3 4 5}

How 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. ^{1 2 4 6 7}

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. ^{1 5 8 9 10}

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

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]

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. England pubmed.ncbi.nlm.nih.gov

Effects of gestational age at delivery and type of labor on neonatal outcomes among infants with gastroschisis&#8224;. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Elective delivery at 34 weeks vs routine obstetric care in fetal gastroschisis: randomized controlled trial. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Preterm vs term delivery in antenatally diagnosed gastroschisis: a systematic review and meta-analysis. [2022]

4. United States 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. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

A prospective trial of elective preterm delivery for fetal gastroschisis. [2016]

6. Spain pubmed.ncbi.nlm.nih.gov

[Gastroschisis. Preterm elective cesarean and immediate primary closure: our experience]. [2014]

7. United States pubmed.ncbi.nlm.nih.gov

Mode of delivery and neonatal survival of infants with gastroschisis in Australia and New Zealand. [2009]

8. United States pubmed.ncbi.nlm.nih.gov

A new regime in the management of gastroschisis. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Outcome of neonates with gastroschisis at different gestational ages using a national database. [2018]

10. United States pubmed.ncbi.nlm.nih.gov

Postnatal outcome in gastroschisis: effect of birth weight and gestational age. [2007]