Fetoscopic Repair for Gastroschisis

Overseen By Becky Johnson

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Baylor College of Medicine

Must not be taking: Antibiotics

Disqualifiers: Fetal anomaly, Preterm labor, Placental abnormalities, High BMI, 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: 1

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new surgical approach for treating gastroschisis (a condition where a baby's intestines are outside the body) before birth. Researchers aim to determine if repairing this condition in the womb can improve the baby's health outcomes after birth. The trial seeks pregnant women with a single pregnancy diagnosed with gastroschisis through ultrasound who have chosen not to terminate the pregnancy. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could enhance future treatment options for gastroschisis.

Do I need to stop my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications. It's best to discuss your specific medications with the trial team to get a clear answer.

What prior data suggests that this fetoscopic surgical approach is safe for fetal repair of complex gastroschisis?

Research is exploring the safety of repairing complex gastroschisis (GS) in unborn babies using a small camera and tools, a method called fetoscopy. Earlier studies in animals, such as baby sheep, have shown that open fetal surgery can be safe and improve the baby's bowel health.

In one case, a similar fetoscopic method repaired gastroschisis before birth, and the long-term results were positive. The procedure involved making tiny cuts, and the outcomes were promising, suggesting it could be safe and beneficial for babies in the future.

However, these findings are still under investigation in humans. The current study aims to learn more about the safety and benefits, focusing on reducing risks for both mothers and their babies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the fetoscopic repair for complex gastroschisis because it offers a minimally invasive approach compared to the traditional open surgery options. Unlike standard treatments that require a larger incision and direct exposure of the fetal organs, this method uses a small camera and instruments inserted through tiny incisions, potentially reducing risks and improving recovery times for both the mother and unborn child. This innovative approach could lead to better outcomes and less trauma, making it a promising alternative to current surgical practices.

What evidence suggests that this fetoscopic surgical approach is effective for gastroschisis?

Research has shown that repairing complex gastroschisis (GS) in unborn babies using a small camera and tools can lead to better outcomes. One study found that 71% of lambs with repaired GS survived until birth, compared to 45% of those not repaired. This suggests the procedure might increase survival rates to birth. Another review highlights the potential benefits of less invasive methods for fetal surgery. Although information on humans remains limited, these findings offer hope that this approach could reduce complications for babies with GS. In this trial, all participants will undergo fetoscopic surgical repair to evaluate its effectiveness in humans. ^{1 2 3 6 7}

Who Is on the Research Team?

Sundeep Keswani, MD

Principal Investigator

Baylor College of Medicine and Texas Children's Hospital

Are You a Good Fit for This Trial?

This trial is for pregnant women over 18 with a single pregnancy between 20-25 weeks, where the fetus has gastroschisis. Candidates must have normal genetic tests and no significant unrelated anomalies or maternal health issues that could complicate surgery.

Inclusion Criteria

My family and I have decided against ending the pregnancy before 24 weeks or standard treatment after birth.

Parental/guardian permission (informed consent) for follow up of the child after birth

Singleton pregnancy

Exclusion Criteria

Maternal-fetal Rh alloimmunization, Kell sensitization, or neonatal alloimmune thrombocytopenia affecting the current pregnancy

Patient does not have a support person (i.e., spouse, partner, or mother) available to support her for the duration of the pregnancy

Placental abnormalities (previa, abruption, accreta) known at time of enrollment

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Fetoscopic Surgical Repair

Participants undergo minimally invasive in-utero repair of complex gastroschisis via a fetoscopic surgical approach

Surgical procedure

1 visit (in-person)

Post-Surgery Monitoring

Participants are closely followed with ultrasound and consultation after the surgery

Until delivery

Multiple visits (in-person)

Follow-up

Infants are monitored for safety and effectiveness after birth, including neuro-developmental outcomes and survival

12 months

Regular follow-ups (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Fetal Repair of Complex Gastroschisis

Trial Overview The study is testing the safety and feasibility of repairing complex gastroschisis in unborn babies using fetoscopy—a surgical procedure performed on the fetus. The aim is to see if this can reduce death and complications after birth.

How Is the Trial Designed?

Group I: fetoscopic surgical repair Experimental Treatment 1 Intervention

Single arm study. All patients will receive the fetoscopic repair.

Fetal Repair of Complex Gastroschisis is already approved in United States for the following indications:

Approved in United States as Fetal Repair of Complex Gastroschisis for:

• Complex Gastroschisis

Who Is Running the Clinical Trial?

Baylor College of Medicine

Lead Sponsor

Trials

1,044

Recruited

6,031,000+

Published Research Related to This Trial

Gastroschisis (GS) is a congenital defect where the bowel protrudes from the abdomen, and its severity can range from simple to complex, with complex cases leading to higher risks of complications and mortality.

Recent advances in prenatal diagnosis and fetoscopic surgery suggest that early intervention, such as fetoscopic repair of complex GS, could potentially prevent bowel damage and improve outcomes, warranting further research and reconsideration of current treatment approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complex gastroschisis: a new indication for fetal surgery? Joyeux, L., Belfort, MA., De Coppi, P., et al.[2021]

In a study involving 24 sheep, fetoscopic techniques for managing gastroschisis were partially successful, with a 62.5% success rate for uterine bag insertion and a 66.6% success rate for intestinal bag placement.

The main challenge was chorioamniotic separation, and while sterilized condoms and V-Loc™ sutures were effective, none of the techniques achieved permanent fixation of the bag to the fetus, indicating a need for improved tools and methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fetoscopic techniques for prenatal covering of gastroschisis in an ovine model are technically demanding and do not lead to permanent anchoring on the fetus until the end of gestation. Bergholz, R., Krebs, T., Cremieux, B., et al.[2021]

A study involving 64 pregnant women with fetuses affected by gastroschisis found that the amnioexchange procedure did not improve outcomes compared to a sham procedure, indicating it is not beneficial for fetal care in this condition.

The research highlighted a correlation between bile acids and inflammatory markers in amniotic fluid, suggesting that inflammation plays a significant role in the complications associated with gastroschisis, pointing to a need for future studies focused on reducing inflammation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomised controlled trial of amnioexchange for fetal gastroschisis. Luton, D., Mitanchez, D., Winer, N., et al.[2022]

In a study of 35 gastroschisis cases over 10 years, it was found that a birth weight of less than 2000g is linked to a higher risk of gastrointestinal complications in newborns, highlighting the importance of monitoring fetal growth.

The study did not identify specific sonographic markers that could predict adverse neonatal outcomes, suggesting that current ultrasound criteria may not be sufficient for assessing risks in cases of gastroschisis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Gastroschisis: Prenatal ultrasonography and obstetrical criteria for predicting neonatal outcome]. Ducellier, G., Moussy, P., Sahmoune, L., et al.[2017]

Fetal interventions for gastroschisis, such as EXIT procedures and amnio exchange, have been explored in humans, but most techniques remain experimental and are associated with significant risks of morbidity and mortality.

In animal models, particularly in fetal sheep, minimally invasive techniques like fetoscopic covering show promise, but further research is necessary to ensure safety and efficacy before applying these methods in human cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fetal Surgery for Gastroschisis-A Review with Emphasis on Minimally Invasive Procedures. Durmaz, LO., Brunner, SE., Meinzer, A., et al.[2022]

In a study involving 21 lamb fetuses with surgically induced gastroschisis, amnioinfusion (saline exchange) significantly improved bowel health, as indicated by increased thickness of bowel muscularis and reduced fibrosis compared to non-infused fetuses.

The results suggest that amnioinfusion may disrupt the inflammatory response associated with gastroschisis, supporting its potential as a therapeutic approach for improving outcomes in affected human fetuses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Influence of amnioinfusion in a model of in utero created gastroschisis in the pregnant ewe. Luton, D., de Lagausie, P., Guibourdenche, J., et al.[2017]

Complex gastroschisis, characterized by intestinal complications like atresia and necrosis, is the primary factor affecting outcomes and contributes significantly to mortality and morbidity in high-resource settings.

The article aims to clarify the definition of complex gastroschisis and discusses various surgical approaches and their timing, highlighting the need for consensus in treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surgical strategies in complex gastroschisis. Emil, S.[2018]

Newborns with complex gastroschisis (cGS) have a significantly higher mortality rate (16.67%) compared to those with simple gastroschisis (sGS) (2.18%), indicating that cGS poses a much greater risk to infant survival.

Infants with cGS experience more severe complications, including delayed enteral feeding, longer hospital stays, and higher risks of conditions like sepsis and short bowel syndrome, highlighting the need for targeted research and improved prenatal diagnosis and management strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complex gastroschisis is a different entity to simple gastroschisis affecting morbidity and mortality-a systematic review and meta-analysis. Bergholz, R., Boettcher, M., Reinshagen, K., et al.[2018]

In a study involving eight German blackhead sheep, researchers successfully created and assessed gastroschisis using fetoscopy in six cases, demonstrating the feasibility of this approach for managing the condition.

However, primary repair by repositioning the intestine was not achievable due to complications, suggesting that fetoscopic prosthetic bag placement may be a promising alternative treatment method.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fetoscopic management of gastroschisis in a lamb model. Bergholz, R., Krebs, T., Wenke, K., et al.[2021]

The survival rate for fetuses with gastroschisis has improved to over 90%, but complications related to bowel dysfunction remain a significant concern.

The amnioexchange procedure, which involves regularly changing the amniotic fluid, shows promise in reducing bowel injuries and inflammation in fetuses with gastroschisis, suggesting a need for further randomized controlled studies to evaluate its efficacy in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prenatal management of gastroschisis: the place of the amnioexchange procedure. Luton, D., Guibourdenche, J., Vuillard, E., et al.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05704257

NCT05704257 | Fetal Repair of Complex Gastroschisis: A ... The goal of this clinical trial is to evaluate the safety and feasibility of fetal repair of complex gastroschisis (GS) via a fetoscopic surgical approach ...

2. ajog.org ajog.org/article/S0002-9378(23)00854-2/fulltext

34 Safety and efficacy of open fetal repair of complex ... 71% (n=5/7) of repaired cGS fetal lambs survived to term compared to 45% (n=5/11) unrepaired lambs. At term, there was no macroscopic evidence of stenosis, ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8947425/

Fetal Surgery for Gastroschisis—A Review with Emphasis ... This review aims to evaluate the reported techniques for the fetal treatment of gastroschisis by focusing on minimally invasive procedures.

4. withpower.com withpower.com/trial/phase-gastroschisis-1-2023-ee750

Fetoscopic Repair for Gastroschisis A study involving 64 pregnant women with fetuses affected by gastroschisis found that the amnioexchange procedure did not improve outcomes compared to a sham ...

5. bcm.edu bcm.edu/healthcare/clinical-trials/h-51929

Fetal Repair of Complex Gastroschisis: A Safety and ... The purpose of the study is to investigate the safety and feasibility of fetal repair of complex gastroschisis via a fetoscopic approach.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10219623/

Prenatal repair of gastroschisis using partial carbon ... We report the long-term outcomes of a case of prenatal gastroschisis repair using a fully percutaneous fetoscopic approach with partial carbon dioxide ...

7. rarediseaseadvisor.com rarediseaseadvisor.com/reports/details-study-testing-in-utero-repair-gastroschisis-presented/

Details of Study Testing in Utero Repair of Gastroschisis ... The primary outcome measures include the feasibility and safety of fetal repair and 12-month mortality. The secondary outcome measures include ...