What side effects are associated with this type of intervention?

The most common treatments for Gastroschisis, particularly those involving fetoscopic surgical repair, can have several side effects. These include risks of preterm labor, infection, and complications related to anesthesia. Additionally, there may be risks of fetal injury during the procedure and potential for maternal complications such as uterine rupture or bleeding. Postnatally, infants may face issues related to bowel function and nutrient absorption.

What prior FDA approvals exist?

There are no specific FDA-approved treatments for gastroschisis that directly align with the fetoscopic surgical repair approach being studied in the trial. Traditionally, gastroschisis is managed postnatally with surgical intervention to place the exposed intestines back into the abdominal cavity and close the defect. The trial on fetoscopic surgical repair aims to explore the feasibility and safety of repairing gastroschisis in utero, which is a novel approach compared to the standard postnatal surgical treatments.

What other types of research exist?

Promising novel alternatives to Fetoscopic Surgical Repair for Gastroschisis patients in 2024 include: 1) Ex Utero Intrapartum Treatment (EXIT) procedure, which allows for partial delivery and immediate surgical intervention while maintaining placental support; 2) Advanced 3D printing and bioprinting techniques for creating custom grafts and scaffolds to support abdominal wall closure; 3) Enhanced prenatal imaging and diagnostics to better plan postnatal surgical interventions; and 4) Minimally invasive postnatal surgical techniques that reduce recovery time and improve outcomes.

← Back to Search

Procedure

Fetoscopic Repair for Gastroschisis

N/A

Recruiting

Led By Sundeep Keswani, MD

Research Sponsored by Baylor College of Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up during first month of life

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to test a new surgery for unborn babies with severe bowel issues where their intestines are outside their belly. The surgery is done through a small opening in the mother's womb using a camera and tiny tools. This method hopes to reduce complications after birth compared to traditional treatments.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects are not explicitly listed, but may include risks associated with fetal surgery such as preterm labor, infection, or complications from anesthesia.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at hospital discharge, an average of 1.5 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at hospital discharge, an average of 1.5 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and at hospital discharge, an average of 1.5 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Successful Repair of Complex Gastroschisis

Secondary study objectives

Bronchopulmonary Dysplasia

Central Line Associated Bloodstream Infection (CLABSI)

Intracranial hemorrhage

+13 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: fetoscopic surgical repairExperimental Treatment1 Intervention

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

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatment for Gastroschisis involves surgical repair, typically performed after birth, to return the exposed intestines to the abdominal cavity and close the abdominal wall defect. The trial studying fetoscopic surgical repair aims to perform this correction in utero, hypothesizing that early intervention can reduce postnatal mortality and morbidity. This approach matters for Gastroschisis patients as it may prevent complications associated with prolonged exposure of the intestines to amniotic fluid, such as inflammation and damage, potentially leading to better overall outcomes and reduced need for extensive postnatal care.