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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
Study Summary
This trial aims to improve fetal surgery for complex cases of gastroschisis, with the hope of reducing infant mortality and morbidity with minimal risk to mother and baby.
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.Check my eligibility
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.See study design
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Successful Repair of Complex Gastroschisis
Secondary outcome measures
Bronchopulmonary Dysplasia
Central Line Associated Bloodstream Infection (CLABSI)
Intracranial hemorrhage
+13 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: fetoscopic surgical repairExperimental Treatment1 Intervention
Single arm study. All patients will receive the fetoscopic repair.
Find a Location
Who is running the clinical trial?
Baylor College of MedicineLead Sponsor
1,001 Previous Clinical Trials
6,002,202 Total Patients Enrolled
2 Trials studying Gastroschisis
48 Patients Enrolled for Gastroschisis
Sundeep Keswani, MDPrincipal InvestigatorBaylor College of Medicine and Texas Children's Hospital
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My family and I have decided against ending the pregnancy before 24 weeks or standard treatment after birth.I do not have HIV or Hepatitis, or I have tested negative for these.I cannot have fetoscopic surgery due to issues like fibroids or uterine problems.I cannot have surgery due to a past uterine procedure or condition.My unborn baby has a significant health issue not related to gastroschisis.I have a health condition that makes surgery or anesthesia unsafe for me.I am a pregnant woman, 18 or older, and can consent for myself.My genetic tests show no significant abnormalities.I am not allergic to antibiotics like Gentamycin or Vancomycin.
Research Study Groups:
This trial has the following groups:- Group 1: fetoscopic surgical repair
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrollment for this trial still open to potential participants?
"Affirmative. Clinicaltrials.gov archives demonstrate that this research trial, which first appeared on February 1st 2023, is actively recruiting participants. The study requires 10 subjects from a single medical site."
Answered by AI
How many participants are being treated in this experiment?
"Yes, the information found on clinicaltrials.gov exhibits that this medical trial is actively soliciting participants. It was first posted on February 1st 2023 and subsequently updated on January 20th of the same year. The research project seeks to recruit 10 patients from a solitary centre."
Answered by AI
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