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Procedure

Open-Uterus Fetal Repair for Neural Tube Defects

N/A
Waitlist Available
Led By Michael Belfort, MD, PhD
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 between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at the time of fetal repair surgery.
Awards & highlights

Study Summary

Spina bifida is a neurological abnormality characterized by an opening in the skin and exposure of the spinal cord on the back of the baby at the time of birth. The complete closure and separation of the spinal cord from the skin occurs in the first month of pregnancy. This form of spina bifida is associated with leg weakness, sensation loss, and bowel and bladder incontinence. The majority of patients (>80%) also develop increased fluid in the brain, called hydrocephalus, and require additional surgery to treat this problem. Standard treatment of myelomeningocele (MMC) involves closing the opening in the back within the first 3 days of life. The surgery releases the spinal cord from the skin and brings the skin edges together to prevent infection and injury to the exposed nerves. Of note, this type of surgery does not improve function. The investigators want to study the open in-utero fetal surgery technique in patients who are candidates for the standard open fetal repair technique but have a pre-pregnancy BMI of 35.0-40.0. The latter is a reason for exclusion for open fetal repair in most centers in the United States.

Eligible Conditions
  • Neural Tube Defects

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during the post-surgical course of pregnancy.
This trial's timeline: 3 weeks for screening, Varies for treatment, and during the post-surgical course of pregnancy. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Complications associated with obesity during Surgery.
Complications associated with obesity during pregnancy.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Open-Uterus Fetal RepairExperimental Treatment1 Intervention
Single arm study. All patients will receive the open-uterus fetal repair.

Find a Location

Who is running the clinical trial?

Baylor College of MedicineLead Sponsor
1,006 Previous Clinical Trials
6,003,307 Total Patients Enrolled
3 Trials studying Neural Tube Defects
198 Patients Enrolled for Neural Tube Defects
Michael Belfort, MD, PhDPrincipal InvestigatorBaylor College of Medicine
2 Previous Clinical Trials
25 Total Patients Enrolled
~0 spots leftby Jun 2025