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NCT03044821 · ClinicalTrials.gov registry record · NA
Open Myelomeningocele Repair With High Maternal BMI
A NA study, sponsored by Baylor College of Medicine.
- Terminated
- Registry status
- NA
- Development phase
- 1
- Enrollment target
NCT03044821 is a NA study that was terminated before completion, run by Baylor College of Medicine. The registered enrollment target is 1 participants.
The verdict
NCT03044821, a NA study, was terminated before completion, sponsored by Baylor College of Medicine.
- TERMINATED
- Registry status
- NA
- Development phase
- 1 participants
- Enrollment target
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.
Interventions
- PROCEDURE Open-Uterus Fetal Repair
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2018-07-18 |
| Est. Completion | 2019-07-16 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03044821
The ClinicalTrials.gov registry entry for NCT03044821 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 1 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Baylor College of Medicine, which has 616 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Open-Uterus Fetal Repair is the first listed.
NCT03044821 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03044821 about?
NCT03044821 is a clinical study titled "Open Myelomeningocele Repair With High Maternal BMI". 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 ...
What is the current status of trial NCT03044821?
This trial is currently terminated. It is a NA study. The enrollment target is 1 participants. The study started on 2018-07-18. Estimated completion is 2019-07-16.
What interventions are being tested in trial NCT03044821?
The interventions under investigation include: Open-Uterus Fetal Repair (PROCEDURE).
Who is sponsoring clinical trial NCT03044821?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
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