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NCT02664207 · ClinicalTrials.gov registry record · NA
Extended Criteria For Fetal Myelomeningocele Repair
A NA study, sponsored by The University of Texas Health Science Center, Houston.
- Completed
- Registry status
- NA
- Development phase
- 12
- Enrollment target
NCT02664207 is a NA study that has completed, run by The University of Texas Health Science Center, Houston. The registered enrollment target is 12 participants.
The verdict
NCT02664207, a NA study, has completed, sponsored by The University of Texas Health Science Center, Houston.
- COMPLETED
- Registry status
- NA
- Development phase
- 12 participants
- Enrollment target
Study Summary
The purpose of this study is to offer pre-natal Myelomeningocele (MMC) repair surgery to pregnant women with one of the former surgery exclusion factors * A BMI of 35-40 kg/m2 * Diabetes; patients will require good glycemic control * History a previous preterm birth, as long as it was followed by a full term birth * Structural abnormality in the fetus; abnormality must be minor, not increasing the risk of prematurity. For example cleft lip and palate, minor ventricular septal defect, pyelectasis. * Maternal Rh alloimmunization. Must have a low level of anti-red blood cell antibody that is not associated with fetal disease, specifically anti-E \< 1:4 or anti-M. Or alloimmunization with negative fetal red blood cell antigen status determined by amniocentesis. We will be extending the Management of Myelomeningocele Study (MOMs) criteria by including these factors. Prenatal clinical and outcome information will be collected; safety and efficacy will be evaluated
Interventions
- PROCEDURE Open Fetal Repair of Myelomeningocele
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2016-01-26 |
| Est. Completion | 2023-12 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02664207
The ClinicalTrials.gov registry entry for NCT02664207 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The University of Texas Health Science Center, Houston, which has 732 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Open Fetal Repair of Myelomeningocele is the first listed.
NCT02664207 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02664207 about?
NCT02664207 is a clinical study titled "Extended Criteria For Fetal Myelomeningocele Repair". The purpose of this study is to offer pre-natal Myelomeningocele (MMC) repair surgery to pregnant women with one of the former surgery exclusion factors * A BMI of 35-40 kg/m2 * Diabetes; patients will require good glycemic control * History a previous preterm birth, as long as it was followed by a...
What is the current status of trial NCT02664207?
This trial is currently completed. It is a NA study. The enrollment target is 12 participants. The study started on 2016-01-26. Estimated completion is 2023-12.
What interventions are being tested in trial NCT02664207?
The interventions under investigation include: Open Fetal Repair of Myelomeningocele (PROCEDURE).
Who is sponsoring clinical trial NCT02664207?
This trial is sponsored by The University of Texas Health Science Center, Houston, which has 732 total clinical trials registered on ClinicalTrials.gov.
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