An interventional study of Open Fetal Repair of Myelomeningocele in Obesity, Myelomeningocele and Pregnancy, sponsored by The University of Texas Health Science Center, Houston. Completed at 2 sites in United States. Open to female participants aged 16 Years to 45 Years. Per ClinicalTrials.gov, last updated 2024-05-08.
Sponsored by The University of Texas Health Science Center, Houston · Not applicable, Interventional, and Treatment
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
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
The purpose of this study is to extend the MOMs requirements for pre-natal MMC repair surgery and evaluate safety and efficacy. This will be accomplished through prenatal and post-operative observation and data collection.
The data collected will be documented and collected from prenatal ultrasounds, operative, and delivery reports. We will share our preliminary data with NAFTNet in order to prompt a multicenter trial; this collaboration will help propagate further research and answer clinical questions regarding this extension in surgery criteria.
56 studies on the registry are indexed under Meningomyelocele; 14 are open to participants now.
This study's enrollment of 12 is below the median of 35 across 39 interventional studies indexed under Meningomyelocele.
Browse Meningomyelocele studies →The University of Texas Health Science Center, Houston is the lead sponsor of 880 studies on the registry; 209 are open to participants now.
Of its 170 completed or terminated interventional studies of FDA-regulated products, 140 (82%) have results posted.
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Exclusion Criteria:
Fetal myelomeningocele repair surgery will be offered to pregnant women meeting the criteria for surgery (as set by the MOMS trial) with the exception of the following: * a BMI greater than 35 (but less than or equal to 40 kg/m2) * (minor) Fetal structural abnormality * (well-controlled) Diabetes * Previous preterm delivery (followed by a full term delivery) * Maternal red cell alloimmunization (must NOT be associated with fetal disease, OR fetus must have negative red cell antigen status as determined by amniocentesis). Intervention: Open Fetal Repair of Myelomeningocele
Procedure: Open Fetal Repair of Myelomeningocele
Fetal repair of myelomeningocele in women with additional medical factors that would have excluded them from this treatment under the MOMs trial inclusion/exclusion criteria
Post-operative complications
Determine if there is an increased risk in women in this group
Time frame: At the time of fetal repair surgery to 40 weeks gestation
Plan to share: Undecided
This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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The University of Texas Health Science Center, Houston