Extended Criteria For Fetal Myelomeningocele Repair
Obesity, Myelomeningocele, Pregnancy
About this trial
This is an interventional treatment trial for Obesity focused on measuring Myelomeningocele repair, Open Neural Tube Defect, BMI of 35-40 kg/m2,, Open Fetal Surgery, Elevated body mass index
Eligibility Criteria
Inclusion Criteria:
- Any woman with a prenatal diagnoses of myelomeningocele.
- Pre-pregnancy BMI of 35-45 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.
- same MOMs Trial inclusion criteria with the exception of the above.
Exclusion Criteria:
- poor glycemic control (i.e., HbA1c ≥ 8%) in spite a medical antidiabetic therapy in accordance with good clinical practice (GCP)
- presence of significant co-morbidities or complications (such as dyslipidemia, uncontrolled arterial hypertension, impaired renal function, neuropathy, retinopathy, CVD)
- severe diabetes complications or associated medical conditions (such as blindness, endstage renal failure, liver cirrhosis, malignancy, chronic congestive heart failure)
- recent (within preceding 12 months) myocardial infarction, stroke or TIA
- unstable angina pectoris
- same MOMs Trial exclusion criteria (with the exception of extended inclusion criteria)
Sites / Locations
- Children's Memorial Hermann HospitalRecruiting
- The Fetal Center at UTHealthRecruiting
Arms of the Study
Arm 1
Experimental
Fetal Surgery in Women with ex
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