Diabetes Mellitus in Pregnancy, Fetal Anomaly, Myelomeningocele, Obesity, Pregnancy
Conditions
Keywords
Myelomeningocele repair, Open Neural Tube Defect, BMI of 35-40 kg/m2,, Open Fetal Surgery, Elevated body mass index
Brief 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
Detailed description
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.
Interventions
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
Sponsors
The University of Texas Health Science Center, Houston
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
16 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative complications | At the time of fetal repair surgery to 40 weeks gestation | Determine if there is an increased risk in women in this group |
Countries
United States
Outcome results
None listed