Fetal Surgery for Spina Bifida Repair – BMI Inclusion Criteria Expansion (= 40)
Lead Physician: Kuojen Tsao, MD
The Fetal Center at Children’s Memorial Hermann Hospital is now accepting patients with a BMI = 40 at their first prenatal visit to participate in an observational trial of fetal repair of myleomeningocele, approved by the UT Human Subjects and Investigation Review Board. The Fetal Center will continue to follow the remaining MOMS trial criteria for myleomeningocele referrals.
The study will allow The Fetal Center to capture clinical and outcome data on all maternal-fetal pairs diagnosed with myelomeningocele who have undergone evaluation at the Fetal Center. The study population will include subjects with a BMI between 35-40 who have undergone fetal surgery and those who have not. Data collected will include clinical reports, delivery reports, NICU reports, pediatric outcomes, and subsequent reproductive outcomes for up to six years after delivery.
For more information about the study, visit clinicaltrials.gov/show/NCT02664207
FETAL SURGERY CRITERIA
Candidates are accepted for open maternal-fetal surgery based on the criteria set forth by the MOMS Trial. The risks and benefits to both mother and baby are considered in this process. Specific factors which exclude mother or baby from undergoing fetal surgery include, but are not limited to the following:
Fetal Exclusion Criteria
- Variants of spina bifida that are not considered open neural tube defects
- A significant fetal condition not related to myelomeningocele
- Kyphosis, an exaggerated curving of greater than 30 degrees in the spine of the fetus
- Pregnancy of twins, triplets or more
- Significant clubbing of the legs or evidence of existing paralysis
Maternal Exclusion Criteria
- UPDATE: Morbid obesity (Body Mass Index = 40 at first prenatal visit)
- Medical or personal reasons for withholding a patient from surgery or anesthesia
- Previous or planned incision on the cervix or documented history of a weak cervix
- A short cervix (less than 20 millimeters by vaginal ultrasound)
- Preterm labor in the current pregnancy
- History of spontaneous preterm delivery in previous pregnancies
- Bleeding in current pregnancy or placental abruption – a partial or full separation of the placenta from the uterus
- Red cell or platelet alloimmunization, a blood condition
- Insulin-dependent diabetes prior to pregnancy
- Abnormal anatomy of the uterus such as uterine fibroids
- Infection with HIV or hepatitis B or C
- Inability to adopt a life-style change of restrictive activity during the remaining portion of the pregnancy
- Inability to travel to The Fetal Center at Children’s Memorial Hermann Hospital or to comply with follow-up care requirements
To refer a patient to The Fetal Center for evaluation for participation in the observational trial, call 832-325-7288 or email us at email@example.com.
To view a patient education video about fetal spina bifida repair, visit childrensmemorialhermann.org/spina-bifida. The video is available in both English and Spanish.
See more info on how spina bifida is treated here at Children's Memorial Hermann Hospital »