Myelomeningocele, Neural Tube Defects, Spina Bifida
Conditions
Brief summary
Researchers are studying a new minimally invasive technique (fetoscopic repair) for repair of spina bifida (MMC) during the second trimester of pregnancy. Researchers are trying to determine if this less invasive surgical approach will have less risk to the mother and at the same time adequate closure of the fetal spina bifida defect.
Interventions
DEVICEMinimally invasive fetoscopic repair of MMC
Uses a technique to open your belly (skin, muscles and abdomen) without opening the uterus, except for a small puncture, to repair the fetal spina bifida defect during the second trimester of pregnancy.
Sponsors
Mayo Clinic
Rodrigo Ruano
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Pregnant women - maternal age 18 years or older * Gestational age at the time of the procedure between 19 0/7 weeks and 25 6/7 weeks * Singleton pregnancy. * MMC diagnosis with the upper boundary located between Thoracic 1 (T1) and Sacral 1 (S1). * Evidence of hindbrain herniation (confirmed on MRI to have an Arnold-Chiari type II malformation). * Absence of chromosomal abnormalities and associated anomalies. * Normal karyotype and/or normal chromosomal microarray (CMA) by invasive testing (amniocentesis or CVS). If there is a balanced translocation with normal CMA with no other anomalies the candidate can be included. * Family has considered and declined the option of termination of the pregnancy at less than 24 weeks. * Family meets psychosocial criteria (sufficient social support, ability to understand requirements for this study). * Pregnant subject capable of consenting for their own participation in this study. * Willingness to undergo an open MMC repair, if necessary * Parental/guardian permission (informed consent) for follow up of child after birth.
Exclusion criteria
*
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maternal Adverse Events | From time of surgery until delivery (up to 21 weeks) | Total number of maternal adverse events |
| Neonatal Adverse Events | From the time of surgery until 28 days of life (up 25 weeks) | Total number of neonatal adverse events |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Pregnant Women Diagnosed With Fetal Myelomeningocele Women subjects who are pregnant and diagnosed with myelomeningocele (MMC), also known as fetal spina bifida or neural tube defect, will undergo a minimally invasive fetoscopic repair of MMC.
Minimally invasive fetoscopic repair of MMC: Uses a technique to open your belly (skin, muscles and abdomen) without opening the uterus, except for a small puncture, to repair the fetal spina bifida defect during the second trimester of pregnancy. | 3 |
| Total | 3 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Infant Death after delivery; therefore, no further follow up occurred | 1 |
| Overall Study | Lost to Follow-up | 1 |
Baseline characteristics
| Characteristic | Pregnant Women Diagnosed With Fetal Myelomeningocele |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 3 |
| other Total, other adverse events | 1 / 3 |
| serious Total, serious adverse events | 1 / 3 |
Outcome results
Primary
Maternal Adverse Events
Total number of maternal adverse events
Time frame: From time of surgery until delivery (up to 21 weeks)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pregnant Women Diagnosed With Fetal Myelomeningocele | Maternal Adverse Events | 2 participants |
Primary
Neonatal Adverse Events
Total number of neonatal adverse events
Time frame: From the time of surgery until 28 days of life (up 25 weeks)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pregnant Women Diagnosed With Fetal Myelomeningocele | Neonatal Adverse Events | 1 participants |