North American Fetal Therapy Network Fetal Myelomeningocele Repair Registry
Data Collection on Maternal and Child Outcomes After Fetal Surgery for Spina Bifida
Hiba Mustafa, MD
Primary Investigator
Brief description of study
The data in the registry will be used to generate retrospective evaluations, investigations, and research studies.
Objectives: (primary and important secondary objectives)
• Collect and analyze data regarding maternal outcomes at maternal-fetal surgery and delivery, with the ability to track subsequent reproductive outcomes.
• Collect and analyze data regarding fetal/neonatal outcomes at maternal-fetal surgery, birth and early childhood, including the physical and neurodevelopmental outcomes of children who have undergone in-utero surgery for spina bifida.
Detailed description of study
- Organizational Structure: Every NAFTNet center performing fMMC repair will be eligible to participate. Each center will submit data to the registry. Long term outcomes will be obtained through routine childhood follow-up for children with spina bifida being followed by their individual care providers.
- Potential Future Use: To monitor outcomes and incidence of complications in mothers and fetuses/children who have undergone maternal-fetal surgery for myelomeningocele. We hope this information will aid us in improving care and long-term outcomes for both mother and child. This registry will also help to propagate further research and answer clinical questions regarding optimization of surgical technique and clinical care.
- Collect and analyze data regarding maternal outcomes at maternal-fetal surgery and delivery, with the ability to track subsequent reproductive outcomes.
- Collect and analyze data regarding fetal/neonatal outcomes at maternal-fetal surgery, birth and early childhood, including the physical and neurodevelopmental outcomes of children who have undergone in-utero surgery for spina bifida.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Maternal-fetal surgery, Fetal Myelomeningocele Repair
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Age: 18 years - 100 years
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Gender: Female
Inclusion Criteria
There are two situations which a participant can be included in the study:
1) Any woman undergoing evaluation for maternal-fetal surgery for myelomeningocele at all participating NAFTNet centers will be included for screening/demographic information. If she is found to be eligible for surgery and goes on to have the surgery, the information from her surgery will also be collected. Informed consent to collect this information will be done at their surgical evaluation visit. If they are not able to be consented at this visit, they will be called and consented verbally.
2). The registry study population will consist of mother/child dyads who have undergone maternal-fetal surgery for myelomeningocele at all participating NAFTNet centers after 12/15/2010. Any subject that is scheduled to have fetal MMC surgery will be approached and consented for the main study.
This study investigates the outcomes of mothers and children who undergo fetal surgery for spina bifida, a condition where a baby's spine does not form properly. The purpose is to collect data on how mothers and their children are affected by the surgery, both during and after the procedure.
The study involves collecting information about the health of mothers and their babies before and after surgery. This includes looking at how the surgery impacts the development of the child and the mother's health during and after pregnancy. Information will be gathered from different centers that perform these surgeries.
- Who can participate: Women who are evaluated for maternal-fetal surgery for myelomeningocele at participating centers may be eligible. The study also includes mother/child pairs who have had the surgery since December 15, 2010.
- Study details: Participants will have data collected about their health and outcomes related to the surgery. This includes tracking the development of children who had the surgery and the health of the mothers.
