Health Problem: Myelomeningocele (MMC) is the most severe form of spina bifida, in which the neural tube does not completely close and a sac of fluid, including cerebrospinal fluid, meninges, and possibly damaged parts of the spinal cord and nerves, protrudes through an opening in the baby’s back. Moderate-to-severe disabilities accompany MMC, including impaired cognition, urinary and fecal incontinence, loss of feeling in legs or feet, and leg paralysis. Common related serious conditions include hydrocephalus (excessive cerebrospinal fluid in the head), Chiari II malformations (due to faulted formation of the back of the brain, e.g., hindbrain herniation), and impaired cognitive development. Higher spinal lesion level and more severe comorbidities are associated with the overall severity of MMC. An estimated 1 to 5 per 1000 infants born, or 1500 births annually, in the United States have MMC.
Technology Description: The MMC closure surgery, itself, is essentially the same whether the surgery is performed prenatally or postnatally. However, performing the surgery on the fetus in utero is an involved process typically performed by open maternal surgery. It entails a combination of general and epidural anesthesia for the mother, incisions in the abdomen and uterus, the fetal procedure, and recovery in hospital, followed by reduced activity and required proximity to the hospital while awaiting a planned cesarean birth.
Controversy: Fetal surgery of any kind presents health risks to both the fetus and its healthy mother, and whether benefits outweigh risks is debated. The results of a prominent multicenter randomized controlled trial (RCT) on fetal surgery are compelling because they suggest health benefit; however, no subsequent RCTs have been published, so the findings have not been confirmed.
Key Questions: This report addresses the following key questions:
- Does fetal surgery for MMC improve clinical outcomes compared with standard postnatal care?
- What risks does fetal surgery for MMC present to the fetus and its mother?
- What are the patient selection criteria for fetal surgery for MMC?
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