MOMS3: Follow-up in the Teen and Young Adult Years to the Management of Myelomeningocele Study

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Phase three of the Management of Myelomeningocele Study (MOMS) — known as “Follow-up in the Teen and Young Adult Years to the Management of Myelomeningocele Study: MOMS3” — is a study monitoring the health outcomes of the children and mothers who participated in the randomized trial.

The study is a collaborative effort, involving researchers from multiple centers. The purpose of MOMS3 is to compare the long-term effects of prenatal surgery and postnatal surgery for myelomeningocele (MMC) with respect to the child’s adaptive behavior, physical and cognitive function, health and well-being, and the future reproductive health of the mother.

The History of MOMS

Spina bifida is a birth defect affecting up to 1 in 1,500 births in the United States and occurs when an area of the spinal column does not form properly, leaving a section of the spinal cord and spinal nerves exposed through an opening in the back. The condition often results in weakness or paralysis based on the location of the defect, leading to an inability to walk unassisted and a loss of bladder and bowel control for many children.

Outcomes at 12 and 30 months

The original MOMS study — co-led by Children’s Hospital of Philadelphia (CHOP) and published in 2011 in the New England Journal of Medicine — compared outcomes after prenatal and postnatal repair of myelomeningocele at 12 and 30 months.

Results demonstrated that prenatal repair can offer significantly better results than traditional postnatal repair. Babies with spina bifida who received prenatal surgery were better able to walk two and a half years after surgery than those operated on after birth and had better overall motor function. They were also less likely to need a shunt.

Outcomes at 10 years

In January 2020, after following those two groups of patients for up to 10 years after birth, researchers in the follow-up MOMS2 trial showed those benefits continue into childhood.

More children in the prenatal surgery group were able to walk independently by the time they were school age, and they showed better gross and fine motor skills. They also demonstrated better control over their bladder and bowel movements; children who underwent prenatal surgery were almost six times as likely to go to the bathroom on their own than those operated on after birth.

Patients who received surgery in the womb continued to need fewer shunts, surgeries and catheterizations into childhood than patients who’d received surgery after birth. Children and families in the prenatal group also reported a better quality of life, with less stress on the family overall.

The study’s primary outcome, which was adaptive behavior in the prenatal versus postnatal surgery group, did not show a measurable difference in the patients’ ability to perform activities needed for communication, social interactions, and daily living in the everyday environment. The study also did not find cognitive benefits in the prenatal surgery group, though the authors noted that all children with myelomeningocele are at risk for significant learning and adaptation challenges, regardless of surgery type.

Outcomes at 15 to 24 years old

MOMS3, which is now enrolling study participants, will continue to follow this same group of children until they are 15 to 24 years old.

MOMS3 Study Details

The MOMS3 study will be conducted at Children's Hospital of Philadelphia (CHOP). The original MOMS trial sought to enroll 200 patients, but the NIH ended the trial in December 2010, after 183 surgeries had occurred, based on clear evidence of efficacy for the prenatal procedure. Of the 183 babies in the original study, only 161 participated in the MOMS2 study, as eight children died before MOMS2 enrollment began, ten declined to participate, and four could not be reached.

MOMS3 will follow children up to ages 15 to 24 and will build upon the research in MOMS and MOMS2. Researchers will follow families involved in the study to measure longer term outcomes in their patients.

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Always Advancing Care of MMC

As a pioneer in the field, CHOP began performing fetal surgery for spina bifida in 1998, three years after CHOP launched the Richard D. Wood Jr. Center for Fetal Diagnosis and Treatment. Since then, the Center has continued to improve the technique and publish on the practice, leading to significant advances even since the MOMS trial.

At CHOP, the length of the fetal surgery itself has decreased, and the gestational age of the infants at the time of birth has increased — an important step, as many of the babies delivered in the MOMS study who’d undergone prenatal surgery were born prematurely. Doctors have also observed improved movement in the lower limbs and continue to follow up with those patients to monitor their progress and outcomes.

In addition, specialists at CHOP continue to perform high volumes of prenatal surgeries for spina bifida, and have shown that an experienced fetal medicine program can achieve beneficial outcomes comparable to or better than those produced in a rigorous scientific trial.

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