MOMS Trial

So a few weeks ago the results of the MOMS trials came out. For those of you who don't know, it was an NIH-sponsored clinical trial where three hospitals were randomizing qualified mothers to either pre or post natal lesion closure. The objective was to determine if closing the lesion in-utero provides a benefit versus post natal; and, if it provides benefits, what are the potential risks and do the benefits outweigh the risks?

In the interest of full disclosure, you should know Chris and I went through the rigorous and emotional process of this trial consideration at Children's Hospital of Philadelphia. We met all criteria, and then had to decide if we would randomize or not: if we would take the next step, and be randomly chosen to either undergo in-utero lesion closure 3 days later, or have the traditional post delivery closure. We opted not to participate, and respected the study too much to proceed and possibly eliminate that slot for another couple who were more willing to participate.

Initially I was very excited to see the press on Spina Bifida when the results were published a few weeks ago. Then I started reading the press and I was agitated at some of the verbiage. Words like *fix* and phrases like *fetal surgery is better* and *novel surgery reduces birth defects* were abound. While the study showed promising results, in my eyes it mostly showed the need for more research. By no means was anyone *cured* of spina bifida, or of the medical complications and developmental delays that accompany it.

I spent a few days thinking about it all, then decided I couldn't squeeze in worrying about this. I also considered that the Spina Bifida community is small. And I do believe you have to tread carefully, because in no way would I want to offend anyone. But the whole thing has been lurking in the back of my mind. More and more I am hearing people say things that equate fetal surgery with best possible outcome, and I just don't feel like we have enough information to guarantee that.

In a very brief nutshell, the study results note that in-utero closure reduces the rate of disability but increases the risk of prematurity. It reduces the need for a shunt, and improves mobility. It increased premature birth (children with prenatal closure were born at an average of 34.1 weeks, children who had closures after birth had an average gestational age of 37.3 weeks, by scheduled c-section). 20.8% of the preterm babies experienced respiratory distress syndrome. The study also found prenatal closure increases the mothers risk for thinning or tearing of the incision. You can read the entire finding here.

The first primary outcome being looked at was, whether by 12 months, the child "had died, or had placement of a shunt or required a shunt" To me, these are two very big differences....um, death, or a shunt. But okay. The second primary outcome was a composite from a test of mental development and assessment of motor function. For the first primary outcome, death or shunt, the occurrences were 67.9% in the prenatal group; 97.9 in post natal. As for the second outcome, the prenatal children scored "significantly higher" than post natal. I don't know what this means...significant is pretty vague. What's significant to me isn't significant to someone else, and I'm also not familiar with the testing used. But I do know, at 30 months old, a child's mental capacity isn't done developing, and either is motor function. As for motor function, forty-two percent of the toddlers in the fetal surgery group could walk without crutches or other support versus 21 percent in the other group. While the study doesn't seperate death from shunt in the percentages, I think it's worth noting that two children died from the prenatal group, and two children died from the post natal group.

In-utero closure is now available as an option to expectant mothers.

But I still have many unanswered questions, and for me it seems the answers are necessary (ie, more research is needed) to really equate prenatal closure with the *best possible outcome* First, the long term study on these outcomes is not complete. What are the outcomes in 15, 30, 60 years? The very first child who had in-utero surgery is 13 years old now, had surgery at 29 weeks gestation in 1997, and he uses a wheelchair, has neurogenic bladder, and has a shunt. I think it's important to see what the majority of in-utero closures long-terms results look like.

Second, many women were excluded from the study by way of other medical concerns (obesity, twins, other medical concerns, and many other medical factors, such as length of cervix...). So we have no idea what prenatal closure would mean for these women in terms of health risks/death posed to them by having this surgery.

Third...it still seems that a comparison of prenatal to postnatal closure isn't really comparing apples to apples. No one knows what the diagnosis will be for a child with meylomenengocele spina bifida in-utero. I other words, they cannot tell you while you are pregnant if your child will need a shunt. If they will walk, if they will need assistance, what their motor function will be, what their mental capacity will be. So to look at a child who had prenatal closure and say that child has a *better outcome* then a child who didn't begs the question (for me, at least), how do you really know? No one knew what that child's outcome would have been, pre or post natal closure.

Forth: what's the impact on the bladder and bowels? Because for me, that's the kicker. Findings will be forthcoming, according to study literature.

My worry is...that the general public, and parents who receive this diagnosis, thinking this surgery fixes Spina Bifida. For me, this study shows that more governmental funding and focus needs to be put into Spina Bifida as a whole. What causes it and how do we prevent it (and don't EVEN get me started on folic acid because along with myself, virtually every other mom I know who has a child with SB took folic acid so there must be some other cause...), how to we eradicate or fix the neurogenic bladder and bowels (which is, in my opinion, and a shared opinion by many adults with SB, is the biggest health complication of spina bifida), how do we capitalize on science and the regeneration of nerves to improve things like walking function, motor function, how do we improve shunts and their longevity/how do we find better technology, how can we educate the world that this is a manageable condition and abortion is not the answer, and how do we start changing the world to stop looking at people as *disabled* and start accepting them for who they are?

This study was a huge stepping stone which hopefully opens the door to discourse and funding and research to get all the pieces of the puzzle and to put that puzzle together.

But we can't stop here. We still need more. So much more.