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.

Party Shoes

This week on the Spina Bifida babycenter group there was a discussion about the emotions we are hit with when another child reaches a milestone our child won’t/is very behind on. I had already been festering from a blog of a *typical* child and the *complaints* the perils this mom was going through. Dude, I thought, I’d give anything to be so fortunate as to struggle with (Fill in the blank - potty training, for example).

Maybe festering isn’t the best word. Let’s try it again.

I’d already been pouting (yeah, pouting!) earlier in the week over the blog. I mean, I get it. I know that we are very fortunate and that there are much harder challenges we could be facing. It was just plain old jealousy on my part. Mean, green-headed jealousy. And that only made me feel worse.

But all this was taking me back to, of all things, something said to us at our first Spina Bifida Clinic when Emily was 2 months old.

Clinic, for those of you who haven’t had the pleasure, is a full day visit where you see a general nurse practitioner, physical therapist, neuro resident/nurse, then neurologist, Urologist resident/nurse, then urologist, orthopedic resident/nurse, then ortho, and social worker. A fun day for all to be had, especially when you add in about a 30 minute wait between everyone.

I remember the first visit for only one reason: what the PT said to me. She said, “Now mom,” (as if I didn’t have an actual name…but this is common practice there, apparently no one can look at your last name on the chart or pay attention when you introduce yourself), “No party shoes for her. Ever.”

I don’t remember anything else about the visit, but I remember the moment she said this clear as day. I remember what the room was like, what she was wearing, what her eyes looked like as she glared, scolded me for something that *might* occur. I believed she knew I wanted Emily to have party shoes. And I thought she delighted in taking that away. She was insensitive. She didn’t understand what it felt like to be told your child, essentially, can’t do a basic thing that virtually any mom of a girl would anticipate: playing dress-up. Having a tea party. Going to a party. Clomping around in a pair of your mom’s old shoes.

And frankly, on top of aaaalllllll the other things we’d been told Emily might/ shouldn’t/ can’t/won’t do, I just didn’t want to hear any more, least of all right then. She was 2 months old. I’d just spent 20 weeks of pregnancy worrying and stressing about everything. Our future was a huge question mark. Emily had just had 3 major surgeries (2 brain surgeries), had only been home a month; I was failing at breastfeeding, and I was a hormonal, worried first time mom. I was sleep deprived, paranoid (as in, measuring Emily’s head circumference every morning…) and this lady had the nerve to say “no party shoes”?

Were they now going to infringe on my kids playtime? Her imagination? I’d been saving retired party shoes for 5 years. I’d been working for 12 years and had a basement stocked with dress clothes and amazing shoes. We were definitely going to dress up, and have parties, and dress up with friends and cousins when they came over, and make up routines to Circle In The Sand by Belinda Carlisle. And, I definitely planned on Emily wearing cute non-dress up shoes. Ones that matched her outfit. Little white patent-leather ones on Easter. Red ones on Christmas. Uggs for our Buffalo winters.

This “no” represented yet another stranger in our lives telling us what we can and can’t have. Another medical professional laying down the rules, dictating what Emily is and isn’t capable of doing. And for me, this incident stands out because that day, it was a stark reminder of all the things I was supposed to give up. Dreams, day dreams, hopes, wishes. So many things I had planned on doing with Emily. So many things I was supposed to do, as her mom. So many things she deserved the right to do.

So sometimes, these little reminders pop up when I least expect it, and try and drag me back to that dark place.

Incidentally, we love party shoes around here. My mom and sister search high and low for adorable shoes that fit over her afo’s, or that she wears without afo’s on. Little red shoes with hearts on them. Her first pair of Stuart Weitzman’s. Ugg boots that she can wear over her afo’s, or without afo’s. Ugg maryjanes that fit like a glove over the afos.

And Emily loves wearing my party slippers.

Leave it to Emily to pull me out of the dark and remind me we make our own destiny.