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Could this device lead to shorter labor and delivery + become childbirth standard of care?

11:59 am by | 27 Comments

materna chart

from Materna Medical

Materna Medical is at work on a device to help protect the more than 80 percent of women who suffer damage or tearing during childbirth.

“The clinical need we’re trying to address is that there’s a tremendous amount of damage that women suffer during childbirth,”  Mark Juravic, founder and CEO of the California-based startup, said. That damage can lead to incontinence, pain, sexual dysfunction and vaginal prolapse, and much of the damage done is to the pelvic muscle because the baby stretches too much too quickly. First-time mothers are particularly susceptible to tearing.

If the device is brought to market, Juravic said there are many value propositions: it could prevent vaginal tearing for the mother, prevent pelvic muscle damage to the mother, and, perhaps most interestingly, could potentially also offer shorter delivery times using less instruments. Juravic said some evidence points to predilated tissues leading to shorter delivery times. With shorter, easier deliveries, for instance, it’s likely forceps would be less necessary, further reducing the chance of tearing and damage to the mother and stress on the baby.

“This can be if it works and provides all these benefits, it could become the standard of care for childbirth,” Juravic said. In theory, it would make the job of childbirth easier on the mother and the physician or midwife.

The device itself is surprisingly simple: a mechanical dilator that would penetrate the first third of the vaginal canal and basically pre-stretch it to full dilation. It would be used for an hour or two during the first stage of labor, and is equipped with sensitive load and location sensors, plus a semi-automatic force-controlled actuation system, so the device can be removed quickly.

The idea translates from sports medicine: slower stretching is more effective and less stressful to the body than a quick stretch. Materna is banking on this kind of slow stretch to prepare the pelvic floor for delivery.

So far, Materna has completed its first in-woman trial for the device in Sydney, Australia. Why Australia? To work with Dr. Hans Peter Dietz, a thought leader in the effects of childbirth on the pelvic floor. With his expertise, the device was used on eight women.

Earlier this year, Materna moved into the Fogarty Institute for Innovation, a non-profit that works as an incubator for the medtech startups it selects. In the company’s time there, Juravic said he will focus on gaining more clinical data. Because Fogarty is based on the El Camino Hospital campus, Juravic gets regular direct feedback from physicians on the device. Mike Stewart, the product designer and former product development engineer on projects for Boston Scientific (BSX), takes that into account for device design and testing. It’s this feedback that leads him to believe the dilator could be a platform technology for Materna.

“A number of obstetricians and gynecologists have taken a look at our device and said, ‘If you could just change this one little thing on it, I would really like to use it on X patient population or Y patient population. . . . ‘ There are a number of devices we could launch close to our core tech.”

Juravic spent his pre-startup life at Guidant, and took the Stanford BioDesign course while working there. The BioDesign course presented a number of issues to the participants, and Juravic was drawn to tears incurred during childbirth because it seemed to him there was a vast clinical need. It was biomechanical, so he thought from his previous work he could offer a unique perspective. Since the course, he began to work part-time on nights and weekends on Materna, eventually quitting his day job in 2010 when the startup secured its first round of funding for the device, $1 million from angel investors.

Now, the company has a $1.2 million target in its sights for this round, which will include some costs associated with regulatory filing. Juravic said more than half of that amount will come from existing investors.

As Materna continues onward and upward, Juravic looks forward to innovation in the obstetrics field. He said because women’s health has been “ignored” for so long, innovators “are recognizing that there are lots of unmet needs.”

Copyright 2014 MedCity News. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

Lindsey Alexander

By Lindsey Alexander

Lindsey Alexander is an Indiana-based freelance writer and editor covering the medical device industry. She earned a degree in journalism from Indiana University and a master's from Purdue.
Visit website | More posts by Author

27 comments
DaanKmiecik
DaanKmiecik

I totally agree with the other comments. This is a horrible and tremedously stupid invention. This should never become real. The last thing women and their babies need is to take the labour proces even further out of their control than what is already standard! A machine in your vagina that stretches you to full dilation; come on!??

Nancy Ann
Nancy Ann

I just had my first baby four months ago, and didn't tear. I labored for 48 hours because Baby was out of position, and birthed squatting in the warm water of a birth pool at our local birth center. There is just not enough concentration on nutrition throughout pregnancy (which keeps muscles healthy and stretchy), birthing position (squatting reduces the length of the birth canal by ~30%, for example), and easing the baby out when the time comes, which gives the vagina much-needed time to stretch, versus "purple pushing" (pushing to exhaustion while someone counts at you).

I find it offensive that this article starts off with a statement from a man that says we women suffer a "tremendous amount of damage" during childbirth. I had an incredibly hard labor, and I would not say that it was "damaging" *at all* - not mentally or physically. I stood up and walked myself to the bathroom and urinated without any issue within an hour after birth. I left the birth center and drove home three hours after I had my baby. Six weeks after my birth, my vagina felt and looked the exact same way as it did before. That statement is misleading at best, misogynistic at worst.

Mamas - Are you truly concerned with tearing? Consider foregoing the epidural. When you get an epidural, you are immobilized and therefore must deliver on your back, and gravity is no longer your friend. When you have a baby on your back, all ~8-9 pounds of that pressure cascades right over your perineum, which will tear you (assuming the doctor hasn't given you an episiotomy already, to make his job of stitching you up easier). 

Maybe if we concentrated on a woman's inborn ability to birth her baby - something we've been doing perfectly since the dawn of our species - devices like this would be entirely unnecessary. But that wouldn't bring in the big money for this fella Juravic so he could quit his day job, would it?

We get as many contractions as our babies need - they help prepare them for their huge job of breathing for the first time. Shortening labor may sound superb, but what effect can it have on the babies who needed those extra contractions to give them the best start at life?

Mary991112
Mary991112

Wow....I don't even know where to start! I'm all for interventions when they're necessary but this is going WAY overboard!!!! I've had three babies, three epidurals, two inductions. I never had a problem with FTP or with tearing (inside or out). I understand the Dr point of trying to save women from tearing but there are just some things you can't "fix" about child birth. It's gonna happen. It's something women having been enduring for centuries and will continue to do so. I don't think id go so far as to call it "device rape" unless of course it done without the mothers knowledge or consent. With that being said, I hope this never becomes mainstream practice. When I'm trying to push my baby out the last thing I want is someone shoving something else up there!!

brista
brista

I hope this doesn't become standard care in childbirth! Isn't it bad enough that "modern" medicine already insists on multiple unnecessary sonograms, inducing with artificial hormones, breaking the water, strapping mom to all kinds of machines and monitoring devices, forcing her to stay in bed, numbing mom from waist down (at best),  then eventually rushing mom to an "emergency" c-section which all could have been prevented in most cases if the doc had not done all those others things....or skipping all that and just scheduling c-section at the convenience of the doc because baby "has a big head". This is ridiculous. Women are built to have babies. In occasional emegerency cases, Western medicine needs to intervene. But not NEARLY at the rate they are intervening. Women are not broken.

CandyThomas
CandyThomas

Yes, because inducing us with fake hormones isn't fast enough for you?! Because we don't function in a way that is convienant for the physician? Too much too fast? How about this, we start using less medical devices, less hands on OBs and let us do what we were born to do. Stop trying to "make it all better" for us with your man made objects and find something else to play God with.

NicoleStepan
NicoleStepan

Yep, that's right moms. You can't do anything else right in birth so now we need to stretch your vaginas for you.  This makes me so angry!  The "unmet need" is you all have completely lost sight of the basic needs of a birthing mother.

RebekahPorter
RebekahPorter

Is that what women truly need or is this just another money maker in Obstetrics? What is wrong with baby doing the stretching? Why not teach women how to stretch the skin themselves before labor? Let women trust their bodies to do what God intended. How about putting money into more lifesaving devices or researching issues that kill mothers or unborn babies?

Cristen
Cristen

This is really gross; I don't know any other way to say it.  Birth is a physiological process that requires some really low-tech things that many birth settings are unable to provide: quiet, privacy, support, and a lack of pressure or timelines.  Science supports these things.  But instead, we throw up all these barriers to labor progress and intact body parts (lithotomy position, continuous monitoring, constant vaginal exams, not allowing moms out of bed, directed pushing, drugs that interfere with a safer process, etc.) and then invent things to combat that -- things that are inserted into our vaginas?

This isn't just unscientific; it's degrading and dehumanizing.  No, thanks, guys.

JulieAnnWilliamson
JulieAnnWilliamson

What the hell!? Are you people insane, this awful medieval torture device should be burned. What about the actual cause of the tearing? A vaginal birth doesn't cause tearing, the tearing is caused by purple pushing, epidurals ( so you can't feel anything), laying flat on your back without the option to move around, no perineal massage, no water birthing, and the fact that most doctors don't know how to help a woman stretch effectively. Start having the vast majority of woman birth with well trained midwives and I guarantee you will see a huge reduction in tearing. Get your technology out of my birth!

VMS80
VMS80

I would tell my doctor where he could shove this device, and it wouldn't be inside me! This is insane. Just another device to make things easier for the doctors. One more thing to make birth a medical, mechanical event rather than a miracle of nature. I was directed how and when to push, and given an episiotomy, told I would tear anyway and it would be better and faster, safer for the baby too since he will come out sooner. My next baby, I let my body use the fetal ejection reflex to bring the baby out in it's own time, and I was able to deliver a baby who was 26oz heavier and 1 inch longer, with a nuchal hand (his hand was on his cheek and that part really hurt when it came out!) without even the tiniest tear!

Guest
Guest

Try this barbaric device out on yourself before messing around with women, please! Of course, it's easier for Dr Dietz to wheel someone into the OR for a c-section after this device screws up their natural labor pattern. After all, cutting a woman open and extracting her baby is more of a "physiological match" than childbirth, right Dr Dietz?

Dora Hardaway
Dora Hardaway

A classic example of men trying to step in to "fix problems" (how anyone can with a sound mind think a person who owns a penis can possibly be wise in areas that which concern such an emotional part of the body such as a vagina is beyond me!!) Women need not be "on time" or "stick to the EDD"s and should not be offered advise that takes power away from her to be in her body ever, but especially during labor. She doesn't need to be told how to birth, she needs services of love, support, tenderness and respect for her body to do what it is designed to do best. As if a body that quietly built an entire material body in 40 short weeks could suddenly "forget" how to release the baby into the world when the time is right??!? The whole hospital physical based birthing industry just p***es me off - sorry if I'm taking this personally but up until I trained to become a prenatal Yoga teacher, non of the real information was available or handed to me - I thought my vagina was going to explode and I ended choosing a CS and missed the most epic welcome party of the century (for my first child) luckily I was a lot more educated for my 2nd and achieved a VBAC so the last time I checked with all the ladies I work with on a daily bases as a specialist in this field, the vagina works just fine. 

The whole "health care industry" is full of loop-holes and it's mostly all exploitation, greed, manipulation and money poured into preying into people's insecurities to make money - I get that we live in a commercial world but to play on the sanctity of birth, it's just dirty money. It's a filthy industry and something has to happen to stop this horror. Births impact mothers and mothers impact families, families impact society and so on... if women were more educated on what REAL labour was, fully supported and respected and got to choose exactly how to birth, where to birth and when to birth - we'd all just flick these "bring ideas" aside and just got on with it! There is something rotten in the current state of "health care" around many sectors, but births being sacred and such an intimate profound chapter in a woman's life - this violation goes beyond physical tears, we are getting emotional scarring from all the intrusion and violations of our fundamental rights as humans - WE HAVE A GOD GIVEN RIGHT TO BIRTH OUR WAY. 

We need empowerment to dilate, not yet another electric invention to "move" our baby's out. 

How do we issue a "red card" and pull the stop signs here...labor union ladies?? 

Road
Road

Disgustingly twisted. The problem is with hospitals mistreatment of woman not the need for a gadget.

Toshia
Toshia

This is a piece of crap. Women experience pelvic floor damage primarily from medical interference so what have they done now? Invented another piece of interference to jam up in women's vaginas. Really does this not reek of rape, violation, and medically deviant behavior? No one else thought that? I swear these guys sit around thinking up ways to shove things up women's vagina's in more disgusting ways and get paid more money to do it. Medically deviant behavior. Stop it now.

ShelliZink
ShelliZink

Omg. Please, no one consent to having this thing used on them!

QuestPickens
QuestPickens

I feel like the only ones they are thinking about is themselves and the mother. They are not thinking about the potential harms this can cause to baby when a woman's body is designed to do this why don't they leave women's bodies alone and go experiment on themselves and men. Clearly men think they know a woman's body better than she does. I do not understand why women have to be subjected to such things and babies too!

marija_m
marija_m

The "damage" that women are facing to our perineums in labor is not due to a lack of a gadget. It is because of common hospital policies which require us to be still and laying down, and the high usage of epidurals.. (That and doctors who mistakenly believe that a cut is better than a tear).  When women are free to move around, eat and drink, and labor in a physiologically appropriate way, there is little to no tearing.  

Lynn Ratcliffe
Lynn Ratcliffe

This is appalling & tantamount to abuse! If women are birthing in their own time, listening to their bodies in positions which allow the baby to descend in it's own time then the female body can give birth with very little perineal damage. Most damage is caused by Valsalva pushing, being in prone or semi-prone positions and with epidural anaesthesia. Women in upright positions, giving birth in water or breathing their babies out suffer less perineal damage. Read Cochrane reviews & invent something useful rather than this nonsense. PLEASE!

PCB
PCB

Great, something else for men to jam up there. Can't you just leave well enough alone? If women were allowed to birth normally, and not forced to do managed, "purple pushing," you would see a sharp drop in the traumas you describe. We women can generally birth babies on our own, thank you very much. It's only because a bunch of guys can't keep their hands and their minds to themselves that childbirth got so messed up in the first place. Please take this device and throw it in a river. Did you even ask the women who had to have this inserted how they felt about it? Can women in labor move around freely with this inside, or will they be confined to the bed. Why don't you learn something about normal, physiological labor and birth before you go messing around with it. And not from gynecologists; they're just as clueless as you are. Talk to WOMEN.

Sooz
Sooz

Good grief, what next? This thing would be painful, and interfere with the natural hormonal cascades that mother nature developed over eons to allow women to birth their babies! Interfering with the stretch receptors before second stage could prove disastrous. All this thing is designed to do is scare women into not trusting their own bodies. Dr Dietz is quoted as saying recently that women's bodies are not designed to birth babies - “human childbirth is a fundamental biomechanical mismatch, the opening is way too small and the passenger is way to big.”
I would doubt the validity of this trial anyway, with only 8 women used as guinea pigs, you couldn't draw any conclusions at all. NONE. Their website is just awful, trying to scare women into using this device. It's jsut wrong. Money would be better spent on models of care that promoted childbirth as the natural process that it is, minimising interference, and I bet you would find an even better result than using this ridiculous thing. There is already a ton of PROPER evidence showing that any interference or intervention increases the chances of a poor outcome.

Lisa
Lisa

This is just horrible!!! Why do they think women need such help? Slow dilation? Dilation goes at its own rate if the woman is let to work at her own pace. All those problems they mention occur precisely because doctors are always hurrying things up. I hope this device won't ever get to market. Really, women don't need help, women need peace, respect and time.

Anon
Anon

This is a terrible idea. It will limit movement in labour, increase the need for pain medication, and introduce a higher risk of infections. If you really want to help prevent pelvic floor damage, perhaps consider changing the system, not the woman.

KDinCA
KDinCA

I think looking at WHY there are so many birth injuries may be more effective.  The female body is MEANT to do this.....the medical industry wants us all to push our babies out in a textbook fashion....but that is not healthy for mama or baby.  Maybe if they stopped pushing inductions and forcing women to push the moment they got to 10cm...they wouldn't have all these issues.  If you just let the body do what it was designed for...that slow, natural stretch will take place.  let the baby naturally decend without the additional pushing....natural contractions will push the baby slowly into the birth canal and help do the stretching in those final moments.  Finding ways to speed up labor and delivery should NOT be the goal....the goal should be to let nature take its course as it was intended.

And....this all coming from someone who had two c-sections because of a breech baby.  I still totally believe the body knows how to do this.  Go collect data in the UK  or with midwife practices where they allow most women to birth naturally with and dont' force them to adhere to some trumped up schedule.....I think that would be a more effective way than shoving some foreigh devise up a woman in labor!

JulieAnnWilliamson
JulieAnnWilliamson

@Mary991112  Actually no, tearing does not need to happen. Tearing is a product of purple pushing, on you back while a nurse yells at you. This restricts the diameter of the birth canal as well as tries to get the baby out as fat as you can. When this happens the baby's head doesn't have time to stretch the vagina like it is intended to.  

If you are in a position that opens the birth canal rather than closes it, like squatting, tearing is greatly reduced. If you allow the baby to sit in the birth canal and stretch the tissue the likelihood of tearing is greatly reduced. Squatting also shortens the birth canal so baby has a bigger, shorter passageway. Perineal massage, hot compresses and oil can all reduce or prevent tearing. 

Vaginal tears are a product of the modern birthing system not a normal part of natural birth.

VMS80
VMS80

@KDinCA Sadly they speed up birth because they can make more money the more babies they can deliver. I was very naive with my first baby and actually envisioned going to the hospital in early labor, being left mostly alone in my room to labor with my family, maybe get checked occasionally to make sure we were OK. And when it's time to push, someone would get the doctor and they'd be there in case of an emergency. Whether it took an hour or a day, I'd be safe and comfortable in the hospital. It seemed simple to me!

So I called the doctor in early labor and was told to come get checked, which I did. I was seen immediately, 1cm, time to go back home and labor some more. This might not even be real labor. Fair enough. 6 hours passed and I was getting very painful contractions and I was ready to get to my room and hunker down and get the baby out. Instead I was sat in a room for almost 2 hrs before triage when I was told I was 4cm and I need to go back home.

In retrospect I should have went home and not went back. But I couldn't go back & forth again. I told them they had to let me stay so I could relax. The drive was so painful, and I was paying 2 taxis for every trip. I couldn't fathom labor getting stronger, and needing to ride in a taxi the 5th time, and go sit in that room AGAIN and go through triage a third time!

They reluctantly kept me and put me on the clock. Every check I had advanced but I was told not quickly enough. I was treated like a hysterical 1st time mom who didn't know anything. They were constantly pushing things to speed my labor up, pitocin, break my water, pushing before I was ready, episiotomy. And less than 30 minutes after my birth, the midwife left in a taxi, and I never saw her again. I was the only one who had to live with the effects of this birth, not her. They then moved me to a recovery room for 2 hrs and then a different recovery room, because there were more women waiting hours in the waiting room & triage. It's a terrible system. i know not everyone has that experience, but I sure did! Nothing like I had pictured. Nothing.