new screening test for shoulder dystocia performed without informed consent

[anrui]

Hello everybody,

If you are concerned about scare tactics used by doctors trying to manage liability, the whole "big baby" scenario, and the issue of informed consent please read my story. I am looking for other women who may have experienced or heard about what happened to me, and also some advice about my rights as a patient and how to proceed (eventually) with filing a complaint or taking other action.

I am 40 weeks + 11 and yesterday I went for an NST and a fluid check. I did not ask them to do a size measurement but the technician proceeded to do one anyway. I realized what she was doing about halfway through but did not stop her.

The result of the measurement was 10 pounds, so she called the OB/sonographer in. After redoing it a couple times to be sure of the result, the OB went into an adjoining room (where I couldn't see her) and started calling out questions (about me) to the technician (height, age, weight etc.). I had no idea what she was doing (she gave no prior explanation at all), so I answered the questions and they had me get up from the examining table.

Then she asked me to wait while she paged my doctor. I overheard her end of the conversation, in which she basically said we have a "new tool" for predicting shoulder dystocia and asked if she could give me the results.

My doctor must have said yes, because then she hung up and proceeded to show me a graph with the results of a new screening test that has just been developed for predicting shoulder dystocias that result in permanent injury to the baby. My risk was very high. She mentioned a website that had information about the test.

Then, in a very alarmist tone, she let me know that I could go directly for a c-section based on the result. She said it was my right to try a vaginal birth anyway, but if I chose to do that I would have to present the graph to whoever was on call when I arrived at labour and delivery so that they would be informed about my risk of shoulder dystocia and could take appropriate measures (which I'm sure will include all kinds of alarmist scare tactics and a consent form for vaginal birth if I don't agree to c-section).

I left the hospital in a state of panic/shock. I am quite an anxious person, I am scared to death of induction/epidural/c-section, and for several nights already I had hardly slept because of the pressure/scare tactics being used to get me to agree to an induction (which my doctor insisted I book 2 days from now).

Now I am scared to death of the reception I will get when I show up at labour and delivery and the various scare tactics that will undoubtedly be used. My confidence in my ability to vaginally birth my second baby (after a completely natural first birth of a boy who was also measuring big) is also shaken.

I am susceptible to bouts of extreme insomnia when under a lot of stress (which have culminated in a panic attack when sleep deprivation reaches a certain point) and last night I did not sleep at all, although I really gave it my best shot.

Finally I got up and went on the Internet, to the site the doctor had mentioned (www.shoulderdystociainfo.com), which I feel is basically a piece of slick marketing (disguised as an information/research review site) sponsored by the newly formed company that is marketing this new "predictive tool" (aka screening test). It includes the following disclaimer:

It must be emphasized that this predictive tool -- called the CALM Shoulder ScreenTM (patent pending) -- is currently undergoing its first clinical applications. It has not been available to obstetricians in the past, and is by no means the current standard of care. However, if the results thus far demonstrated by this predictive technique continue to be validated, the standard of care for the preventative management of shoulder dystocia may soon change.

I am incensed that this "tool"--which is in fact an unproven screening test in the validation phase--was used on me without my prior knowledge and consent, and with no explanation of its unproven status.

So, here are the questions I would like to throw out about this:

-Has anybody had this new screening test done?

-If you are aware of this test or go to look at the site, what do you think about it?

-Does anybody know if it is considered acceptable practice to perform such a test without the patient's knowledge and without informed consent?

-Does anyone know an organization or group that could give me more information about my rights as a patient (particularly in Canada--I live in Montreal, where the doctor who developed the test practices).

I am not planning to try to take action about this before the birth (besides discussing it with my doctor and signing their bloody consent form). But I'm really angry that this screening test was used without my consent, and after I have got through the birth and early post-partum I intend to--at the very least--file a formal complaint with the hospital. If I find that I have any grounds for further action, perhaps I will take it further.

Any comments/information from anybody will be greatly appreciated. Thank you for reading this!

[CEG]

Well, if it is a study that's being done and you did not sign a consent then they should have have performed the test. Also, in fact you did not consent to the test at all so they should not have performed it at all. The problem that comes in in hospitals is that often the blanket consent allows this kind of behavior. If I were you I would contact the hospital's Institutional Review Board (IRC). They should be monitoring the research that goes on. At least at my hospital express consent must be obtained to make anyone part of a study.

My guess RE: the "tool" is that it is using the same things that OBs already think predict shoulder dystocia- maternal size (exterior which we know means nothing) and estimated baby size (per US which we know is not valid). My guess is that it rolls all the misconceptions up into one handy package to convince women they need a c-section/induction. Shame on the tech for her behavior, trying to convince you to have a c-section. Techs are not supposed to diagnose and it was poor practice for your doctor to allow her to tell you the "results". I would definitely make an issue of this.

If the induction does not sit well with you one effective thing I have seen is to say you are "sick" on the day with diarrhea. Don't say vomitting or they will want you to come in for monitoring. No one wants to deal with diarrhea. Remember that your baby is no bigger now than it was before they gave you this "diagnosis."

[kkar]

I've never heard anything about this test, but didn't want to read without posting.

First off, Please don't let this stress you out. My first born (8 lbs 5 oz) baby had shoulder dystocia, and it had nothing to do with size. It had everything to do with the baby's position, large head, and my bone shape - nothing of which could have been accurately predicted prior to her birth.

The doctor running this study clearly has one objective - which is to promote his product and study. You were unfortunately pulled into all of this without your consent - an unethical practice if you ask me. I don't know about your obligation to show the study when you enter Labor and Delivery, but given my past experience, I don't know that I would as it would seem to increase your chances at a c/s.

Believe me, if your baby encounters shoulder dystocia, they will know soon enough to do something about it. And, if the baby turns out to have a small enough head for your bone structure (which statistically is likely) and turns into a good position during labor, there shouldn't be a problem...

Stay positive, and focused. And, most importantly...relax! It's the healthiest thing you can do right now for you and your baby.

[huggerwocky]

can they use this graph if it was made without consent? I'd try get it out of my files.

[musicmomto5]

What about the very, very big possibility of the weight not being accurate at all? The later the US, the bigger the variation. I am sure we have all heard the stories that women were told their babies were much bigger then they actually ended up being.

That said, my "biggest" baby was the one that weighed the least. She was shorter, had a bigger head/shoulders/chest.

[cottonwood]

I find the site confusing. While being upfront about the problems inherent in using the following factors (maternal height, maternal weight, parity, gestational age, baby’s estimated weight, and maternal history of gestational diabetes or previous shoulder dystocia) to predict SD, they go ahead and use those very factors to try to predict it.

I'm astounded that they totally dismiss the hands-and-knees maneuver as impractical and unproven in favor of much more invasive procedures, including (as a last resort) symphysiotomy or pushing the baby back up and performing a cesarean.

[jengacnm]

Originally Posted by fourlittlebirds

I'm astounded that they totally dismiss the hands-and-knees maneuver as impractical and unproven in favor of much more invasive procedures, including (as a last resort) symphysiotomy or pushing the baby back up and performing a cesarean.

Just goes to show you who developed the tool. Certainly not midwives.

Let's just say you want a big family. Each c section becomes progressively more dangerous. If you have a c section based on their recommendation, and the baby weighs LESS than they predicted, can you sue due to loss of future fertility based on inaccurate information?

Grrr this makes me twitch.....


Jennifer

[Munchkimo]

I was aware of this "test" before you mentioned it here. When I read through the site, I came to essentially the same conclusion that the OP and Fourlittlebirds came to--It's a marketing ploy disquised as a medical test and it's "results" are almost entirely based upon unreliable indicators. I don't see where they have any legal right to insist that you present the graph to whomever is on call when you arrived at labour and delivery, much less to insist that you induce. Don't let 'em bully you. You can birth this baby!

[cappuccinosmom]

I hadn't heard of that. But what a disgusting scare-tactic. :

[anrui]

Thanks for all these great replies.

As I mentioned in my original post, I did not sleep at all last night, and that is following 3 nights of very little sleep due to the general stress of being overdue and all the tests and warnings I have been subjected to.

I have been trying all day to sleep with no luck. I called in and a nurse suggested Benadryl and a hot tub bath. I went out and got the Benadryl and took a hot shower and a bath. It made me nice and sleepy for a short while, but then the anxiety took over again.

I can clearly feel the tension and fear in my body. Even though I realize that this test is not valid, and that the scare graph that comes with it is not worth the paper it's printed on, these OBs have managed to put a deep scare into me.

Before I was not scared about the birth at all and felt sure that I would not need induction or an epidural, the prospect of which terrify me. Now I am scared about all the different possible scenarios, including vaginal birth! I know it doesn't make sense, but the fear is there and it's not going anywhere soon.

As any of you familiar with severe insomnia and anxiety/panic difficulties realizes, I can't "just relax". I've learned from past experience that I just have to manage the situation until the anxiety ebbs out of my system. The key right now is sleep, but it just won't come!

Reading your comments and words of encouragement has helped a lot. And after the birth I will definitely look into whether the hospital has an institutional review board or some equivalent body.

As for trying to keep the screening test out of my file, I think that's impossible. The OB that did the test will certainly write it up in some form, and she has already notified my doctor. Of course I won't hand it over to whoever is on call at the labour and delivery department when I arrive as I was told to do.

I will discuss it with my doctor tomorrow morning when I see her, and if she insists on having a copy I will give her one (I am keeping the original in my files). I have a number of questions prepared for her concerning how it will affect my management.

My doctor is a GP who luckily has a reputation for being one of the most natural-birth friendly doctors in the city. She is generally very good about discussing issues, respecting the principle of informed consent and basing her practice on solid research ("the weight of the evidence", as she puts it).

If she takes this test seriously once I show her the page I've printed out with information from the web site, I will be astounded. However, she may be obligated to consult with an OB based on this, and may feel bound to have me sign a waiver.

The waiver is OK with me, but if she has to consult with an OB I will not be happy at all. If, god forbid, she has to transfer care to an OB, I will freak.

We came to an agreement about induction prior to the test (stripping the membranes, followed by "ARM only" the next morning, and then we play it by ear), and I intend to follow through with it, but if she insists on basing any decisions on this test or involving an OB, that will be a deal breaker for sure.

As an aside, I just learned that a colleague of hers (another GP in the same family practice unit) allowed a patient to be induced in hospital using Black Cohosh with the support of a doula who is a herbalist, and the doctor caught the baby with the woman on her hands and knees. Of course the woman had to sign a waiver, but still it's pretty impressive for a hospital, heh?

[turtlewomyn]

Well, that risk screening wasn't used on me, but I have seen that site in searches on shoulder dystocia. I had a cnm/ob coerced c-section for fetal macrosomia under the fear of shoulder dystocia. I was told they had missed GD (even though my glucola test was way below the threshhold of 140 - I had a 67) and that my 4300g baby was too big to give birth to and I had a 20% chance of SD, I think the doctor pulled that figure out of his heiney. This was all from a "post dates" ultrasound to "make sure I had enough fluid" (I had too much for them actually, my AFI was 25). Never mind that I had 9 and 10 pound cousins, big babies run in my family.
Anyway, I hope you can be stronger than I was. I regret giving in every day. I hope that you go in pushing and have your baby the way nature intended. I think the key is to keep mobile in labor, don't let them put you on your back pushing with feet in stirrups. Squatting, hands and knees, are all good positions.
Good luck, don't let this scare you, chances are you grew the right size baby for your body.

[wifeandmom]

From reading some of the website you posted, it appears they have developed this screening tool based on past deliveries where they've evaluated who had SD during delivery, how big mom was, how big baby was, did mom have GD, etc etc etc.

If they apply their mathematical formula to a large sample of deliveries (thus they KNOW for certain which ones ultimately had SD), it appears the false positive rate they are seeing is 2.7%. What that means is their screening tool says there should be a SD case when there was NOT in 2.7% of cases.

Dr. Hamilton’s formula has been tested against several large independent samples of patients who had experienced shoulder dystocia with permanent injury. The data—some already published, some in the process of submission—shows that it is possible to consistently identify 50-70% of patients destined to have a shoulder dystocia with a false positive rate (rate of additional cesarean sections) of only 2.7%. (Dyachenko, Hamilton 2006)

Honestly, if the false positive rate is that low and your 'score' (or however they graphed it) was very high, I'd be incredibly nervous. I'd DEFINITELY want a provider VERY comfortable with handling SD if I attempted vaginal delivery.

Bottom line is it really doesn't matter that u/s weight predictions are typically 'off'....if this mathematical formula can accurately predict SD in over half of the cases that ultimately experienced SD with a 2.7% chance of being wrong, I'd take it very seriously.

The limitation of the screening test seems to be more centered around the fact that it only picks up 50-70% of SD cases, NOT that it predicts SD in a large number of cases where it ultimately did not occur. What that means is if the test says you're at high risk, it's only wrong 2.7% of the time. If the test says you're NOT at risk, you might still be in the 30-50% of SD cases that it fails to predict.

Of course, the math teacher part of me would rather see the actual sample sizes they have evaluated, something I didn't see right off when I checked out the website. It could certainly be that this tool has simply not been 'used' enough to provide accurate and reliable data. That is, over time, as they evaluate more deliveries, the false positive rate may increase. I'd want to know how many deliveries they've evaulated with the tool to arrive at the 2.7% false positive rate before I decided how much weight to give the results.

I'd also highly suggest, and insist upon myself, the latest/greatest u/s technology with the best/most experienced provider to be certain the estimated fetal weight was as accurate as humanly possible.

How big do YOU feel like the baby is? I've seen over and over how eerily accurate mothers are at estimating fetal weight. I know I certainly guesstimated all four of my children's birth weights amazingly close. I was 4oz off on one of my twins, and I was 2oz off on the other three. Interestingly enough, each time I *underestimated* their weights.

[anrui]

In answer to your question, wife and mom, I believe my baby is around 8 pounds. They predicted a large baby with my first and he was only 7 pounds.

I am not a math teacher, but the statistics they give on the site about the false positive rate don't scare me at all, because the site itself states that the overwhelming consensus based on research up until 2006 is that SD cannot be predicted.

Then two studies in 2006 seem to find some link between certain factors, and some doctor comes out immediately with this tool, gets some backers to form a company, sponsors an "independent" doctor to put his name on the site and they trot out some handy statistic about the false positive rate so that they can start to market their tool and test it out in clinical practice. Personally, I think their agenda is pretty clear...

What's the saying....there are lies, damn lies and statistics....? Something like that anyway.

turtlewomyn, thanks very much for posting your story. It's the same thing with me, all this is coming from the post-dates ultrasound to check for fluid. They certainly seem to have coerced you by pulling some statistics out of a hat, and trying to claim that they "missed GD", what a crock. Was your baby even close to the size predicted by the late ultrasound?

I recently read somewhere that in the US, an OB gets around $3,000 for a vaginal delivery and over $30,000 for a c-section. Does anyone know if this is true? I'm sure the hospital gets a lot more as well. It's easy to see that an OB has a huge vested interest in boosting his c-section rate a few notches, especially when the hospital is probably rooting for him every step of the way.

I live in Canada where we have nationalized health insurance, but it's basically the same deal. Plus here we have a shortage of specialists (because all round they earn less than specialists in other parts of Canada and the US, so many of the ones trained here relocate.) They use this as leverage in negotiations with the government about the set rates. At the beginning of this year OBs in certain hospitals here actually threatened to stop doing deliveries for a period of time as a pressure tactic.

[turtlewomyn]

anrui - My baby actually was within two ounces of their prediction (they said 9lb10oz, she was 9lb8.5oz) but this was a week after their ultrasound (we fought the csection for a while) and I was pumped full of fluid, she was down to nine pounds by the time I left the hospital, I think a lot of that was the fluids they pumped into me. However, like I said, I had two cousins that were 9 and 10 pounds, that is the size that women in my family give birth too. I never heard of them having problems with SD or anything. My mom's babies were small, but she smoked through her pregnancies and was told not to gain more than 15 lbs.

I do agree with wifeandmom that you need a care provider that is comfortable with dealing with SD, my understanding is that many of the problems with SD may actually be caused by a care provider panicking and not performing the correct procedures (the gaskin manuever, the McRoberts manuever, etc.)

[koru]

i'm so sorry for your stress, mama. i know how debilitating panic attacks can be & i truly wish you rest & peace. (rescue rememdy?)

as for the SD scare tactic....i would print out the disclaimer from the study's website & highlight "is by no means the current standard of care.....if the results." hand this to your care providers at the hospital along with the test results in a very matter-of-fact way, letting them know you are not confident your baby will have shoulder dystocia & do not want to be treated that way!!!

[Lady Lilya]

Originally Posted by anrui

I recently read somewhere that in the US, an OB gets around $3,000 for a vaginal delivery and over $30,000 for a c-section. Does anyone know if this is true? I'm sure the hospital gets a lot more as well. It's easy to see that an OB has a huge vested interest in boosting his c-section rate a few notches, especially when the hospital is probably rooting for him every step of the way.

In another thread (about eating during labor) I said that doctors have every incentive to forbid eating in labor so the mother gets worn out and consents to a c/s, and I was accused of being cynical.

I agree that an OB had a big vested interest. Just all the extended care after the birth is a big money maker for the hospital. Staying in the hospital longer, drugs they give you, tending to your wound.

[anrui]

I just wanted to let everyone know the outcome of this story.

My GP agreed with me that we didn't need to heed the screening test. She confirmed that it's a very new test that hasn't been validated at all, and also said it does not include an estimate of the size of the woman's pelvis. She said I had the "pelvis of a queen" and was not worried about shoulder dystocia.

She also agreed to only break by waters and then wait and see before starting Pitocin. Almost no fluid came out when she broke the bag, but very soon afterward I started having regular contractions that picked up steam very quickly.

Two hours later, after a pushing stage of only 10-15 minutes, I gave birth to a 9 1/2 pound baby. He slipped right out with no problem at all!

[AbbieB]

Congratulations on your birth!!!

I wanted to add to the discussion that there is up to a 30% difference in the size of a women's pelvic outlet depending on position. Flat on your back or semi reclining on your tail bone, which is the standard in hospitals, is the worst position for maximizing your pelvis outlet. Squatting and hands and knees are the best.

I wonder if a lot of the data collected to come up with the SD tool was based on Mommas in the standard position rather than squatting or kneeling.

And moving to a hands and knees position if it looks like your are dealing with SD can often correct the problem (called the Gaskin Maneuver I believe).

[SublimeBirthGirl]

It's never too late to find a more trustworthy care provider. Homebirth midwives will often take new clients even very close to their due dates...

EDIT: Oops! Should've read the whole thread before posting. Congratulations!

[yeahwhat]

So you are one of that supposed 2.whatever% "false positive" rate. What a remarkable coincidence. I hope your smooth vaginal birth gets added in to the stats on the success of this tool! Sadly you're probably one of the few who will refuse the c-section when it's pushed on them.