Informed refusal = lose the baby?

This post disturbed me, but I was unable to find independent verification of it — no other news reports, no online articles, nothing but this blog’s post. Can anyone confirm or deny this?

Here is the first post, and here is the second post.

In brief, a New Jersey mom went to a hospital with a 50%+ C-section rate, and was asked to sign a consent form for a possible C-section (I think this was upon admission — but definitely with no medical indications that a C-section might be necessary), and the woman and her husband were turned over for an investigation for child abuse and neglect, although the woman gave birth vaginally and the baby was perfectly fine. They had a hearing where their parental rights were terminated — because the judge thought if the woman got argumentative with the hospital staff over an unnecessary C-section, she might argue with the child’s pediatrician or school teacher in the future. Um, yeah.

I daresay I would be more than a little argumentative — doctors and teachers are fallible, so it would be ridiculous for all parents to just meekly submit to whatever the “authorities” say, particularly when they might be wrong. I would think if this were me, I’d be in contact with any and every news service I possibly could to tell my story and generate publicity in my favor and negative publicity for the hospital. Which makes me wonder why I couldn’t find anything else but this one blog that told the story. Of course, there may have been some sort of “gag order” or the parents may be private people and not wanting to draw so much attention to themselves.

So… what do you all say? “Impossible — it must be a prank”? “Horrifying, but I could see that happening”? What?

Free CIMS Webinar

Informed Consent and Refusal in Maternity Care, on Friday, June 19. Sounds cool!

How’s *this* for a consent form?

From a p*$$ed off mama denied a VBAC — priceless!

h/t to Maternal Instincts for the link

Informed Consent for Anesthesia

Regarding the role of the health care professional, the American Medical Association defines informed consent in the following way:

Informed consent is more than simply getting a patient to sign a written consent form. It is a process of communication between a patient and physician that results in the patient’s authorization or agreement to undergo a specific medical intervention. In the communications process the physician providing or performing the treatment and/or procedure (not a delegated representative), should disclose and discuss with [the] patient:

(1) The patient’s diagnosis, if known;

(2) The nature and purpose of a proposed treatment or procedure;

(3) The risks and benefits of a proposed treatment or procedure;

(4) Alternatives (regardless of their cost or the extent to which the treatment options are covered by health insurance);

(5) The risks and benefits of the alternative treatment or procedure; and

(6) The risks and benefits of not receiving or undergoing a treatment or procedure.

In turn, [the] patient should have an opportunity to ask questions to elicit a better understanding of the treatment or procedure, so that he or she can make an informed decision to proceed or to refuse a particular course of medical intervention.

Do you feel like you have truly given your informed consent when it comes to procedures that were performed on you during pregnancy, labor, birth, or postpartum? Not just anesthesia, but for everything  — like an IV, being forced to stay in bed, or deprived of food and water, or having continuous fetal monitoring.

The above italicized portion was from Nursing Birth blog. Click here to read the rest of the very informative post, including an actual hospital informed consent form which you can read right now, instead of waiting until you are deep in labor.

“But what if the test is wrong?”

On one of my email lists, we were recently discussing amniotic fluid levels — how low is too low, what can be done for low levels, etc., and one woman told her personal experience. She had a non-stress test in which the technician said her amniotic fluid level was so low she’d have to be induced that day. Stunned, she said the first thing that came to mind — “What if the test is wrong?” That, in turn, stunned the technician, because no one had ever asked that question before. She said, “Let me check again,” and to her surprise, the second measurement was twice as high as the first one, and an induction was not indicated.

I’ve said it before and I’ll say it again — get a second opinion! (Sometimes even from the same person.)

One question to keep in mind with this sort of thing is always, “What’s the false positive rate?” Because if a recommendation is made to you to induce or perform a C-section or have some other intervention based on one thing alone, and that “thing” is wrong almost half the time, then how confident can you — and the doctor, for that matter — be in the diagnosis and subsequent intervention. If, however, there is a low false-positive rate, then you can be more confident that your diagnosis is indeed accurate. Getting a second opinion, or relying on two or more factors reduces the margin of error. Some doctors are more willing to err on the side of caution — after all, they’re not going to have to recover from abdominal surgery, and performing a C-section may make them feel lawsuit-proof. But it’s your body, your baby, and your choice, so you need to know how often they’re wrong on average.

Another question would be, “What are my options?” Some doctors might say, “You don’t have any.” But if you press and ask, “Can I wait a day?” or, “What happens if I refuse?” you may hear some different answers. Very likely, they’ll pull out a worst-case scenario in which it’s possible your baby may die. And they may be absolutely right; but they may just be exaggerating the situation to get you to go along. It comes down to how much you trust your doctor’s opinion. This is where it becomes important to get a second opinion, do your own research, find out your own options, etc. You may find out that declining the intervention raises the risk to your baby astronomically, and you would be stupid to refuse; or you may find out that your doctor was astronomically exaggerating the increase in risk, and you may be comfortable with the slight increase in risk to avoid the risks of the intervention.

Another question to ask includes questions about the rate of complications in the scenario. It’s one thing for doctors to say that having some medical condition or refusing some intervention “doubles your risk” — which sounds very bad — but it’s another to find out that the “risk” is still only 1 in 50,000 (which is double the risk of 1/100,000). Sure, nobody wants to be that one, but that means that 99,999 mothers and babies are subjected to an intervention which also carries risk. It’s about perspective — a balance — a trade-off between two different courses of action. Nothing in life is guaranteed (except death and taxes); and there are risks and benefits for every course of action. It’s up to you to choose which risks are acceptable for the proposed benefit.

And certainly remember to ask, “What if the test is wrong?”

There are no do-overs

In a recent email conversation, one of my fellow independent childbirth instructors, Dale Bernucca, commented that she includes this statement in her childbirth education series. There are no do-overs. This is important to keep in mind, because, whatever the outcome, you can’t go back and do it differently. You have to make your choices, using the best information that you have at the time. If something happens in your birth that you afterwards wish had happened differently, know that that is normal, but don’t beat yourself up over it — you did what you thought was best at the time.

But this also underscores the importance of being educated in the first place, so that you can make the best decision possible.

Cytotec (ge. misoprostol, a.k.a. “miso”)

The obstetric community at large loves this drug. Some doctors refuse to use it at all, and some use it rarely. It’s a little white pill that as one person put it, “turns the cervix into absolute MUSHIE.” That’s the good side. But you know there has to be a bad side. First of all, notice the little picture of the pregnant woman with the big red slash over it. That obviously means it should not be given to pregnant women. The red rectangle on the side is a verbal description of why.

As a pharmacy tech for over 5 years, I’m well acquainted with drugs, their intended effects, and their side effects. All drugs have side effects. Sometimes this effect is so slight that people don’t even notice it; other times it’s overwhelming, or even deadly. Even something as innocuous as Tylenol (acetaminophen) can be deadly. Years ago, I read a story of a college student who accidentally overdosed on acetaminophen and required an emergency liver transplant, because she took several cold medicines and didn’t realize that all of them had acetaminophen in them.

Here is the package insert for Cytotec, taken from the FDA’s website. You should first know what this drug is–it’s to treat ulcers. They found out that it causes uterine contractions, which is why it’s contraindicated for pregnant women. I’ve heard of women inducing their own abortions by getting this medication and taking a few of them. The package insert says that after the 8th week of pregnancy, this drug can cause uterine rupture, but some abortion clinics’ websites I found said they use this drug in 2nd-trimester abortions.

But, after doctors found out that it can ripen an unfavorable cervix, it began to be used popularly in hospitals. I’ve heard more than one report that women are being given this without their knowledge, and/or without informed consent. One of my fellow childbirth educators was the first to tell an OB-resident of the potential dangers of this drug. He had never heard of the risks. Many women are just told that they’ll be given a pill (usually vaginally) to ripen their cervix. They are not told that this drug is contraindicated in pregnant women; nor are they told that it is an off-label use of the drug. What the doctors are doing is completely legal, but I consider it to be unethical not to give these women the full information.

Here is the information from the package insert about labor and delivery:

Cytotec can induce or augment uterine contractions. Vaginal administration of Cytotec, outside of its approved indication, has been used as a cervical ripening agent, for the induction of labor and for treatment of serious postpartum hemorrhage in the presence of uterine atony. A major adverse effect of the obstetrical use of Cytotec is hyperstimulation of the uterus which may progress to uterine tetany with marked impairment of uteroplacental blood flow, uterine rupture (requiring surgical repair, hysterectomy, and/or salpingo-oophorectomy), or amniotic fluid embolism. Pelvic pain, retained placenta, severe genital bleeding, shock, fetal bradycardia, and fetal and maternal death have been reported.

There may be an increased risk of uterine tachysystole, uterine rupture, meconium passage, meconium staining of amniotic fluid, and Cesarean delivery due to uterine hyperstimulation with the use of higher doses of Cytotec; including the manufactured 100 mcg tablet. The risk of uterine rupture increases with advancing gestational ages and with prior uterine surgery, including Cesarean delivery. Grand multiparity also appears to be a risk factor for uterine rupture.

In the year 2000, Searle (this drug’s manufacturer, since taken over by Pfizer) issued a letter of warning to health care providers who might consider using this drug to induce labor or cause an abortion. (My thanks to “americanmum” for reminding me of this!) It says in part:

“Serious adverse events reported following off-label use of Cytotec in pregnant women include maternal or fetal death; uterine hyperstimulation, rupture or perforation requiring uterine surgical repair, hysterectomy or salpingo-oophorectomy; amniotic fluid embolism; severe vaginal bleeding, retained placenta, shock, fetal bradycardia and pelvic pain.

Searle has not conducted research concerning the use of Cytotec for cervical ripening prior to termination of pregnancy or for induction of labor, nor does Searle intend to study or support these uses.”

You may be wondering why anybody uses it at all. This drug can ripen the cervix and/or induce labor. In the case of a medically indicated induction, many women have an unfavorable cervix, and the induction is likely to fail, thus necessitating a C-section. If Cytotec is used, and the cervix dilates and effaces, then the woman can have a vaginal birth and be spared a C-section. That’s a good thing. But at what cost?

Some doctors and even some midwives consider this benefit to be so good, and the risk of a ruptured uterus to be so slight, that they will use it. But isn’t that a choice for the patient to make? And shouldn’t the patient be given all of the information? That’s the simple idea behind “informed consent.” I will grant that most women do not have a problem with this drug. I will allow that most babies will survive with few negative sequelae after a Cytotec induction. But these are choices that the mother must make, weighing all the risks and benefits.

Here is a link to Ina May Gaskin’s website, where she has compiled a summary of articles about Cytotec’s use in labor. It has been quite some time since I’ve read it, but I remember that at least one trial was stopped because of the high rate of uterine ruptures in women who had had a C-section. I hope that if you’ve had a C-section, that your doctor will not use this drug on you, but he is legally allowed to use the drug any way he sees fit. The contraindication warning of this drug to pregnant women does not make it illegal to induce a woman with this drug.

In addition to the above article, here are some more true stories of women who have had negative outcomes from the use of this drug. No drug is 100% safe–not even Tylenol. When the benefit outweighs the risk, it makes sense to use it. But it is up to the person who takes the drug to decide the benefit-risk level.

This woman was induced for her 6th birth, and ended up nearly dying from a uterine rupture.

Here is a link to an investigative report that aired in Nashville, about the potential dangers of Cytotec.

Here is a link to a story that aired on CBS news a few years ago.

There are many other stories I could share, but I will let you conduct your own internet searches. The known disastrous side effects are rare but extremely serious. If you believe that Cytotec/misoprostol/miso should not be used on you, then you should discuss this with your doctor or midwife and have that in writing. Some of the doctors and nurses who have talked about this drug have such cavalier attitudes toward it that they may give it to you without even telling you what they’re doing, or giving you an option. But it’s your body, your baby, and should be your choice.

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