Opposing Views on Cytotec (Miso, misoprostol)

Recently, two of the blogs I read have posted opposite conclusions regarding the safety of Cytotec as a cervical ripening and/or induction agent. First, A Midwife’s Tale voices the pro-Cytotec opinion (obviously, within reason — not on women with a uterine scar, and at low doses); secondly, Science & Sensibility voices the anti-Cytotec opinion. I put them both up so you can see what has been said for and against it, and you can leave comments on either site if you have any questions about it.

On a side note, it is interesting that even though they cite the same studies (both mention the Cochrane Database, for example), the conclusions are anything but the same. Which is a lesson in how one’s views colors or biases how you look at the data. This has ramifications far beyond birth or studies, but life — look at politics, as an example of how opposing sides can take the same facts to each bolster their own argument and tear the other down. Interesting how that works, sometimes.

Some people have noted that home-birth and natural-birth advocates will point out the possibility of a uterine rupture with Cytotec, playing up the danger of its use, while downplaying the possibility of uterine rupture with VBACs. Perhaps it is hypocritical — however, repeat C-sections have risks of their own both to the mom, the baby, and any future babies; and often the “risk” of not using Cytotec is merely avoiding a non-medical induction. Sometimes inductions are necessary, but of course, often they’re not. Cytotec is introducing an artificial risk into a natural situation; whereas VBAC is a natural process that only an artificial surgery can circumvent. That is a difference. To me, anyway. Vaginal birth is not an intervention; Cytotec is.

I like what the Science & Sensibility article emphasizes:

ACOG STATEMENT: “No studies indicate that intrapartum exposure . . . has any long-term adverse health consequences to the fetus in the absence of fetal distress [emphasis mine]. . . .” (p. 387).

FACT: Well, that’s the catch, isn’t it? The long-term adverse health consequences to the fetus occur in the presence of fetal distress subsequent to uterine rupture…

So, as long as the Cytotec doesn’t cause fetal distress, it doesn’t seem to hurt the baby in the long-term. But how often does it cause fetal distress? I mean, “as long as your baby doesn’t drown in the bathtub, leaving him alone in the tub doesn’t cause any harm.” But how many times will the baby drown without competent adult supervision? I might also say, “In the absence of fire, an electrical short doesn’t seem to cause long-term adverse consequences”; “As long as it doesn’t hit you, lightning doesn’t seem to hurt you”; “As long as you’re not in a car wreck, seat belts don’t help to keep you safe.”

Both blog posts I linked to include multiple study references and/or links, so you can do your own research and reading. For my part, I still don’t like Cytotec — especially as it’s being used and overused. If interventions only happen with the risk of doing nothing outweighed the risk of doing something, then that would be one thing. But they’re not. You don’t have to read very far — birth blogs or birth story websites or just among your friends, family and coworkers — to find stories of women who got unnecessary interventions. And when they’re used when they’re medically unnecessary, then it only serves to introduce medical risk without the corresponding benefit. If, for example, a woman is electively induced then any induction method introduces risks, whereas the “risk” of doing nothing is… nothing. If a woman does need to be induced — for example, if the baby isn’t moving much and seems to be compromised, or she has pre-eclampsia or something — then there is a risk if they do nothing which is greater than the risk involved in doing something.

Finally, let me emphasize that the midwife at A Midwife’s Tale is not a “medwife” — she recently said she has a 6% or less C-section rate, which I don’t think would be possible if she were inducing unnecessarily or otherwise intervening too much. Also, my second midwife (a CPM) liked Cytotec, and thought it helped save some of her mamas from otherwise-certain C-sections. So, Cytotec is a controversial topic, but not everyone who is pro-Cytotec is anti-home/natural birth, nor a medwife.

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Uterine rupture with an unscarred uterus

A previous post (and comment), led me to investigate this topic further. I’d heard of previous C-section scars giving way; and I’d heard of uterine rupture in the case of labor induction or augmentation; but I’d never heard of an unscarred uterus rupturing.

This study talks about it. Unfortunately, it is just an abstract, so I’ve got a few questions which I’m sure could be answered if I had access to the full study. Oh, well. It identified 13 ruptures in an unscarred uterus, and says 3 were caused by car wrecks, and were excluded from the study; oxytocin was used in 4 cases; prostaglandin in 3;  vacuum or forceps in 3; 2 were in women who were grand multiparas; and 2 had fetal malpresentation. It gave a rate of 1 uterine rupture in an unscarred uterus per 16,849 births. Questions I have include whether all of these ruptures were complete, or if some were dehiscence; and whether any of the women with an “unscarred uterus” had any prior uterine surgery (including a D&C, which carries with it a slight possibility of a punctured uterus). I’m assuming that all of the ruptures were complete, considering that in the study discussed in the previous post, all three uterine ruptures in unscarred uteri were complete. Of those three, two occurred in women with prior D&C, but one said she had had no prior uterine surgery.

The numbers above add up to more than 10, though, so I can’t tell from the abstract whether or not obstetric intervention was used in all of them, or if some women had both oxytocin induction or augmentation and forceps removal of the baby. It’s seems reasonable that the babies that were in a poor position were also more likely to have induction of labor or vacuum/forceps use, since such women tend to have longer and slower labors (probably the contractions help to guide the baby into a better position if given enough time; but many hospital and/or doctor protocols don’t allow that much time).

Moving along, there is this tantalizing abstract which talks about a woman whose uterus ruptured after misoprostol was used to induce labor at 29 weeks (for an intra-uterine fetal demise). It says it includes “a review of all cases of uterine rupture with misoprostol induction,” which I’d like to be able to see. There were numerous other case studies and reports of women who suffered a ruptured uterus with second-trimester abortions, typically associated with misoprostol use, sometimes with a previous C-section.

Here’s a second-trimester rupture due to placenta percreta (the placenta grew not just into the uterine lining which is normal, but through the uterine wall).

Here’s one due to fundal pressure (when the mom was pushing, somebody pressed on the top of her uterus, to “help” her push her baby out). The World Health Organization relegates this to “Practices for which Insufficient Evidence Exists to Support a Clear Recommendation and which Should be Used with Caution while Further Research Clarifies the Issue.”

This case was extremely interesting, in that the researchers said, “To the best of our knowledge, this is the first documented rupture of a gravid [pregnant] uterus occurring before onset of labour without previous risk factors.” The woman denied having a D&C or any previous abortions, didn’t have any uterine malformations or anything which were known risk factors. She went to the hospital at 32 weeks gestation because of sharp abdominal pain. Quite interesting, especially since it gives a short summary of various risk factors that other reports and studies have not mentioned. Mother and baby were fine.

This study from Ireland noted a rupture rate in unscarred uteri at 0.02% (8 cases out of more than 48,000 women who had had a previous pregnancy, not counting 0 cases out of nearly 28,000 first-time moms). But there is this case study in which a first-time mom had an unexplained uterine rupture.

This woman from California had her uterus rupture during second-stage labor (pushing), which was blamed on the rate of oxytocin (Pitocin, “Pit”) for labor induction. The researchers noted that despite having contractions every 2-3 minutes, the rate kept being increased during first- and second-stage labor. Although an emergency C-section was performed, the baby had signs of asphyxia.

So, rupture of an unscarred uterus can happen but is blessedly rare, especially when drugs used to induce or augment labor are avoided.

Misoprostol taken without doctors? NO!

This post is inspired by a search term somebody used to find my blog. I hope they found what they were looking for; but just in case, let me be crystal clear in this post:

Misoprostol can be a very dangerous drug to a pregnant woman and her baby.

Used early in pregnancy, it can induce a miscarriage or abortion; the further along in pregnancy a woman takes it, the greater the risk of negative sequelae, like uterine rupture, retained placenta, and postpartum hemorrhage. All of these things, if left untreated, can kill a woman. Even if they are treated, the woman can be left with long-term consequences. For instance, a uterine rupture may necessitate a hysterectomy; a retained placenta can cause heavy blood loss and/or infection; postpartum hemorrhage is by definition a heavy blood loss. Have you ever given a pint of blood as a blood donor? One time I did, I was dragging around all day, from the loss of one little pint of blood. Imagine losing a quart! (Or possibly more.)

The use of Cytotec (misoprostol, “miso”, the “little white pill”) may be beneficial in some select circumstances — in fact, may be preferable to a D&C for miscarriage, for instance. But in my opinion, it should never be used without medical attendance — the potential side effects, though rare, can be deadly. I know some home-birthing midwives will use Cytotec and don’t see a problem with it. I think that’s dangerous. If the uterus becomes hyper-stimulated at home, and the baby can’t handle the oxygen deprivation, or if the uterus splits in two due to the hard contractions, what can be done at home? Can they make it to the hospital in time? Will the hospital be prepared to react the second the woman enters, or will it be another 30 minutes until the O.R. can be prepped?

I rather suspect, however, that the person who was searching for that information was actually wondering about it for use in an abortion. If this applies to you, I will say this to you: Don’t do it! It doesn’t work all the time anyway, can damage the baby if it doesn’t work, and damage you even if it does successfully kill the baby. Go to RealChoice for some stories about women who have died following abortions even under medical care — women whose symptoms of infection, retained products of conception, postpartum (or rather, post-abortion) hemorrhage went undetected or ignored by doctors. If you are wanting to induce an abortion so that your family or friends don’t find out that you are pregnant, and you end up with one of these dangerous and potentially deadly events, they won’t know you’re even sick, or what to do. If you do have a problem, and they take you to the hospital unconscious from lack of blood, they may not know what the problem is, or be able to take the proper steps in time to save your uterus, or even your life.

I think that taking misoprostol is playing with fire anyway, but to do so without any medical supervision is just plain dumb!

I hope I wasn’t unclear.

R – E – S – P – E – C – T

It’s more than the name to a catchy tune. In real life, it matters quite a bit. Unfortunately, so many people just don’t get it. That’s not an intentional pun, although it could be a play on words: many people don’t understand that despite their education and training and knowledge, they still need to treat others with respect; and many people do not get the respect they deserve.

Let me give you an example.

My sister had an abnormal Pap. A nurse at her gynecologist’s office said she had to have a certain procedure — no ifs, ands, or buts — no other options. My sister fired her gynecologist — the doctor who had attended the births of her last two children — because of this basic lack of respect. She went to her family doctor (who had had training in obstetrics and gynecology, but practices family medicine because it is less hazardous to his malpractice insurance costs), and while he came to the same conclusion, he did it in a different, more respectful way. Had the gynecologist’s office practiced this way, she would have remained with him. The family doctor explained the reasons why she had to have this procedure — what it did, why there really was no other procedure for an alternative, etc., etc. Since she felt she had full information, she had no problem with submitting to this necessary procedure. She accepted it from a doctor who was respectful of her, but refused it from someone who just expected her to be a good little girl and follow orders without question.

Inductees in basic training learn how to follow orders without question. They learn how to be subordinate; to do as told. They are dressed uniformly, as a part of the “breaking down” process in order to act uniformly. While these actions and this behavior are perfectly suited for the military (their lives, and the lives of their comrades may be lost by hesitating at a command given by a superior), is that what birthing women are supposed to act like? Allowing the doctors and nurses to think for them? Never to question the opinion of the medical establishment?

I was made to think along these lines, not simply because of my sister’s experience, but because of a recent commenter’s story. She had had a miscarriage, and the doctor told her she had retained products of conception, and the only choice she had was for an emergency D&C. She ended up with Asherman’s Syndrome, and impaired fertility. She asked about alternatives (including medications) and was told her only choice was a D&C. She tried to get a second opinion, but no gynecologists would make time for her, saying the earliest appointment was some months future. Although she didn’t want to have the surgery in which the walls of her uterus would be scraped with a knife — wanted to miscarry naturally or take a pill to complete the miscarriage — she was given no alternative, so submitted to the D&C, which took away her ability to have a child. She was not told of that possibility at the time of the operation.

Why did the doctor treat her like that? Although I haven’t read a whole lot about miscarriages, use of medications (such as misoprostol or mifepristone) to complete a miscarriage, D&Cs, etc., I read up on the subject while discussing it with this woman. Apparently, misoprostol is most effective (with the least side effects) in the first two months of pregnancy; and the further along in pregnancy a woman is, the less effective it is. It’s possible that her doctor took it upon himself to decide that in her case, the medication would not work, and she would end up needing a D&C anyway, so issued an edict that she just have it. But that wasn’t his call to make — it was hers! It was her uterus, which ended up being scarred! It was her body, not his, which cannot now bear children (unless surgery to remove the adhesions is successful in her case).

Although I may have some of the particulars wrong — I’m not a gynecologist, and as I said, only have passing knowledge in this area — this is what I envision could have happened, had her doctor been respectful: “Mrs. Smith, I regret to tell you that your baby has died. From the ultrasound, it looks as if the baby stopped growing a few weeks ago. We can wait, to see if you will miscarry naturally, but the risk of infection goes up the longer it takes for the pregnancy to pass. You can take these pills, which may induce a miscarriage, but at your stage of pregnancy, there is a slight risk of uterine rupture, and the pills may not work. I’m recommending a D&C — a procedure in which we artificially dilate the cervix and scrape the walls of the uterus with a curved knife, to remove all of the products of conception. The risks of this procedure include [fill in the blank, including telling her about Asherman’s syndrome, and the risk of infertility]. The longer the time from fetal demise until we do the D&C, the more likely you are to get Asherman’s syndrome. Since the pills may not work, and you may not miscarry naturally, I’d like to do a D&C, so that we can reduce both the risks of infection and of having to do the D&C at a later date.”

I’m not suggesting that D&C is the way to go, by any means! In fact, I rather suspect that D&Cs are much overused, just like C-sections, episiotomies, and hysterectomies. These are old, well-established procedures, and many doctors are trained to use them as the first resort, or as a sort of cure-all. Any female problem can be solved by removing the uterus, right?, so why not just take it out at the first sign of trouble? Except that a hysterectomy is not easy on a woman — the surgery takes weeks of recovery, and the sudden removal of the female organs plunges a woman overnight into full-blown menopause. (The term “hysterical” is derived from “hysterectomy”, to describe women who had undergone that procedure and had periods of apparent uncontrollable emotions.) Nor does a hysterectomy solve all female problems: by removing the uterus the source of one problem may end, only to have the lack thereof lead to other problems. There is disagreement and ignorance about the full roles that female hormones play — every year it seems that some new study is released with a flourish proving the benefits of hormone replacement therapy, only to be contradicted the next year by a study showing that HRT leads to this or that risk — the risk of one cancer may be reduced, only to have the risk of another cancer increased, for instance; or the risk of some already rare cancer is reduced but the risk of osteoporosis is greatly increased.

With all the confusion and uncertainty, it is all the more important for women to be given full knowledge of all the known risks and benefits of all courses of treatment, and not just the doctor’s favorite treatment, or what is most commonly done. What might be right for one woman may not be right for another. It’s your body; know your options; demand respect.

A near-death experience, courtesy of Cytotec

When independent childbirth educator Nicole D. was pregnant with her first child, she consented to an induction when she went nearly two weeks past her due date. Although she said she was “naive and unprepared,” she did know that she most certainly did not want Cytotec (a.k.a. “misoprostol”, “miso” or “the little white pill”) used on her. Her doctor was in agreement with her, saying he never used it. Unfortunately, the doctor who was at the hospital when she went in to be induced did use it — against her express wishes, and without informing her that he had done so.

Read the rest of her story here.

For more information about Cytotec, please visit the Tatia Oden French Memorial website. Tatia Oden French was induced with Cytotec when she went past her due date, and both she and her baby died. Her mother vowed, “That drug is going to go away.” You can read more about her efforts here.

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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