Is Cytotec still used for induction? - Page 2 - Mothering Forums

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#31 of 54 Old 05-01-2009, 08:15 PM - Thread Starter
 
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Alexis T, I'm from England, but live in Baltimore now. There are lots of things that are done differently over there!
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#32 of 54 Old 05-01-2009, 08:56 PM
 
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Yep, I had my daughter there.

DD 01/2007, DS 09/2011

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#33 of 54 Old 05-01-2009, 10:15 PM
 
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I was being threatened w/ induction before I thankfully went into labor naturally w/ my 7 week old DD. This drug was the first one my OB mentioned when the discussion happened (I'm in SC, USA).
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#34 of 54 Old 05-02-2009, 12:41 AM
 
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I met a first time mom once who was planning a natural birth with a respected CNM practice which is known for being hands off. They induced her with cytotec because she reached 41 weeks and they had lost a baby once at 42 weeks. No pitocin, only two doses (I'm not sure the amount) of cytotec. Two hours after her induction began her son was born by emergency cesearean and she had to have a blood transfusion. I don't know all the details of her story but she was a bit shocked by her traumatic birth.

"Two hours after her induction began" meaning two hours after the second dose and 6 hours after the first?

I'm willing to bet dollars to donuts that it was a 50 mg dose given four hours apart.

Why should cytotec not require continuous monitoring? Especially since it can't be turned off like pitocin once its started.

After oral administration, miso peaks in plasma in 12 minutes and has a 20-40 minute half life. If any hyperstimulation or fetal compromise will happen, it will happen in the first hour. Pitocin is a continuous infusion. In the above studies, women first got an NST, then got miso, then were monitored for anywhere from 1 to 4 hours before being sent home.

I for one would not go to any birth center where it was used for cervical ripening.

You wouldn't go to one, or you wouldn't choose to use cytotec if given the option? Because making that kind of sweeping judgement based on the clinical decision making of other professionals, and on the women who accept it who make an informed decision, seems a bit harsh. They don't us it willy nilly, they use it as a last resort, when all other methods have been tried, with very informed consent, on carefully selected women. They're not giving it to women on the sly or slipping it into their water. If it were offered to you, you wouldn't have to take it.

Please understand I'm not sending any fruit your way, but enjoy discussing this with you. You said that your collaborating doctor will not let you use cytotec. Why is this? Its obvious that you've done a lot of research on this topic but do you have any personal experience administering this drug? Please share, I appreciate your perspective.

I equally appreciate that this discussion is happening, and that it is happening in quite a civil manner. I haven't talked much with my doctor about it, but I'm guessing she had some sort of bad outcome from it.

My experience with it was an interesting side by side. When I was in graduate school (late 90's), I still worked as a labor and delivery nurse. At the hospital where I worked, they gave 50 mg every 4 hours. These women didn't get induced, they were launched into orbit. Crazy precipitious labors, terminal bradycardias, forceps deliveries because of low fetal heart rates, c sections, and a few abruptions. It made babies come flying out at warp speed, and moms and babies were equally stunned.

Meanwhile, down the street, at the hospital where I did clinicals, they used 25 mg every 6 hours. They experienced few, if any, of the side effects happening at the other hospital down the street. It induced women very nicely, and few of them required pitocin.

Now, storm bride:

"One question. Would you tell your patients that there are warnings about it, and that use for induction is off-label...or would you just give it to them?"

I actually find this question quite offensive. My patients don't get so much as a blood test without understanding why they're getting it. I would discuss it with them, as I would any procedure. I would share my experience with them (described above), share my literature review with them, share how irresponsible use of it led to tragic outcomes and a bad reputation. I would also share the maker's contraindication.

(By the way, the reason for them doing that is directly because of the tragic outcomes. Putting the contraindication on their drug absolves them of responsibility in a lawsuit.)

Finally, I would offer for them to come to boards like this to read about how awful it is.

If, after all that, they come back to me the next day and want to use it, we would.


Again-cytotec is not the devil, overuse/overdose of it is.

Jennifer
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#35 of 54 Old 05-02-2009, 12:51 AM
 
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#36 of 54 Old 05-02-2009, 09:37 AM
 
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Originally Posted by jengacnm View Post
"Two hours after her induction began" meaning two hours after the second dose and 6 hours after the first?

I'm willing to bet dollars to donuts that it was a 50 mg dose given four hours apart.
No. It went exactly like I said. She had two doses (again I'm not sure of the amount of the dose) one hour apart and 2 hours after her first dose was given her son was born by emergency cesarean. This was less than a year ago.

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(By the way, the reason for them doing that is directly because of the tragic outcomes. Putting the contraindication on their drug absolves them of responsibility in a lawsuit.)
All drugs have some tragic outcomes when misused. Pitocin itself has had some tragic outcomes and it is approved for this use.

If this drug was as effective and safe as you (and these studies claim) then couldn't they stand to make a lot of money on this drug by researching it and proving it safe. I understand that Cytotec is dirt cheap because no research has been done on it by the manufacturer other than for ulcer research. And if they did studies regarding labor induction the cost of the drug would increase and they would be able to charge more for it.

One of the problems I see is that because both the FDA and Searle won't approve this drug for use there is no clear standard of use. There are no guidelines. Even though clinical trials have been done, differing practices use different doses throughout different timelines. You yourself have said this.
Quote:
My experience with it was an interesting side by side. When I was in graduate school (late 90's), I still worked as a labor and delivery nurse. At the hospital where I worked, they gave 50 mg every 4 hours. These women didn't get induced, they were launched into orbit. Crazy precipitious labors, terminal bradycardias, forceps deliveries because of low fetal heart rates, c sections, and a few abruptions. It made babies come flying out at warp speed, and moms and babies were equally stunned.

Meanwhile, down the street, at the hospital where I did clinicals, they used 25 mg every 6 hours. They experienced few, if any, of the side effects happening at the other hospital down the street. It induced women very nicely, and few of them required pitocin.
Perhaps most of the experience of the women shared here would be of the former group.

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After oral administration, miso peaks in plasma in 12 minutes and has a 20-40 minute half life. If any hyperstimulation or fetal compromise will happen, it will happen in the first hour. Pitocin is a continuous infusion. In the above studies, women first got an NST, then got miso, then were monitored for anywhere from 1 to 4 hours before being sent home.
Pitocin's Half life is 1-6 minutes once its turned off. Pitocin has to be an continuous infusion because it is metabolized so quickly. Source: http://www.drugs.com/pro/pitocin.html I am relieved to see that the women were monitored before going home. I read from your original post on the topic that women were just administered the drug and sent home to labor on their own for a while. That is why I expressed concern about it being used in birth centers for induction purposes. Thank you for clarifying this.

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#37 of 54 Old 05-02-2009, 09:40 AM
 
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#38 of 54 Old 05-02-2009, 10:01 AM
 
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Not a BP.

I was given cytotec to deliver our 2nd trimester stillborn son in 2005. I was given it by my midwives in hospital. I didn't ask any questions at all about it.

I was given cervadil for 38 week induction of my dd in 2006. I've actually been wondering in the last week what the difference is between the two and will now go do more research. Am hoping not to do an induction of any kind this time around, though!

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#39 of 54 Old 05-02-2009, 01:18 PM
 
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Oh Jengacnm, I can't just leave you all by yourself up here!

I think people are missing the point that there is a way to use Cytotec for induction judiciously, just like there is a way to use Pitocin judiciously. If we look to the past we can see that many of the same horrors that have happened with the use of Cytotec also happened when Pitocin was first introduced. Yes, it's terrible that women were used a guinea pigs for both of these drugs and many are still being used as such by uninformed practitioners - which is why we have all these terrible stories.

At this point in time, there is research available (as our friend Jengacnm summarized so nicely) that allows for the safest usage of Cytotec as an induction drug. The same goes for Pitocin - it too can now be used safely. Which doesn't mean that either don't carry risks. And yes, everyone should be provided with information on the use of either before consenting.

Many drugs are used off label. Many, many, many drugs that are commonly used in obstetrics also carry the same warning against usage in pregnancy - Fentanyl, for example.

Clinical Herbalist. Trained but never certified, licensed, or registered as a midwife.
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#40 of 54 Old 05-02-2009, 05:13 PM
 
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Originally Posted by Equuskia View Post
Actually, it's not off-label, it is contraindicated, right on the label, by Searle. They have also send "Dear Doctor" letters to discourage the use of cytotec in pregnant women.
The only reason it's contraindicated is because it can result in birth inducing contractions.

Another that can appreciate the judicious and well informed usage of this much misunderstood drug. I wish that there were a better larger knowledge base of it.

Non Practicing Midwife, going back to school! Mamma to my 3 loves, living each day to the fullest.
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#41 of 54 Old 05-02-2009, 06:33 PM
 
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I am reading this discussion with interest...jengaCNM I appreciate your summary of the available literature, scanty as it may be. I am a new CNM practicing in a hospital where our only options for induction are Cytotec or Pitocin (though our docs are currently trialing the double balloon Cook catheter). Having trained primarily in an out of hospital setting I am uncomfortable (secondary to my lack of familiarity) with pharmaceutical induction methods over all. Learning that my only option for cervical ripening was Cytotec has been unnerving. However, our practice DOES NOT offer elective induction prior to 42 weeks, ever, so the women that we are inducing are either 42+ weeks or have a true medical indication. I appreciate some discussion that can guide my consent process and decision making as a practitioner....will continue to follow along.

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#42 of 54 Old 05-02-2009, 10:25 PM
 
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Originally Posted by Belle View Post
If this drug was as effective and safe as you (and these studies claim) then couldn't they stand to make a lot of money on this drug by researching it and proving it safe. I understand that Cytotec is dirt cheap because no research has been done on it by the manufacturer other than for ulcer research.
The patent on Cytotec has expired. This is what makes it cheap. No drug manufacturer will do expensive research on a drug which can then be produced for pennies by a generic manufacturer, not when its use is so widespread anyway and sales will not increase.

There are numerous other drugs which have no official approval, despite longstanding use. There's no official approval to use magnesium sulfate in preeclamptics. Betamethasone is not approved for maturing the lungs of preterm babies. They work and they save lives, but they do not have FDA approval for these uses.

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#43 of 54 Old 05-03-2009, 01:59 AM
 
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The only reason it's contraindicated is because it can result in birth inducing contractions.

Another that can appreciate the judicious and well informed usage of this much misunderstood drug. I wish that there were a better larger knowledge base of it.
That's incorrect. From Searle themselves:

Quote:
WARNINGS
CYTOTEC (MISOPROSTOL) ADMINISTRATION TO WOMEN WHO ARE PREGNANT CAN CAUSE ABORTION, PREMATURE BIRTH, OR BIRTH DEFECTS. UTERINE RUPTURE HAS BEEN REPORTED WHEN CYTOTEC WAS ADMINISTERED IN PREGNANT WOMEN TO INDUCE LABOR OR TO INDUCE ABORTION BEYOND THE EIGHTH WEEK OF PREGNANCY (see also PRECAUTIONS, and LABOR AND DELIVERY). CYTOTEC SHOULD NOT BE TAKEN BY PREGNANT WOMEN TO REDUCE THE RISK OF ULCERS INDUCED BY NON-STEROIDAL ANTI-INFLAMMATORY DRUGS (NSAIDS) (See CONTRAINDICATIONS, WARNINGS and PRECAUTIONS). PATIENTS MUST BE ADVISED OF THE ABORTIFACIENT PROPERTY AND WARNED NOT TO GIVE THE DRUG TO OTHERS.

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#44 of 54 Old 05-03-2009, 10:14 AM
 
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Here's an older article by Marsden Wagner about the difference between "off-label" usage and "against-label" usage of Cytotec:

http://www.midwiferytoday.com/articles/cytotec.asp

Dr. Wagner also has an extensive discussion about Cytotec usage in "Born in the U.S.A." I recall in the book he mentioned that many hospital pharmacists refuse to give the (doctor-prescribed) smaller doses that require pill-cutting since it's apparently impossible to completely accurately dose a cut pill, and Searle (Pfizer?) does not make doses that some HCPs want.

I found this, but didn't peruse it fully. Looks like it's the page of a lawyer who specializes in Cytotec cases:
http://www.cytoteccase.com/

Anyway, if you're interested, under "Dear Doctor" you can read the letter sent by the Searle to OB/GYNs asking them to not give misoprostol to a pregnant woman.

That's my internet research for the day!
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#45 of 54 Old 05-06-2009, 12:39 PM
 
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My OB recommended cytotec to ripen my cervix at 35 weeks for induction of pre-e last year. I was given pitocin too though. I can't remember when I was given the cytotec. I'm guessing the night before the pitocin was started. I knew that cytotec carried some risks from reading posts on MDC. I talk to my doctor about my concerns and my only other option was cervadil (sp?) which I had for my first induction (also for pre-e) and it didn't do a darn thing for me. I wanted to have a pain med free birth and thought if I could get my cervix to ripen and dilate as much as possible before the pitocin started, I would have a better chance at acheiving that goal and avoiding a c-section. So I trusted my OB and went with the cytotec. My labor was really mild for the first 4 hours even with the pit. I agreed to let the OB break my water. That's when labor really kicked in and according to the nurse, the cytotec and pitocin were both causing me to have contractions at that point. They were trying to help me out and get the contractions to space themselves out but it didn't work. I felt like I was being squeezed and twisted in two so I got the epidural. It took away my back pain but didn't have time numb my legs or anything else before DD was born which was good. I just don't know what to do for baby # 3 who will also be born via induction most likely due to pre-e again. I didn't like the cytotec causing contractions and making my labor more painful. But at the same time, it was quick and I'm overall satisfied with how things turned out. I'm afaid to go back to using cervadil because it may not do enough for me and I could end up with a c-section which I absolutely do not want. I've got plenty of time to think about it and decide thankfully.
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#46 of 54 Old 05-06-2009, 01:11 PM
 
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there is an unfinished study of a delivery system for misoprostol a vaginal insert like the one used for dinoprostone- and here in town is one of the clinical sites for the phase III study- there are over 50 places inrolled in the study so probably many people are still using cytotec for induction.
there are also docs locally who just use the pills orally or vaginally at fairly high doses --
the 25mcg dose mentioned by jengacnm is not commonly done that way but I could see that it may be a reasonable compromise, post dates or PROM much higher likelihood of a vaginal birth instead of a c-section ---

by the way the phase III study is OK'd so is not truly "off label"use- it is used for study purposes
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#47 of 54 Old 05-06-2009, 10:16 PM
 
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I'm putting on my fruit-proof suit, too, to comment.

I do use Cytotec, rarely, for medical induction. Sometimes there are true reasons that pregnancy must be ended early - pre-eclampsia being the one I see most commonly. The studies jengacnm mentions are all for outpatient cervical ripening, there are many, many studies done on inpatient cervical ripening/labor induction as well.

While there are alternatives to Cytotec (and I use them sometimes as well) including cervidil and mechanical methods such as balloon catheters, cytotec does tend to be more effective. I choose it for the very unfavorable cervix with strong indication for delivery (so, for the 35 week severe pre-eclamptic, but not the 41 1/2 week elective induction.) Our hospital policy is 25 mcg vaginally no sooner than every 4 hours, maximum of 3 doses, and no pitocin may be used within 6 hours of a dose. Also, if for some reason pitocin is stopped and cytotec started, there must be at least 30 minutes between pit and cytotec. We also REQUIRE a specific consent form which clearly states that cytotec is not FDA approved for induction of labor, and spells out the risks/benefits.

Definitely not a drug to be used lightly, but I do think there is a role for cytotec. I would rather use a cervical ripening agent that is likely to be effective and promote a vaginal birth if possible. Of course if a client declines, that's that.
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#48 of 54 Old 05-07-2009, 09:49 PM
 
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Not a birth prof. but wanted to share my Cytotek experience. With my first baby, I was 42 weeks when the birth center where I was to deliver began to talk about sending me to a hospital for induction. A pitocin/cervadil induction with IV, CEFM, (and probably an epidural/emergency cesarean knowing I labored over 24 hrs and pushed for 3) At a hospital I had never visited and an OB I had never met. Basically the problem was they were not insured to attend a birth past 42 weeks, and so that was the problem--liability. I was very pro-natural birth and prepared to go late, but not prepared to find a backup care provider or plan a homebirth at 42 weeks. I had tried everything "natural"--accupressure, sex, castor oil, black and blue cohosh, I even consented to having my membranes stripped and my cervix manually stretched. The midwives at the birth center did some creative accounting and moved my due date back so that I wouldn't be "officially" 42 weeks until the following Tuesday.

At a checkup on a Friday (when I was 42 weeks 2 days) I consented to have 25 mg. of Cytotek inserted vaginally. I knew all about the drug and its risks. Basically, what we discussed was it was a small dosage (they manually quartered the 100mg pill) and I was to stay in close contact with them throughout the evening for ANY change. I accepted this intervention, knowing full well the risks, because
1) the data do show some increased risks for babies somewhere past 41ish weeks. . .not huge but still, enough that I was becoming concerned that the risk of waiting was becoming even or equal to the risk of intervening in some way to encourage labor. (now I know so many 42+ week women IRL and online I probably would not feel the same way)
2) I was very fearful of the hospital induction scenario. They actually called and scheduled me for an 8:00 Tuesday a.m. check-in for my induction. My midwives wouldn't be there, I didn't have a doula. . .I didn't even KNOW a midwife who did homebirths. . . I had no experience or wherewithal at that time in my life to pursue a UC or a homebirth--I would NOW, but I was not at that place in my life.
3) The amount was small and I was told that if it would work, it would work quickly. . .that it wouldn't kick in later over the weekend when I was on my own.

Well, it did absolutely nothing. No change to my cervix or dilation, no increase in contractions (just the same old BH) It was inserted at around 5pm on a Friday and my labor didn't even begin until very late Saturday night (close to bedtime, over 24 hrs later) I did not have a hard, fast Cytotek labor, rather, a pretty typical first-time labor, where I stalled at a 4cm on Sunday, went home, had dinner, and things picked back up overnight, by Monday 5am I was 10cm and had 3 hrs. of pushing. . .delivered by 8.
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#49 of 54 Old 05-08-2009, 04:23 AM
 
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I was also induced w/Cytotec in 2002. I was 36w and had very low amniotic fluid (according to my records, it was 3.09) and was already in the hospital on bedrest. My midwife and her accompaning OB both suggested Cytotec as a way to ripen my cervix since it was determined that I needed to be induced. They did a dose vaginally (don't know the dose) which did cause me to have some contractions and did help ripen the cervix, though by the next morning I was put on Pitocin to get my contractions regular.

It did work out for me, I am happy with the outcome as I was able to have my son naturally and I feel it helped me avoid a c-section by starting my labor enough so that I could finish it KWIM?

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#50 of 54 Old 05-08-2009, 05:40 AM
 
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I was induced with Cytotec in 2002, with my first son. The hospital in Germany first gave me Pitocin IV for 48 hours, which didn't do a thing as I was 0% effaced - it only messed up my blood count. On the fourth day, they gave me two dosages of Cytotec 8 hours apart and the contractions were HELL. I refused to take drugs/ pain relief because I really wanted a normal birth, and I knew that an epi would probably lead to even more complications - the consultant was already pushing me to have a c-section anyway. It was absolutely awful, I was in excrutiating pain for 8 hours, vomitting, shaking. I suffered from serious birth trauma.
I just had my second son 6 months ago, at home in water, and I cannot even begin to describe the difference - I had hardly any pain (opposed to the Cytotec contractions that I literally thought would tear me apart and kill me) and an easy 4 hour labour. Cytotec is the devil. Our bodies know what to do if they are just left in peace to do their work; don't interfere!
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#51 of 54 Old 05-08-2009, 11:17 AM
 
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See, I'm not a fan of using cytotec for elective inductions, or for times when there is no urgency. But I have to disagree that "Our bodies know what to do if they are just left in peace to do their work; don't interfere!" for every woman, every pregnancy. Sometimes there are true medical reasons to end a pregnancy early, and cytotec is one tool that can be used - of course with consent and complete explanation of the options.
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#52 of 54 Old 05-08-2009, 12:06 PM
 
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Originally Posted by doctorjen View Post
See, I'm not a fan of using cytotec for elective inductions,
Does that mean you are a fan of "elective inductions" in general?

"Elective" as in - I feel perfectly fine, pregnancy is progressing perfectly fine, I'm just "tired of waiting" or "I want to schedule the date"?

Do you induce in those cases?
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#53 of 54 Old 05-08-2009, 12:40 PM
 
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I am not a fan of elective inductions at all. The thing is, I'm a lone voice crying in the wilderness here, and it's darn difficult to outright refuse to do them when every other doc for an hour in every direction does them without concern. I will not do an elective induction prior to 40 weeks, and not without a favorable cervix, but I do them. I don't offer them, either - but believe me, the grand majority of my clients are definitely bringing it up themselves. I always counsel about the increased risk of cesarean (double for a first time mom!) and risks of longer, harder labor, more stress to baby, etc, and that does convince quite a few people to wait. But there are a lot of folks who are adament that they understand the risks and just cannot for whatever reason stay pregnant, so I do an occasional elective induction.
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#54 of 54 Old 05-08-2009, 01:46 PM
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Ok so not a huge fan of Cytotec before, and not a BP but nothing I have read here as convinced I want to be anywhere near Cytotec.

Understanding of course that every woman is different and there is real need for induction with some women, I guess I would rather have an IV of pitocin that I know could be turned off immediately than a pill in my vagina that may or may not have been dosed correctly because it had to cut up to be used in the first place.

Scary stuff all around really.
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