NOTE - Much of this material is from several
years ago, mostly before 1998. Since then, lots more
research has been done, and some good summary articles have been
written.
Please pay attention to the dates of the
references articles!
By Betsy Bates, 6/19/09
"The modification of the oxytocin infusion protocol at a large
university-affiliated community hospital nearly halved the number
of emergency cesarean deliveries over a 3-year period, reported
Dr. Gary Ventolini.
. . .
“More and more data are showing us that we are using too much
oxytocin too often,” Dr. Ventolini, professor and chair of
obstetrics and gynecology at the university, said in an interview.
Study
Finds Adverse Effects of Pitocin in Newborns [ACOG,
5/7/13] - "Induction and augmentation of labor with the
hormone oxytocin may not be as safe for full-term newborns as
previously believed . . . These results suggest that Pitocin use
is associated with adverse effects on neonatal outcomes. It
underscores the importance of using valid medical indications when
Pitocin is used.”
"But overall, women randomized to oxytocin discontinuation had longer labor, as Dr. Joanne N. Quiñones, senior author of the report, noted in email to Reuters Health. They also had a higher risk for chorioamnionitis related to intrauterine pressure catheter (IUPC) use and duration of membrane rupture."
This is great news for women in situations where induction is medically advised but who want to avoid unnecessary drugs. Obviously, allowing the body to drive the rhythm of labor is going to take longer than adding additional oxytocin in the form of pitocin. Risks associated with rupture of membranes and IUPC can be avoided by not rupturing membranes artificially and not using the IUPC. The IUPC may be necessary when pitocin is used to augment active labor when there is a lack of progress without it. But it shouldn't be necessary when pitocin is used just to get labor over the threshold into active labor.When Research is Flawed: Can You Prevent Cesarean Sections by Inducing More Labors? by Henci Goer
Commentary on: Nicholson, J. M., Yeager, D. L., & Macones, G.
(2007). A preventive approach to obstetric care in a rural
hospital: Association between higher rates of preventive labor
induction and lower rates of cesarean delivery. Ann Fam Med, 5(4),
310-319. [Abstract]
Amniotic-fluid
embolism
and medical induction of labour: a retrospective,
population-based cohort study.
Kramer MS, Rouleau J, Baskett TF, Joseph KS; Maternal Health Study
Group of the Canadian Perinatal Surveillance System.
Lancet. 2006 Oct 21;368(9545):1444-8.
INTERPRETATION: Medical induction of labour seems to increase the
risk of amniotic-fluid embolism. Although the absolute excess risk
is low, women and physicians should be aware of this risk when
making decisions about elective labour induction.
Metabolic
acidosis
at birth and suboptimal care--illustration of the gap between
knowledge and clinical practice.
Jonsson M, Nordén-Lindeberg S, Ostlund I, Hanson U.
BJOG. 2009 Oct;116(11):1453-60. Epub 2009 Jul 28.
CONCLUSION: Metabolic acidosis at birth is often associated with suboptimal intrapartum care. The high rate of suboptimal care with regard to oxytocin use and fetal surveillance illustrate a gap between guidelines and clinical practice. Metabolic acidosis and related neonatal morbidity could potentially be prevented in 40-50% of cases. The adherence to guidelines must be checked. [Ed: These conclusions are a little vague that many cases of suboptimal care were really hyperstimulation associated with pitocin.]
Response from a hospital-based midwife:
Although this is not news to many of us, it is always a good thing to review and remember the possible outcomes of the mismanagement of Pitocin and the importance of due diligence when it comes to abnormal tracings. Our hospital has revamped their Pitocin Protocol and it is possibly in response to research like this. They are suggesting increasing the Pitocin dose up and stopping at 6 milliunits, whereas before we would go up to 24 and then the nurses ask for an order to go up to 30.
So this is a huge change based on research like this but also I suspect on research that states there is no need to go higher than 6 mus in order to create cervical change. The nurses can still increase the dose depending on the uterine activity but it does stop them pushing up the dose beyond what the uterus needs.
[Ed: Yes! It makes sense to nudge the pitocin up just to
the level where cervical change is occurring. The original
meaning of induction was to get the level of pitocin just up to
the point where the woman's body would take over to keep labor
going. We need to go back to this model to reduce
complications of hyperstimulation from pitocin overuse.]
Women Induced in Morning Require Fewer Interventions [Medscape is free.]
Morning
compared
with evening induction of labor: a nested randomized controlled
trial.
Dodd JM, Crowther CA, Robinson JS.
Obstet Gynecol. 2006 Aug;108(2):350-60.
With routine induction on the rise, we are also seeing an increase of babies who are presumed to be mature enough to be born but are actually premature at birth and need intensive care to survive.
How can this happen with good dates from early ultrasound? Simple. Not all babies have a standard 40-week gestation. Some will appear "term" at 37 weeks, others not until 44 weeks. This is normal biological variability similar to the different timetables for babies cutting their first teeth, taking their first steps, or speaking their first words.
Genetic heritage has
a huge effect on a baby's natural gestation length.
Induction of
labour - Excellent Patient Education from Kent Midwifery
Practice in the UK (Kay Hardie and Virginia Howes)
This is a good critique of the classic multi-center study that is
often used to justify induction, and which is now so old that it
is inappropriate as a basis for such a serious intervention.
LEGAL ISSUES AND RISK MANAGEMENT: Best Practices in Perinatal
Care: Evidence-Based Management of Oxytocin Induction and
Augmentation of Labor
Laura R. Mahlmeister PhD, RN
Journal of Perinatal and Neonatal Nursing
October/December 2008
Volume 22 Number 4
Pages 259 - 263
The
Seduction
of Induction - excellent slideshow from Penny Simkin.
Four
Parameters Predict C-Section Risk After Induction of Labor -
British researchers have devised a model incorporating maternal
body mass index, height, cervical length on transvaginal
ultrasound and parity to predict the risk of cesarean section
after induction of labor.
Induction Dangers, Compiled by Leilah McCracken for
birthlove.com, a subscription site that is well worth the small
cost! [Ed: birthlove.com is not available at this time.]
CONCLUSION: Compared to routine induction at 42 weeks, induction at 41 weeks is associated with a significantly higher risk of use of medical interventions and associated complications, with no observable benefits.
The following information is from Volume 3, Issue 3 of Research Summaries for Normal Birth, July 2006, from the Lamaze Institute for Normal Birth:
Summary: This retrospective study compared outcomes of “post-term” pregnancies occurring when a hospital protocol required induction at 42 weeks with those occurring after the protocol was changed to require routine induction at 41 weeks. Prior to the protocol change, a routine cardiotocogram (non-stress test) was performed at 41 weeks and if normal, induction was scheduled at 42 weeks. The hospital was a university-affiliated obstetric unit in Hong Kong performing over 5000 births per year.
Routine induction of labor at 41 weeks only reduced the mean gestational age at delivery by 3 days while more than doubling the rate of labor induction in women at or beyond 41 weeks of gestation. The average length of labor was significantly longer, and use of epidural analgesia was significantly more common among “post-term” women after the protocol changed. There were no differences in maternal characteristics, mode of birth, or newborn outcomes across the two groups. Outcomes were unchanged when the researchers repeated their analyses controlling for parity.
Significance for Normal Birth: Complex hormonal signals between baby and mother allow labor to begin on its own. While this may happen for many women up to two weeks (or more) after the estimated due date, many care providers believe that routine induction at 41 weeks is associated with improved perinatal outcomes. This assertion is based on previous research that may be critically flawed.
This retrospective study is not big enough to detect differences
in rare adverse maternal and infant outcomes, but it provides
compelling data that suggest that inducing labor at 41 weeks is
associated with very high rates of obstetric interventions. Use of
pharmacologic induction agents and epidural analgesia became much
more common on this obstetric unit once the clinical protocol
began requiring induction of labor at 41 weeks. Labor was also
considerably longer when induction was required at 41 weeks,
compared with labors occurring at the same hospital prior to the
protocol change. The trade-off of such excessive intervention was
a mere 3-day difference in the average gestational age at birth.
Women facing induction at 41 weeks need to know that waiting just
a few more days will likely allow labor to start on its own and
help avoid potentially harmful interventions.
Routine
induction
of labour at 41 weeks gestation: nonsensus consensus. [Full
text] [Ed: birthlove.com is not available at this time.]
Menticoglou SM, Hall PF.
BJOG. 2002 May;109(5):485-91.
Evaluation
of
glyceryl trinitrate, misoprostol, and prostaglandin E2 gel for
preinduction cervical ripening in term pregnancy
Yuthika Sharma, Sunesh Kumar, Sunita Mittal, Renu Misra and Vatsla
Dadhwal
Journal of Obstetrics and Gynaecology Research
Volume 31 Issue 3 Page 210 - June 2005
Conclusion: The findings of the present study suggest that GTN is
safer, but less efficacious, compared with prostaglandins for
preinduction cervical ripening at term. [Ed. Perhaps
repeated applications of the safer GTN would ultimately be as
effective as a single use of prostaglandins?]
Conclusion Nulliparous women [i.e. women having a first baby] are
at a significant increased risk of cesarean delivery if elective
induction is performed. The individual physician has a
contributing effect to this increased risk.
Labor
induction
with dinoprostone or oxytocine and postpartum disseminated
intravascular coagulation: a hospital-based case-control study.
De Abajo FJ, Meseguer CM, Antinolo G, Garcia Rodriguez LA, Montero
D, Castillo JR, Torello J.
Am J Obstet Gynecol. 2004 Nov;191(5):1637-43.
CONCLUSION: The pharmacologic induction of labor is associated
with an increased risk of postpartum DIC, regardless the substance
used. Although the absolute risk seems to be quite low, the
obstetricians should not neglect it, in particular for the special
risk groups identified [a maternal age older than 34 years (AOR =
9.5; 95% CI: 2.4-37.7), complications during pregnancy (AOR = 5.5;
95% CI: 1.3-22.8), and a gestational age of over 40 weeks (AOR =
3.5; 95% CI: 1.1-11.1)]
Births
by
Day of the Year - a panel chart below showing data for the
period from 1 November of one year through 31 January of the
following year.
I am about to pull my hair out here with what seems to be an INDUCTION EPIDEMIC.
In the past year I have had eight doula clients; six were induced. If my memory serves me correctly, only one of these inductions was truly needed. Most of my clients are middle-class women who "want to go natural and avoid an epidural but will get one if they really can't handle it." They know enough to want to hire a doula, but aren't really "earth mommas" Here's how things went:
There seems to be an induction epidemic here too! I tell all of
my clients about Bishop scores and ask them to ask their doctor
what their Bishop score is when they bring up induction. Then I
direct them to the online Bishop score tool at childbirth.org
where they can read for themselves their likelihood of having a
successful, non-interventive birth. I also give them the article
"Let the Baby Decide" and some info on natural induction methods
to try getting their cervix ready IF there is a medical indication
for induction-which is rare.
What make me SO MAD is when docs induce and even I know it isn't going to work and you can see hours and hours of work and pain from the crazy ctx and they just keep letting it go as if it is normal.
I seriously am ready to tell clients that if their Bishop's score
is unfavorable and they are not willing to wait, they just need to
save themselves the trouble and schedule a c-section!!!!
I started taking a tough-love approach and I say over and over again:
You have been pregnant for 280 days so far, give or take. Labor and Delivery is the natural conclusion to this state and it is up to you and your baby to finish the job when your body and baby tell you to. This body and baby know on a cellular level how to birth and be born--they are tied up in an intricate dance of the most graceful kind. Do you really want to interrupt what has been working so well for all of these months?
I know you're tired, I know you feel like an elephant, I know you are ready to look like a mom who has a baby in her arms. But what you are doing now is the ultimate act of motherhood--you are honoring your child's needs by letting her do this at her developmental level. Although we say a child should be reading and writing comfortably by the winter of 1st grade there is no parent or teacher who throws a child into a specialist the day the calendar says 'first day of winter'. We look at process and change. Has your baby been growing? Do you feel how that baby is becoming ready for this world? That is progress and change--all remarkably just as it should be.
Today it is the 9th of March and you are 40 weeks and 2 days pregnant. I can guarantee you that when you see April on your calendar you will have a baby in your arms and if you wait for that baby to give you her signal that she is ready for that time, you will be looking back at a labor that is very different from the one that is highly typical of inductions and rarely with exception.
Then I talk about 3 or 4 different induction stories and tell them again to finish the job and honor their body and their baby.
If they are getting flak from their docs I tell them to tell the doctor that they feel fine, baby feels fine, they are fine with NSTs as the doc wants.
What make me SO MAD is when docs induce and even I know it isn't going to work and you can see hours and hours of work and pain from the crazy ctx and they just keep letting it go as if it is normal. It is the only situation you will me tell clients that they need to ask for vaginal checks because they get that hyperstim of the uterus which measures like a ctx although even on the EFM does not look like one, and if you feel the belly, it doesn't feel like one--it feels like a muscle in a panic! And it rarely produces change.
I am sick of the suffering the women go through just to save a
couple days! I put this up on my website:
http://www.seattlebirthnet.com/inductlinks.html
Editor: In my low-volume midwife practice, I have the luxury of
spending many hours with each client, and this also gives me much
time for reflection during the ongoing hours of labor.
I have concluded that nature mostly "knows best" in the sense of
generally starting labor when baby is safely mature but not so
overcooked that the head has hardened or the baby has outgrown the
ability of the placenta to transfer oxygen adequately for the
stresses of labor. There will always be exceptions to this,
and we need to provide some safe limits. Ideally, we would
be able to identify a baby's ideal gestation length, possibly by
detailed gestational age assessments in utero to identify each
baby's growth rate? (Yes, this seems very difficult, but other
than that, we mostly just have genetics to go on. Asian babies
seem to have shorter gestations; Scandinavian babies seem to have
longer gestations. Maybe we can identify maternal or fetal genes
that affect the ideal length of gestation for this baby?) If we
knew baby's ideal arrival date, then we could induce labor if the
baby goes an appropriately small number of days past this.
That all seems like a pipe dream at this point.
So, what else can we do?
We can identify the ways in which circumstances or the mother's
choices have already affected the onset of labor, and we can take
measures to reduce those impediments.
1) As a woman ages without giving birth, the cervix calcifies and
thus becomes naturally longer and harder. This means that
baby's first signals to try to be born will be ignored because the
weak contractions of early labor aren't sufficient to effect
enough cervical change to cause the shift into active labor.
This delays the onset of labor by several days at least, possibly
even a week or more. This can be countered by the use of
herbs in the last four weeks of pregnancy to soften the cervix and
do some of the work of early labor before the woman starts losing
sleep. For those working in the medical model who are
suspicious of herbs but confident in pharmaceuticals, they could
use low-dose misoprostol instead. For example, ten
micrograms per day starting at 38 weeks would do a lot to soften
the cervix and return control of the onset of labor to the baby.
2) The use of high doses of omega 3 supplementation delays the
ripening of the cervix. Omega-3s are anti-inflammatory
agents, and the natural ripening of the cervix is an inflammatory
process. Women can be weaned off omega-3s at 37 weeks. This
is reported to be a common practice in island-dwelling people who
normally consume large amounts of fish rich in omega-3s.
Alternatively, low-dose misoprostol could over come this.
3) The use of progesterone in early pregnancy has become almost
routine in some practices. Progesterone may help to prevent
a miscarriage (research isn't conclusive), or it may help to
prevent preterm labor. It does this by delaying the
development of the processes by which labor is initiated, i.e. the
recruitment of oxytocin receptors in the uterus. This is
great until the woman reaches term and she wants to have plentiful
oxytocin receptors in the uterus. Midwives use cottonroot
bark tincture as a mildly estrogenic herbal supplement after 37
weeks to increase the recruitment of oxytocin receptors.
4) Gestational diabetes or sub-clinical gestational diabetes. It has long been known that gestational diabetes predisposes to stillbirth. Recent research shows that this may be partly attributable to the ways in which elevated glucose levels during pregnancy interfere with uterine maturation. So the baby reaches their ideal term but is not able to initiate labor because the uterus is not mature. This can be remedied by greater attention to overt and sub-clinical gestational diabetes, and by the use of cervical and uterine ripening agents as described above.
Why
not induce everyone at 39 weeks? [5/17/16]
Contemporary OB/GYNObstetrics-Gynecology & Women's HealthACOG
annual meeting 2016
Preventive
Induction of Labor: Does Mother Nature Know Best? - Henci
Goer Examines the ARRIVE Study
This is a fabulous article from Mothering Magazine:
Let
the
Baby Decide: The Case against Inducing Labor
Issue 105, March/April 2001
By Nancy Griffin
In this 7/12/06 Wall Street Journal article, THE INFORMED PATIENT - New Practices Reduce Childbirth Risks Amid Soaring Liability Costs, Hospitals Curb Use of Drugs And Other Procedures to Speed Labor By LAURA LANDRO, she writes, "Inappropriate use of labor-inducing drugs" is one of "The top six contributors to obstetrics litigation".
"Pitocin is used like candy in the OB world, and that's one of
the reasons for medical and legal risk," says Carla Provost,
assistant vice president at Baystate, who notes that in many
hospitals it is common practice to "pit to distress" -- or use the
maximum dose of Pitocin to stimulate contractions.
"Pit to Distress": Your Ticket to an "Emergency" Cesarean?
"Pit
to
Distress" 2: Why We Are All Distressed
Does
synthetic oxytocin (Pitocin) cause autism? [12/22/18 by
Sarah Buckley
The above is out of date, as of Aug., 2013. Dr.
Mehl-Madrona was just eleven years ahead of his time.
Induced
Labor Linked to Raised Risk of Autism, Study Suggests - Male
children seem to be most vulnerable, researchers report [8/12/13
from webmd.com]
Gregory SG, Anthopolos R, Osgood CE, Grotegut CA, Miranda ML.
JAMA Pediatr. 2013 Aug 12. doi:
10.1001/jamapediatrics.2013.2904. [Epub ahead of print]
CONCLUSIONS AND RELEVANCE Our work suggests that
induction/augmentation during childbirth is associated with
increased odds of autism diagnosis in childhood. While these
results are interesting, further investigation is needed to
differentiate among potential explanations of the association
including underlying pregnancy conditions requiring the eventual
need to induce/augment, the events of labor and delivery
associated with induction/augmentation, and the specific
treatments and dosing used to induce/augment labor (eg, exogenous
oxytocin and prostaglandins).
Autism
linked to induced or augmented labor, study says [8/12/13] -
Male infants born in deliveries in which labor was both induced
and augmented were 35% more likely to have autism than those whose
mother did not have either of these treatments. For induction
alone, risk was elevated 18%. For augmentation alone, risk went up
15%.
The
FDA's
PDR-style page about Cytotec
The Tatia Oden French Memorial
Foundation - dedicated to the memory of the mother and baby
who died as a result of inappropriate use of cytotec for
induction.
This is a fabulous article from Mothering Magazine:
Induced
and
Seduced: The Dangers of Cytotec
Issue 107, July/August 2001
By Ina May Gaskin
The
Misoprostol/Cytotec
Controversy from Ina May
Gaskin's site
Induction of
Labor: The Misoprostol Controversy (Full-Text Article)
Is misoprostol safe and effective for inducing labor in carefully
selected women? from Journal of Midwifery & Women's Health,
Jul 2003 Alisa B. Goldberg, MD, MPH, Deborah A. Wing, MD
4/02 - The
FDA
said yesterday that it has changed the label of the drug Cytotec
to reflect the fact that it is widely used by doctors to induce
labor and is also part of the FDA-approved regimen for inducing
medical abortion, Reuters Health reports. The label for
Cytotec, which is known generically as misoprostol and was
originally approved to treat ulcers, had stated that pregnant
women should not take the drug under any circumstances, a warning
that the FDA has now removed. The change reflects the
frequent off-label use of the drug by obstetricians and
gynecologists to induce labor and delivery. In addition,
Cytotec, which is made by Pharmacia, is prescribed in combination
with the drug mifepristone (RU-486) to induce abortions early in
pregnancy. The new label will keep the warning that women
who are taking Cytotec to treat ulcers should not become pregnant
(Reuters Health, 4/18). An
FDA
summary of the label changes is available online. In
addition, the
new
label itself may be viewed online.
ACOG
Supports
Use of Misoprostol for Medical Abortion and Labor Induction
- (November 30, 2000)
The Devil Cytotec - An excellent collection of relevant
information and links. [As of spring, 2002, the
BirthLove site is by subscription only - it's well worth the $10
membership fee.]
Cytotec is the trade name of a synthetic prostaglandin analogue,
misoprostol. It is marketed in the USA as a specific drug for the
prevention and treatment of NSAID induced stomach ulcers. In
Brazil it is widely used as an abortifacient. There have been
several clinical trials of its use as a cervical ripening and
labor inducing agent. It is extremely effective at very low doses,
is very cheap, and has been used on many many women without their
being aware that it really is still an experimental use. A good
MedLine search will get you gobs of references...if you don't have
access to MedLine through the hospital, go to medscape
(www.medscape.com) or a similar site. Keywords "misoprostol" and
"pregnancy". The green journal (Obstetrics and Gynecology) has at
least one article on misoprostol in almost every issue the last
year! I just picked one at random off my shelf...Vol 88#4, October
1996...it has an article detailing an RCT of vaginal misoprostol
for the induction of labor.
Misoprostol. A synthetic prostaglandin, it is approved by the FDA for the prevention of nonsteroidal anti-inflammatory, drug-induced gastric ulcers. It also induces uterine contractions and expulsion of uterine contents and thus can be used in combination with mifepristone or methotrexate. When taken orally, it is rapidly absorbed and undergoes de-esterification to its active free-acid compound. It reaches peak serum levels 15 to 30 minutes after oral administration and has a terminal half-life of 20 to 40 minutes. The usual dose for the prevention of gastric ulcer is 200mcg po qid. Misoprostol is used as an abortifacient in combination with methotrexate or mifepristone.
For use as an abortifacient in Europe, misoprostol 400mcg is
taken orally 36 to 48 hours after mifepristone. When oral versus
intravaginal misoprostol was studied with methotrexate, 800mcg of
misoprostol intravaginally was more effective and had fewer side
effects than 400mcg of oral misoprostol.[8] Misoprostol 800mcg has
also been studied intravaginally in combination with
mifepristone.[9-11] With methotrexate, however, the slight
increased effectiveness of a misoprostol suppository does not
warrant the added costs of compounding one.[12] After
methotrexate, therefore, the recommendation is to use misoprostol
tablets administered by finger into the vagina.
Misoprostol is commonly used to soothe stomach irritation. It is effective at inducing labor, half a tablet in the vagina every 4 hrs prompted 88 percent (15 of 17) pregnant women to give birth within 36 hrs. (With standard therapy, 47% went that quickly.)
I must say that I have heard some great things about cytotec myself. I know some people who have used it, and say that they have pretty good luck with it. It sounds like your ladies are pretty classical of its effects. 2 hour labors and such. Just be careful. I would have to say that the biggest danger is leaving the woman alone. The stuff turns the cervix to complete MUSHIE and opens it with a couple of contractions. So whatever you do, remember that you must not stay gone too long. You are pretty much committed to it after that first dose.
I was reading a study recently on why Cytotec is so effective. It
turns out that the type of prostaglandin that was previously
thought to be the best/closest precursor to labor/oxytocin is a
type E prostaglandin. (we are talking about the "gel" here.)
Cytotec is a type F prostaglandin, and is obviously showing much
better results with its use in terms of a prostaglandin to induce
labor.
Oral
misoprostol
or vaginal dinoprostone for labor induction: a randomized
controlled trial. [Medscape
summary
- Medscape registration is free]
Dallenbach P, Boulvain M, Viardot C, Irion O.
Am J Obstet Gynecol 2003 Jan;188(1):162-7
"CONCLUSION: We found no difference in terms of effectiveness and
safety between low-dose oral misoprostol and vaginal dinoprostone
used for induction of labor. This regimen avoids the excessive
uterine contractility noted in previous studies, where higher
doses of misoprostol were administered at longer intervals."
[low-dose misoprostol was defined as 20 mcg given every 2 hours]
Oral Misoprostol Equivalent to Catheter Plus Dinoprostone For Labor Induction [Medscape registration is free]
Cervical
ripening
and induction of labor with misoprostol, dinoprostone gel, and a
Foley catheter: a randomized trial of 3 techniques.
Barrilleaux PS, Bofill JA, Terrone DA, Magann EF, May WL, Morrison
JC.
Am J Obstet Gynecol 2002 Jun;186(6):1124-9
Titrated
oral
misoprostol solution for induction of labour: a multi-centre,
randomised trial.
Hofmeyr GJ, Alfirevic Z, Matonhodze B, Brocklehurst P, Campbell E,
Nikodem VC.
BJOG 2001 Sep;108(9):952-9
Dr. G. J. Hofmeyr, of the University of Witwatersrand, South Africa, and colleagues conducted a randomized clinical trial comparing the effects of titrated oral misoprostol solution and vaginal dinoprostone. At hospitals in South Africa and Liverpool, UK, 695 women undergoing labor induction after 34 weeks of pregnancy were randomized to receive oral misoprostol solution or two doses of vaginal dinoprostone (2 mg) given 6 hours apart.
"The smallest preparation of misoprostol available in trial countries was a 200 µg tablet," the team explains in the September issue of the British Journal of Obstetrics and Gynecology. "For induction of labour a starting dose of 20 µg was required. To overcome the problem...we dissolved the tablet in 200 mL water."
After two or three doses, depending on the site, the dose was increased to 40 µg. The solution was administered every 2 hours until adequate contractions occurred.
The investigators observed no significant difference between the groups in failure to deliver vaginally within 24 hours. Sixteen percent and 20% of misoprostol patients and dinoprostone patients, respectively, required cesarean section (relative risk 0.80). Four percent of misoprostol patients and 3% of dinoprostone patients experienced hyperstimulation with fetal heart rate changes (RR 1.32).
Women with intact membranes and unfavorable cervices who were treated with misoprostol had a slower response to induction of labor than those treated with dinoprostone. The response was slower in patients treated with dinoprostone when membranes were ruptured. The team observed no significant differences in neonatal outcomes between the groups.
"A possible solution to the problem of hyperstimulation [with
misoprostol]," Dr. Hofmeyr and colleagues suggest, "is the use of
a single, small vaginal dose to achieve the local effect in women
with unfavourable cervices, followed by frequent, small titrated
oral doses to 'fine-tune' the uterine response." [Br J Obstet
Gynecol 2001;108:952-959.]
Use
of
Misoprostol for Cervical Ripening [Medscape registration is
free]
Abstract:
We evaluated the effectiveness of oral misoprostol for outpatient
cervical ripening and labor induction in prolonged pregnancies. We
performed a randomized, double-blind, placebo-controlled study of
women at 40 to 42 weeks' gestation with well-dated pregnancies,
singleton gestations, Bishop scores less than 6, vertex
presentations, and intact membranes. Subjects received either oral
misoprostol 100 microg or placebo daily for 3 days unless the
subject developed significant cervical change or began labor
spontaneously. Study drug was repeated every 24 hours for a
maximum of three doses if subjects did not develop significant
cervical change or enter labor. Induction of labor was not allowed
while the subject was enrolled in the study. Forty-three subjects
were randomized to receive misoprostol and 44 randomized to
receive placebo. A significant difference was noted in reduction
of time from study entry to both active phase (p < 0.001) and
delivery (p < 0.001) in the misoprostol group. Fewer women
remained undelivered after the 72-hour study period in the
misoprostol group. There were no differences in route of delivery
or neonatal outcomes between groups.
CONCLUSION:
Daily administration of oral misoprostol over 3 days to women with
prolonged pregnancies shortened time intervals from dosing to
entry into active labor and delivery compared with placebo.
Use of
misoprostol on an outpatient basis for postdate pregnancy.
Kipikasa JH1, Adair CD, Williamson J, Breen JM, Medford LK,
Sanchez-Ramos L.
Int J Gynaecol Obstet. 2005 Feb;88(2):108-11. Epub 2004 Dec 28.
Abstract
OBJECTIVE: Within the obstetric community, several studies suggest
that cervical ripening and labor induction after 40 weeks'
gestation leads to improved maternal and neonatal outcomes. The
most effective drug regimen to safely promote labor has not been
determined.
METHOD: Forty-nine subjects followed in an outpatient obstetrical
clinic with pregnancies of at least 40 weeks' gestation, and an
unfavorable Bishop score were assigned randomly to receive oral
misoprostol 50 or 25 microg every 3 days for a maximum of three
doses.
RESULTS: Twenty-three subjects received misoprostol 25 microg and
26 received 50 microg. The mean interval (+/-standard deviation)
from start of cervical ripening to delivery was 2.4 days +/-0.3
vs. 3.9 days +/-0.7 for the 50 and 25 microg groups (P<0.05).
No adverse events were noted. However, due to small sample size,
less frequent adverse events may be missed. Type II errors cannot
be excluded.
CONCLUSION: In the prevention of postdate pregnancy, outpatients
use of oral misoprostol 50 microg appears to result in earlier
delivery, as compared to 25 microg.
Is anyone using CYTOTEC for cervical ripening?? I understand that
it has few side effects and only costs about forty cents per
tablet. I would like any info you may have.
At my suggestion our high risk OB referral hospital tried cytotec
- 1/2 tab per vagina - and after two cases of hyperstimulation
stopped its use.
Did your colleague use half of a 100 microgram tablet or half of
a 200 microgram tablet? It makes a huge difference. I have
found that it works wonderfully, and the best response seems to be
using 50 micro grams. There are a few pts who are very
sensitive and take off with just a 25 ug dose.
2 tablets in one time few hours before a (D) & C. You don't
need any D any more. But it is not approved for induction at term
with living baby.
We use 50 micrograms of misoprostol in the posterior fornix every 4 hours until the cervix is "ripe" or until regular contractions (greater than 6-8 per hour) occur. A recent report in Obstetrics and Gynecology (Kramer et al., 1997; 89(3):387-391) reported on 100 micrograms in a similar regimen compared to IV oxytocin, with a significantly decreased time to delivery (585 versus 885 minutes). They reported that 70% of misoprostol patients developed tachysystole. We only rarely see this at the 50 microgram dosage. Wing et al. (AJOG 1995;172:1804-1810) reported tachysystole in about 37% of patients receiving 50 micrograms, but, again, we have not seen many problems with this. However, we provide continuous fetal monitoring in all our patients receiving misoprostol. The bottom line is the stuff works very well for cervical ripening, and many patients do not need oxytocin.
Finally, I had a patient recently with an 18 week fetal death in
utero who rapidly progressed through labor and delivered the
fetus, but did not deliver the placenta. Oxytocin and time did not
help. I gave her 600 micrograms of misoprostol and she delivered
the placenta 30 minutes later. There were no side-effects in this
"series of one".
While we do not use it for ripening, we are using it (almost exclusively) for induction of labor in any patient whose cervix is <2-3 cm. We've done a local RCT comparing 50 mcg to 25 mcg and 50 is the superior dosage. We've seen no cases of hyperstimulation that did not respond to a 2 gram bolus of MgSo4. You can almost count on a delivery 12 hours after inserting the Cytotec tablet.
The usual side effects of prostaglandin are minimized with this
medication...almost non-existent, though one must certainly
exercise judgment with asthmatics.
We using cytotec 25-50 mcg for cervical ripening as well as for labor induction/augmentation. The common dose is 50 mcg. 25 mcg is used for patients with some uterine activity. Hyperstimulation, rarely occurs and is well controlled with terbutaline . No tachycardia observed. Delivery occurs after 2-3 doses.
It was used for labor induction for a patient with IUFD at 18 weeks. It worked fast, without the side effects of prostaglandins.
It was used successfully on patients who refused IV fluids.
Used Misoprostol for the first time this weekend (first time for
me and for the hospital.) Started with Cervidil for twelve hours,
then pit then cervidil then pit. No cervical change. The pharmacy
cut a 200mg tablet into four (no 100mg tabs) and the first 'chunk'
did nothing. The second piece had a rapid response and she
delivered (from 80% / 2cm / posterior /firm /-2 station) to
delivery) three hours into the second dose. She did have a large
(1000cc) postpartum atonic bleed, which responded to bimanual
massage and methergine. Do you see atony often, or was it just the
induction meds, which occurs often in these situations?
Our hospital sponsored a dosage study comparing 50 mcg and 25 mcg
for efficacy as well as complications. There was no increase in
the incidence of postpartum hemorrhage due to atony. (N=150)
As you correctly surmised the placement of a tablet whether
50,100, or 200ug of misoprostol will remain for far more than
2-3hrs. The relevant data I have not seen published would be the
absorption characteristics and measured serum levels of drug in
the patient. It is likely that you will find a substantial spread
as happens with many drugs absorption and bioavailability
coefficients. A good example is the use of procardia for preterm
labor. There are rapid and slow metabolizers of the drug. The only
pregnancy study from Stanford showed markedly discrepant values
which would then characterize the two populations. The March
Obstet Gynecol 89: 392-397 (1997)has two articles on misoprostol
for induction. The oral 100ug dose had an high rate of
hyperstimulation. From my own experience with both terminations
and induction, be very careful about the use of 100 or 200ug doses
of drug.
Protocol:
Misoprostol
(Cytotec) for Cervical Ripening and Induction of Labor
By Myer S. Bornstein, M.D. and Don Shuwarger, M.D., F.A.C.O.G.
Cytotec is a relatively new agent for cervical
ripening/induction. There is no one protocol. However, the dosages
most often used are 25 or 50 micrograms q 4 hours if contractions
are less than q 3 minutes. The tablets are 100 micrograms and our
pharmacy chops them up.
Our protocol is 50 mg every 4 hours to a max of 200 mg in one 24
hour period (never seen a woman who needed more than 100 mg total
tho...). If it is a IUFD we use 100 mg at a dose. I was
unfortunate enough to see a woman (viable baby) who received 200mg
in 1 hour (PROM-FTA) she was a thick, posterior, high and tight
but went to delivered in less than 3 hours... thank G-d the baby
was OK despite the ctx. Again, as with the Laminaria, please
research and develop a protocol before using a modality...and
while you are at it develop an informed consent.
We are using it at Yale for cervical ripening, and although there is a format for how to give it, there is still controversy on to whom to give it. The protocol is for cervical ripening/induction. Pharmacy uses one of their nifty little pill cutters and sends us 1/4 of a 100microgram tablet (remember this stuff was made for treatment of ulcers!) Some places use more than 25 mcg.
The tablet is placed in the posterior fornix, and can be used with ROM. Mom is continuously monitored for a couple hours, and if she is not contracting regularly, she may go home. The dose can be repeated q4h as long as contractions are not more than every 3 minutes. The protocol says it can be given up to 5 cm. This is all very arbitrary, however, and I don't think there are any studies to say if this is the optimum use.
In our limited experience, most women go into active labor with just 1 or 2 doses. I think it is much better than PG gel for ripening, and works a lot better than pit if the cervix is not ripe.
However, I think it needs to be used with caution....at least til
there is a greater experience with it. I have seen
hyperstimulation with it, and it seems a lot like the buccal pit
of yore in that if you have problems, you can't shut it off. Our
practice has arbitrarily decided not to use it with
oligohydramnios, IUGR or other situations where we feel that the
fetus is entering labor in a compromised (or potentially
compromised) state.
I have used Cytotec, but only in the hospital. 1/2 hr of monitoring is done prior to insertion to assure fetal well being ( a non-stress test essentially), and then 30 -60 minutes of monitoring after insertion to assess for contraction pattern and fetal response....
The standard dose on a woman with intact membranes is 50mcg every 4-6 hrs. Some practitioners use 25mcg every 4-6 hrs. I used 25mcg on women with SROM every 6, but some use the 50 mcg dose for that as well. You can administer the meds either vaginally or by mouth...different thoughts on each route. Theoretically, you can "wash out" the meds from the vagina in the event of fetal distress or uterine tachysystole (hyperstim)-- but I personally doubt that it works. I think it just makes the providers feel better!
My thoughts on the monitoring: You can do an Auscultated Acceleration test using a fetoscope or a Doppler and document those numbers prior to insertion. After insertion, you could do the same - (maybe at 15 min intervals for one hour) and additionally document the woman's contraction pattern and her response to them for that same time period.
I am not sure if I would feel comfortable with using it at home, though I might consider it. It seems that many of the women who receive it are pretty "quiet" for a few hours, but once the meds kick in- labor starts with a bang and keeps on going- sometimes with an uncharacteristic ferocity that scares me. The reason many people like the cytotec is that it can stimulate a labor faster than Pitocin and PG gel in many cases- but sometimes I wonder if the "faster" part is worth it. Contractions really do seem to come back to back, leaving little time for coping....(with the 50 mcg doses esp.) The smaller doses of 25mcg seem to be much more humane
It is a powerful little tablet that can work wonders and saves
time, energy and money for many involved- but I think it should be
used with caution and respect!
[from ob-gyn-l]
We've talked about Cytotec every few months or so on this list,
so will just try to summarize. It's a prostaglandin developed in
an oral form specifically to protect the stomachs of people who
have a chronic need for NSAID use (arthritis, etc). Someone
discovered that the oral pills can be used vaginally and have an
effect similar to prostin gels, but MUCH more cheaply and without
the need for hospitalization (if used carefully and judiciously).
Some hospitals have been using Cytotec for inductions and have
written protocols, but they seem scattered about - there sure
aren't any around here. I've personally used it twice and had
excellent results in women wanting homebirths, but going
postdates. I'm sending my own protocol (below) for anyone
interested. Again, I warn that I am no expert and I consider this
protocol to be a "work in progress" - it will certainly change as
I gather experience and information about this drug.
B. Clinical indication must exist to justify the use of Cytotec for cervical ripening or labor induction and well-documented in the chart.
D. Use of Cytotec should always be preceded by careful prenatal exam to document fetal position, size, and well-being, as well as Bishop score of the cervix.
E. For ripening the cervix: Client may insert 50 mcg Cytotec (1/4 of a 200 mcg tablet) as far back into her vagina as she can reach (posterior fornix, if possible) at bedtime for several days as needed until desired change has occurred.
F. For labor induction: Start with ripening instructions as above; if labor does not ensue and there is no evidence of hyperstimulation of the uterus, client may increase dose to 100 mcg (1/2 of a 200 mcg tablet), repeating dose every 4-6 hours for up to 4 doses (?) in the absence of hyperstimulation until contractions are regular and cervical change is accomplished.
G. To induce miscarriage in cases of documented missed ab: Client may insert 100 mcg (1/2 of a 200 mcg tablet) as above; repeat dose in 4-6 hours x 1; should be watched carefully to make sure that miscarriage is complete and bleeding resolves appropriately as some clients may have incomplete miscarriage as a result of Cytotec.
H. Do not repeat Cytotec dose if adverse side effects or
prolonged contractions result.
I just started looking this up. See Mundle, et al., "Vaginal Misoprostol for Induction of Labor," Ob Gyn 1996; 88:521-5. Patients who met reasonable criteria had a 50 microgram tablet (half of the standard 100 mcg. dose) placed in the fornix q 4 hrs. until labor occurred. They were compared to a Prostin group and there were no significant differences (e.g. C/S rate, hyperstim rate, low apgars, etc.)
Other protocols referred to are 25 mcg. q 2hrs., 50 mcg. q 3 hrs., or 100 mcg. given once, but these were not addressed in this paper.
What I would like to see is a study where we place a single
misoprostol in the fornix in the office at 4:00 p.m., monitor,
then send home, and begin the induction the next morning.
Misoprostol (Cytotec) is a synthetic PGE1 analogue.
For cervical ripening and induction:
Two references on the cytotec induction I think you would be well
to read and have handy: NEJM 333:537 (August 31, 1995.) This is
the original article by Dick Hauskenecht. The second reference is
from the Medical Letter 38:39. (April 26,1996). The reason I think
it important that you have it, is that the anti-abortion legal
group (out of Texas) just sent circulars out this week asking that
complications from this method be reported to them. Thorough
documentation of management would seem imperative.
Now we're using Misoprostol for induction. In 50 cases, we've
only failed to get someone into labor once and our C/S rate is
around 18%.
We use 25 micrograms vaginally q 2-3 hours until either labor
starts, or the cervix is ripe, at which time we start pitocin.
From OBGYN.NET
By Myer S.Bornstein and Don Shuwarger
In the papers reviewed the Misoprostol is inserted into the posterior vaginal fornix by speculum examination, and the Dinoprostone gel is inserted INTRA-CERVICALLY via speculum. UK practice would be digital insertion of either into posterior fornix - i.e.. VAGINALLY for both.
If no one out there ( US/UK/the world ! ) is using it regularly for induction of labour how safe, sensible and medico-legally sound is it for a unit with no research experience of Misoprostol to start using it ?
Finally, in the studies induction was only in nice low risk women, singleton, >36 weeks, vertex presentation and no uterine scar - we have lots of women that don't fulfill these criteria.
Now the questions !
Is anyone out there using the stuff regularly ?
What protocols do you use ?
What restrictions ?
How have you found it ?
Do you guys really put the Dinoprostone in the cervical canal ? (
Thought I'd read somewhere that is less effective than in the
posterior fornix ! )
Yes. We routinely use this via a protocol instituted by the Ob/Gyn department at our hospital. Our hospital is a large, tertiary private hospital (I actually read it was the busiest private hospital in the U.S. last year, which explains my call schedule) with in-house anesthesiology coverage, in-house Ob/Gyn coverage (my partners and I), and an in-house perinatologist (the infamous Armando Fuentes).
I believe the protocol is something like: use only if Bishop's score is less than 7, there are fewer than 6 contractions per hour (it might be 10), baby vertex, no distress (etc.). Place 50 micrograms into post fornix every 4 hours until contractions greater than 6-10 per hour or labor ensues. Patients must be on continuous fetal monitoring.
All drugs and therapies have possible side effects, but this stuff has worked extremely well for us. Failed inductions are subjectively far less common. I have heard of one case of uterine rupture (prior c/s, large doses over 2 days for pregnancy termination in a patient with a 2nd-trimester, non-viable fetus). I have used this in the 3rd-trimester at least 30 times, and have never seen tachysystole (yes, I know, my time will come), known uterine rupture, or other major complications. Sometimes the induction will not work, but in most cases 1 or 2 doses is enough, and labor begins or dilatation ensues. I believe careful fetal monitoring is necessary since the literature does report tachysystole.
Don't use Dinoprostone very much. In fact, misoprostol is now the
drug of choice for labor induction in our hospital, and other than
a few folks who use prostaglandin gel (put in at night; patient
comes back in a.m.), the overwhelming majority of Ob/Gyns around
here will now bring patient to the labor unit in the morning,
place the misoprostol, and "stand back" (just kidding)!
I do have concerns about higher doses and we don't know if the incidence of in utero meconium aspiration syndrome is increased or any other complication of labor induction for that matter. We've measured intrauterine contractile pressures after a single 50mcg dose of Misoprostol and have found them in the usual ranges. We place the medication in the posterior vagina. We repeat the doses in 6-8 hours if no effect.
We are having patients use this medication under an experimental
protocol with a separate consent that outlines published reviews
of the medication, as well as benefits and risks. The patient
signs this form prior to induction.
I have been using regularly for over two years and have not used
pitocin for induction in that time. Most recently I have been
using oral dosing, which seems to me to be much more predictable
than the intravaginal approach. The same clinical judgment of
whether the patient is going to be more or less sensitive (i.e.,
the term patient with a dilated cervix more sensitive, the preterm
with an unripe cervix less so) as is appropriate to the use of
pitocin is applicable to the use of misoprostol.
The misoprostol protocol we currently use:
Usage:
I've suggested to the nurses on Labor and Delivery that the day will come when the OB/GYN lines up all of her/his 39 weekers on a Thursday. They have an early lunch followed by an NST in the office. If reactive, and all other criteria are met, they have 50 mcg Cytotec placed in the vagina in the late afternoon and head over to LandD. If all looks well they'll be sent home and asked to return when contractions are stronger, SROM, bleeding, etc.... The majority will return around 1am and deliver before outpatient surgery starts on Friday morning.
The nurses seem unenthusiastic about this plan, and Thursday
night might be an experience, but it would certainly improve my
attitude about the rest of the week!
My question for those who use cytotec on regular basis: If after
the first dose the woman is contracting vigorously (Q 2 min) but
no cervical change, do you go ahead with next scheduled dose every
4 hrs?
We are using it, and if the patient is in labor, with normal
contractions we don't repeat the misoprostol. If needed we rupture
the membranes. Most of the times you only need one dose. Sometimes
the cervix doesn't change initially, but after a few hours becomes
shorter and dilate very quickly.
I advise residents to skip repeat doses of Cytotec if the patient
has palpable contractions greater than every 6 minutes on average.
I think cytotec should be used as a ripening agent and not an
agent to induce hard and regular contractions. @ 50mg/4h I have
seen a lot of hyperstimulation and some acidotic babies. I usually
recommend 30mg/3h for 3 dose, which was found to have less
hyperstim and reasonable effectiveness.
I don't think it is wise to continue with further dose of cytotec
if your patient is contracting in that manner as you are quite
right that the risk of hyperstimulation is very high. From your
findings, I think your patient did show some progress in cervical
ripening. I have encountered a few cases where the cervix
progressed from 1-2 cm to fully within less than 4 hours after 1-2
dose of cytotec.
Our protocol states that if the patient is contracting more than
6-8 (can't remember exactly which one) times per hour, she cannot
have more misoprostol.
It has subjectively dramatically improved the time to delivery
and induction success rate, and I'm waiting for the pregnant
nurses to take some home to induce labor when they hit 38 weeks :)
We are still using cytotec Our dosing is 50 mcg q 4 hrs usually
not needing more than two doses or 100mcs po times one dose. No
major problems. If the patients doesn't response to cytotec we
have also seen no response to other oxytocics and have led to c/s
I usually preferred to administer through vaginal route - no
doubt there is no proven absorption and distribution rate studies
that has been documented ( anyone had any paper on it ?). The
advantages that I find personally is that I can VE the patient for
progress of the labour at the same time , and sometimes when the
labour contractions becomes too strong and tumultuous, the same
tablet can be extracted out ( I usually used about 100 mcg dose in
the vagina)easily and the contraction occasionally ceased. I
wonder any of you have the same experience to share?
Don't know how many of you saw two papers on Misoprostol for labour induction in Am.J.Obstet.Gynecol. 1997; 89(4): ( April ):
They were reviewed in our departments Journal Club last week ( when I was on leave ). On the basis of these two papers one of my colleagues is suggesting we should go straight over to Misoprostol and obviously save vast amounts of money !
My problems are that:
The first study shows an increased CS rate in the Misoprostol group ( the other paper doesn't, but I view the results on that outcome as being so heterogeneous to warrant suspicion ).
The obvious explanation for superiority of Misoprostol is that it
is either given in big doses or doses are repeated every 4 hours,
whereas the Dinoprostone is only ever repeated 6hrly in studies.
We tend to continue the Cytotec until the pt has established a satisfactory labor pattern and is well into the accelerated phase of labor, (perhaps naively) relying on tocolytics to get us out of hyperstim (which hasn't happened to us yet). I have backed down to 25 mcg a couple of times, when the uterus looks a little too active.
My partner and I have done over a hundred oral misoprostol inductions since we started using Cytotec in March of this year. We use 50 mcg po q 4h, monitor continuously for 1 hr after each dose, then intermittently for the next three hours, feed the patient, without IV, (assuming there are no other indications for IV or IV med), until they are in the accelerated phase of labor, and ambulate them during the three hours they're intermittently monitored. I don't remember the last time we started an induction with pit. We do use pit occasionally to augment.
I used to avoid doing inductions with Bishop's scores less than 6 or so, and could never get enthusiastic about the cervical prostaglandins, but now I just schedule the induction, regardless of the cervix, and have had very good outcomes.
Our biggest fear is that the company will pull Cytotec from the
market, since our internist/GI buddies tell us that it isn't worth
a darn for its labeled indication.
Misoprostol
Administered
by Epithelial Routes: Drug Absorption and Uterine Response.
Meckstroth KR, Whitaker AK, Bertisch S, Goldberg AB, Darney PD.
Obstet Gynecol. 2006 Sep;108(3):582-590.
CONCLUSION: Although serum levels were lower for buccal compared
with the vaginal routes, the three routes produced similar uterine
tone and activity. Rectal administration produced lower uterine
tone and activity. Vaginal serum levels were two to three and a
half times higher than those observed in prior misoprostol
pharmacokinetic studies. LEVEL OF EVIDENCE: II-1.
Oral
misoprostol
for induction of labour at term: randomised controlled trial.
Dodd JM, Crowther CA, Robinson JS.
BMJ. 2006 Feb 2; [Epub ahead of print]
CONCLUSIONS: This trial shows no evidence that oral misoprostol
is superior to vaginal dinoprostone for induction of labour.
However, it does not lead to poorer health outcomes for women or
their infants, and oral treatment is preferred by women.
There is a shorter interval to vaginal birth with vaginal application; however, the more frequent occurrence of fetal heart rate graph abnormalities in this group suggests that, until the optimal dosing interval for vaginal use is determined, the preferred route of misoprostol administration might be oral.Basically they found that the vaginal route worked much faster, but was associated with more tachysystole and hyperstimulation. All the babies were fine.
They quote someone who studied the pharmacokinetics of cytotec
and found that vaginally administered, it had three times the
systemic bioavailability of oral dosing.
Prostaglandins are absorbed 10X more efficiently through the gut
than through the vaginal mucosa, with respect to semen and labour
onset. Might it be possible that cytotec is more effective given
orally than vaginally? And I am curious about whether the safety
factor is affected by route of administration.
Spot on, there is a difference in absorption between routes.
Various studies have been done/are underway to look at dosing
differences by the two routes. Currently the evidence is you need
less orally, but not so far convincing enough. An issue for us in
UK is we only have a bigger dose available than you guys in USA,
it might even be better for us to stick with the higher dose PV
than the lower dose PO.
Dr. Maslow at the perinatology center in Tacoma prefers the po
route, as there seems to be less uterine irritability and similar
outcomes. He's got several supportive articles/protocols too. He's
the one that does a NST in the office, gives the pill (50mcg) and
sends the women out to come back in 4 hours. Claims >90%
success with this, with no additional complications. I'd like to
see comparisons of large vs. small women, and primips vs. multips.
I have been using oral for the last 2 pts, and found it worked
well. When I give it intravaginally, I often find the softened
pill just sitting there. Then when I rub it around the posterior
fornix, she jump-kicks into really fast contx, which I don't much
care for. Orally, the last 2 have been much more mellow, but still
work.
The last 2 I did cytotec on I gave it orally. One because SROM,
the other had Previous GBS septic baby. Both went into nice slow
labor - one needed pit after 2 doses and no progress, but del w/i
6 hrs of starting pit. Big study. Pure anecdotal. but it does work
orally.
I think one of the big problems we are having establishing dosage
of misoprostol is that the effective/over-effective dosage is
dependent on the patient's characteristics. this includes cervical
status, parity and gestational age, at least. in addition, after
selection of the initial dosage in mcg., the important modulation
may be in the dose interval rather than the amount of the drug.
Does it make any sense that one should adjust the dosage of
Cytotec depending on the woman's body weight?
Someone talked about this at the Midwifery Today
conference. I can't recall the amounts, or at what weight
you would increase the dose- its in my notes somewhere. She
also felt that obese women have a deficit in oxytocin- I can't
remember if the reasoning was that they make the same amount as
non-obese women but it is too diffuse in their body, or they make
less oxytocin because they are obese. She thought
cytotec was a great thing for these ladies, and much less painful
than a pit induction.
Not if given vaginally and probably not if given orally. In
it's on label use (ulcer prevention) there is no information about
lipid binding and need to adjust for body size.
I would think it would depend on where you are putting it!
Intravaginally, I wouldn't think so, since it is being absorbed
directly at the site of action; orally, maybe so since it must
pass thru the liver, etc., to get where it's going. Just my
thoughts, I have no evidence (and I suspect no one else does yet)
one way or the other.
The whole thing is totally uncontrolled, uncontrollable anyway.
we don't even know why some tabs don't even dissolve, and are
found just sitting in the vagina. ?ph? ?KY jelly? The dosage is
made by crudely dividing a table into 1/2 or 1/4,,,,don't think it
could get too terribly precise.
I don't think that has been studied at all. I think that the
indivdual responsiveness to prostaglandins is more significant
than weight.
Another question - can one assume that the active ingredient is
evenly and homogeneously distributed throughout the tablet? Is it
possible that all the active ingredient can be in just one
section of these little pills.
We have seen very variable results with cytotec. Some women do nothing, some have tumultuous labors. We use 25 mcgs q4h unless there are frequent contractions.
My question: since cytotec is a pill for oral use, can we be
assured that the active ingredient is evenly distributed
throughout the inert carrier?
The same question about distribution of the active ingredient when a tablet is quartered has come up in conversation here as well, we have just started using cytotec and have already seen lots of variable responses.
The latest green journal has an article about uterine rupture
after the use of misoprostol in 25mg. doses q 4 hrs., hope this
won't prove to be too much of a wild card to continue to use.
Maybe what we need to do is have the pharmacist grind the tabs
into 4 cc of gel, and then divide it into 4 syringes (ala old days
of home made prostin gel).
CAUTION - Homebirth use of Cytotec is very dangerous before the baby is born! (It's fine for controlling bleeding after the baby is born!)
As a homebirth practitioner, I take the cautions of hospital midwives very seriously concerning the potential dangers of Cytotec, but have still chosen to present it as an option to clients on a few occasions when it seemed important to get labor going (when the usual arsenal of labor-starters had failed).
I tell clients up front that the use of Cytotec for this purpose is not FDA approved, nor is its use compatible with the local standard of care (as far as I know, it isn't being used by any hospital practitioners around this area). I explain that we don't have a lot of published data on the safety of the drug, and then share what my limited experience is (making sure they also understand that I'm talking truly limited). The risks are reviewed, particularly the possibility of tetanic contractions, but the studies I have read show no adverse fetal outcomes. My written protocols call for starting with a small test dose (like 25 mcg) first to determine a client's individual sensitivity to the drug.
So far, I've had only positive experiences with Cytotec - usually a few hours of lag time and then the onset of contractions that seem to very effectively dilate the softened cervix. Clients have been very pleased.
My sample is so tiny, though, and if adverse consequences happen
only one out of every twenty times, it will take me forever
(maybe) to even see one. That doesn't make that one any less
important or likely. So I will probably continue to be very
cautious, do as careful informed consent, and only offer the
option is I feel that the indications are clear (not just "I'm
tired of being pregnant - can't we get this going?" kind of
thing). [Ed: This was NOT written by me, but by a midwife in a
part of the world where this use is legal.]
Forced
Labor - "Why are obstetricians speeding deliveries with an
ulcer drug that endangers mothers and their babies?" from Mother
Jones.
One of the precipitous births that we experienced, the pill came out on the baby's head. Obviously not dissolved -- of course she only had about a 1 hour labor -- primip -- since then we don't use as much. She was not in labor at all, no contractions, when we inserted the tablet.
We have had one very precipitous birth, and a couple of pretty
fast ones. I have used it to successfully induce really hard
cervixes, though, and very overdue clients. They were not
precipitous at all. Labor stated right away, and I continued the
cytotec every 4 hours or so, for 2 or 3 insertions. When labor was
well under way, I quit. Clients had nice normal labors. I've been
experimenting with using just a tiny little "crumb" of cytotec,
not very scientific -- I know. I have had very good results. i
have never had any bad heart tones, meconium, or low apgars, no
hypertonic contractions -- seems a lot safer to me than pitocin. I
think that if you start with a very small amount, and you are
patient, that you can finally get labor going, and have a
manageable, not precipitous labor. Clients also claim that labor
doesn't hurt as much -- don't know if that is true or not, but
have been told that several times -- my whole experience if very
limited, though.
I have used cytotec a few times OOH and haven't seen the all-or-nothing response that Betsy describes... well, I have seen a "nothing" response. But the other times, I saw a latent period and then a nice labor, usually short, but not with the harsh abruptness of many Pit-induced labors I've seen. The moms have not felt overwhelmed and their contractions weren't overly long or close. I suspect that the shortness of the labor has to do with the incredible softness of the cervix that can result from the cytotec as well as stimulation of uterine activity.
Having said that, I have a great respect for others clinical
experience and know there are some who have used Cytotec a lot
more than I have and have good reason for their opinions. That's
why I want to have a GOOD reason to use it and am very judicious
about the doses I use. I give lengthy informed consent (which
includes the lack of FDA approval and the uncertainty of
response). I have prescriptive privileges, so can use the stuff
legally. Those of you who are not licensed and do not have
prescriptive privileges are certainly taking a bigger
medical-legal risk by using a non-approved prescription drug at
home in an attempt to induce labor. I'd advise extreme caution.
I DO NOT like the uncontrolled labors I have seen with cytotec, my lit search shows "uterine tachysystole" to occur in just about every study, regardless of the dose (25 to 100mcg) route (oral or vaginal), and frequency (q 3 to q 6 hours). What good does it do to induce labor rapidly and effectively if you end up sectioning a woman at 9 cms for fetal distress (and find an 80% abruption in the OR). I admit it, I'm scarred, because this is just what happened to the first lady I cared for on Cytotec (4 years ago now, when I was an L&D nurse). I'm also scared because of what I see as the hidden assumptions behind the "jump on the bandwagon" approach to Cytotec inductions. These are (in no particular order):
And I am really concerned that it will start to be used in an
unmonitored way by practitioners (from OBs to midwives to the
women themselves) who don't believe that something so little can
pack such a punch. I have been a student of the history of health
care for most of my life. The path from then to now is littered
with the corpses of good ideas with horrific outcomes. We have
refined out a few nuggets, and even in the core of the worst
tragedies there has been knowledge gained. Still, I think about
retrolental fibroplasia, and DES, and amphetamines for weight
control, and telling pregnant moms to only gain ten pounds. I
think about the surgical fads, like sprinkling the beating heart
with talcum powder, and routine tonsillectomy, and routine
episiotomy. Thalidomide (which by the way is turning out to be a
very valuable drug in the treatment of leprosy, and possibly even
some cases of AIDS). The kids who got polio from the first,
inadequately tested batch of vaccine. The soldiers infected with
hepatitis in their Yellow Fever vaccine. And even more recently,
moms I have seen in pulmonary edema from their tocolytics, or in
SVT from the same drugs. So, yes, I'm wary. That doesn't mean that
I wouldn't use cytotec. But it does mean that I would think long
and hard about it, and I would involve the family in the decision
as much as possible. But, of course, isn't that what midwives do
anyhow?
I saw a PP woman today who was big-time unhappy re her experience with cytotec. She said she was 3cm-3cm-3cm-3cm X 24 hours, then delivered in 30 minutes. She was Muslim, came to our practice for female providers, and was attended by a male resident....there was no time to call the mw.
I can't explain why it seems to be all or nothing. Maybe it is
the lubricant or placement of the tablet in the vagina.
[from ob-gyn-l]
We are looking for clinical experiences with misoprostol for labor induction or cervical ripening. Have read many studies but now are interested in what folks are finding in their clinical experiences. Have reviewed several protocols with varying dosages and routes of admission and wonder what is working for folks.
Our first attempt with induction went like this: A primip at 39 wks with mild PIH had an unfavorable cx. At 9am she got 50mcg of misoprostol vaginally. Repeated dose 2 more times 4 hours apart. FHTs reactive, BL 150's through out the day. 12 hours after the first dose she started having strong UCs q 2-3 minutes. She went from 2cm to delivery in less than 2 hours which resulted in some fetal distress. Vac Ext delivered 6# 13oz male infant apgars 3/8.
Are people giving it vaginally, orally?? and in what dosages? Anyone else finding rapid labors such as this one? Any protocols you might be willing to share?
G3, P2 with 2 previous cesareans. Decided to use Cytotec at 38 weeks to ripen cervix, induce labor and increase chances of vaginal birth.
Day 1: 4 doses of 50 mcg spaced 3 hours apart. No contractions. Day 2: 4 doses of 100 mcg spaced 3 hours apart. No contractions. Day 3: Waters broke and labor started in the middle of the night.
Uncomplicated vaginal birth within 12 hours.
Only recommendation is to allow more rest in between doses so
that mother isn't so exhausted at birth.
The other article in the Green: I thought it would be interesting for the list because there has been so much talk about misoprostol:
So I guess it looks like we will ultimately be using it vaginally?
Actually, i suspect the more rapid absorption and degradation
with oral administration to make use via this route more
predictable. i have just about given up vaginal use in favor of
oral because my clinical observation suggested more rapid onset
and more predictability.
I agree. We have been very happy with using misoprostol orally
(about 40 patients in our practice so far), especially since that
route makes it usable and effective in PROM, etc. We HOPE the
future lies in using in PO use at home (in patients who have a neg
BPP and NST, etc.)
Does anyone have any sort of protocol for office use of
misoprostol? In theory it sounds very attractive.
One of our physicians uses Misoprostol at home, sees them
evaluates with a NST then give 100-200 mcgrams po and either they
come back in active labor or return the next morning for pitocin.
Actually, i suspect the more rapid absorption and degradation with oral administration to make use via this route more predictable. i have just about given up vaginal use in favor of oral because my clinical observation suggested more rapid onset and more predictability.