|September 6, 2000|
Volume 2, Issue 36
|Midwifery Today E-News|
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In This Week's Issue:
1) Quote of the Week
1) Quote of the Week:
"I honour the process of birth as natural and instinctual, relying on the 'forces of nature' and the use of practical, non-intervening skills to facilitate this passage."
- Diane Smith, midwife
2) The Art of Midwifery
If you have a "bleeder" from a tear that you can see, try direct pressure with a sterile gauze pad on which you have placed Yunan Paiyu, A Chinese herbal combination in capsule form. Three applications of one capsule each emptied on the gauze pad worked well for me over a twenty minute period. The tear actually looked cauterized!
- Donna Vidam, Midwifery Today Issue 49
Share your midwifery arts with E-News readers! Send your favorite tricks to firstname.lastname@example.org
3) News Flashes
Cranberry juice can prevent cystitis and other urinary tract infections from occurring because cranberries contain isolated compounds called condensed tannins or proanthocyanidins, according to a recent study. These compounds are capable of preventing Esherician coli (E coli) from attaching to cells in the urinary tract. One of the researchers on the State University of New Jersey team that led the study estimates that a 300 ml glass of high-concentration cranberry juice drink consumed daily would help prevent E coli urine infections. -Pro-fessional Care of Mother & Child, Vol. 10, No. 1
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DOCTORS ARE THE THIRD LEADING CAUSE OF DEATH IN THE US, Causing 250,000 Deaths Every YEAR. Seems hard to believe, but the most widely circulated medical periodical in the world, JAMA, published this information last month. Read all the details at www.mercola.com and learn how you can protect yourself and your family from their actions.
While the United States has a system in place to insure that all drugs must be evaluated by the FDA before they are allowed on the market and that certain drugs are to be dispensed only through physician prescription, there is a hole in this system. Once a drug has been approved by the FDA for one use and put on the market, there is nothing to prevent a physician from using that drug for whatever use at any dose. Trials of new uses of drugs are important as long as the trials are done as research and everyone understands that this use is experimental with informed consent from the patient. Misoprostol induction shows potential for certain benefits but these benefits must be documented by careful research which, at the same time, looks carefully for the risks.
We can't just throw drugs at people in an uncontrolled way. If a practitioner hears about a new use and simply starts using the drug this new way, this is experimenting on patients without the usual safeguards in place for research subjects. And while practitioners should report to the FDA on such off label trials and should always report to the FDA on side effects and risks found, in reality only a very small number of practitioners ever report anything to the FDA. As a result, a large information vacuum exists in the United States with regard to what prescription drugs are being used for which purposes and what side effects and serious risks have occurred. So when practitioners simply begin to use a drug for a new purpose, there follows a phenomenon I have experienced for years as a practicing clinician but rarely see described in print--the informal spread of clinical experience. In hospital corridors, lunchrooms and staff lounges, doctors, midwives and nurses share their ideas and experience.
A recent technology makes it possible to listen in on such clinical chat--online web pages and chat rooms. By accessing the World Wide Web and then using key words such as "misoprostol" and "pregnancy," many web pages and chat lines appear. Clinicians, scientists, policy makers and patients should read these Internet pages from time to time. While clinicians writing on the web are not necessarily representative of all clinicians, it is possible to discover how at least some of today's clinicians think and act. It seems like eavesdropping because of their candor and their blunt way of expressing ideas and opinions and revealing their attitudes. It is the informal communication of uncontrolled clinical experience which has driven the spread of misoprostol induction as is apparent from the following actual statements taken from the Internet in 1998: (2)
"Cytotec 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."
"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 happy with its effects--two-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 (web message emphasis, not mine) and opens it with a couple of contractions. So whatever you do, remember that you must not stay gone too long."
"At my suggestion our high risk OB referral hospital tried Cytotec--one-half tab per vagina--and after two cases of hyperstimulation stopped its use."
"We've seen no cases of hyperstimulation after Cytotec that did not respond to a two-gram bolus of MgSo4. You can almost count on a delivery twelve hours after inserting the Cytotec tablet."
"We are using it at Yale and although there is a format for how to give it, there is still controversy on to whom to give it. Pharmacy uses one of their nifty little pill cutters and sends us one-fourth of a 100 microgram tablet (remember this stuff was made for treatment of ulcers!)"
"We are using misoprostol regularly for induction--my department loves it. We use one of the protocols published on OBGYN.Net web page."
"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."
What is apparent from this Internet medical practice is the lack of appreciation of any borderline between experimenting on patients and practicing medicine on patients and the absence of concern for patient's rights to informed consent.
Also apparent from reading the Internet is the inability of many
clinicians to critically review published papers. The general
assumption is that since there are, as stated in one web message
"gobs of references" (2), the scientific work has been done and it is
okay to use this drug for this purpose. The tendency for clinicians
to misinterpret scientific papers is in part because of a difference
in approach since scientists must believe they don't know while
clinicians, in order to do what they do, must believe they do know. A
common attitude among clinicians, revealed by Internet messages, is
that pregnancy and birth are dangerous until proven safe while
technology and drugs are safe until proven dangerous. -Marsden Wagner, MD, Misoprostol (Cytotec) for Labor Induction: A Cautionary
Tale. Read the entire article on the Midwifery Today website:
The June 1999 issue of the American Journal of Obstetrics and Gynecology published the article "Uterine rupture associated with the use of misoprostol in the gravid patient with a previous cesarean section." The data in this article are truly frightening. "Uterine rupture occurred in 5 of 89 patients with previous cesarean delivery who had labor induced with misoprostol. The uterine rupture rate for patients attempting vaginal birth after cesarean was significantly higher in those who received misoprostol, 5.6 percent, than in those who did not, 0.2 percent or 1 in 423, p=0.0001)." Furthermore, a medical records review turned up several more cases of uterine rupture associated with using Cytotec with VBAC not included in their calculations.
Be clear on what this says. Over five percent of women given Cytotec for VBAC had a ruptured uterus, a 28-fold increase over those who did not have Cytotec induction for VBAC. This is a truly shocking rate of uterine rupture. And one of the five women with uterine rupture ended up with a dead baby as a result of the rupture.
Just in case you think this paper reports an aberration, the same issue of this journal has a second paper in which three of eighty-one women receiving Cytotec for a VBAC had uterine rupture--a still shocking rate of 3.7 percent. And one of the three babies died in the NICU after the rupture. Both these papers were retrospective which means that none of the women given Cytotec were part of a research project. Thus, none had received the protection of research subjects, including information on the experimental nature of the drug given to them. So in these two papers, of 170 women given Cytotec for induction with VBAC, eight have lost their uterus and two lost a baby as well. It is my educated guess that to this day none of them has been told that they were given a drug for a purpose not approved by the FDA nor has been told their case is described in published papers saying this drug should not be used in this way.
These women and babies paid a very big price because their practitioners were willing to use a very powerful drug before it has been approved by the FDA for this purpose and before it was adequately evaluated by prospective, controlled research. Hopefully, no midwife will ever be involved in any birth where Cytotec is used for VBAC and all midwives will do everything possible to prevent the use of Cytotec for any type of induction until we have more complete evaluation.
- Marsden Wagner MD, MSPH
When uterine overactivity occurs [due to artificial means], an attempt must be made to remove the drug that is causing the problem. Turning off an oxytocin infusion is fast and easy, and usually results in a rapid return to more normal uterine activity. Some dinoprostone products are made with a string and are easy to remove quickly. When dinoprostone gel is used, attempts can be made to flush it from the vagina with sterile saline-clearly a slower and less effective procedure. With misoprostol, attempts can be made to remove the pill, if it has not yet been absorbed. More often than not, the pill has already been completely absorbed. In this case, there is no choice but to ride out the excessive contraction pattern with careful monitoring and measures to maximize the supply of oxygen to the fetus.
- Jennifer Enoch, Midwifery today Issue 49
Midwifery Today Issue 49 discusses at length the use of misoprostol
(cytotec). To order the issue, go to:
E-News readers talk about Cytotec:
A primagravida mom went a week postdates and her doctor wanted to induce labor. He admitted her at 9 pm, and started Cytotec at 9:45. At 1:45 she was checked, and no change was noted, so another dose was inserted. At 6 pm she was contracting mildly, about 7 mins apart. At her next vag check, she was found to be 2-3 cms and 80% effaced, which was great progress from 0 dilation and no effacement at all. I'm told by her there was no cervical discomfort with Cytotec, and no pain or cramping that she noticed. Other clients who have induced using Cervadil and Progestagel have complained of burning at the cervix and intense cramping from use. From this I would ascertain that Cytotec seems to be equally useful as an induction agent, but seems to be less uncomfortable for the moms. Has anyone else come to this conclusion? I would love to hear your stories.
- Gina Acosta,ICCE,CD,
I can only provide insight from the patient's perspective as I have not used Cytotec in my clinical setting. Each of my pregnancies have been complicated by pregnancy-induced hypertension. With my fourth and most recent birth on August 4, I was induced at 38 weeks for PIH as my blood pressures on bedrest were 160s/100s (in labor they were as high as 200/100 and I got a dose of Apresoline). I had headaches for several days that wouldn't resolve with analgesia. I put off induction for a week, against the advice of two OBs and a perinatologist. Before the day I was induced, I was feeling well and had a Bishop's score of 5. I decided to go ahead with it as I just didn't have the same feeling of well-being that I had had in previous weeks. Something just wasn't right. I had a Bishop's score of 8 on the day I was induced and my baby's head was ballotable.
I had been induced with Pitocin twice before, once for PIH and once for severe preeclampsia. I opted to try Cytotec this time so that I could be more mobile and use hydrotherapy. After getting us settled in, my labor nurse inserted a 50 microgram tablet of Cytotec vaginally. In no time at all I was contracting every 1-2 minutes. Compared to Pitocin, my contractions didn't peak as fast with Cytotec and I felt I could cope with the discomfort better. I felt so tied down with Pitocin and felt more in control this time because I wasn't stuck in bed on my left side. I'm glad I had Cytotec as an induction option for this birth.
- Maurenne Griese, RNC, BSN, CCE, CBE
When it was introduced at my hospital I did my own research and found many reasons not to use Cytotec at the dosage we use (100 mcg PO) but was told I either give it or quit. About two years later the research is still saying a lower dose is better as it doesn't carry the risk of hyperstimulation and is just as effective. Clinically, I must say I haven't seen the problems I had expected and it has proven to be much more effective than any other methods tried. One big advantage is the intermittent monitoring so women can be out of bed, walk, enjoy the tub, etc. Because it is so cheap and easily obtainable I worry that it may be used out of the hospital. A friend of mine was given a few doses of Cytotec to be used for a clinic birth, suffered hyperstimulation, and the baby was born with a 0 Apgar, severely brain damaged and is unlikely to survive for long. Use EXTREME caution when using Cytotec!
- Valerie G., RNC, CD
I am a CNM in an out-of-hospital (OOH) birth practice and I will admit to using Cytotec RARELY in the past few years. I am very well informed about the risk and benefits of Cytotec and that I can appropriately offer it to a RARE client for whom indications exist for getting labor going. I tend to resent the attitude of midwife purists who believe that, as an OOH birth midwife, I should only be catching babies that fall into my hands out of the lowest-risk moms--no interventions allowed. The idea, apparently, is that if a client is high enough risk to need Cytotec induction, she is too high risk for an OOH birth anyway.
This might be true in some cases and we OOH midwives need to remain sensible with our risk assessment, but there are certainly other cases in which the woman's risk is low, but clearly increasing with time. If we sit on our hands and wait indefinitely for labor, her risk continues to increase and she may well find herself in an interventive hospital birth situation, whereas if we push her into labor now, she will deliver OOH as a low-risk person.
Case in point: a 29-year-old motivated healthy G3P2 with a history of PIH in her first pregnancy (induced in the hospital at 42+ weeks), no PIH with second pregnancy (fast and easy homebirth at 42 weeks), developing PIH in the current pregnancy. She is extremely desirous of another homebirth, very adverse to hospital birth. Motivated and healthy, she eats a high-protein diet, rests on her left side at prescribed intervals, takes her cal/mag supplement, monitors her BP at home in-between visits. She does everything she can do to remain low-risk, but her BP is clearly climbing, from 112/72 in mid-pregnancy to 130/80 at 32 weeks to 140/84 at 36 weeks to 142/90 at 39 weeks to 150/92 at 40 weeks. She has no swelling or excessive weight gain, DTRs are WNL, her cervix is 3 cm, EFW is 8-1/2 pounds. Her history of two previous 42 week pregnancies would suggest that this kid probably planning to come out soon, but her BP is not one that you'd want to watch rising for another 2 weeks. She doesn't have fulminating preeclampsia, obviously, but her risk is clearly increasing with her BP.
She tries herbs, homeopathics, nipple stim, lovemaking, etc., and finally, after a long discussion of risks and benefits (and signing a consent form), we bring her into labor slowly with two small doses of Cytotec. Her healthy baby boy (8lbs 6 oz) is born easily at home that evening. Was it inappropriate to use the Cytotec in this case? I'm a nurse practitioner with prescriptive privileges, so it is within my professional authority to prescribe. It's legal, but is it good midwifery? Should I have allowed her to become more hypertensive, leading to increased risk for her and her baby and possibly an interventive hospital birth? Not in my mind.
If Cytotec is becoming the candy of the OOH birth midwife as people are reporting, we're in big trouble because women are going to get hurt (and midwifery will get hurt as well). But we don't need to throw the baby out with the bathwater. Clear indications for induction, extensive informed consent, extremely cautious dosing (max of two widely-spaced tiny doses in any day), and careful OOH monitoring need to be a part of any appropriate use of Cytotec OOH.
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Cytotec can be very useful in midwifery but it needs to be used with prudence. There doesn't seem to be common ground on what the dosage should be. Because it was never meant to be used on pregnant women, safe dosages have not been established. From my experience, you need very little--17-20 micrograms to start. It can be smeared on the cervix in situations where the woman has spontaneous PROM, she is postdates with a very large baby, or is exhibiting other signs of needing to have her baby.
Cytotec works differently on different women. Some need very little in their system, while others need several doses. Never administer more than 50 micrograms at a time, and that as a general rule is too much. Just because a woman is obese does not justify a large dose; her cervix is still the same size. Contractions are very fast and close together without giving the baby or mom a chance to recover. Generally, I would say 89 percent of babies birthed with Cytotec induction suffer some degree of respiratory distress. Another side effect is that moms bleed, if not a major hemorrhage, the cervix will bleed because it has had to dilate so fast. I've seen Cytotec erase swollen anterior cervical lips.
Most midwives will not be comfortable using Cytotec because there is so much we do not know or understand about it and it was never designated for obstetrical use. However, I feel if it is used with prudence, it can be a very valuable tool in our birth bag. I believe that in the hospitals Cytotec is being used too frequently and at too high a dose. Its use with VBACS is totally contraindicated. We must remember that it cannot be turned off, up or down like Pitocin. Once it gets into the system, it takes several hours to clear out. As midwives we need to learn patience and watch and wait. Cytotec should never be used for our own convenience, or to induce a woman who is tired of being pregnant. It should be saved for rare situations, and treated with the utmost respect.
- Cathy O'Bryant, CPM
With recent articles in several midwifery publications regarding the risks associated with the use of Cytotec for inducing labor, and reports that Cytotec is the induction agent of choice in many hospitals, readers may be interested in this memo. The manufacturer is finally taking a stand on the off-label use of this drug.
- Susan Hodges
IMPORTANT DRUG WARNING CONCERNING UNAPPROVED USE OF INTRAVAGINAL OR ORAL MISOPROSTOL IN PREGNANT WOMEN FOR INDUCTION OF LABOR OR ABORTION
Dear Health Care Provider:
The uterotonic effect of Cytotec is an inherent property of prostaglandin E1(PGE1), of which Cytotec is stable, orally active, synthetic analog. Searle has become aware of some instances where Cytotec, outside of its approved indication, was used as a cervical ripening agent prior to termination of pregnancy, or for induction of labor, in spite of the specific contraindications to its use during pregnancy.
Serious adverse events reported following off-label use of Cytotec in pregnant women include maternal or fetal death; uterine hyperstimulation, rupture or perforation requiring uterine surgical repair, hysterectomy orsalpingo-oophorectomy; amniotic fluid embolism; severe vaginal bleeding, retained placenta, shock, fetal bradycardia and pelvic pain.
Searle has not conducted research concerning the use of Cytotec for cervical ripening prior to termination of pregnancy or for induction of labor, nor does Searle intend to study or support these uses. Therefore, Searle is unable to provide complete risk information for Cytotec when it is used for such purposes. In addition to the known and unknown acute risks to the mother and fetus, the effect of Cytotec on the later growth, development and functional maturation of the child when Cytotec is used for induction of labor or cervical ripening has not been established.
Searle promotes the use of Cytotec only for its approved indication. Please read the enclosed updated complete Prescribing Information for Cytotec. Further information may be obtained by calling 1-800-323-4204.
Michael Cullen, MD
5) Check It Out!
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6) Midwifery Today's Online Forum
"I want to start a movement that asks state legislatures and the federal government to mandate that insurance companies pay for homebirth. If they can make insurance companies pay for birth control which is considered a "reproductive right," then homebirth should also be a reproductive right.
Besides, it will save the insurance companies money for every homebirth. Do you think this could happen?"
To respond: Go to: www.midwiferytoday.com/forums. Click on "Legal Battles and Birth Politics."
7) Question of the Week
Is perineal massage necessary? Does it help or hinder tearing? I have been trained to do perineal massage and it seems to me that all it does is make the tissues edematous. I'm beginning to think that hot compresses and oil as well as positioning may be enough.
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8) Question of the Week Responses
Q: A friend recently had a late miscarriage (18 wks) due to a partial septum in her uterus. She is now considering surgery to remove the septum, and wonders whether the risks/complications and success rate of such surgery would make it a better choice than simply continuing to try to carry a foetus to term (she realizes she may have to endure many miscarriages if she chooses the latter). Does anyone have any experience with this kind of surgery?
- Jennifer Landels, BA, CBE
A: I had a uterine septum. My first pregnancy ended at 35 weeks with a vaginal breech birth. My second pregnancy went to 31 weeks (following 3 days of tocolytics in hospital), c-section for footling breech, and the baby (now 8 yrs old and strong as a horse) spent 3 1/2 weeks in the NICU. I had outpatient hysteroscopic septaplasty (laparoscopically assisted, and under general anesthesia) in anticipation of my third pregnancy, conceived after waiting three normal menstrual cycles for healing (was given estrogen to take after the surgery for a couple weeks to facilitate this process), and went to 38 1/2 weeks. Ultrasound during that pregnancy could still "see" vestiges of the septal remains. We had a lovely vertex homebirth! The baby didn't commit to being head down until 36 weeks. Now I am 30 weeks along with a TWIN pregnancy! Ultrasound shows no sign of the septum, and the babies both change presentation on a daily basis. So, based on my personal experience, I can say that depending on the results of your hysterosalpingogram, the results are DEFINITELY worth it! In my case the septum was not vascular tissue, so there is no intrauterine scarring from the procedure. The defect was not palpable externally, and I never knew about it until I was well into my first pregnancy when I was 27 years old.
I will note that with our homebirth we had a 65 minute (but otherwise uncomplicated) third stage, and the placenta had been implanted along the former septal site, which was still apparently non-vascular, as that area of the placenta was composed of cartilaginous-type tissue and no vascular area.
- Jennifer Seymour, CNM
9) Question of the Quarter for Midwifery Today magazine
Who is in your birth community? What does the concept "birth community" mean to you? How have you or how would you go about organizing one? Send us your favorite story about your birth community.
Please submit your response by September 15, 2000 to:
10) For Coming E-News Themes
1. Choose a favorite herb or two from your birth bag and share a use
or two. Be specific about amounts, dosages, frequency, duration. Or
tell a brief story as an example of its effectiveness!
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More on rhogam [Issue 2:35]:
Iserve a large Amish community. One of my clients is an only and oldest child, an extreme rarity in the Amish community. Her mother and father buried six children due to Rh sensitization. Their oldest daughter, Rosie, was born on the eve of the availability of Rhogam in the 60s. I have listened for many hours to stories about the other babies, and the lengths that Rosie's mom went to, to ensure living children. She traveled to the tertiary care children's hospital, had many many amniocentesis, and would tell me how black the fluid was, how the doctors would shake their heads, and how she knew yet another baby was to die, either in utero or shortly after birth.
I can't imagine how hard it was for Rosie to grow up under the umbrella of all that grief, yearning, and dashed hopes. It is hard to be an only child in the Amish community because most socialization is done with sisters. Most Amish women do not have close female friends the way their non-Amish counterparts do. She lives with her mother and father, husband and her children, and is isolated and lonely. She has no one except her very immediate family to share her concerns, joys, and fears.
Her mother seems to be chronically depressed, and is on medication. Rosie underwent very serious depression during her last birth with me, barely able to get out of bed, and ended up on Prozac before the baby was born.
Most of my Amish clients ask for 28 week rhogam because they have received it from the doctors in previous pregnancies. Most of them know the risks of sensitization and do not want to take any chances. There are many genetic diseases in the Amish community that cannot be prevented, but this condition can be prevented and they are very willing to pay the price for the rhogam shot, and I am very willing to come to their homes and give it to them.
Most of my clients know most Rhogam is probably unnecessary, but the price is extreme if sensitization occur, and it is not one I am willing to pay or to suggest to my clients.
- Jennifer Williams, CPM
I am negative and have had Rhogam or anti-D after four births. I don't like having it but I did "just in case." I have since found out that a test within the first 48 hours after a birth shows if there is any transfer of baby's blood across. This would save having Rhogam if there is no blood transfer and also give women time to have it if there is.
I have found that postpartum depression (PPD) is almost always related to low thyroid function after a birth. All the hormone levels take a dip after birth and then most come back up to a non-pregnant normal state. But the thyroid often stays depressed. If asked, women with PPD often admit to additional symptoms of dry skin, brittle hair, chocolate cravings, poor night vision, inability to loose weight after birth, fuzzy thinking, and tiredness as well as the depression.
I often find that giving Thytrophin PMG and Iodomere from Standard Process Labs is sufficient to pull them out of postpartum depression. I prefer to stay away from straight kelp at that point because it can flavor the milk and turn baby away from nursing. The Thytrophin PMG helps induce the thyroid to work normally again. Sometimes I end up sending women to an endocrinologist for thyroid balancing. We have a local one who has actually done research on the connection between postpartum depression and low thyroid. Many of them do not understand the connection. If women go to a GP, he will often only check the simple thyroid hormone level and it will be low normal, so they do not check further. You need to run all the thyroid tests to find the problem. Most GPs will simply put the mother on an antidepressant for years to come. To me that is tragic.
- J. Jones, CPM
I would be very grateful for any advice, tips etc. of how to come to some peace over a disappointing birth. I have some ideas myself, but would be grateful for more! This is not sadness over things that had to change for the health of the baby, but things that were and were not done which were on my birth plan and were pre-agreed, and could easily have been done without upset or hindrance to the birth, the baby or myelf.
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