Press Release: FDA Alert on Cytotec
On May 16, 2005, the FDA issued an FDA Alert on the risk of Cytotec (Misoprostol) when used in labor and delivery, which states:
"This Patient Information Sheet is for pregnant women who may receive Misoprostol to soften their cervix or induce contractions to begin labor. Misoprostol is sometimes used to decrease blood loss after delivery of a baby. The FDA does not approve these uses. No company has sent the FDA scientific proof that Misoprostol is safe and effective for these uses.
"There can be rare but serious side effects, including a torn uterus (womb), when Misoprostol is used for labor and delivery. A torn uterus may result in severe bleeding, having the uterus removed (hysterectomy), and death of the mother or baby. These side effects are more likely in women who have had previous uterine surgery, a previous Cesarean delivery (C-section), or several previous births."
The FDA Alert makes it clear that 1) Cytotec should not be used for labor induction 2) BUT that, if it is to be used against this FDA recommendation every woman receiving Cytotec for induction has the right to fully informed consent which must include the risks listed in this FDA release. Failure to provide a woman with ALL the information regarding the side effects of Cytotec (Misoprostol) when used for the induction of labor denies the patient the right to give her fully informed consent and may result in serious legal exposure to those health care providers as well as needlessly jeopardizing the health of the mother and her child.
The TOFM Foundation petitioned the FDA in November 2004 to issue a more comprehensive advisory regarding the dangers of Cytotec (Misoprostol). The TOFM Foundation applauds the action of the FDA, yet there is more that must be done to alert physicians, nurses, hospitals, pharmacists and patients related to potential catastrophic outcomes that can occur when Cytotec (Misoprostol) is used for inducing labor and/or ripening the cervix.
The FDA Alert on Cytotec can be found at: http://www.fda.gov/cder/drug/infopage/misoprostol/default.htm
— Tatia Oden French Memorial Foundation http://www.tatia.org
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Research to Remember
A Texas Tech University Institute of Environmental and Human Health study of breastmilk from 36 women in 18 states has concluded that perchlorate, a toxic component of rocket fuel, most likely contaminates breastmilk in "virtually all" women. An average concentration of 10.5 micrograms per liter was found in the samples. Health experts say infants and fetuses are the most vulnerable to the chemical's effects. Perchlorate blocks iodide and inhibits thyroid hormones, which are necessary for normal brain development and cellular growth of a fetus or infant. Impaired thyroid development may preclude neurological defects and attendant learning disabilities. Members of the research team recommend that pregnant and nursing women block the effects of the substance by taking iodine supplements.
— Environmental Science and Technology, February 2005
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Physiology of Pushing
Reviewing the basic physiological facts about the body's miraculous birthing mechanisms is an excellent first step in rebuilding our trust in second stage.
The Uterine Muscle: Sensations from the uterus during labor are communicated on two pathways to the brain. Visceral (organ) pain is carried by the hypogastric nerves, which are part of the sympathetic nervous system. One theory is that the source of pain impulses carried on these nerves, such as cramping with menstruation and labor pains, is the result of hypoxia in the muscle itself when blood vessels are compressed. This is similar to angina in a heart muscle. The second pathway involves sensations carried on nerves located directly on the surface of the uterine muscle, broad ligaments, fallopian tubes and so on. These nerves communicate to the central nervous system in the spinal cord at T-11 through L-1 and after translate into referred pains in the lower back and/or sides. It is in first stage in particular that these two types of pain seem to dominate.
The Cervix: Specialized nerve endings called "stretch receptors" are located throughout the body to communicate changes in tone, volume and tension. The stretch receptors located in the lower uterine segment and cervix probably account for the complex variety of sensations that accompany the end of first stage. These messages are carried by the somatic nerves which, in effect, become "louder" than the earlier sensations of the hypogastric nerves as the presenting part stretches the cervix to its greatest capacity just before "slipping through" into the birth canal. This stretching also causes the pituitary gland to release more oxytocin, leading to the long duration and close frequency of contractions at the end of first stage.
The Resting Phase: It is at the nexus between first and second stages that the phenomenon known as the "resting phase" can occur. Once the presenting part has passed through the cervix and into the birth canal, the uterine muscle may require a period of readjustment to the decreased volume within its walls. This requires the muscle fibers of the upper uterine segment to shorten and thicken even further (a process which has been occurring slowly all during first stage). Not until this process of "taking up the slack" has been completed will the positive feedback loop of contraction-descent-stretch-increased oxytocin-more contractions resume. Also called the "latent phase," this period may involve a decrease in both the timing and intensity of contractions during which the mother may rest or even sleep. This phase has been estimated to last about 10 to 20 minutes. However, empirical evidence among midwives includes descriptions of women resting/sleeping as much as two hours or more, waking with an active pushing urge and delivering their babies soon after.
The Birth Canal: Critical to moving from the latent phase into an active phase of pushing is the position of the baby within the birth canal. Unless there is direct contact with the pelvic floor, there may be little or no maternal urge felt. Studies have found no significant difference in speed of delivery when mothers are made to push at this time versus waiting for the urges of the active phase. What has been found is an increase in strain and damage to the muscles of the vagina and perineum and the uterine support ligaments.
The Contractions of Second Stage: After the resting phase, should one occur, contractions will again increase in intensity, frequency and duration. During this period uterine contractions have two distinct qualities. First, there is the contraction itself that occurs as a rise in uterine muscle tone to a peak, which then declines to a resting state. This bell-shaped contraction results in intrauterine pressures of 70 to 80 mm/Hg at its peak. Superimposed on these, and unique to second stage, are a series of additional surges lasting about five to seven seconds each and occurring three to five times within each contraction. During the surge an additional 70 to 80 mm/Hg of pressure is added. Compare this potential for pressures of 140 to 160 mm/Hg in second stage to the average of 40 to 60 mm/Hg total in first stage contractions and a resting tonus of 8 to 12 mm/Hg between contractions. It is presumed these surges reflect the addition of abdominal muscle contractions bearing down on the uterus.
Stretch Receptors and the Urge to Push: Stretch receptors again play an important role as the baby's presenting part moves into the birth canal. Receptors in the wall of the vagina, the rectum, and ultimately, the perineum communicate the pressure of the baby's presence, especially during these surges. It may be that a combination of the uterine surges, increased abdominal pressure and activation of these sensors translates into the "overwhelming urge to push" described by many women.
The "dance" of these various stretch receptors may account for those rare instances when women report no urge to push. Most often, these situations are more likely due to a failure to recognize that the mother is in the resting phase and will eventually feel the urge if empowered to trust her body and wait. However, it is also conceivable that in some women, these stretch receptors may be "turned down." We know that repeated ignoring of messages from the bladder, which communicates our need to urinate by way of stretch receptors, results in diminished signals; that is, if we don't empty our bladder when our body tells us, it eventually stops telling us. It may be possible that in some mothers, prior history or simply the anatomical changes of pregnancy in the vaginal and rectal area could result in this "turning down" phenomenon.
Vaginal Wall Involvement: Most birth practitioners have a clear image of the disadvantages of active pushing before the presenting part has cleared the cervix. The possibility of cervical edema or tearing or damage to the transverse cervical ligament is obviously to be avoided. Once second stage has started, there is a parallel issue to be considered involving the anterior wall of the vagina. The baby's downward movement during second stage can cause an anterior vaginal fold to descend in front of the presenting part. This can produce a shearing action that may result in damage to the bladder fascia with potential complications such as incontinence and bladder prolapse. It appears that the normal mechanism that can prevent this occurs at the start of the contractions, before the surges are felt. The musculature of the vagina, along with that of the uterus, draws up and tightens the lining of the birth canal, or vaginal mucosa. This provides a taut surface against which the baby may slide downward. When women are told to push immediately at the onset of their contractions, this important pulling up of the vaginal wall may be prevented, leading to possible damage and actually slowing progress in the descent.
Maternal and Fetal Oxygenation: Finally, there is the critical consideration of oxygen delivery to mother and baby during second stage. When the bearing-down effort involves breath-holding and closing the glottis, also called Valsalva's maneuver, the result is an increase in the mother's intrathoracic pressure. This pressure in the chest causes a sudden drop in venous blood return to her heart, which decreases the volume of blood available to circulate to the lungs, pick up new oxygen and leave the heart (cardiac output). This leads to lowered arterial pressure, which is the force responsible for the delivery of the oxygen-bearing blood to the placenta. The baby receives less blood from the placenta, and his or her oxygen supply is thus diminished. Maternal arterial pressure decreases dramatically relevant to the length of time closed-glottis pushing continues. The effect on the infant is made more dramatic by the fact that during all this, the mother is also holding her breath and not taking in any new oxygen. Thus, the blood that actually can reach the placenta and baby may not be adequately saturated with oxygen. A final factor to take into account is that above pressures of 50 to 60 mm/Hg, uteroplacental blood flow ceases. This means that the baby will receive no new oxygen during the surges and at the peak of the overall contraction, a physiological fact they are well designed to compensate for. However, what may be more difficult to tolerate is a drop in arterial pressure and saturation as soon as the contraction starts that continues throughout and beyond the last of these natural surges. It is ironic that incidences of fetal hypoxia are cited as a major rationale for both limiting the length of second stage and for trying to hurry it up with aggressive pushing techniques.
— Mayri Sagady, excerpted from "Renewing Our Faith in Second Stage," The Second Stage Handbook, a Midwifery Today book
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Read this review now online:
I am a student midwife, and we are currently talking in class about assessment of risks for women who smoke during pregnancy. Do you accept [as clients] women who smoke or have smoked during part of their pregnancy? If they were smokers who stopped as soon as they found out they were pregnant, would you take them on? How about if they were still smoking by time they had the first prenatal visit but seemed open to quitting or cutting down?
I personally would not feel comfortable at this point accepting a woman who was still smoking at the first prenatal visit unless she really wanted help quitting and felt that quitting was really important for the health of her baby. Please share your opinions and experiences.
Share your thoughts and experience about this topic.
**Please do not send your responses to E-NEWS!**
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Question of the Week
Q: How long do you normally stay after a homebirth, and do you leave written instructions (guidelines so parents know what's normal for both mom and baby) with the couple? What things do you look for (e.g., mom urinating, baby nursing well, etc.) before you leave?
SEND YOUR RESPONSE to firstname.lastname@example.org with "Question of the Week" in the subject line. Please indicate the topic of discussion *and the E-News issue number* in the message.
Question of the Week Responses
Regarding double footling breech [Issue 7:11]:
A: Your physician is correct. At the stage that you describe, it is likely that pressure from the head is occluding blood flow through the umbilical cord. This situation will rapidly result in fetal hypoxia and poor neonatal outcomes. The appropriate management of this situation is to deliver the arms (by sweeping them forward/midline/+down across the chest of the baby; remember which way baby arms bend) and then to deliver the head by maintaining it in a *flexed* position. There are several variations of the maneuver to accomplish this task; look under the names Mauriceau-Smellie-Veit. The most important thing is to keep the fetal head flexed (do not pull the baby downward). William's Obstetrics has a nice chapter (Ch. 22) about breech delivery, with good pictures.
Most practitioners do not recommend delivery of vaginal breeches if at all avoidable because of the risks of hypoxia and neurological deficit, which approach 20% according to most research studies. However, every birth practitioner should be familiar with the maneuvers in the event that they walk into the situation you describe.
— Raquel, CNM
A: Did you deliver this baby or did you catch it? If the baby is on the way out, wouldn't the mother's body and natural process answer the question?
— Nikki Lee, RN, MS, Mother of two, IBCLC, CCE
A: The obstetrician is correct. You did the right thing. You must be a wonderful nurse to have acted so adequately. Hope the baby was well.
— Simone Valk
Regarding uterine prolapse [Issue 7:8]:
A: In Traditional Chinese Medicine terms, any type of prolapse (uterine, hemorrhoids, etc.) is due to qi deficiency in the Spleen Organ System and can be treated through herbs and acupuncture. This will help tonify the supporting muscles and the organ. Strengthening the qi will help "lift" the organ back into place. Find someone trained in Traditional Chinese Medicine, not just acupuncture, for the best all-around care.
Editor's Note: Responses to any Question of the Week may be sent to E-News at any time. Write to email@example.com. Please indicate the topic of discussion *and the E-News issue number* in the subject line or in the message.
Stillbirth after Cesarean:
Since the famous Gordon Smith article in the Lancet in 2003* that analyzed 120,000 singleton second births, it is well-known that a previous cesarean section causes an unexplained stillbirth - in the next pregnancy in 1 in 1000 pregnancies. Women are not informed of this fact when they sign the consent for cesarean section.
Since there are 1 million cesareans per year in America, all of them lacking proper informed consent, I am looking for women who are willing to join a class-action suit for damages that resulted from lack of informed consent.
Conservatively, 120,000 women have another pregnancy after the cesarean, which results in 120 unexplained stillbirths (not the result of birth defects, diabetes, high blood pressure, etc.) in America per year. Even 10 or 20 angry women with unexplained stillbirths following a cesarean will compose an impressive class-action suit.
I am hoping to interest women who have experienced stillbirth after cesarean in joining a class-action suit that will change the current trend of increasing cesareans (27.6% in 2003) or at least improve informed consent.
— Judy Slome Cohain, Certified Nurse Midwife
*Cesarean section and the risk of unexplained stillbirth in subsequent pregnancy. Lancet 2003; 362: 1779–84.
I would like to respectfully disagree with Alison Osborn's position on client education in her article "Keeping Birth Normal" [Issue 7:10]. While I understand her concern about creating fear where it is not necessary, I find that failing to fully explain each symptom and possible cause is robbing the client of the potential to take some of the responsibility for her prenatal care.
I also have a problem with Alison's statement regarding transferring during labor: "My discussion of emergencies is limited to telling my client and her partner that I'll make the decision to transport if needed. I tell them I will inform them about what is going on, I will call the hospital…"
It is attitudes such as this that have created a need for women to leave traditional medicine and empower themselves by taking charge of their bodies and their births through midwifery care. The message given by the "I will decide" statements is very similar to the mindset of traditional medicine. This is why we have so many unnecessary c-sections. The doctor "decides" that it is necessary. I am not saying that Ms. Osborn is promoting unnecessary interventions, but I feel she is underestimating the intelligence of most women by not fully educating them and giving them a role in the decision-making.
It is my opinion that women should be given *all* the information regarding possible complications, and then be allowed to decide what route is best for them. If there is a strong disagreement between the midwife and her client in the manner that a potential complication should be handled, then perhaps the two are not compatible and should part ways before the birth.
— Tina Henry, doula
I have a client whose last pregnancy was twins. She started labor at 35-1/2 weeks, so she decided to go to the hospital. The first baby was vertex and was birthed easily and beautifully within minutes of arriving to the hospital. There was no obstetrician on staff, just a resident doctor, who upon seeing the second baby coming breech, flipped out. He instructed the woman not to push and forcibly held the baby in for 18 minutes to wait for the OB. Finally, a nurse who was more experienced than the doctor told him to just let the baby come. The baby needed lengthy resuscitation and still has some effects of that apnea today at two years old.
Another client was breech at home, and we had the baby's scrotum and bottom on the perineum for hours. My mentor assured me that it was fine. The baby came in his own time with no problems. I think the moral of the story is let your moms do what they want. Pay close attention to your fetal heart rates and color. It's easy to confuse bruising with blue if the baby has been on the perineum for a while. But know that a mother, even with a breech, usually knows best how to birth her baby if we all just get out of her way.
I used netsy cups years ago when I nursed my sons. They were wonderful. Where could I find them again? I have a niece who would benefit from them.
— J. Nuttall
I am writing a book for Mosby Publishing called Prenatal Massage: A Textbook of Pregnancy, Labor and Postpartum Bodywork. Along with A & P, massage technique and so forth, the book will contain case histories. I am looking for stories about working with pregnant, laboring, postpartum women
- who are survivors of abuse
- are addicted - cigarettes, alcohol, drugs
- have a preexisting serious illness or injury
- use interesting rituals, or cultural techniques
- have interesting stories to share.
Full credit will be given in the text.
— Elaine Stillerman, LMT www.MotherMassage.Net firstname.lastname@example.org
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