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Making an informed choice: Cytotec[R] for induction.

Editor's Note: On November 30, 2004, Cytotec[R] was featured on the CBS Evening News with Dan Rather. The short piece focused on a family who had a four-year-old daughter whose birth was induced using Cytotec[R]. The mother experienced a uterine rupture and the little girl has cerebral palsy and mental retardation as a result. Several physicians were interviewed, including Marsden Wagner. The family was angry that they had not been informed that there were any risks associated with using Cytotec[R] for induction and CBS did a good job bringing out the issue of informed consent.

The practice of inducing labor has been a part of obstetrics in industrialized nations for generations. With the medicalization of childbirth came the standard of artificially initiating labor by the forty-second week of pregnancy if labor had not begun on its own by that time. Within the past decade, patience seems to have waned, potential risks of prolonging pregnancy beyond the 41st week have been studied, and women are now encouraged more frequently to induce labor by the 41st week of pregnancy (or earlier) if they have not already birthed their baby.

Up until the mid 1990s, the medications most commonly used to ripen a woman's cervix, thereby enabling the cervix to dilate more effectively with contractions, were Prepidil[R] and Cervidil[R], both category C (not proven safe or unsafe for pregnancy) prostaglandin E2 gels. Both of these prostaglandin gels have been used with varied success.

Over the past decade, a different prostaglandin has become more widely used to ripen a woman's cervix and to initiate labor. Misoprostol, more commonly known as Cytotec[R], has become the drug of choice in many medical centers across the nation and around the world.

Cytotec[R] is a category X (contraindicated for pregnancy) El prostaglandin in tablet form that can be administered orally or vaginally for the induction of labor. It was originally developed for the prevention of nonsteroidal anti-inflammatory drug (NSAID)- associated gastritis and is not FDA approved for labor induction.

Physicians frequently prescribe drugs for indications other than those on the product label. Reasons for such off-label use during pregnancy include: inhibition of premature labor, reduction of fetal or neonatal infection, reduction in development of pre-eclampsia and its complications, and ripening of the cervix or induction of labor. A physician has a legal right to prescribe for off-label indications despite regulatory, manufacturer, and cost constraints. Such prescribing habits would not be considered experimental if based on sound scientific evidence. Adequate and well-controlled studies are difficult to perform during pregnancy. Evidence of widespread use and support from other qualified clinicians are methods of justifying off-label prescribing. Each patient is entitled to know why she and her fetus would benefit from the treatment and whether any unnecessary risk is anticipated. Legible documentation of these discussions in the medical record is important. Reference: Rayburn WF. A physician's prerogative to prescribe drugs for off-label use during pregnancy. Obstetrics and Gynecology 1993;81:1052-1055.

The appeal of Cytotec[R] within the medical community is multifold: It is known to have a greater success rate in initiating spontaneous labor (84.5% vs. 41.8% of other labor inducing techniques); it is more likely to lead to a vaginal delivery within 24 hours (70% vs. 50%); it results in fewer Cesarean deliveries (15.6% vs. 21.5%); it is less likely to require the additional use of Pitocin (35% vs. 62%); it is more rapidly absorbed, has a shorter induction to birth time frame as opposed to E2 Prostaglandins, and is likely to resolve postpartum hemorrhage more quickly. It is also significantly less expensive than alternative induction methods, costing cents per dose as opposed to the hundreds of dollars associated with the cost of PGE2 preparations and Pitocin. That, in and of itself, has had a significant impact in the wide spread use of Cytotec[R] in this country, around the world and, in particular, third world countries.

Along with much positive feedback comes stories of poor outcomes and words of caution, both from members of the medical community, families who have experienced poor maternal and fetal outcomes as a result of the use of Cytotec[R], and from the drug manufacturing company (Searle) itself. The majority of information that is available regarding the benefits and risks of Cytotec[R] is anecdotal and not study-based. The study-based information examines such small sample sizes that the results cannot be deemed statistically significant. Nonetheless, the information is important and worth examining.

Looking at the evidence that we currently have, there are numerous concerns with the use of Cytotec[R] for labor induction. Many issues are known to be dose related: the higher the dose and the more frequent the administration, the more likely these adverse events are to occur. When Cytotec[R] is used, there is an increase in the rate of uterine rupture for women who have had prior uterine surgery as well as for women who have never had uterine surgery. There is an increase in uterine hyper stimulation (when there is no or limited relaxation of the uterine muscles): 5.6% vs. 3.1%. There is an increase in the incidence of tachysystole (having more than 6 contractions in a 10 minute time frame): 22.8% vs. 10.3%. Interestingly, this is generally considered to be acceptable with the absence of fetal distress. The use of Cytotec[R] in labor is associated with the increased risk of amniotic fluid embolism (AFE), which is now the leading cause of maternal death in the United States. It is associated with an increase in meconium aspiration, fetal bradycardia, operative deliveries and possibly an increase in NICU admission.

Searle was concerned over the possibility of legal repercussions from poor outcomes resulting from the use of Cytotec[R] in pregnancy. They issued a letter to all health care providers reminding them that Cytotec[R] had not been approved for use in pregnant women or for labor induction, and to issue a warning of possible negative outcomes associated with its use.

Searle reported that the following serious adverse events were reported following off-label use of Cytotec[R] in pregnant women: maternal or fetal death; uterine hyperstimulation, rupture or perforation requiring uterine surgical repair, hysterectomy or salpingooophorectomy; amniotic fluid embolism; severe vaginal bleeding, retained placenta, shock, fetal bradycardia and pelvic pain.

Searle has not conducted research concerning the use of Cytotec[R] 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[R] when it is used for such purposes.

Searle included in the packaging information a clear illustration of the contraindication of the use of Cytotec[R] in pregnant women. The obstetrical community initially responded by limiting or eliminating the use of Cytotec[R] for labor induction out of concern for legal ramifications. The desire to use Cytotec[R], however, remained. Ultimately, with enough pressure from the obstetrical community, ACOG (American College of OB/GYN--the governing board of obstetricians and gynecologists) issued a position statement supporting the off-label use of Cytotec[R] for the induction of labor. In May of 2002, the FDA approved changes to the Cytotec[R] insert which recognizes the off-label use of the medication in obstetrics and provides the necessary safety information.

One of the greatest challenges to the consumer is accessing evidence-based unbiased information regarding Cytotec[R] that would enable the consumer to make an informed choice. The cost and time benefits that Cytotec[R] provides are hard to ignore, especially in this day and age when health care costs are sky rocketing and time available for patient care is at a minimum.

But the risks are real and can occasionally be catastrophic. There are a number of clear contraindications to a Cytotec[R] induction which include previous uterine surgery, placenta previa, a prolapsed cord, a transverse lie, an active herpes outbreak, and more than 12 contractions per hour. Relative contraindications include abnormal fetal heart rate patterns, maternal heart disease, multiple gestation, evidence of cephalopelvic disproportion, and a breech position. Other issues worth considering are severe maternal hypertension, polyhydraminos, chorioamnionitis, copious vaginal bleeding and a baby that has not entered the pelvis (-3 station or higher).

There are other options for induction, both natural and medical. In the spirit of informed choice, a woman and her family should be educated about any and all methods that are considered to be safe for her and her unborn child with clear information about all benefits and risks. Natural methods worth exploring are sexual intercourse, bowel stimulation, nipple stimulation, walking, acupuncture, herbal and homeopathic remedies, hypnosis and visualization. Other methods which require the involvement of a medical care giver include the stripping of membranes, mechanical dilation (cervical balloon catheter, for example), and artificial rupture of membranes (amniotomy). Pharmacologic methods include prostaglandin administration (including misoprostol) and Pitocin.

While considering the information regarding labor induction options, an essential question to think about is whether or not an induction of labor is medically necessary and would benefit the health and well being of the mother and/or her unborn baby. As expectant women and their families are pressured into considering a medical induction, the discussion often centers around medication and procedure options, weighing out the benefits and risks of each option. What we frequently fail to consider is the option of time and patience. Trusting that the woman's body will know when to labor and birth the baby that it has nourished and nurtured for the duration of the pregnancy, in the absence of evidence indicating maternal or fetal compromise, is a viable and valuable consideration and one that the medical community has an obligation to support.

References:

Chalmers C. Speech titled: Update on Induction--Current Trends in Misoprostol (Cytotec[R]) Use. Partners in Perinatal Health Conference: 2004

Cullen M (medical director for Searle pharmaceutical company): Letter of warning concerning use of misoprostol (Cytotec[R]) for labor induction. August 23, 2000

Gaskin I. Cytotec: Dangerous Experiment or Panacea? Salon.com 2000

Shetty A, Martin R, Danielian P, Templeton, A. A Comparison of Two Dosage Regimens of Oral Misoprostol for labor Induction at Term. Acta Obstetrica et Gynecologica Scandinavica. 2002; 81(4):337-342

Wagner M. Adverse Events Following Misoprostol Induction of Labor. Midwifery Today 2004; 71:9-12

Wilson C. The Nurse's Role in Misoprostol Induction: The Proposed Protocol. JOGNN 2000; V29N6:574-583

Randi Bigelow is a certified childbirth educator and professional labor assistant/doula who has been working with and supporting families in the greater Boston area for the past decade. She teaches independently and in hospital settings, and offers labor support to families birthing in hospitals, birth centers and at home. Randi lives in Dedham win her husband and two children.
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Title Annotation:Pregnancy and Birth
Author:Bigelow, Randi
Publication:Special Delivery
Geographic Code:1USA
Date:Dec 22, 2004
Words:1799
Previous Article:CDC releases preliminary birth data for 2003.
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