Running head: EFFECTS OF INDUCING LABOR WITH CYTOTEC
Effects of Inducing Labor with Cytotec
Jennifer Housel
Ferris State University
ENGL 321
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Abstract
Many patients have their labor induced with Cytotec in the Birth Center at Lapeer McLaren
Region Hospital, but few of them question the risks of the medication. A background of the
ongoing debate regarding the safety of the use of Cytotec in pregnant women is provided. The
research design for this inquiry paper included a questionnaire for birth center nurses and a
literature search. Primary research in this paper includes the surveying of 18 nurses using a
questionnaire interviews with seven nurses. In addition, multiple articles on this topic were
gathered in a literature search to use in comparison to the interviewees’ opinions. Disadvantages
and advantages of inducing labor with Cytotec have been explored. After considering the issue
of Cytotec for the induction of labor, new questions regarding the necessity of induction itself
arouse.
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Effects of Inducing Labor with Cytotec
I work as a labor and delivery nurse in the Birth Center at Lapeer McLaren Region
Hospital. Since being hired six months ago, I have induced multiple patients into labor under the
orders of a physician. The way that patients are induced at the Birth Center is with a vaginally
inserted medication called Cytotec. I had never questioned the safety of the medication until I
recently watched the documentary, “More Business of Being Born”. In the film Rikki Lake
interviews Ina May Gaskin on maternal mortality related to the use of Cytotec. Ina May Gaskin,
a leading home-birth midwife and prominent national and international speaker on maternity
care, described the risks of inducing labor with Cytotec. “Maternal deaths must be reviewed to
make motherhood safer” (Gaskin, 2008). This documentary made me interested about the
potential risks of the medication.
It is important for me to know as much as possible about this topic so that I can be
confident in my profession. Part of my responsibility as a nurse is to educate patients on
procedures, medications, and treatments. Therefore, it is also important for the patients that I am
informed about the medications they are receiving. If a patient asks me about the potential
adverse effects of a medication, it is my job to provide them with an unbiased and educated
answer. I have researched the effects of inducing labor with Cytotec.
During my time of employment at the Birth Center, I have used two different types of
medications to induce a patient’s labor. The two medications are Cytotec and Pitocin. Both
medications have received their fair share of negative attention, especially Cytotec. During my
research for this study I was shocked at the extreme amount of negativity towards the medication
Cytotec. This is the medication that I routinely give my patients to induce labor. How could I
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have not heard about the potentially deadly side effects before? Surely doctors would not be
ordering medications that were unsafe, would they?
For this paper, the advantages and disadvantages of inducing labor with Cytotec have
been explored. Over a period of five weeks, personal interviews with multiple labor and delivery
nurses in the Birth Center Department at McLaren Lapeer Hospital were conducted. These
interviews were based on a questionnaire made up of seven open-ended questions (see Appendix
A).
The advantages and disadvantages of inducing labor with Cytotec as well as the
precautions that must be taken for patient safety to be ensured will be described in this paper.
Questions regarding the safety of inducing labor could be answered using the information gained
from the surveyed nurses. Providing patient education on medications and procedures is one
possible solution to the public fear of being induced.
Background
Inducing labor is becoming increasingly more popular. Therefore, it is not a surprise that
new and different ways of induction are being used. Some methods of induction are more
natural, while others are based on medical interventions. The trending medication for induction
at the moment is Cytotec. Cytotec is the brand name for the medication, misoprostol. “Cytotec
is synthetic protaglandin E1 analogue that was designed for the prevention and treatment of
peptic ulcer associated with the use of nonsteroidal anti-inflammatory drugs” (Moore, 2002).
While the FDA has approved Cytotec to prevent aspirin-induced gastric ulcers, in obstetrics it is
administered for induction of labor. Around 1990 obstetricians found that Cytotec is also helpful
in inducing labor contractions (Scaer, 2001). The Food and Drug Administration has not
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approved this use of the medication. Nevertheless, Cytotec is widely used in the United States
and throughout the world for induction of labor.
The goal of inducing labor is to achieve delivery vaginally by stimulating uterine
contractions before the spontaneous onset of labor. Generally, induction of labor has merit as a
therapeutic option when the benefits of expeditious delivery outweigh the risks of continuing the
pregnancy. The amount of Cytotec used vaginally for induction of labor is different than what is
used orally to treat ulcers. The recommended adult oral dose of Cytotec for ulcer prevention is
800 mcg per day in four divided doses.
At my present place of employment, 25 mcg of Cytotec is used as the initial dose for
cervical ripening and the frequency of administration is never more than every 6 hours. Cervical
ripening is the process of affecting the physical softening and dispensability of the cervix in
preparation for labor and birth. The FDA supports off-label use of approved medications as long
as it is based on sound medical evidence. The American College of Obstetricians and
Gynecologists (ACOG) has a published statement regarding the use of Cytotec for induction of
labor. The physicians that order the medication for induction of labor are following the advice of
ACOG.
ACOG is the nation’s leading group of physicians providing health care for women and
“strongly advocates for quality health care for women, maintains the highest standards of clinical
practice and continuing education of its members, promotes patient education, and increases
awareness among its members and the public of the changing issues facing women’s health care”
(2013). The ACOG Committee on Obstetric Practice reaffirms that Cytotec is a safe and
effective agent for cervical ripening and labor induction when used appropriately [emphasis
added] (Scaer, 2001).
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Research Design
In the Birth Center Department a sample of seven registered nurses were questioned
about their experience regarding the effects of inducing labor with Cytotec. The years of nursing
experience ranged from one to 33 years of labor and delivery nursing experience (see Appendix
C, Table C1). Based on a questionnaire that had been previously distributed to them via intra-
department mail, the nurses were individually interviewed. Seven open-ended questions
regarding their professional experience with inducing labor and the medication Cytotec were
asked on the questionnaire (see Appendix A). The nurses all had similar experiences and
opinions regarding medication safety based on the results (see Appendix B). In order to compare
the interviewees’ opinions with those of the general medical profession, a literature search was
conducted.
Primary Research
Using intra-department mail the questionnaires were distributed, and then a personal
interview was conducted on the phone. The survey included an attached memo that described
the rationale for the questionnaire and the purpose of the research study; the questionnaire was
attached to the memo. The 7 interviewed nurses agreed to respond truthfully and expressed their
interest in contributing. Nurses in the Birth Center Department have had similar experiences as
far as inducing labor is concerned, according to the results. All 18 nurses surveyed have used
Cytotec countless times on patients under the orders of a physician.
Literature Search
Using the database CINAHAL, a literature search exploring perceived or real risks
existing for patients being induced with Cytotec was conducted. The key words Cytotec,
misoprostol, pregnancy, labor, induction, drug effects, tachysystole, and uterine rupture were
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used. The articles selected were empirically based and examined perception of medication safety
in addition to being peer-reviewed. From published and credible sources, five relevant and
useful articles were found. Since Cytotec remains unapproved by the FDA for induction of
labor, the search did not exclude older articles in favor of more current articles. Furthermore,
medication safety remains a consistent theme in nursing practice.
Observations and Analysis
The present safety in inducing labor with Cytotec is documented in the primary research
findings. Jennifer Dohm discloses, “When I induce a patient, I follow hospital and department
protocol for monitoring the patient’s uterine contractions and the baby’s heart rate” (personal
communication, October 19, 2013). The statement provides insight into the nurses’ compliance
with monitoring guidelines for induction patients. Barbra Wager emphasized the importance of
reporting contraction patterns in a timely manner to the physician (personal communication,
November 9, 2011).
From the literature review similar results were yielded. Various ways that a patient is
monitored before and during induction of labor have been described. The patient’s uterine
contractions are monitored either externally with a Tocodynamometer (TOCO) or internally with
an Intrauterine Pressure Catheter (IUPC). The importance of following the guidelines and
protocols set by the Association of Women’s Health, Obstetric and Neonatal Nurses
(AWHONN) by closely monitoring the force of uterine contractions was reiterated in the Journal
of Obstetric, Gynecologic, and Neonatal Nursing (JOGNN), in a published research article
(Teplick, 2012).
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Disadvantages
Every medication has side effects when the labels are read. For example, just read the
terrifying list of potential adverse effects on the side of a bottle of generic Tylenol. Serious
complications such as liver failure can be found. When the black box warming is read from the
Cytotec medication label, serious complications such as uterine rupture are listed.
“Disadvantages are uterine hyperstimulation and, in rare instances, uterine rupture and death”
(Moore, 2002). The terms hyperstimulation and hypercontractility are currently no longer used.
During her interview, Luanne Pearsall notes “it is recommended that the term tachysystole, with
or without corresponding FHR decelerations, be used instead” (personal communication,
December 1, 2013). Tachysystole is defined as more than five contractions in 10 minutes,
averaged over a 30-minute window.
Multiple cases of uterine tachysystole with corresponding FHR decelerations have been
documented. Mahlmeister commented on the legal risk involved with such adverse events:
However, the administration of prostaglandin cervical ripeners is not without risk.
Researchers have reported uterine hyperstimulation requiring tocolysis, non-reassuring
fetal heart rate (FHR) patterns, and in rare instances, serious complications, including
precipitate labor and delivery, fetal hypoxia, and even uterine rupture in women without
uterine scars. When negative outcomes occur with the use of prostaglandin ripening
agents, litigation often ensues (2005).
The real trouble is not in the court cases, but in the lives affected. In 2010, an article on labor
and delivery about a child diagnosed with cerebral palsy was published in the Legal Eagle Eye
Newsletter for the Nursing Profession. The newsletter reported that the child’s injuries were a
result of reduced oxygen due to contractions that were rapid and prolonged during the last hours
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of his mother’s labor. The labor and delivery nurses were blamed for the child’s injuries since
they failed to report the uterine tachysystole to the physician (p. 7).
Advantages
While the disadvantages for using Cytotec to induce labor are scary, the advantages must
also be considered. The nurses believe, and the literature corresponds, that Cytotec has
significantly improved the rate of successful induction. Due this improved rate of successful
inductions, Cytotec has also been shown to reduce the incidence of cesarean sections associated
with failed induction attempts (Mahlmeister, 2005). Sandra Johnson cited a belief that women
experience “shorter duration of labor” when induced using Cytotec (personal communication,
November 9, 2011).
Many people have shared their distress and anxiety over the use of medicine to induce
labor, and some have even voiced their opinion that the FDA should ban the use of Cytotec in
pregnancy. Others have contradicted this view:
The use of Cytotec to induce labor is not part of some conspiracy. Like any medication,
including oxytocin, it has a risk of complications, such as uterine hyperstimulation.
Uterine rupture of the unscarred uterus has been reported with the use of Cytotec, but has
also occurred in unaugmented labor. In my practice I have found Cytotec valuable to
reduce the likelihood of cesarean delivery. When I have to induce labor for a medical
complication such as hypertension, I have found that with the use of Cytotec I can
provide a good chance of a successful induction and vaginal delivery for a woman who,
in the past, would have been thought to have an unfavorable cervix unamenable to
induction. Of course any medication is dangerous when misused (Devitt & Goer, 2003).
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New Questions
Currently, many obstetricians frequently use Cytotec to induce labor and have had great
success doing so. Why is it necessary for so many patients to be induced? The induction rate in
the United States is increasing at an alarming rate. Mary Lou Moore inquired on this topic:
Occasions occur when medical induction is appropriate. However, some inductions are
associated with issues of convenience, either for a physician or for a mother and her
family. If an induction is considered, it is appropriate for the mother to discuss with her
physician the risks and benefits both of the induction and of the medication and dosage
that will be used (2002).
Mary Lou Moore made me think of a few other questions. Since inductions are not emergency
procedures, why are informed consents not required before the use of Cytotec? “Women should
be given should information about what is known and not known regarding methods of induction
in order to be able to participate fully in making decisions about induction of labor”
(Mozurkewich et al., 2011).
In conclusion, the best available evidence should be used when choosing methods of
labor induction. This study, along with the literature, shows that there can be real risks, as well
as benefits when using Cytotec to induce labor. Many women have been successfully induced
with Cytotec in spite of the risks. Accurate nursing assessments of mother and child increase the
overall safety of induction. Obstetricians must follow ACOG’s guidelines on conservative initial
dosing, and much can be done to educate patients on medication and dosage. Additionally,
nurses can reinforce this patient education in a childbirth education class. It is in this way that
nurses can provide information before patients consent to risky procedures.
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References
American Congress of Obstetricians and Gynecologists. (2013). Who we are. Retrieved from
http://www.acog.org/About_ACOG/Who_We_Are
Devitt, N., & Goer, H. (2003). Cytotec (misoprostol). Goer H. In the literature: "Spin doctoring"
the research. Birth 2003;30:124-9. Birth: Issues In Perinatal Care, 30(4), 285. Retrieved
from CINAHL Plus with Full Text.
Gaskin, I. M. (2008). Maternal death in the United States: A problem solved or a problem
ignored? The Journal of Perinatal Education, 17(2), 9-13. Retrieved from CINAHL Plus
with Full Text.
Labor & delivery: nurses failed to report uterine hyperstimulation. (2010). Legal Eagle Eye
Newsletter for the Nursing Profession, 18(5), 7. Retrieved from CINAHL Plus with Full
Text.
Moore, M. (2002). Research update. Misoprostol -- is more research needed?. Journal Of
Perinatal Education, 11(3), 43-47. Retrieved from CINAHL Plus with Full Text.
Mozurkewich, E., Chilimigras, J., Berman, D., Perni, U., Romero, V., King, V., & Keeton, K.
(2011). Methods of induction of labour: a systematic review. BMC Pregnancy &
Childbirth, 1184. Retrieved from CINAHL Plus with Full Text.
Scaer, R. (2001). Misoprostol (Cytotec, Searle) induction controversy. Genesis, 3. Retrieved
from CINAHL Plus with Full Text.
Teplick, F. (2012). Assessment of an Alternative Stablization Device for Electronic Fetal
Monitoring Utilizing External Ultrasound and Tocodynamometer in Labor and Delivery
Patients. JOGNN: Journal of Obstetric, Gynecologic & Neonatal Nursing, 41S140.
doi:10:1111/j.1552-6909.2012.01362
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